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2026-10-22 13:46 3d ago
2026-10-22 07:30 3d ago
BridgeBio to Report Third Quarter 2026 Financial Results and Commercial Updates on October 29, 2026 at 4:30 pm ET
BBIO BridgeBio Pharma
FMP Stock News
Original source text
PALO ALTO, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it will release its third quarter 2026 financial results and business update after the market closes on Thursday, October 29, 2026. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day.
2026-10-16 11:55 9d ago
2026-10-16 07:30 9d ago
BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
BBIO BridgeBio Pharma
FMP Stock News
Original source text
PALO ALTO, Calif., Oct. 16, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that on October 14, 2026, the compensation committee of BridgeBio’s board of directors approved equity grants to 32 new employees in restricted stock units for an aggregate of 57,853 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2027, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates.

The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
2026-10-13 14:56 12d ago
2026-10-13 09:00 12d ago
BridgeBio: Maintaining 'Strong Buy' Additional Encaleret Data ADH1 And Three Expected FDA Reviews
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma maintains a "Strong Buy" rating, driven by robust revenue growth and multiple late-stage pipeline catalysts. The company delivered Q2 2026 net revenues of $243.7M, up from the prior year's $110.6M, outperforming despite competition. Three NDA submissions—BBP-418, oral infigratinib, and encaleret—are under Priority Review, with PDUFA dates spanning late 2026 to mid-2027.
2026-10-11 21:09 14d ago
2026-10-11 14:30 14d ago
Acoramidis Associated with Significantly Improved Clinical Outcomes Versus Tafamidis in ATTR-CM in an Independent, Real-World Study of U.S. Electronic Health Records
BBIO BridgeBio Pharma
FMP Stock News
Original source text
- In an independent, propensity score-matched analysis of 2,684 individuals living with ATTR-CM from Epic COSMOS, the largest U.S. electronic health record database, acoramidis was associated with a statistically significant 18% lower risk of a composite of death, all-cause hospitalization, new-onset atrial fibrillation, and diuretic intensification versus tafamidis (HR 0.82; 95% CI 0.73-0.93; p<0.01)

- Early separation of the composite curves was noted within one month in this contemporary cohort of patients from 2025, with consistent results across unadjusted, matched, and biomarker-adjusted analyses

- Acoramidis was associated with significant reductions in hospitalization, among the outcomes that matter most to people living with ATTR-CM, with a 27% lower risk of cardiovascular hospitalization, 27% lower risk of heart failure hospitalization, and 25% lower risk of all-cause hospitalization as compared to tafamidis (all p<0.001) 

- These findings replicate the earlier Wright et al. Komodo claims analysis published in Cardiology and Therapy, in which acoramidis was associated with a 34% reduction in clinical worsening events versus tafamidis (p=0.046), making this the second real-world comparative effectiveness analysis, and the first in electronic health records, to favor acoramidis, supporting the reproducibility of the benefit

- ATTRibute-CM data also presented at HFSA underscore the importance of hospitalization reduction: mortality risk approximately doubled after a single cardiovascular hospitalization and quadrupled after two or more, making hospitalization prevention a central treatment goal in ATTR-CM

- Together, these data have the potential to inform the use of acoramidis as the stabilizer of choice, both in newly diagnosed patients and in those on other disease-modifying agents

PALO ALTO, Calif., Oct. 11, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced that new, independent and contemporary real-world evidence as well as Phase 3 ATTRibute-CM sub-analyses of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2026 in Phoenix, Arizona. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

"In a prior real-world claims analysis, acoramidis was associated with fewer diuretic intensification events, suggesting the possibility of greater clinical stability on acoramidis, but this obviously needed to be interpreted with caution. This new, larger, electronic health record study of nearly 2,700 individuals with ATTR-CM with longer follow-up and more granular data is better able to address the question, and shows a similar signal, with a significant difference in rates of cardiovascular or heart failure hospitalizations favoring acoramidis compared to tafamidis, with approximately one quarter lower risk of events," said David Lanfear, M.D., M.S., Chief Scientific Officer, Vice President of Research at Henry Ford Health, U.S. "While electronic health record studies have well-recognized limitations, these data allow us to see how these therapies perform outside of a clinical trial, across a diverse and contemporary patient population. Moreover, there appears to be some consistency of findings across data sources and endpoints, supporting validity. Additional investigations to replicate and extend these findings are warranted."

In a retrospective analysis conducted and presented by Dr. Lanfear, individuals with ATTR-CM newly initiating acoramidis had lower rates of adverse cardiac outcomes than individuals newly initiating tafamidis. The study leveraged data from Epic COSMOS, the largest U.S. electronic health record database, with over 300 million patients. This dataset includes detailed, anonymized clinical records captured in the course of routine patient care, such as laboratory values and medication records. After matching, 910 acoramidis-treated and 1,774 tafamidis-treated individuals were included, with similar baseline characteristics across treatment groups. Key findings included:

The composite endpoint of death, all-cause hospitalization, new-onset atrial fibrillation, or diuretic intensification was significantly lower with acoramidis across all three analyses: unadjusted (HR 0.82; 95% CI 0.72-0.90; p<0.001), primary (18% lower risk; HR 0.82; 95% CI 0.73-0.93; p<0.01), and a sensitivity analysis adjusting for a combined standardized NT-proBNP and BNP variable where available (HR 0.84; 95% CI 0.72-0.97; p=0.02)Acoramidis-treated individuals had statistically significantly lower rates of hospitalization than tafamidis-treated individuals, including a 27% lower risk of cardiovascular hospitalization (HR 0.73; 95% CI 0.62-0.86; p<0.001), a 27% lower risk of heart failure hospitalization (HR 0.73; 95% CI 0.62-0.87; p<0.001), and a 25% lower risk of all-cause hospitalization (HR 0.75; 95% CI 0.64-0.88; p<0.001)Diuretic intensification, an early marker of disease progression, was 17% lower with acoramidis (HR 0.83; 95% CI 0.71-0.95; p<0.01). Diuretic intensification was defined as use of parenteral loop diuretics, initiation or dose-equivalent escalation of oral loop diuretics, or use of a thiazide-like diureticDifferences in death (HR 0.85; 95% CI 0.62-1.20; p=0.34) and new-onset atrial fibrillation (HR 0.88; 95% CI 0.68-1.13; p=0.31) numerically favored acoramidis, consistent with the composite, but did not reach statistical significance, reflecting lower event counts and limited duration of follow-up for these longer-term endpoints. These endpoints will be reassessed as the cohort maturesKaplan-Meier time-to-event curves for the composite endpoint showed early and sustained separation between treatment groups over follow-up (p=0.0014)The consistency of the treatment effect across unadjusted, matched, and biomarker-adjusted analyses and across multiple clinical outcomes supports the robustness of the observed difference These findings in electronic health record data replicate and expand on the results of the first peer-reviewed, claims-based real-world comparative effectiveness study of TTR stabilizers in ATTR-CM, in which acoramidis was associated with a 34% reduction in a composite of clinical worsening events (diuretic intensification, heart failure hospitalization, and mortality) versus tafamidis (p=0.046), supporting the reproducibility of the observed benefit across independent data sources and data types.

As with all observational studies, there are inherent limitations. Although propensity-score matching balanced patient baseline characteristics and results remained consistent across both unweighted and sensitivity analyses, the possibility of residual confounding cannot be fully excluded. Follow-up was relatively short due to recent approval of acoramidis, which limited the number of events available to assess less frequent outcomes, such as mortality. These factors would not be expected to affect one treatment group differently than the other, and the consistency of results across multiple endpoints and in multiple studies supports the robustness of the findings. As data continue to mature, additional analyses with longer follow-up periods will be shared. The full results of this analysis are currently under peer-review by a journal.

Three additional analyses presented at HFSA ASM 2026 continued to reinforce the acoramidis narrative, reaffirming the importance of reducing cardiovascular-related hospitalizations (CVH) in ATTR-CM, the differentiated cardiorenal impact of acoramidis, and the benefit of acoramidis within variant ATTR-CM patients:

Cardiovascular-related hospitalizations associated with higher risk of mortality: Association Between the Burden of CVH and All-Cause Mortality (ACM) in Transthyretin Amyloid Cardiomyopathy: Insights from ATTRibute-CM, presented by Quan Bui, M.D. of UC San Diego Health, U.S. In this post hoc analysis of ATTRibute-CM (pooled treatment groups; N=611), fewer than half of participants who experienced two or more cardiovascular-related hospitalizations were alive at 30 months. Survival fell from 86.7% in participants with no CVH events to 68.4% with one and 47.7% with two or more (log-rank p<0.0001)Mortality risk approximately doubled after a single hospitalization and quadrupled after two or more, establishing CVH burden as a marker of subsequent mortality risk and reinforcing hospitalization prevention as a clinically meaningful treatment goal in ATTR-CMAcoramidis reduced the annualized frequency of CVH by 50% through Month 30 versus placebo (p < 0.0001), with Kaplan-Meier curves for time to first CVH separating from Month 3 Unique cardiorenal impact of acoramidis: Early eGFR Dip Following Acoramidis Initiation is Associated With Reduced Risk of Mortality and Recurrent Cardiovascular-Related Hospitalizations in ATTR-CM, presented by Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S. In the ATTRibute-CM study, acoramidis-treated participants with a greater Day 28 eGFR dip following treatment initiation were associated with a significantly reduced risk of mortality or recurrent CVH versus placebo, with no clinically concerning changes observed in laboratory parameters or blood pressureThese findings provide additional context for the reported association between greater early eGFR decline and improved first CVH outcomes with acoramidis, and build upon the 42% reduction in recurrent CVH/ACM previously demonstrated with acoramidis over placebo in ATTRibute-CMThese results build upon analyses previously published in Circulation: Heart Failure; details on results can be found here Acoramidis benefit in p.Val142Ile variant patients: Acoramidis Preserves Functional Capacity and Quality of Life in p.Val142Ile Variant Transthyretin Amyloid Cardiomyopathy: Results from ATTRibute-CM, presented by Lily Stern, M.D. of Cedars-Sinai Heart Institute, U.S. In this post hoc analysis of 35 ATTRibute-CM participants with the p.Val142Ile variant (acoramidis, n = 23; placebo, n = 12), acoramidis significantly attenuated 30-month declines in heart failure-related health status and quality of life versus placebo: differences of 23.3 points in KCCQ-OS score (p = 0.005), 25.8 points in EQ VAS score (p = 0.003), and 0.26 in EQ-5D-5L index score (p = 0.018), each several-fold above published thresholds for clinically meaningful change.Decline in 6-minute walk distance was numerically smaller with acoramidis (LSM difference: 67.2 m; p = 0.136)These findings complement the previously reported 69% reduction in the risk of all-cause mortality or first cardiovascular-related hospitalization with acoramidis through Month 30 in this subgroup
In addition to the two rapid-fire oral presentations, one oral presentation, and one poster presentation highlighted, there was one additional rapid-fire oral presentation and five additional poster presentations along with four encore poster presentations shared at HFSA ASM 2026, which included:

Ratio of Serum Transthyretin to NT-proBNP is a Novel Prognostic Measure for Transthyretin Amyloid Cardiomyopathy: Insights from ATTRibute-CM, presented by James L. Januzzi, M.D. of Massachusetts General Hospital, U.S. and simultaneously published in JACC: Heart Failure
In ATTR-CM, early acoramidis-mediated sTTR increases were associated with later NT-proBNP decreases. The Day 28 sTTR to Month 12 NT-proBNP ratio, integrating early pharmacodynamic response with downstream cardiac stress, is a prognostic biomarker of clinical risk in ATTR-CM Falls and Fractures Drive Increased Hospitalizations and Costs in Patients with Transthyretin Amyloid Cardiomyopathy Compared with Controls, presented by Nitasha Sarswat, M.D. of University of Chicago, U.S. ATTR-CM was associated with increased falls and fall-related consequences, including fractures, bleeding after a fall, discontinuation of oral anticoagulant use, and related hospitalizations and costs, compared with matched heart failure (HF) and non-HF controls, consistent with substantial disease burden beyond cardiac manifestations and with higher healthcare resource utilization Evaluating the Long-Term Effects of Acoramidis on Cardiac Function, Structure, and Amyloid Burden in Transthyretin Amyloid Cardiomyopathy: ASCEND-ATTR, presented by Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S. ASCEND-ATTR will determine whether long-term transthyretin stabilization is associated with sustained improvement in myocardial structure, function, and amyloid burden. By integrating serial CMR and echocardiography, the study aims to provide mechanistic insights into cardiac remodeling during treatment and help define imaging biomarkers of therapeutic response Real-World Burden of Transthyretin Amyloid Cardiomyopathy Disease and Outcomes in Patients on Tafamidis Prior to Initiating Acoramidis, presented by Richard Wright, M.D. of Pacific Heart Institute, U.S. Nearly half of patients receiving tafamidis exhibited markers of ATTR-CM clinical worsening within the 6 months preceding acoramidis initiation. This burden appears higher than previously reported real-world disease progression rates after tafamidis initiation and warrants further study. Future research should evaluate drivers of switching therapy and outcomes after transitioning to acoramidis Acoramidis Reduces Risk of Cardiovascular-related Mortality and Hospitalization in Women with Transthyretin Amyloid Cardiomyopathy, presented by Margot Davis, M.D. of University of British Columbia, Vancouver, Canada
Among women enrolled in ATTRibute-CM, who entered the trial older and with a more advanced clinical phenotype than men, acoramidis reduced the risk of cardiovascular mortality or first cardiovascular-related hospitalization through Month 30 and attenuated the rise in NT-proBNP versus placebo. Treatment effects in women aligned with the overall population, with no significant treatment-by-sex interaction. This may represent the first reported analysis from a phase 3 ATTR-CM trial to show a nominally statistically significant treatment effect for this endpoint among women. While the small number of women enrolled limits precision, these findings support the efficacy of acoramidis in women and underscore the need for adequately powered, sex-informed evidence in ATTR-CM
Effect of Acoramidis on Heart Failure-Related Health Status Before and After Cardiovascular-Related Hospitalization: Insights from ATTRibute-CM, presented by Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S. Worsening KCCQ-OS precedes CVH and may serve as an early indicator of an adverse outcome in patients with ATTR-CM. Following a CVH event, acoramidis was associated with recovery of health status versus continued decline observed with placebo, suggesting a beneficial effect on post-CVH health status trajectory Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Additional data on the benefit of Attruby for individuals with ATTR-CM is planned for future medical meetings.

About Attruby® (acoramidis)

INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions, or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the real-world and ATTRibute-CM data regarding acoramidis, including the potential for the findings to inform treatment selection for newly diagnosed patients and patients currently receiving other disease-modifying therapies and to support switching individuals to acoramidis; the potential reproducibility, durability and broader clinical significance of observed benefits associated with acoramidis across independent data sources, including with respect to cardiovascular and heart failure hospitalizations, clinical stability and other outcomes; the potential clinical and therapeutic implications of the ATTRibute-CM analyses, including with respect to cardiovascular hospitalization, cardiorenal outcomes, biomarkers, health status and outcomes in patient subgroups; the design, conduct and anticipated findings of ASCEND-ATTR, including whether long-term TTR stabilization is associated with sustained improvement in myocardial structure, function and amyloid burden and the potential to identify imaging biomarkers of therapeutic response; and BridgeBio’s plans and expectations regarding additional analyses, longer-term follow-up, future research, publications and presentations of data regarding acoramidis. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the risk that results from retrospective, observational, real-world evidence studies, including studies based on electronic health records or administrative claims data, may be subject to confounding, selection bias, residual bias, incomplete or inaccurate data, limited follow-up or other limitations and may not be predictive of future clinical outcomes or treatment effects; that observed associations and differences between acoramidis and tafamidis may not be replicated in additional analyses, independent studies or longer-term data or may not translate into improved long-term clinical outcomes; that results from post hoc analyses, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects and may not be replicated in additional analyses or studies; that observed effects on cardiovascular hospitalizations, cardiorenal outcomes, biomarkers, health status or outcomes in patient subgroups may not be replicated or translate into meaningful long-term clinical benefit; that the findings may not meaningfully inform treatment selection or support switching patients to acoramidis; that mechanistic or prognostic interpretations of observed data, including potential relationships among TTR stabilization, cardiac remodeling, cardiorenal effects, biomarkers and clinical outcomes, may not be borne out by further analyses or additional data; that ASCEND-ATTR may not demonstrate sustained improvement in myocardial structure, function or amyloid burden or identify useful imaging biomarkers of therapeutic response; that additional analyses, longer-term follow-up or future research may yield results that differ from or do not confirm the findings described in this press release; that plans or timing for future analyses, medical meeting presentations or scientific publications may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-10-06 20:46 19d ago
2026-10-06 16:01 19d ago
BridgeBio to Present New Acoramidis Data, Including Independent Comparative Real-World EHR Data at the HFSA Annual Scientific Meeting 2026
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that one oral presentation, three rapid-fire oral presentations, and six poster presentations on acoramidis in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM) will be shared at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2026, taking place in Phoenix, Arizona on October 9-12, 2026. The data further strengthen the differentiated clinical profile of acoramidis, reinforcing it as the first-line treatment of choice for individuals with ATTR-CM. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Oral Presentation:
Association Between the Burden of Cardiovascular-Related Hospitalizations and All-Cause Mortality in Transthyretin Amyloid Cardiomyopathy: Insights from ATTRibute-CM
Presenter: Quan Bui, M.D., UC San Diego Health, U.S.
Date/time: Saturday, October 10 at 7:45 am MST

Rapid-Fire Oral Presentations:
Real-World Comparative Effectiveness Study of Acoramidis Versus Tafamidis in Transthyretin Amyloid Cardiomyopathy Using the Epic COSMOS Data Platform
Presenter: David Lanfear, M.D., M.S., Chief Scientific Officer of Henry Ford Health, U.S.
Date/time: Sunday, October 11 at 11:30 am MST

Early eGFR Dip Following Acoramidis Initiation is Associated with Reduced Risk of Mortality and Recurrent Cardiovascular-Related Hospitalizations in ATTR-CM
Presenter: Ahmad Masri, M.D., M.S., Oregon Health & Science University, U.S.
Date/time: Sunday, October 11 at 11:12 am MST

Ratio of Serum Transthyretin to NT-proBNP is a Novel Prognostic Measure for Transthyretin Amyloid Cardiomyopathy: Insights from ATTRibute-CM
Presenter: James L. Januzzi, M.D., Massachusetts General Hospital, U.S.
Date/time: Sunday, October 11 at 10:45 am MST

Poster Presentations:
Falls and Fractures Drive Increased Hospitalizations and Costs in Patients with Transthyretin Amyloid Cardiomyopathy Compared with Controls
Presenter: Nitasha Sarswat, M.D., University of Chicago, U.S.
Date/time: Friday, October 9 at 6:15 pm MST

Evaluating the Long-Term Effects of Acoramidis on Cardiac Function, Structure, and Amyloid Burden in Transthyretin Amyloid Cardiomyopathy: ASCEND-ATTR
Presenter: Ahmad Masri, M.D., M.S., Oregon Health & Science University, U.S.
Date/time: Saturday, October 10 at 1:45 pm MST

Real-World Burden of Transthyretin Amyloid Cardiomyopathy Disease and Outcomes in Patients on Tafamidis Prior to Initiating Acoramidis
Presenter: Richard Wright, M.D., Pacific Heart Institute, U.S.
Date/time: Saturday, October 10 at 5:45 pm MST

Acoramidis Reduces Risk of Cardiovascular-Related Mortality and Hospitalization in Women with Transthyretin Amyloid Cardiomyopathy
Presenter: Margot Davis, M.D., University of British Columbia, CA
Date/time: Saturday, October 10 at 6:15 pm MST

Acoramidis Preserves Functional Capacity and Quality of Life in p.Val142Ile Variant Transthyretin Amyloid Cardiomyopathy: Results from ATTRibute-CM
Presenter: Lily Stern, M.D., Cedars-Sinai Heart Institute, U.S.
Date/time: Sunday, October 11 at 8:15 am MST

Effect of Acoramidis on Heart Failure-Related Health Status Before and After Cardiovascular-Related Hospitalization: Insights from ATTRibute-CM
Presenter: Ahmad Masri, M.D., M.S., Oregon Health & Science University, U.S.
Date/time: Sunday, October 11 at 8:15 am MST

About Attruby® (acoramidis)

INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-10-06 20:46 19d ago
2026-10-06 16:01 19d ago
BridgeBio to Present Additional Evidence from the Phase 3 CALIBRATE Trial of Encaleret in ADH1 at the ASBMR 2026 Annual Meeting
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that additional evidence from the Phase 3 CALIBRATE trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1) will be shared at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting, taking place in Boston, Massachusetts on October 9-12, 2026.

BridgeBio will present the effects of encaleret on patient-reported outcomes and on bone turnover from the Phase 3 CALIBRATE trial. In partnership with the HypoPARAthyroidism Association, BridgeBio will also share findings from regional family cascade genetic testing events that evaluated a proband-initiated model designed to bring no-cost genetic testing and counseling directly to at-risk relatives in their home region.

BridgeBio will also have a poster featuring data showing a lack of peripheral FGFR1 inhibition at clinically relevant infigratinib exposures, supporting the safety profile observed in children with achondroplasia in the PROPEL clinical program.

ADH1 Oral Presentations:
Encaleret Restores Mineral Homeostasis and Increases Bone Turnover in Autosomal Dominant Hypocalcemia Type 1 (ADH1): 24-Week Results from Phase 3 CALIBRATE Trial
Presenter: Erik A. Imel, M.D., Indiana University School of Medicine
Date: Sunday, October 11 at 11:42 am EDT

Participant-Reported Changes in Symptoms and Treatment Experience with Encaleret in Autosomal Dominant Hypocalcemia Type 1: 24-Week Findings from the Phase 3 CALIBRATE Trial
Presenter: Steven W. Ing, M.D., Ohio State University Wexner Medical Center
Date: Sunday, October 11 at 11:54 am EDT

ADH1 Posters:
Baseline Symptom Burden and Impact on Daily Functioning in Autosomal Dominant Hypocalcemia Type 1: Exit Interview Findings from the Phase 3 CALIBRATE Trial
Presenter: Susan Martin, MSPH, RTI Health Solutions
Date: Saturday, October 10 at 2:00 pm EDT

Family Cascade Genetic Testing for Autosomal Dominant Hypocalcemia Type 1: A Multi-Stakeholder Regional Event Model
Presenter: Mark Warren, M.D., Physicians East, Greenville, NC
Date: Saturday, October 10 at 2:00 pm EDT

Achondroplasia Poster:
Lack of Peripheral FGFR1 Inhibition at Clinically Relevant Infigratinib Exposures Supports the Safety Profile Observed in Children with Achondroplasia
Presenter: Bhavik Shah, BridgeBio Skeletal Dysplasias
Date: Sunday, October 11 at 2:00 pm EDT

About Autosomal Dominant Hypocalcemia Type 1 (ADH1)
ADH1 is a common form of genetic hypoparathyroidism caused by gain-of-function variants in the calcium-sensing receptor gene (CASR). The calcium-sensing receptor (CaSR) constantly monitors and balances blood calcium levels by regulating parathyroid hormone secretion and calcium reabsorption in the kidneys. Individuals with ADH1 typically experience hypocalcemia, hypercalciuria, and inappropriately low levels of PTH. Symptoms of hypocalcemia may include severe muscle cramps, muscle spasms (tetany), a burning or prickling sensation in the hands or feet (paresthesia), brain fog, fatigue, and seizures. Hypercalciuria may result in kidney calcification (nephrocalcinosis), kidney stones (nephrolithiasis), and kidney failure.

About Encaleret
Encaleret is an investigational, orally administered small molecule under investigation to treat ADH1 and chronic hypoparathyroidism that is designed to selectively negatively modulate the calcium-sensing receptor. Encaleret has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation in the U.S., European Union, and Japan.

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-10-06 13:24 19d ago
2026-10-06 07:30 19d ago
BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

- Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic option for children with achondroplasia

- If approved, oral infigratinib would be the first and only approved oral therapy and a potential best-in-class treatment option for children with achondroplasia

- PROPEL 3 met its primary endpoint and key secondary endpoints, delivering the strongest efficacy package reported to date in achondroplasia: the largest AHV treatment effect of any Phase 3 study (+2.10 cm/yr; p<0.0001), and the first and only statistically significant improvement in both body proportionality and arm span in an achondroplasia Phase 3 trial (Proportionality: mean difference of -0.05 in ages 3–8, p<0.05; arm span z-score: +0.37 SD, p<0.0001)

-Treatment with oral infigratinib for 52 weeks in PROPEL 3 also resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events

- BridgeBio anticipates U.S. launch of oral infigratinib upon approval

PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.

"Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia," said Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias. "We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA."

PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children with achondroplasia, met its primary endpoint of change from baseline in annualized height velocity (AHV) at Week 52 (LS mean treatment difference of +1.74 cm/year; mean treatment difference of +2.10 cm/year; p<0.0001) and its key secondary endpoint of change from baseline in height Z-score (p<0.0001). In a pre-specified exploratory analysis in children younger than 8 years (more than half of participants), oral infigratinib became the first therapeutic option to show a statistically significant improvement in body proportionality against placebo in a randomized achondroplasia trial. Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug. These data were published as an original research article in The New England Journal of Medicine and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. The results can be found here. Additionally, BridgeBio also shared emerging data for oral infigratinib at ESPE about improvements beyond height for people with achondroplasia, including stabilizing sleep apnea measures, reducing rate of ear infections, and impacting body composition. The results can be found here.

“For children and families living with achondroplasia, today’s news represents meaningful progress toward potentially expanding the range of available options,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Our community holds diverse priorities and perspectives, and what matters is that individuals and families have meaningful choices as they consider their own healthcare goals. This milestone brings us one step closer to potentially having another option for families to consider together with their healthcare providers. We appreciate BridgeBio’s continued engagement with the achondroplasia community and its efforts to incorporate community perspectives throughout the development process.”

BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.

Oral infigratinib has received Breakthrough Therapy Designation from the FDA based on results from the PROPEL 2 clinical trial, which met the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. Oral infigratinib is the only therapeutic option in development for achondroplasia to hold Breakthrough Therapy Designation. In addition, oral infigratinib has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA, as well as Orphan Drug Designation from the EMA.

Information about PROPEL I&T trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia, and other skeletal dysplasia conditions, which hold significant unmet needs for families.

About Achondroplasia
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia can be associated with medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis, which may impact overall health and wellbeing. The condition is uniformly caused by an activating variant in FGFR3.

About Oral Infigratinib
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3. Oral infigratinib has received Breakthrough Therapy Designation, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. FDA, as well as Orphan Drug Designation from the European Medicines Agency (EMA).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding oral infigratinib, including the potential for oral infigratinib to provide benefits beyond growth and to meaningfully affect a broader range of medical and functional outcomes associated with achondroplasia; the potential for oral infigratinib to become the first and only approved oral therapy and a potential best-in-class option for children living with achondroplasia; the potential regulatory approval and commercialization of oral infigratinib, including the timing and likelihood of potential FDA approval and BridgeBio’s anticipated U.S. launch upon approval; BridgeBio’s plans to submit a Marketing Authorization Application for oral infigratinib in achondroplasia to the European Medicines Agency in the fourth quarter of 2026; BridgeBio’s plans to further evaluate and share the potential impact of oral infigratinib on measures beyond growth; and BridgeBio’s plans to continue exploring the potential of oral infigratinib to address broader medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions.

Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials; the risk that results from exploratory endpoints, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed trends or improvements in medical or functional outcomes may not be replicated in additional analyses or studies or translate into meaningful long-term clinical benefits; that oral infigratinib may not demonstrate benefits beyond growth or achieve the anticipated clinical, regulatory or commercial profile; that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, including by the FDA’s February 4, 2027 PDUFA target action date, or may require additional data, studies or other information; that BridgeBio may not launch oral infigratinib in the U.S. upon approval or on the anticipated timeline; that BridgeBio’s planned regulatory submissions, including its planned MAA submission in the fourth quarter of 2026, may be delayed or may not occur as expected; that oral infigratinib may not become the first and only approved oral therapy or a best-in-class option for achondroplasia; and that BridgeBio’s plans to further evaluate, share, study or develop oral infigratinib for broader medical and functional impacts or additional skeletal dysplasia conditions may change or may not result in successful development or regulatory approval; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-10-05 20:16 20d ago
2026-10-05 16:01 20d ago
BridgeBio and Community Partners Launch Nationwide ATTR-CM Education Effort Ahead of World Amyloidosis Day
BBIO BridgeBio Pharma
FMP Stock News
Original source text
- October 6 YouTube premiere featuring Sway Calloway, Howard “H” White and leading medical and cultural voices anchors community education nationwide

PALO ALTO, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the “Company” or “BridgeBio”), a commercial-stage, multi-product biopharmaceutical company focused on genetic diseases, today announced a nationwide education effort with community partners to increase awareness of transthyretin amyloid cardiomyopathy, also called ATTR cardiac amyloidosis (ATTR-CM). ATTR-CM is an underrecognized cause of heart failure that occurs when TTR, a protein that plays an essential role in the transport of vitamin A and thyroxine, becomes unstable, breaks down and builds up in the heart, causing it to become thicker and stiffer and making it harder to pump blood effectively. Because symptoms may resemble more common heart conditions or be dismissed as normal aging, ATTR-CM can be overlooked or identified later in the disease journey.

The effort will begin with an October 6 YouTube premiere and continue through community conversations and educational programming leading up to World Amyloidosis Day on October 26.

The premiere features a candid conversation on Black men’s heart health and ATTR-CM moderated by veteran broadcaster, Sway Calloway. The panel includes sports executive, author, philanthropist and ATTR-CM advocate, Howard “H” White; Albert J. Hicks III, M.D., MPH, Director of Cardiopulmonary Care and Heart/Lung Transplant at Integris Baptist Medical Center in Oklahoma; and Hip Hop Public Health (HHPH) Founding Artist and Founder, Doug E. Fresh and HHPH Founder and Board Chair, Olajide Williams, M.D., M.S., who serve as Community and Health Education Partners for the initiative. The program will premiere October 6 at 6:00 pm EDT at HowardWhiteStory.com/premiere.

The nationwide effort is supported by community partners including the Association of Black Cardiologists (ABC), the National Minority Quality Forum (NMQF), 100 Black Men of the Bay Area, Inc. and the National Medical Association (NMA). Partners will host or support viewings and related educational programming at 40 locations nationwide, including Atlanta, Chicago, Houston, Los Angeles, New York, Oakland, and Washington D.C.

“ATTR-CM deserves greater attention as part of the cardiovascular health conversation, particularly for Black Americans who may be at increased risk. We’re proud to support BridgeBio in helping patients, families and healthcare professionals recognize when there may be more to a heart failure diagnosis,” said Kevin Kwaku, M.D., Ph.D., President of the Association of Black Cardiologists.

“Approximately 1 in 25 Black Americans carries a genetic variant associated with ATTR-CM, and too often the diagnosis comes only after the heart has already been significantly affected,” said Uma Sinha, Ph.D., Chief Scientific Officer at BridgeBio. “Our understanding of this progressive disease has moved faster than awareness of it. Shortness of breath, fatigue, and carpal tunnel in both wrists can be written off as aging or as a more common form of heart failure, and years can pass before anyone names the real cause. Putting clinicians, cultural leaders and Howard ‘H’ White’s lived experience in the same room, alongside partners rooted in these communities, is how we close this gap.”

At the center of the conversation is White, who is living with ATTR-CM and founded the Howard H. White Center for Cardiac Amyloidosis. Drawing on his own journey from symptoms to diagnosis, he has become a prominent voice for recognizing changes in one’s health, speaking up and advocating for answers.

As the Community and Health Education Partners, Dr. Williams and Doug E. Fresh reinforced the importance of moving health conversations from awareness to action, particularly through trusted voices, culture and community.

“At Hip Hop Public Health, we know that people are more likely to engage with health information when it is relevant to their lives and delivered through voices and cultural touchpoints they trust. Our goal is to make these conversations accessible and actionable, so people feel empowered to recognize changes in their health, ask questions and advocate for themselves and their families,” said Dr. Williams.

ATTR-CM exists in two forms: wild-type disease associated with aging and hereditary, or variant, disease passed through families. Certain variants are more commonly carried by people of African ancestry. Approximately 1 in 25 Black Americans in the United States carries the V142I, also known as V122I, variant associated with ATTR-CM, although not everyone who carries the variant will develop the disease.1–3

“ATTR-CM can hide in plain sight because its symptoms often mirror heart failure we see every day. For Black patients, particularly those with ancestry-linked risk, knowing when to look beyond the familiar diagnosis can change the course of the disease,” said Dr. Hicks. 

The discussion also examines broader cardiovascular disparities affecting Black Americans and why greater awareness, earlier recognition and conversations with healthcare providers matter.

Watch the premiere on October 6 at 6:00 pm EDT at HowardWhiteStory.com/premiere.

Learn more about ATTR-CM and hear Howard “H” White’s story at HowardWhiteStory.com.

About Hip Hop Public Health
Hip Hop Public Health (HHPH) is a 501(c)(3) nonprofit organization that uses the power of music, culture and science to make health information accessible, relevant and actionable. Founded by Dr. Olajide Williams and Doug E. Fresh, HHPH develops evidence-based educational resources and community partnerships that advance health literacy, disease prevention and health equity. HHPH serves as the Community & Health Education Partner for this initiative. For more information, visit hhph.org.

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube and TikTok.

BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the planned YouTube premiere, community viewings and educational programming; BridgeBio’s plans to support ATTR-CM education and awareness; and the potential benefits of greater awareness, earlier recognition and diagnosis of ATTR-CM. Although the Company believes that its plans, intentions and expectations as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that such plans, intentions or expectations will be attained or achieved. Actual results may differ materially from those described in the forward-looking statements due to a number of risks, uncertainties and assumptions, including those risks set forth in the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]

References
1. Attruby.com, “What Is ATTR-CM?” Disease overview and symptom information. Accessed January 27, 2026.
2. Attruby.com, “Signs & Symptoms” section. Accessed January 27, 2026.
3. Quarta CC, Buxbaum JN, Shah AM, et al. The amyloidogenic V122I transthyretin variant in elderly black Americans. N Engl J Med. 2015;372(1):21-29. Accessed January 27, 2026.
2026-10-05 12:56 20d ago
2026-10-05 07:30 20d ago
BBP-418 Demonstrates Potential to Be Disease Modifying Therapy, Restoring Cardiac and Disease Markers to Unaffected Levels
BBIO BridgeBio Pharma
FMP Stock News
Original source text
- In exploratory analyses at Month 12, among individuals with LGMD2I/R9 (FKRP-related) with elevated HS troponin I at baseline, 100% treated with BBP-418 returned to the normal range by Month 12 versus 40% in the placebo arm (p=0.0248); HS troponin I, a blood marker of heart muscle injury, declined more with BBP-418 than placebo (LS mean difference -17.8 ng/L; 95% CI: -35.1 to -0.5; p=0.0443)

- 54% of BBP-418-treated individuals had stable or improved LVEF at Month 12 versus 25% in the placebo arm (p=0.0262)

- In data presented separately, BBP-418 treatment of LGMD2I/R9 in FORTIFY increased mean glycosylated αDG by Month 3 to the levels of asymptomatic heterozygous FKRP carriers, who do not exhibit disease; this result was sustained through Month 12

- Taken together, these findings support the potential of BBP-418 to act as a disease modifying therapy by addressing the condition at its source

- BBP-418 is under FDA Priority Review with a PDUFA target action date of November 27, 2026

PALO ALTO, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a biopharmaceutical company focused on developing medicines for genetic conditions, today presented new exploratory cardiac data from the 12-month interim analysis of FORTIFY, the Phase 3 clinical trial of oral BBP-418 in individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) (FKRP-related). The data were presented in an oral presentation at the 31st annual Congress of the World Muscle Society in Hiroshima, Japan by Volker Straub, M.D., Ph.D. of Newcastle University, UK.

“Cardiac involvement is a major driver of morbidity and mortality in LGMD2I/R9, which is why it remains one of the greatest concerns for people living with the condition, families and treating physicians. Historically, we have been able to monitor the heart and manage complications, but we have not been able to address the underlying cause of the disease," said Dr. Straub. “What stands out in this analysis is how consistent it is: high-sensitivity troponin I fell and, in those who entered the study with elevated levels, it normalized; ejection fraction stabilized; and this happened alongside walking farther and breathing better. It’s encouraging to see that the therapeutic approach seems to work across the whole muscular system, including the heart.”

Cardiomyopathy affects approximately 30% of individuals with LGMD2I/R9 and approximately 60% of those with other FKRP genotypes, and is progressive, with an annual loss of approximately 0.4% of left ventricular ejection fraction (LVEF). In FORTIFY, 22.9% of participants (25/109) had elevated high-sensitivity (HS) troponin I at baseline and 17.1% (18/105) had an LVEF below 50%. Exploratory cardiac findings at Month 12 showed:

HS troponin I is a blood test used to detect injury to heart muscle. 100% of the participants treated with BBP-418 returned to the normal range for HS troponin l by Month 12 versus 40% in the placebo arm (p=0.0248); HS troponin I declined more with BBP-418 than placebo (LS mean difference -17.8 ng/L; 95% CI: -35.1 to -0.5; p=0.0443)At Month 12, 54% of participants treated with BBP-418 had stable or improved LVEF, a measurement of how much blood the heart's main chamber pushes out with each beat, compared with 25% of those on placebo (p=0.0262)Both HS troponin I and LVEF will continue to be monitored in the ongoing FORTIFY study
A consistent pattern across the FORTIFY interim analysis is the proportion of treated individuals reaching normal or near-normal levels on markers of the disease e.g., 38% of patients whose CK reached normal levels. In addition to the HS troponin I finding, in which 100% of evaluable BBP-418-treated participants with elevated levels at baseline returned to the normal range by Month 12, separate data presented at WMS 2026 by Anne Katrine Kjemsø Jensen, a medical student in the laboratory of John Vissing M.D., D.M.Sci., Copenhagen Neuromuscular Center of Rigshospitalet, DK, quantified αDG glycosylation in 34 asymptomatic heterozygous FKRP carriers. Results showed:

Asymptomatic carriers showed significantly reduced glycosylation versus healthy controls, thereby establishing a reference point for the level associated with normal muscle function (34% of control)In FORTIFY, BBP-418 treatment increased mean glycosylated αDG above carrier levels by Month 12, suggesting that BBP-418 can restore glycosylated αDG to asymptomatic levelsWhile many therapies in progressive neuromuscular disease aim to slow decline, BBP-418 was developed to target LGMD2I/R9 at its source, and the pattern of biomarker normalization observed to date, alongside functional improvement from baseline rather than stabilization, is consistent with the potential for BBP-418 to be a disease modifying therapy
In the Phase 3 FORTIFY trial, BBP-418 met all primary and secondary endpoints at the pre-specified 12-month interim analysis, showing treated individuals improving while placebo recipients declined across every key measure. These results were presented as a late-breaking oral presentation at the 2026 MDA Clinical and Scientific Conference, which are available here.

BridgeBio believes BBP-418 is positioned to become the first and only approved therapy for individuals living with LGMD2I/R9, addressing a significant unmet need in this disease and potentially representing the first approval of a therapy for any form of LGMD. Approximately 7,000 individuals currently live with LGMD2I/R9 and other addressable α-dystroglycanopathies in the U.S. and Europe. BBP-418 is under FDA Priority Review with a PDUFA target action date of November 27, 2026. The Company is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in Europe.

BBP-418 has previously received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA and Orphan Drug Designation from the European Medicines Agency (EMA). BBP-418 received Priority Review from the FDA, highlighting the potential for BBP-418 to address unmet need in LGMD2I/R9. Consistent with Rare Pediatric Designation from the FDA, if BBP-418 is approved, BridgeBio may qualify for a Priority Review Voucher. The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age in the first half of 2027 and in LGMD2M/R13 and LGMD2U/R20 in the near future.

About Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)
LGMD2I/R9 is a monogenic autosomal recessive disease caused by partial loss of function mutations in the fukutin-related protein (FKRP) gene, and FKRP mutations impair glycosylation of alpha-dystroglycan (αDG), a protein associated with stabilizing muscle cells. Clinical manifestations typically present as a skeletal myopathy affecting the lower and then upper limbs, which is commonly later accompanied by pulmonary muscle and cardiac muscle involvement. Individuals who harbor a homozygous L276I genotype typically develop disease manifestations during late childhood with progression to loss of independent ambulation (25%), assisted ventilation (10%), and cardiomyopathy (30%) in adulthood. Cardiomyopathy is progressive, with an annual loss of 0.4% of left ventricular ejection fraction (LVEF). Individuals with other FKRP genotypes typically have an earlier childhood onset with a more severe clinical course, rapid loss of mobility by 20 years of age, more frequent cardiac involvement (60%), and eventual pulmonary decline by 30 years of age in nearly all cases.

About BBP-418
BBP-418 is an investigational oral glycosylation substrate therapy with potential to be the first and only therapy for LGMD2I/R9. BBP-418 is designed to saturate the partially functional FKRP enzyme with substrate thereby enhancing residual FKRP function and restoring glycosylation of αDG. Through restoration of αDG glycosylation, BBP-418 may stabilize or improve muscle function, including gross motor, ambulatory, and cardiopulmonary function.

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of data regarding BBP-418, including the potential for BBP-418 to act as a disease-modifying therapy for LGMD2I/R9, restore or normalize disease biomarkers, and stabilize or improve cardiac, gross motor, ambulatory and pulmonary function; the potential for BBP-418 to become the first and only approved therapy for individuals living with LGMD2I/R9 and potentially the first approved therapy for any form of LGMD; the timing and likelihood of potential regulatory approval and commercialization of BBP-418, including the PDUFA target action date of November 27, 2026; BridgeBio’s interactions with regulatory authorities regarding a potential expedited path to approval for BBP-418 in Europe; BridgeBio’s potential eligibility to receive a Priority Review Voucher if BBP-418 is approved; the continued evaluation of cardiac and other clinical measures in the ongoing FORTIFY study; and BridgeBio’s plans to initiate additional clinical studies of BBP-418, including in individuals with LGMD2I/R9 less than 12 years of age and in individuals with LGMD2M/R13 and LGMD2U/R20. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data; the exploratory and non-alpha-controlled nature of certain analyses described in this press release and the small sample sizes on which certain of those analyses are based; that observed biomarker changes, including normalization of HS troponin I, glycosylated αDG or other disease markers, may not be replicated in additional analyses or studies or predict or translate into long-term clinical benefit, sustained improvement in cardiac or other muscle function, or prevention of disease progression; that BBP-418 may not demonstrate the anticipated efficacy, safety, therapeutic benefit or disease-modifying potential in ongoing or future clinical studies; that the design, enrollment, conduct, timing and success of ongoing and planned clinical trials may differ from current expectations; that the FDA or other regulatory authorities may not approve BBP-418 on the anticipated timeline or at all, may not agree with BridgeBio’s regulatory approval strategies, clinical trial designs, conduct or methodologies, or the sufficiency of data submitted, or may require additional data, studies or other information; that BBP-418 may not become the first and only approved therapy for LGMD2I/R9 or the first approved therapy for any form of LGMD; that BridgeBio may not identify or obtain an expedited path to approval for BBP-418 in Europe; that BridgeBio may not qualify for or receive a Priority Review Voucher; that plans to initiate additional clinical studies, including studies in individuals less than 12 years of age or in other forms of LGMD, may be delayed, modified or may not occur as expected; the potential size of the target patient populations BBP-418 is designed to treat not being as large as anticipated; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact
Kaitlyn Reilly, Director, Communications
[email protected]  
(650) 789-8220

BridgeBio Investor Contact
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-09-26 11:04 29d ago
2026-09-26 04:03 29d ago
BridgeBio Pharma Eyes Four Global Launches by 2027 as Attruby Nears Blockbuster Status
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (NASDAQ:BBIO) expects 2027 to be a transformative year as it expands from one commercial product to four globally launched therapies, President and CFO Thomas Trimarchi said during a Bernstein discussion.

Trimarchi said the company’s strategy centers on developing medicines for genetic diseases with substantial unmet need, particularly where a genetic mechanism can be directly targeted. He also emphasized capital allocation discipline and net present value considerations as elements of BridgeBio’s operating model.

“We are here in this world to help as many patients living with genetic disease as we possibly can in the shortest amount of time,” Trimarchi said. Attruby Launch and New Evidence Trimarchi said Attruby, the company’s treatment for ATTR cardiomyopathy, is annualizing at more than $1 billion globally about six quarters after launch. BridgeBio expects the drug to reach global blockbuster status on a full-year basis by the end of the year, he said.

The company estimates that 15,000 to 16,000 patients annually are now reaching the “bottom of the funnel” in the ATTR cardiomyopathy market, compared with an estimated 8,000 patients two years earlier. Trimarchi said Attruby has about 25% share of new patient starts and that share is growing.

BridgeBio recently released real-world data comparing acoramidis, the active ingredient in Attruby, with tafamidis. According to Trimarchi, the analysis showed a 34% improvement for acoramidis on a composite measure of diuretic intensification, cardiovascular hospitalizations and all-cause mortality. He said the company also published data suggesting a kidney-protective effect, although the mechanism remains under investigation.

Julie Miller Everett, chief operating officer of BridgeBio’s Skeletal Dysplasias Business, said emerging evidence across the category has reinforced the company’s confidence in Attruby’s differentiation. BridgeBio continues to project more than $4 billion in peak-year sales for acoramidis.

Trimarchi said the company expects quarterly Attruby revenue increases of approximately $25 million to $30 million for the next several quarters, potentially through late 2027. He attributed the near-term pace partly to normalization in switches from tafamidis and to the changing mix between second-line and treatment-naive patients.

BridgeBio is also pursuing lifecycle-management efforts including the ACT-EARLY primary-prevention study in certain asymptomatic variant patients, a cardiac imaging study, further research into the renal findings and a once-daily formulation that Trimarchi said could enter the clinic within 12 to 18 months.

Rare-Disease Launches Ahead Among the company’s planned launches, BBP-418 is being developed for Limb-Girdle Muscular Dystrophy Type 2I/R9. Trimarchi described the condition as a progressive disease with no approved therapy, affecting an estimated 2,000 to 2,500 people in the U.S., approximately 5,000 in Europe, and another roughly 2,000 patients in Japan with related Fukuyama Muscular Dystrophy.

He said BBP-418’s Phase 3 trial showed statistically significant benefits versus placebo across measures including the North Star Ambulatory Assessment, forced vital capacity and a 10-meter walk test. BridgeBio expects an FDA decision on or before a Nov. 27, 2026, PDUFA date, according to Trimarchi. He said the company has identified about 500 U.S. patients with confirmed genotypes and mapped prescribers, which will form the initial launch pool.

BridgeBio also has encaleret under FDA review for autosomal dominant hypocalcemia type 1, or ADH1. Trimarchi said the therapy is designed to address activating mutations in the calcium-sensing receptor. In its Phase 3 study, more than 75% of patients discontinued conventional calcium and vitamin D therapy and achieved normal-range blood and urine calcium levels after six months, he said.

The drug has a May 8 PDUFA date, and BridgeBio has begun a Phase 3 study in postsurgical hypoparathyroidism. Trimarchi said the company expects to enroll that study next year and potentially report results from late 2027 to early 2028.

Infigratinib Targets Achondroplasia Miller Everett outlined BridgeBio’s planned launch approach for infigratinib in achondroplasia. She said the oral therapy directly targets the FGFR3 mutation associated with the condition, unlike currently available CNP analog treatments.

According to Miller Everett, infigratinib demonstrated statistically significant benefits in annualized height velocity and proportionality within 52 weeks. BridgeBio also presented data on otitis media, or ear infections, and sleep apnea, which she said showed benefits within 52 weeks.

She said only about 20% to 30% of U.S. families have opted for available treatment, compared with an estimated 70% to 80% outside the U.S. BridgeBio sees three potential sources of demand: untreated patients, patients seeking to move from injectable therapies, and patients who previously discontinued treatment.

BridgeBio has deployed medical personnel and is building commercial infrastructure in the U.S., while establishing country-specific commercialization models internationally. Trimarchi said the company sees the next 18 months as a period in which its four-product portfolio could support a broader, durable biopharmaceutical business.

About BridgeBio Pharma (NASDAQ:BBIO) BridgeBio Pharma, Inc is a biopharmaceutical company focused on discovering, developing and delivering medicines for patients with genetically driven diseases and cancers. Founded in 2015, the company operates through a group of subsidiary biotechnology businesses, each generally focused on a specific disease area or therapeutic program.

BridgeBio’s research and development activities span rare diseases, genetically defined cancers, cardiovascular conditions and other serious disorders.
2026-09-26 08:37 29d ago
2026-09-26 04:03 29d ago
BridgeBio Pharma Eyes Four Global Launches by 2027 as Attruby Nears Blockbuster Status
BBIO BridgeBio Pharma
FMP Stock News
Original source text
The Phase 3 Failure That Sent Biotech Winners and Losers in Opposite DirectionsBridgeBio Pharma NASDAQ: BBIO expects 2027 to be a transformative year as it expands from one commercial product to four globally launched therapies, President and CFO Thomas Trimarchi said during a Bernstein discussion.

Trimarchi said the company’s strategy centers on developing medicines for genetic diseases with substantial unmet need, particularly where a genetic mechanism can be directly targeted. He also emphasized capital allocation discipline and net present value considerations as elements of BridgeBio’s operating model.

Get BridgeBio Pharma alerts:

BridgeBio's Volatile Week Puts Biotech Stocks Under a Microscope“We are here in this world to help as many patients living with genetic disease as we possibly can in the shortest amount of time,” Trimarchi said.

Attruby Launch and New Evidence Trimarchi said Attruby, the company’s treatment for ATTR cardiomyopathy, is annualizing at more than $1 billion globally about six quarters after launch. BridgeBio expects the drug to reach global blockbuster status on a full-year basis by the end of the year, he said.

The company estimates that 15,000 to 16,000 patients annually are now reaching the “bottom of the funnel” in the ATTR cardiomyopathy market, compared with an estimated 8,000 patients two years earlier. Trimarchi said Attruby has about 25% share of new patient starts and that share is growing.

BridgeBio recently released real-world data comparing acoramidis, the active ingredient in Attruby, with tafamidis. According to Trimarchi, the analysis showed a 34% improvement for acoramidis on a composite measure of diuretic intensification, cardiovascular hospitalizations and all-cause mortality. He said the company also published data suggesting a kidney-protective effect, although the mechanism remains under investigation.

Julie Miller Everett, chief operating officer of BridgeBio’s Skeletal Dysplasias Business, said emerging evidence across the category has reinforced the company’s confidence in Attruby’s differentiation. BridgeBio continues to project more than $4 billion in peak-year sales for acoramidis.

Trimarchi said the company expects quarterly Attruby revenue increases of approximately $25 million to $30 million for the next several quarters, potentially through late 2027. He attributed the near-term pace partly to normalization in switches from tafamidis and to the changing mix between second-line and treatment-naive patients.

BridgeBio is also pursuing lifecycle-management efforts including the ACT-EARLY primary-prevention study in certain asymptomatic variant patients, a cardiac imaging study, further research into the renal findings and a once-daily formulation that Trimarchi said could enter the clinic within 12 to 18 months.

Rare-Disease Launches Ahead Among the company’s planned launches, BBP-418 is being developed for Limb-Girdle Muscular Dystrophy Type 2I/R9. Trimarchi described the condition as a progressive disease with no approved therapy, affecting an estimated 2,000 to 2,500 people in the U.S., approximately 5,000 in Europe, and another roughly 2,000 patients in Japan with related Fukuyama Muscular Dystrophy.

He said BBP-418’s Phase 3 trial showed statistically significant benefits versus placebo across measures including the North Star Ambulatory Assessment, forced vital capacity and a 10-meter walk test. BridgeBio expects an FDA decision on or before a Nov. 27, 2026, PDUFA date, according to Trimarchi. He said the company has identified about 500 U.S. patients with confirmed genotypes and mapped prescribers, which will form the initial launch pool.

BridgeBio also has encaleret under FDA review for autosomal dominant hypocalcemia type 1, or ADH1. Trimarchi said the therapy is designed to address activating mutations in the calcium-sensing receptor. In its Phase 3 study, more than 75% of patients discontinued conventional calcium and vitamin D therapy and achieved normal-range blood and urine calcium levels after six months, he said.

The drug has a May 8 PDUFA date, and BridgeBio has begun a Phase 3 study in postsurgical hypoparathyroidism. Trimarchi said the company expects to enroll that study next year and potentially report results from late 2027 to early 2028.

Infigratinib Targets Achondroplasia Miller Everett outlined BridgeBio’s planned launch approach for infigratinib in achondroplasia. She said the oral therapy directly targets the FGFR3 mutation associated with the condition, unlike currently available CNP analog treatments.

According to Miller Everett, infigratinib demonstrated statistically significant benefits in annualized height velocity and proportionality within 52 weeks. BridgeBio also presented data on otitis media, or ear infections, and sleep apnea, which she said showed benefits within 52 weeks.

She said only about 20% to 30% of U.S. families have opted for available treatment, compared with an estimated 70% to 80% outside the U.S. BridgeBio sees three potential sources of demand: untreated patients, patients seeking to move from injectable therapies, and patients who previously discontinued treatment.

BridgeBio has deployed medical personnel and is building commercial infrastructure in the U.S., while establishing country-specific commercialization models internationally. Trimarchi said the company sees the next 18 months as a period in which its four-product portfolio could support a broader, durable biopharmaceutical business.

About BridgeBio Pharma (NASDAQ:BBIO)BridgeBio Pharma, Inc is a biopharmaceutical company focused on discovering, developing and delivering medicines for patients with genetically driven diseases and cancers. Founded in 2015, the company operates through a group of subsidiary biotechnology businesses, each generally focused on a specific disease area or therapeutic program.

BridgeBio's research and development activities span rare diseases, genetically defined cancers, cardiovascular conditions and other serious disorders.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-09-23 19:31 1mo ago
2026-09-23 13:59 1mo ago
BridgeBio Pharma, Inc. (BBIO) Presents at Bernstein Insights: Healthcare Leaders and Disruptors - 3rd Annual Healthcare Forum Transcript
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma, Inc. (BBIO) Presents at Bernstein Insights: Healthcare Leaders and Disruptors - 3rd Annual Healthcare Forum Transcript
2026-09-23 12:05 1mo ago
2026-09-23 07:47 1mo ago
Acoramidis Demonstrates Real-World Benefit Versus Tafamidis in ATTR-CM, Reducing Risk of Clinical Worsening
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

- In the first peer-reviewed, real-world, contemporary, comparative effectiveness study of TTR stabilizers in ATTR-CM using U.S. claims data, acoramidis was associated with a statistically and clinically significant 34% reduction in a composite of clinical worsening events (diuretic intensification, heart failure hospitalization, and mortality) versus tafamidis (p=0.046), supporting improved clinical stability of acoramidis over tafamidis

- Acoramidis was also associated with a significant 43% reduction in risk of diuretic intensification versus tafamidis (p=0.021); diuretic intensification is an early marker of worsening heart failure and worse clinical outcomes

- Separation in clinical outcomes emerged within weeks of treatment initiation and increased over time, reinforcing a consistent early treatment effect and durable clinical stabilization

- Findings underscore acoramidis’s differentiated profile, with potential to inform frontline treatment decisions and support switching individuals to acoramidis

- An additional, independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data is expected to be released at an upcoming 2026 medical meeting

PALO ALTO, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced results published in Cardiology and Therapy from the first peer-reviewed, contemporary real-world comparative effectiveness retrospective study of transthyretin (TTR) stabilizers in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating that acoramidis was associated with significantly lower risk of early clinical worsening compared to tafamidis. This represents the first peer-reviewed, real-world evidence differentiating clinical outcomes between approved TTR stabilizers, reinforcing acoramidis’s differentiated clinical profile in present-day practice.

“These findings further position acoramidis as a differentiated TTR stabilizer in contemporary clinical practice,” said Richard Wright, M.D., M.A.C.C. of the Pacific Heart Institute, U.S. “The significant reduction in diuretic intensification, an early indicator of worsening heart failure, points to improved disease control and clinical stability. The progressive nature of ATTR-CM is evident in all Phase 3 trials and is seen again here. This demonstrates the need for clinicians to proactively mitigate disease progression, and these data have the potential to meaningfully inform treatment selection in newly diagnosed patients and in patients currently on other treatments.”

In this analysis of newly treated individuals living with ATTR-CM, acoramidis showed early, consistent, and clinically meaningful advantages compared to tafamidis across key measures of disease progression during a mean follow-up of 4.6 months.

The key findings from the study comparing acoramidis benefit versus tafamidis in individuals with ATTR-CM:

34% statistically and clinically significant reduction in risk of composite clinical worsening (HR 0.66; p=0.046), including diuretic intensification, heart failure hospitalization, and all-cause mortality43% reduction in risk of diuretic intensification (HR 0.57; p=0.021), an established early marker of worsening heart failure and predictor of hospitalization and mortality; diuretic intensification was rigorously defined as initiation or dose-equivalent escalation of oral loop diuretics, parenteral loop diuretics use, or addition of a thiazide-type diuretic48% reduction in initiation or dose-equivalent escalation of oral loop diuretics (HR=0.52; p=0.014)Rapid benefit, with separation of Kaplan-Meier curves observed within weeks of treatment initiation and increasing over timeFewer individuals with acoramidis initiated alternative ATTR-CM therapy as compared to those treated with tafamidis (4.6% vs 7.7%, respectively), consistent with findings of improved clinical stability with acoramidisBackground heart failure therapies in this study were well balanced across arms and reflect contemporary practice: 43-44% SGLT2i, 36-39% MRAMultiple falsification analyses testing for residual bias were nonsignificant
The study leveraged a retrospective, longitudinal, new-user, active-comparator design using U.S. claims data and incorporated a unique dataset linking Komodo Healthcare Map U.S. claims with Claritas hub and specialty pharmacy data. After weighting, the analysis included 170 individuals with acoramidis and 448 individuals with tafamidis newly initiating treatment between Dec 2024-April 2025 and followed through July 2025, with a mean follow-up of approximately 4.6 months.

Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Additional data on the real-world benefit of acoramidis versus tafamidis in individuals living with ATTR-CM is planned for fall medical meetings and scientific publications, including an independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data, expected to be released at an upcoming 2026 medical meeting.

As with all real-world evidence studies, these findings should be interpreted in the context of inherent limitations of administrative claims data, including limited capture of cardiac biomarkers and other clinical measures of disease severity. Follow-up was limited given the recent approval of acoramidis, and longer-term data are needed to further add to these findings.

About Attruby® (acoramidis)

INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the real-world data regarding acoramidis, including the potential for the findings to inform frontline treatment decisions and treatment selection for newly diagnosed patients and patients currently receiving other treatments, and to support switching individuals to acoramidis; and BridgeBio’s plans and expectations regarding the presentation and publication of additional real-world data regarding acoramidis, including an independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data expected to be released at an upcoming 2026 medical meeting. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the risk that results from retrospective, observational, real-world evidence studies, including studies based on administrative claims data, may be subject to confounding, selection bias, residual bias, incomplete or inaccurate data, limited follow-up or other limitations and may not be predictive of future clinical outcomes or treatment effects; that the observed associations and differences between acoramidis and tafamidis may not be replicated in additional analyses, independent studies or longer-term data or may not translate into improved long-term clinical outcomes; that the findings may not meaningfully inform treatment selection or support switching patients to acoramidis; that additional real-world studies, including the independent study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data, may yield results that differ from or do not confirm the findings described in this press release; that plans or timing for future medical meeting presentations or scientific publications may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]  
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-09-18 21:53 1mo ago
2026-09-18 16:01 1mo ago
BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., Sept. 18, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that on September 18, 2026, the compensation committee of BridgeBio’s board of directors approved equity grants to 36 new employees in restricted stock units for an aggregate of 63,009 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2027, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates.

The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-09-15 18:03 1mo ago
2026-09-15 13:11 1mo ago
BridgeBio Pharma, Inc. (BBIO) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma, Inc. (BBIO) Morgan Stanley 24th Annual Global Healthcare Conference September 15, 2026 10:00 AM EDT

Company Participants

Chinmay Shukla - Senior Vice President of Strategic Finance
Julie Everett - Chief Operating Officer of Skeletal Dysplasias

Conference Call Participants

Sean Laaman - Morgan Stanley, Research Division

Presentation

Sean Laaman
Morgan Stanley, Research Division

Good morning, everyone. I'm Sean Laaman, Head of U.S. Mid-cap Biotech Equity Research here at Morgan Stanley, and welcome to the Morgan Stanley Global Healthcare Conference. Before we commence, I'll make you aware of some important disclosures. For those disclosures, please visit the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative.

For this session, we have the pleasure of hosting Bridge Biopharma with Julie Everett, COO of BridgeBio Skeletal Dysplasia and Chief Business Officer, Chinmay Shukla. Welcome to both of you, and thank you for your time today.

I've got some macro considerations. We're just talking about interest rates offline, but just some macro considerations to discuss before we really dig in on Bridge. But how is the rise of China originated innovation changing your competitive positioning, if at all? And does it influence your BD and R&D playbooks?

Question-and-Answer Session

Chinmay Shukla
Senior Vice President of Strategic Finance

Yes. Happy to talk about that. And Sean, first of all, thank you for hosting us, and thank you to all the investors for joining us today and across the day as we try to tell our story. So in terms of China, we see that as an opportunity, and there are some risks, but we do see it mainly as an opportunity. I think the speed of innovation is much faster. We do have active relationships with investigators and universities in China.
2026-09-15 13:05 1mo ago
2026-09-15 04:27 1mo ago
VIRGINIA RETIREMENT SYSTEMS ET Al Invests $715,000 in BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
FMP Stock News
Original source text
VIRGINIA RETIREMENT SYSTEMS ET Al bought a new stake in shares of BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) during the 2nd quarter, according to its most recent filing with the SEC. The fund bought 9,600 shares of the company’s stock, valued at approximately $715,000.

Several other hedge funds have also recently added to or reduced their stakes in BBIO. California State Teachers Retirement System grew its stake in shares of BridgeBio Pharma by 7,463.2% in the 2nd quarter. California State Teachers Retirement System now owns 12,532,377 shares of the company’s stock valued at $933,411,000 after purchasing an additional 12,366,674 shares during the period. Lionsbridge Wealth Management LLC bought a new position in shares of BridgeBio Pharma during the 2nd quarter worth approximately $704,000. Susquehanna Fundamental Investments LLC acquired a new stake in BridgeBio Pharma in the 2nd quarter valued at $289,000. Two Sigma Securities LLC acquired a new stake in BridgeBio Pharma in the 2nd quarter valued at $1,317,000. Finally, Harvey Capital Management Inc. acquired a new stake in BridgeBio Pharma in the 2nd quarter valued at $10,340,000. Institutional investors and hedge funds own 99.85% of the company’s stock.

Insider Transactions at BridgeBio Pharma In other news, CEO Neil Kumar sold 10,000 shares of the company’s stock in a transaction that occurred on Wednesday, August 19th. The shares were sold at an average price of $84.03, for a total transaction of $840,300.00. Following the transaction, the chief executive officer directly owned 505,686 shares in the company, valued at approximately $42,492,794.58. This represents a 1.94% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CAO Maricel Apuli sold 2,000 shares of the stock in a transaction that occurred on Thursday, July 30th. The shares were sold at an average price of $80.06, for a total transaction of $160,120.00. Following the sale, the chief accounting officer directly owned 127,401 shares in the company, valued at $10,199,724.06. This trade represents a 1.55% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last ninety days, insiders have sold 257,103 shares of company stock worth $21,579,211. Corporate insiders own 14.23% of the company’s stock.

BridgeBio Pharma Stock Performance Shares of BBIO stock opened at $72.38 on Tuesday. BridgeBio Pharma, Inc. has a 52 week low of $48.78 and a 52 week high of $93.42. The stock has a market capitalization of $14.15 billion, a PE ratio of -20.27 and a beta of 0.97. The stock’s fifty day moving average is $80.54 and its 200-day moving average is $73.74. BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last released its quarterly earnings results on Monday, August 10th. The company reported ($0.78) earnings per share (EPS) for the quarter, missing analysts’ consensus estimates of ($0.58) by ($0.20). The company had revenue of $243.68 million during the quarter, compared to analyst estimates of $220.91 million. The firm’s revenue was up 120.4% compared to the same quarter last year. During the same period last year, the company earned ($0.95) earnings per share. As a group, analysts forecast that BridgeBio Pharma, Inc. will post -2.64 earnings per share for the current fiscal year.

Analysts Set New Price Targets BBIO has been the subject of several recent analyst reports. Truist Financial increased their price objective on BridgeBio Pharma from $102.00 to $107.00 and gave the stock a “buy” rating in a research note on Wednesday, August 12th. JPMorgan Chase & Co. boosted their target price on shares of BridgeBio Pharma from $100.00 to $111.00 and gave the company an “overweight” rating in a research note on Wednesday, August 12th. HC Wainwright reaffirmed a “buy” rating and issued a $120.00 target price on shares of BridgeBio Pharma in a report on Thursday, September 10th. Wells Fargo & Company upped their target price on shares of BridgeBio Pharma from $98.00 to $102.00 and gave the stock an “overweight” rating in a report on Tuesday, August 11th. Finally, UBS Group reiterated a “buy” rating on shares of BridgeBio Pharma in a research report on Wednesday, September 2nd. Twenty investment analysts have rated the stock with a Buy rating, two have assigned a Hold rating and one has assigned a Sell rating to the company. Based on data from MarketBeat, the company presently has an average rating of “Moderate Buy” and an average price target of $102.61.

Read Our Latest Analysis on BBIO

(Free Report)

BridgeBio Pharma, Inc is a biopharmaceutical company focused on discovering, developing and delivering medicines for patients with genetically driven diseases and cancers. Founded in 2015, the company operates through a group of subsidiary biotechnology businesses, each generally focused on a specific disease area or therapeutic program.

BridgeBio’s research and development activities span rare diseases, genetically defined cancers, cardiovascular conditions and other serious disorders.

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2026-09-10 18:35 1mo ago
2026-09-10 12:17 1mo ago
BridgeBio Pharma, Inc. (BBIO) Presents at 12th Annual Cantor Fitzgerald Global Healthcare Conference Transcript
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma, Inc. (BBIO) Presents at 12th Annual Cantor Fitzgerald Global Healthcare Conference Transcript
2026-09-10 13:41 1mo ago
2026-09-10 08:25 1mo ago
BridgeBio Pharma: Attruby Peak Sales Set To Rise
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio pharma has delivered multiple clinical and commercial successes, yet shares have repeatedly sold off after positive catalysts. Infigratinib's dwarfism trial outperformed the market leader, and Attruby continues to beat sales estimates, with management now guiding higher peak sales. Recent competitor setbacks and new data on Attruby's kidney benefits and hospital day reduction further strengthen BBIO's commercial outlook.
2026-09-09 23:04 1mo ago
2026-09-09 18:47 1mo ago
BridgeBio Pharma, Inc. (BBIO) Presents at Wells Fargo 21st Annual Healthcare Conference Transcript
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma, Inc. (BBIO) Wells Fargo 21st Annual Healthcare Conference September 9, 2026 1:30 PM EDT

Company Participants

Chinmay Shukla - Senior Vice President of Strategic Finance
Anna Wade - BD & Operations

Conference Call Participants

Derek Archila - Wells Fargo Securities, LLC, Research Division

Presentation

Derek Archila
Wells Fargo Securities, LLC, Research Division

Well, good afternoon, everyone. Thanks for joining us here after the [ lung ] session, getting right back into the fireside discussion. So my name is Derek Archila. I'm one of the biotech analysts here at Wells Fargo. Really excited to have next here BridgeBio. From the company, we have Chinmay Shukla, Chief Business Officer. Congratulations on that. As well as Anna Wade, COO of the Neuromuscular division. So thank you guys for joining us.

Chinmay Shukla
Senior Vice President of Strategic Finance

Derek, thank you for hosting us, and thanks to the investors for joining us. We are excited to speak to you today and excited for all our conversations.

Question-and-Answer Session

Derek Archila
Wells Fargo Securities, LLC, Research Division

Excellent. Well, Chinmay, maybe just to kind of level set us with the business and where you guys are. We've got a pretty solid growing base business with Attruby, a couple -- 3 launches upcoming. So maybe just give us a state of the business before we dig in.

Chinmay Shukla
Senior Vice President of Strategic Finance

Yes. It's a great question. So state of the business today is if you look at our post-Phase III drugs, right, that's in ADH1, limb-girdle, ATTR-CM, obviously, and achondroplasia. We have $8 billion of derisked peak year sales potential. Total, if you look in the entire pipeline, we have $10 billion of risk-adjusted sales potential. So we feel great about that.

I think if you look at Attruby, second quarter
2026-09-09 18:11 1mo ago
2026-09-09 12:31 1mo ago
BridgeBio Pharma (BBIO) Down 10.7% Since Last Earnings Report: Can It Rebound?
BBIO BridgeBio Pharma
FMP Stock News
Original source text
A month has gone by since the last earnings report for BridgeBio Pharma (BBIO - Free Report) . Shares have lost about 10.7% in that time frame, underperforming the S&P 500.

Will the recent negative trend continue leading up to its next earnings release, or is BridgeBio Pharma due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for BridgeBio Pharma, Inc. before we dive into how investors and analysts have reacted as of late.

Q2 Earnings Miss, Sales Beat EstimatesBridgeBio reported a second-quarter 2026 loss of 78 cents per share, wider than the Zacks Consensus Estimate of a loss of 64 cents. Despite the miss, the figure improved compared to the year-ago loss of 95 cents.

Revenues surged 120% year over year to $243.7 million, beating the Zacks Consensus Estimate of $222.6 million. This growth was primarily driven by Attruby.

Attruby Sales Drive the Top LineAttruby generated $222.4 million from product sales in the United States. The figure more than tripled from the $71.5 million recorded in the year-ago period.

Per BridgeBio, Attruby continued to gain share among treatment-naive patients, which management views as the key long-term growth driver for the franchise. Meanwhile, the pool of patients switching from Pfizer’s Vyndaqel/Vyndamax, a key competing ATTR-CM therapy, has begun to normalize after elevated switching activity in prior quarters. Management expects continued first-line share gains to support sales growth going forward.

Royalty revenues increased to $15.4 million from $1.6 million, primarily reflecting Attruby sales in the EU and Japan, where it is marketed as Beyonttra.

License and services revenues fell more than 84% year over year to $5.8 million, as the prior-year period benefited from a $30 million regulatory milestone.

Costs Rise on Commercial InvestmentsResearch and development expenses increased 34% year over year to $149.4 million, reflecting continued investment in late-stage programs.

Selling, general and administrative expenses climbed 44% to $186.3 million as the company supported Attruby commercialization and pre-commercial work for upcoming launches.

As of June 30, 2026, cash, cash equivalents and marketable securities totaled $720.2 million, down from $940.2 million in the previous quarter. The figure excludes the $1 billion preferred equity financing that closed July 1, which lifted the company's cash balance to about $1.7 billion.

How Have Estimates Been Moving Since Then?Since the earnings release, investors have witnessed a downward trend in estimates review.

The consensus estimate has shifted -18.21% due to these changes.

VGM ScoresAt this time, BridgeBio Pharma has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. Following the exact same course, the stock has a score of F on the value side, putting it in the bottom 20% quintile for this investment strategy.

Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, BridgeBio Pharma has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.

Performance of an Industry PlayerBridgeBio Pharma belongs to the Zacks Medical - Generic Drugs industry. Another stock from the same industry, Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) , has gained 0.8% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026.

Teva Pharmaceutical Industries reported revenues of $4.14 billion in the last reported quarter, representing a year-over-year change of -0.8%. EPS of $0.02 for the same period compares with $0.66 a year ago.

For the current quarter, Teva Pharmaceutical Industries is expected to post earnings of $0.71 per share, indicating a change of -9% from the year-ago quarter. The Zacks Consensus Estimate has changed -2.8% over the last 30 days.

Teva Pharmaceutical Industries has a Zacks Rank #4 (Sell) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C.
2026-09-09 10:48 1mo ago
2026-09-09 04:00 1mo ago
Oral Infigratinib Shows Meaningful Benefits Beyond Growth Within 52 Weeks in Children with Achondroplasia in the Phase 3 PROPEL 3 Trial
BBIO BridgeBio Pharma
FMP Stock News
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- Treatment with oral infigratinib for 52 weeks in PROPEL 3 resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events

Stabilization of sleep apnea measures: The mean total Apnea-Hypopnea Index (AHI) at 52 weeks remained consistent with the baseline mean in the oral infigratinib group, with a 10.4% increase, versus a 49.2% increase in the placebo group; in children younger than 8 years of age, the mean total AHI was unchanged for the oral infigratinib group, versus a 63.2% increase in the placebo groupReduction in rate of ear infections: The estimated annualized rate of otitis media events was 38% lower in the oral infigratinib group compared to the placebo group; in children younger than 8 years of age, the annualized rate of otitis media events was 47% lower in the oral infigratinib group compared to the placebo group
- In children treated for up to three years in the PROPEL program, oral infigratinib demonstrated sustained improvements in growth (CFBL in height Z-score of +0.92 SD at Year 3) and body proportionality (CFBL in upper-to-lower body segment ratio of -0.15 at Year 3), with a well-tolerated safety profile and no new safety signals

- These findings build on the previously reported PROPEL 3 primary and secondary endpoint results published in NEJM, in which oral infigratinib demonstrated a +2.10 cm/year improvement in AHV versus placebo (p<0.0001) and a statistically significant improvement in body proportionality within 52 weeks in children younger than 8 years of age

- BridgeBio submitted an NDA to the FDA for oral infigratinib in achondroplasia and anticipates a U.S. launch in mid-2027 

PALO ALTO, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today presented new exploratory analyses from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, showing directionally favorable trends beyond growth across medical complications associated with achondroplasia, including sleep apnea, otitis media, and body composition. These data were presented at the Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2026 in Marseille, France, in a late-breaking oral presentation by Julie Hoover-Fong, M.D., Ph.D. of Johns Hopkins University, U.S.

"In the past, achondroplasia research has focused largely on measuring growth because height can be readily determined. But families have consistently emphasized that their priorities extend well beyond the growth chart," said Melita Irving, M.D. of Guy's and St Thomas' NHS Foundation Trust, London, UK. "Growth is only one part of the picture of this medically complicated condition in which children experience disrupted sleep, recurring ear infections, or other health challenges associated with achondroplasia. What I find especially encouraging here is not only the consistent benefit observed across each measure, but that the longer-term data from the PROPEL program show improvements in growth and body proportionality sustained through three years of treatment, and a safety profile that remained favorable with no new safety signals identified. Taken together, these findings suggest there is potential to address a broader range of outcomes that may meaningfully affect a child's health and daily life over time."

The new exploratory results from PROPEL 3 shared at ESPE 2026 include:

Stabilization of sleep apnea measures: The mean total apnea-hypopnea index (AHI) at 52 weeks remained consistent with the baseline mean in the oral infigratinib group, with a 10.4% increase, versus a 49.2% increase in the placebo groupIn children younger than 8 years of age, the mean total AHI at 52 weeks was unchanged for the oral infigratinib group, versus a 63.2% increase for the placebo group Reduction in rate of ear infections: The estimated annualized rate of otitis media, a recurrent complication in children with achondroplasia that can affect hearing and speech development, was 38% lower in the oral infigratinib group compared to the placebo group, and in children younger than 8 years of age, 47% lower in the oral infigratinib group compared to the placebo groupImpact on body composition: Mean change from baseline in body mass index was smaller in the oral infigratinib group compared to placebo (0.50 versus 0.93 kg/m2), with a greater increase in lean body mass (1.77 versus 1.58 kg) and smaller increases in body fat mass (0.95 versus 1.12 kg) and visceral fat volume (1.55 versus 18.42 mL) compared to placebo
In addition to the late-breaking oral presentation at the Annual ESPE Meeting 2026, BridgeBio shared a poster, Longer-Term Efficacy and Safety Results of Infigratinib in Children with Achondroplasia, presented by Dr. Irving. These findings showed that in children treated for up to three years in the PROPEL program, oral infigratinib demonstrated sustained improvements in growth, with a change from baseline in height Z-score relative to the achondroplasia population of +0.92 SD at Year 3. Additionally, oral infigratinib demonstrated sustained improvements in proportionality, with a change from baseline in upper-to-lower body segment ratio of -0.15 at Year 3. Results showed that oral infigratinib continued to be well-tolerated, with no new safety signals identified.

BridgeBio also shared one poster focused on PROPEL Infant & Toddler (I&T), an ongoing Phase 2/2b study in children under 3 years old with achondroplasia and one eposter focused on qualitative research on the impacts of hypochondroplasia.

PROPEL 3 demonstrated best-in-class improvements in annualized height velocity (AHV) and, for the first time in a Phase 3 achondroplasia study, statistically significant improvements in body proportionality and arm span, supporting its potential as the first oral targeted therapeutic option that directly impacts FGFR3. The topline results can be found here. These data were published as an original research article in the New England Journal of Medicine (NEJM) and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. The results can be found here. 

BridgeBio believes oral infigratinib is positioned to become the first and only approved oral therapy and a potential best-in-class option for children living with achondroplasia. The Company submitted an NDA to the FDA for oral infigratinib in achondroplasia and anticipates a U.S. launch in mid-2027. The Company intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026. 

Oral infigratinib has received Breakthrough Therapy Designation from the U.S. FDA based on the shared results from the PROPEL 2 clinical trial, which meet the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoints. In addition to receipt of Breakthrough Therapy Designation, oral infigratinib has also received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA. If oral infigratinib is approved, BridgeBio may qualify for a Priority Review Voucher. 

Information about PROPEL I&T trial (NCT07169279) can be found here on clinicaltrials.gov. Information about ACCEL, the Company’s observational lead-in study for oral infigratinib in hypochondroplasia’s Phase 3 study (NCT06410976) can be found here, and information about ACCEL 2/3, BridgeBio’s Phase 2/3 clinical study of oral infigratinib in hypochondroplasia (NCT06873035) can be found here. BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia, and other skeletal dysplasia conditions, which hold significant unmet needs for families. 

About Achondroplasia 
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia can be associated with medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis, which may impact overall health and wellbeing. The condition is uniformly caused by an activating variant in FGFR3. 

About Oral Infigratinib 
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3.

About BridgeBio 
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok. 

BridgeBio Forward-Looking Statements 
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions, or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding oral infigratinib, including the potential for oral infigratinib to provide benefits beyond growth and to meaningfully affect a broader range of medical and functional outcomes associated with achondroplasia; the potential for oral infigratinib to become the first and only approved oral therapy and a potential best-in-class option for children living with achondroplasia; the potential regulatory approval and commercialization of oral infigratinib, including BridgeBio’s anticipated U.S. launch in mid-2027; BridgeBio’s plans to submit a Marketing Authorization Application for oral infigratinib in achondroplasia to the European Medicines Agency in the second half of 2026; BridgeBio’s potential eligibility to receive a Priority Review Voucher if oral infigratinib is approved; and BridgeBio’s plans to continue exploring the potential of oral infigratinib to address broader medical and functional impacts of achondroplasia, hypochondroplasia, and other skeletal dysplasia conditions. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials; the risk that results from exploratory endpoints, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed trends or improvements in medical or functional outcomes may not be replicated in additional analyses or studies or translate into meaningful long-term clinical benefits; that oral infigratinib may not demonstrate benefits beyond growth or achieve the anticipated clinical, regulatory or commercial profile; that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, or may require additional data, studies or other information; that BridgeBio may not launch oral infigratinib in the U.S. in mid-2027 or on the anticipated timeline; that BridgeBio’s planned regulatory submissions, including its planned MAA submission, may be delayed or may not occur as expected; that oral infigratinib may not become the first and only approved oral therapy or a best-in-class option for achondroplasia; that BridgeBio may not qualify for or receive a Priority Review Voucher; and that BridgeBio’s plans to study or develop oral infigratinib for broader medical and functional impacts or additional skeletal dysplasia conditions may change or may not result in successful development or regulatory approval; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact: 
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220 

BridgeBio Investor Contact: 
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-09-07 13:15 1mo ago
2026-09-07 04:20 1mo ago
Frazier Life Sciences Management L.P. Sells 1,900,000 Shares of BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Frazier Life Sciences Management L.P. decreased its stake in shares of BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 55.1% during the second quarter, according to its most recent filing with the Securities and Exchange Commission. The institutional investor owned 1,548,139 shares of the company’s stock after selling 1,900,000 shares during the period. BridgeBio Pharma makes up 2.5% of Frazier Life Sciences Management L.P.’s investment portfolio, making the stock its 11th largest holding. Frazier Life Sciences Management L.P. owned approximately 0.79% of BridgeBio Pharma worth $115,305,000 as of its most recent filing with the Securities and Exchange Commission.

Other hedge funds and other institutional investors also recently modified their holdings of the company. Silvant Capital Management LLC bought a new stake in BridgeBio Pharma during the 2nd quarter valued at approximately $28,000. Allworth Financial LP bought a new position in shares of BridgeBio Pharma in the 2nd quarter worth approximately $31,000. Harvest Fund Management Co. Ltd purchased a new position in shares of BridgeBio Pharma in the 3rd quarter valued at approximately $34,000. Jones Financial Companies Lllp purchased a new position in shares of BridgeBio Pharma in the 1st quarter valued at approximately $35,000. Finally, Global Retirement Partners LLC boosted its position in shares of BridgeBio Pharma by 271.5% during the fourth quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock valued at $39,000 after purchasing an additional 372 shares in the last quarter. Hedge funds and other institutional investors own 99.85% of the company’s stock.

Wall Street Analyst Weigh In A number of equities analysts have issued reports on BBIO shares. TD Cowen increased their price objective on BridgeBio Pharma from $95.00 to $110.00 and gave the stock a “buy” rating in a report on Tuesday, August 11th. Truist Financial upped their target price on shares of BridgeBio Pharma from $102.00 to $107.00 and gave the stock a “buy” rating in a research report on Wednesday, August 12th. JPMorgan Chase & Co. upped their target price on shares of BridgeBio Pharma from $100.00 to $111.00 and gave the stock an “overweight” rating in a research report on Wednesday, August 12th. HC Wainwright reiterated a “buy” rating and issued a $120.00 price target on shares of BridgeBio Pharma in a research note on Wednesday, September 2nd. Finally, Raymond James Financial cut shares of BridgeBio Pharma from an “outperform” rating to a “market perform” rating in a research report on Tuesday, May 26th. Twenty analysts have rated the stock with a Buy rating, two have issued a Hold rating and one has assigned a Sell rating to the stock. According to MarketBeat, BridgeBio Pharma presently has an average rating of “Moderate Buy” and an average target price of $101.53.

Get Our Latest Analysis on BridgeBio Pharma BridgeBio Pharma News Summary Here are the key news stories impacting BridgeBio Pharma this week:

Positive Sentiment: HC Wainwright reaffirmed its Buy rating and $120 price target, indicating that the analyst believes BridgeBio’s longer-term growth potential remains intact despite the earnings-estimate reductions. HC Wainwright Reaffirms Buy Rating for BridgeBio Pharma Positive Sentiment: Barclays and Cantor Fitzgerald also maintained Buy ratings on BridgeBio Pharma, providing additional analyst support for the stock. Barclays Sticks to Its Buy Rating for BridgeBio Pharma Cantor Fitzgerald Remains a Buy on BridgeBio Pharma Neutral Sentiment: HC Wainwright’s estimates still imply a transition from losses in 2026 to profitability in 2027, forecasting a $1.88 per-share loss for fiscal 2026 and $1.31 in earnings for fiscal 2027. Negative Sentiment: HC Wainwright lowered its fiscal 2026 EPS forecast to a $1.88 loss from a $1.50 loss and cut its fiscal 2027 estimate to $1.31 from $2.19. It also reduced estimates for several 2027 quarters, including Q1 to a $0.18 loss from $0.11 in earnings and Q2 to $0.19 in earnings from $0.44. Negative Sentiment: The estimate cuts extend to near-term results: Q3 2026 EPS was lowered to a $0.40 loss from a $0.38 loss, while Q4 2026 EPS was trimmed slightly to $0.13 from $0.14. These revisions may weigh on sentiment because they point to slower-than-previously-expected earnings progression. Insider Buying and Selling In related news, Director Andrea Ellis sold 17,167 shares of the stock in a transaction dated Thursday, July 9th. The shares were sold at an average price of $84.00, for a total transaction of $1,442,028.00. Following the sale, the director directly owned 22,579 shares of the company’s stock, valued at approximately $1,896,636. This represents a 43.19% decrease in their position. The sale was disclosed in a document filed with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Hannah Valantine sold 2,808 shares of the firm’s stock in a transaction dated Monday, June 22nd. The shares were sold at an average price of $68.00, for a total transaction of $190,944.00. Following the sale, the director owned 11,455 shares of the company’s stock, valued at approximately $778,940. This represents a 19.69% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold a total of 347,343 shares of company stock worth $27,591,000 over the last quarter. 14.23% of the stock is owned by insiders.

BridgeBio Pharma Stock Performance Shares of NASDAQ:BBIO opened at $74.84 on Monday. The stock has a fifty day simple moving average of $80.74 and a two-hundred day simple moving average of $73.61. BridgeBio Pharma, Inc. has a 12-month low of $48.78 and a 12-month high of $93.42. The stock has a market capitalization of $14.63 billion, a price-to-earnings ratio of -20.96 and a beta of 0.97.

BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last released its earnings results on Monday, August 10th. The company reported ($0.78) EPS for the quarter, missing analysts’ consensus estimates of ($0.58) by ($0.20). The firm had revenue of $243.68 million during the quarter, compared to analysts’ expectations of $220.91 million. During the same quarter in the prior year, the company posted ($0.95) earnings per share. The company’s revenue was up 120.4% on a year-over-year basis. As a group, equities research analysts predict that BridgeBio Pharma, Inc. will post -2.64 EPS for the current year.

BridgeBio Pharma Company Profile (Free Report)

BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.

BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.

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2026-09-02 11:36 1mo ago
2026-09-02 07:30 1mo ago
BridgeBio to Present New Data on the Impact of Oral Infigratinib on Medical Complications in Achondroplasia at the Annual ESPE Meeting 2026
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., Sept. 02, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that one late-breaking oral presentation on the impact of oral infigratinib on medical complications in achondroplasia from PROPEL 3 will be shared at the Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2026, taking place in Marseille, France on September 8-10, 2026.

In addition to the late-breaking oral presentation, two posters and one eposter will be shared on longer-term data for oral infigratinib in achondroplasia, PROPEL I&T–an ongoing Phase 2/2b study in children under 3 years old with achondroplasia, and qualitative research on the impacts of hypochondroplasia.

BridgeBio is committed to exploring the potential of oral infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasia conditions, which hold significant unmet needs for families.

Late-Breaking Oral Presentation:
A Randomized Controlled Trial of Oral Infigratinib in Children with Achondroplasia: Results from the PROPEL 3 Study
Presenter: Julie Hoover-Fong, M.D., Ph.D., Johns Hopkins University, U.S.
Date: Wednesday, September 9 at 10:00 am CEST

Posters:
Longer-Term Efficacy and Safety Results of Infigratinib in Children with Achondroplasia
Presenter: Melita Irving, M.D., Guy's and St Thomas' NHS Foundation Trust, London, UK

PROPEL Infant and Toddler: Study Design and Ongoing Enrollment of a Phase 2/2b Study of Infigratinib in Children under 3 Years Old with Achondroplasia
Presenter: Melita Irving, M.D., Guy's and St Thomas' NHS Foundation Trust, London, UK

ePoster:
Potential Medical Challenges and Functional Impacts of Hypochondroplasia: Qualitative Interviews with Children and Parents
Presenter: Melita Irving, M.D., Guy’s and St Thomas’ NHS Foundation Trust, London, UK

About Achondroplasia
Achondroplasia is the most common cause of disproportionate short stature, affecting approximately 55,000 people in the U.S. and European Union (EU), including up to 10,000 children and adolescents with open growth plates. Achondroplasia impacts overall health and quality of life, leading to medical complications such as obstructive sleep apnea, middle ear dysfunction, kyphosis, and spinal stenosis. The condition is uniformly caused by an activating variant in FGFR3.

About Oral Infigratinib
Oral infigratinib is an investigational small molecule designed to inhibit FGFR3 signaling and target skeletal dysplasias, including achondroplasia and hypochondroplasia, at their source. Overactivating FGFR3 pathogenic variants drive downstream MAPK and STAT1 signaling that aberrates growth plate development, thereby causing disproportionate short stature and the potential for serious health complications. Oral infigratinib improves bone growth by decreasing the overactivity of FGFR3.

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]   
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected] 
2026-09-01 18:35 1mo ago
2026-09-01 13:35 1mo ago
Trump's MFN Push Goes Beyond Big Pharma, Adds 9 Mid-Sized Drugmakers
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways Nine mid-sized drugmakers agreed to lower prescription drug prices under Trump's MFN pricing proposal.The companies committed at least $19.6 billion collectively to near-term U.S. manufacturing.The nine deals lift MFN coverage to 26 drugmakers, spanning 89% of the branded drug market. On Monday, President Trump announced that his administration has signed separate drug-pricing agreements with nine mid-sized pharmaceutical companies to lower drug prices in the country. These companies include Alcon, Astellas Pharma (ALPMY - Free Report) , BeOne Medicines (ONC - Free Report) , BridgeBio Pharma (BBIO - Free Report) , CSL (CSLLY - Free Report) , Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals (TEVA - Free Report) and UCB (UCBJY - Free Report) .

Drug Pricing Deals Leave Some Details UnclearUnder the agreements, these companies agreed to reduce the prices of their prescription drugs to match those in comparable developed countries, as part of President Trump’s Most-Favored-Nation (“MFN”) pricing proposal. However, the announcement does not provide details on the drugs that will be covered or specify the exact size of the price reductions for individual medicines.

In return, each drugmaker will receive a reprieve from import tariffs on pharmaceutical ingredients, contingent upon expanding its domestic manufacturing operations. According to a White House disclosure, these nine companies are committed to investing at least $19.6 billion collectively in U.S. manufacturing in the near term.

New Pharma Deals Also Include API Supply CommitmentsSome of the participating drugmakers have also agreed to contribute active pharmaceutical ingredients (API) for key products to a government stockpile reserve called the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). The reserve is intended to reduce reliance on foreign suppliers and help ensure adequate supplies of critical medicines during emergencies.

In this connection, Astellas has agreed to contribute 25 kg of tacrolimus, which is used to help prevent organ rejection in people who have had organ transplants. In contrast, Teva will supply 45 metric tons of metronidazole, used to treat certain bacterial and parasitic infections, as well as 4.8 tons of amlodipine, a drug used to lower blood pressure.

Meanwhile, UCB has agreed to provide 163 tons of levetiracetam, which is used to control and prevent seizures, while Sun Pharma plans to contribute 71.4 tons of clindamycin and 6.75 tons of doxycycline, antibiotics used to treat bacterial infections.

Trump’s MFN Push Now Covers 26 DrugmakersThe latest agreements build on the administration’s earlier push to secure MFN pricing from the industry’s largest pharmaceutical companies. Pfizer became the first drugmaker to sign such an agreement with the Trump administration in September 2025. This was followed by 16 other major pharmaceutical manufacturers, with Regeneron being the last to sign in April 2026.

With the addition of the nine mid-sized companies, the total number of drugmakers with MFN agreements has risen to 26. The White House said the agreements now cover 89% of the branded drug market.

Notably, the latest group is more geographically diverse than the first 17 companies, which were predominantly based in the United States and Europe. The new cohort includes Sun Pharma from India, Teva Pharmaceuticals from Israel, Astellas and Kyowa Kirin from Japan and CSL from Australia, broadening the reach of the administration’s MFN pricing campaign beyond its earlier focus.

Our Take: MFN Push Enters a New PhaseThe expansion to nine mid-sized drugmakers suggests that the administration’s MFN strategy is moving beyond its initial focus on Big Pharma and becoming a broader industry-wide pricing push. With 26 drugmakers now covered and the administration continuing to pursue additional agreements, the pressure on other manufacturers to strike similar deals could intensify in the coming months.

If this momentum continues, the policy could eventually move beyond voluntary agreements and toward a more permanent framework. The Trump administration has also called on Congress to codify its MFN agreements into law through the Great Healthcare Plan, potentially giving the policy a longer-term footing if enacted.

The timing of the latest agreements is notable, as the administration heads toward the November 2026 midterm elections. Continued announcements around lower drug prices could help reinforce the administration’s message on healthcare affordability, particularly as TrumpRx.gov has already become a key component of its drug-pricing strategy. The White House said the platform has generated more than $700 million in savings since its February launch, with GLP-1 drugs among the most prominent examples of discounted medicines.
2026-09-01 16:09 1mo ago
2026-09-01 12:01 1mo ago
4 Rare Disease Drugmakers With Strong Long-Term Growth Prospects
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways Alnylam's product revenue rose 94%, led by Amvuttra in ATTR-CM, while cemdisiran offers a near-term catalyst.BioMarin is expanding Voxzogo's label and adding new programs to extend its rare-disease growth runway.Ultragenyx and BridgeBio are advancing late-stage candidates alongside growing commercial portfolios. Rare diseases have moved steadily from being an overlooked corner of medicine to an important frontier for drug innovation. The FDA estimates that more than 7,000 rare diseases affect more than 30 million Americans, while most of these conditions still lack approved treatments. The agency defines a rare disease as one affecting fewer than 200,000 people in the United States, a threshold that has supported a specialized regulatory framework and incentives for orphan-drug development.

The scientific case is equally compelling. Many rare diseases are caused by genetic changes, making them suitable for targeted treatments such as RNA interference (RNAi), antisense oligonucleotides, enzyme replacement and gene therapy. Advances in molecular biology and genetic medicine are enabling drugmakers to target the root causes of these diseases instead of just managing symptoms. At the same time, the large collective patient population and high unmet need create significant commercial opportunities for therapies that can demonstrate meaningful clinical benefits.

Against this backdrop, Alnylam Pharmaceuticals (ALNY - Free Report) , BioMarin Pharmaceutical (BMRN - Free Report) , Ultragenyx Pharmaceutical (RARE - Free Report) and BridgeBio Pharma (BBIO - Free Report) stand out. While their platforms differ, all four have commercialized therapies targeting rare or genetically defined disorders and are advancing additional programs to extend their growth runways. Their combination of established product revenue, pipeline catalysts and exposure to diseases with substantial unmet needs makes these stocks worth watching for long-term growth opportunities. All four companies currently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Alnylam PharmaceuticalsAlnylam has built a leading RNAi franchise around genetically validated disease targets. Its commercial portfolio includes Amvuttra and Onpattro for hereditary transthyretin (ATTR) amyloidosis, Givlaari for acute hepatic porphyria and Oxlumo for primary hyperoxaluria type 1. Amvuttra is also approved for ATTR cardiomyopathy (ATTR-CM). In the first half of 2026, AMVUTTRA generated $1.90 billion in global net product revenue, up 137% year over year, while Givlaari and Oxlumo contributed $164.2 million and $103.4 million, respectively. Total product revenue increased 94% to $2.21 billion, driven primarily by higher demand for Amvuttra, particularly among U.S. ATTR-CM patients.

Year to date, ALNY shares have plunged 39.4% against the industry’s 8.7% growth.

Image Source: Zacks Investment Research

Looking ahead, Alnylam has several pipeline opportunities that could extend its growth beyond its current commercial portfolio. The most immediate opportunity is cemdisiran, which Alnylam is developing in partnership with Regeneron. The FDA is currently reviewing a new drug application (NDA) for cemdisiran monotherapy in generalized myasthenia gravis under the priority review pathway, with a decision expected in November 2026. The candidate is also under review in the EU for the same indication. Cemdisiran is also being evaluated in phase III studies for additional indications, including paroxysmal nocturnal hemoglobinuria and geographic atrophy.

Beyond cemdisiran, Alnylam’s other potential longer-term growth drivers include nucresiran, being developed in separate late-stage studies for hereditary ATTR polyneuropathy and ATTR-CM. Mivelsiran is being studied in separate phase II studies for cerebral amyloid angiopathy and Down syndrome-associated Alzheimer’s disease, while ALN-6400 is undergoing mid-stage development for hereditary hemorrhagic telangiectasia and von Willebrand disease. ALN-HTT02 is being evaluated in a phase Ib study for Huntington's disease.

BioMarin PharmaceuticalBioMarin is a leading global rare-disease biotechnology company focused on developing medicines for genetically defined conditions, supported by a broad commercial portfolio. In the first half of 2026, Voxzogo, indicated for achondroplasia, generated $472.4 million, up 9% year over year, driven by higher sales volume from new patients. Naglazyme, for mucopolysaccharidosis type VI, generated $265.3 million, up 9%, while Palynziq, for phenylketonuria, brought in $224.7 million, up 13%, supported by higher patient starts, primarily in the United States. Galafold, approved for Fabry disease, contributed $105.7 million, and Pombiliti plus Opfolda, for Pompe disease, generated $30.3 million following BioMarin’s acquisition of Amicus in April 2026.

Year to date, BMRN stock has gained 9.8% compared with the industry’s 8.7% growth.

Image Source: Zacks Investment Research

Beyond its commercial portfolio, BioMarin has several opportunities to extend its rare-disease growth runway through label expansions, clinical-stage programs and business development. The FDA is currently reviewing BMRN’s application seeking full approval of Voxzogo in children with achondroplasia, with a Feb. 28, 2027, decision date. Additionally, it also submitted a supplemental NDA for Voxzogo to treat hypochondroplasia in July after phase III success. The company has also advanced the drug in clinical studies for two other short-stature pathway conditions — idiopathic short stature and Noonan Syndrome — in separate mid-stage studies.

BioMarin also has several potential growth drivers beyond Voxzogo. BMN 333, a long-acting CNP, entered a registration-enabling phase II/III study for achondroplasia in April 2026. BioMarin also acquired U.S. rights to BMN 820, a potential first-in-class oral CCR2 inhibitor for focal segmental glomerulosclerosis. Last month, BMRN agreed to acquire ALE1, an oral phase I/IIa candidate for hypophosphatasia, for $275 million upfront plus potential milestone payments, from Alesta Therapeutics.  Together with the expanding Voxzogo franchise and the newly added Amicus assets, these programs provide avenues for extending growth well beyond the company's current products.

Ultragenyx PharmaceuticalUltragenyx is perhaps the clearest pure-play rare-disease name in the group, focused on developing and commercializing therapies for serious rare and ultra-rare genetic diseases. Its four commercial products are Crysvita for X-linked hypophosphatemia and tumor-induced osteomalacia, Dojolvi for long-chain fatty-acid oxidation disorders, Evkeeza for homozygous familial hypercholesterolemia and Mepsevii for mucopolysaccharidosis type VII. RARE commercializes Evkeeza outside the United States under its partnership with Regeneron. In the first half of 2026, total revenues increased 14% to $350 million. Growth was primarily driven by higher Crysvita sales, particularly in Latin America, due to an increase in patients and the favorable timing of shipments, as well as continued international expansion of Evkeeza.

Year to date, RARE shares have gained 9.6% compared with the industry’s 8.7% growth.

Image Source: Zacks Investment Research

Ultragenyx has since added another commercial asset. Last month, the FDA granted accelerated approval to Genglycos (DTX401) for adults and children at least eight years old with glycogen storage disease type Ia, making it the company's fifth FDA-approved therapy. Meanwhile, an NDA for UX111 to treat Sanfilippo syndrome type A is currently under FDA priority review and has a Sept. 19, 2026, decision date.

RARE has several late-stage pipeline candidates. GTX-102 is in phase III development for Angelman syndrome, with pivotal data expected in September or October 2026. UX701, an investigational AAV9 gene therapy, is being evaluated in a phase I/II/III Cyprus2+ study to treat Wilson disease and expects to share top-line data in the fourth quarter. DTX301 is also undergoing late-stage development for ornithine transcarbamylase deficiency.

BridgeBio PharmaBridgeBio is a commercial-stage biopharmaceutical company focused on medicines for genetic diseases. Attruby (acoramidis) is its sole major commercial product in the United States, marketed as Beyonttra internationally, approved for ATTR-CM. In the first half of 2026, product revenues surged 272% year over year to $403 million, reflecting continued commercial expansion and strong patient demand for Attruby. The company is also evaluating the potential kidney-protective benefits of acoramidis, while a recent government agreement is expected to broaden access to Attruby for Medicaid patients.

Year to date, BBIO shares have gained 0.1% compared with the industry’s 6.3% growth.

Image Source: Zacks Investment Research

Looking ahead, BridgeBio has three late-stage candidates that could broaden its rare-disease portfolio. BBP-418, an oral therapy for limb-girdle muscular dystrophy type 2I/R9, is currently undergoing FDA priority review, with a Nov. 27, 2026, decision date. An NDA for encaleret, a potential targeted treatment for autosomal dominant hypocalcemia type 1, is also currently under FDA review with a decision expected on May 8, 2027. Additionally, BridgeBio has submitted an NDA seeking FDA approval of low-dose infigratinib for achondroplasia. BBIO is also evaluating these candidates for additional indications, with encaleret being evaluated in a phase III study for chronic hypoparathyroidism and infigratinib in a phase II/III study for hypochondroplasia.

BridgeBio is also expanding its longer-term opportunity around acoramidis. The company recently dosed the first patient in ASCEND-ATTR, a phase IIIb/IV study evaluating the long-term effects of acoramidis on cardiac structure, function and amyloid burden in ATTR-CM.
2026-09-01 13:42 1mo ago
2026-09-01 07:30 1mo ago
BridgeBio to Participate in September Investor Conferences
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., Sept. 01, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced that members of its management team will participate in fireside chats at the following healthcare investor conferences:

21st Annual Wells Fargo Healthcare Conference, Boston, MA: Wednesday, September 9 at 1:30 pm EDT2026 Cantor Global Healthcare Conference, New York, NY: Thursday, September 10 at 9:10 am EDTMorgan Stanley 24th Annual Global Healthcare Conference, New York, NY: Tuesday, September 15 at 10:00 am EDTBernstein Insights Healthcare Leaders and Disruptors 2026, New York, NY: Wednesday, September 23 at 9:40am EDT
To access the live webcast of BridgeBio’s presentations, please visit the “Events and Presentations” page within the Investors section of the BridgeBio website at https://investor.bridgebio.com. A replay of the webcasts will be available on the BridgeBio website for 90 days following the event.

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected] 
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-08-31 20:42 1mo ago
2026-08-31 15:44 1mo ago
BridgeBio Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

- This voluntary agreement expands access for Medicaid patients to BridgeBio’s currently marketed medicine and lowers drug costs for Americans without jeopardizing innovation and sustainability in rare diseases

- BridgeBio will continue to offer Attruby® via Medicare Part D without any future pricing mandates

- The agreement has no impact on ForgingBridges®, a copay assistance program that helps reduce out-of-pocket costs to as little as $0 per month for qualifying patients

PALO ALTO, Calif., Aug. 31, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it has entered into a voluntary agreement with the U.S. government to expand access to its medicines and lower costs for American patients. Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio, joined President Donald J. Trump and members of his Administration at the White House to discuss the new agreement, which improves access to treatments for rare genetic diseases without jeopardizing innovation or sustained investment. 

Millions of people worldwide live with rare genetic conditions that have no approved treatment options because developing medicines for rare diseases has never been commercially straightforward. Today’s agreement with the Administration is intended to ensure that BridgeBio will be able to continue bringing medicines to people living with rare genetic diseases. As part of the agreement, BridgeBio will expand state Medicaid access to its currently marketed medicine via the GENEROUS Model.

This builds on the Company’s existing patient access work, including ForgingBridges, BridgeBio’s patient support program, which provides reimbursement navigation and financial assistance to qualifying patients, potentially minimizing out-of-pocket costs to as little as $0 per month.

BridgeBio does not expect to be subject to future pricing mandates. The specific terms of the agreement remain confidential.

“As an American biotech, it’s a privilege to be working alongside the Administration to ensure the broadest possible access for Americans to the medicines that we make. Thirty million Americans suffer from rare genetic disorders, and our intent is to reliably innovate new medicines and bring them to as many communities as possible,” said Dr. Kumar. “Within the field of ATTR-CM, we’ve already launched the lowest-priced product with the best data at 30 months, and we continue to look forward to working with anyone who wants to help improve access to treatment for the patients who need it.”

BridgeBio’s model was built to make drug development and innovation economically viable for genetic conditions that affect small patient populations. The Company’s approved medicine, Attruby, is available to people with transthyretin amyloid cardiomyopathy, and the Company has three additional medicines under FDA review, each for a genetic condition with limited or no approved treatment options: BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PDUFA date with Priority Review: November 27, 2026); encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027); and infigratinib for achondroplasia.

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

These forward-looking statements include statements regarding the anticipated implementation, scope and effects of BridgeBio’s agreement with the U.S. government, including BridgeBio’s plans to expand Medicaid access to Attruby through the GENEROUS Model; BridgeBio’s expectation that it will not be subject to future pricing mandates; and the anticipated impact of the agreement on patient access, affordability and BridgeBio’s ability to continue developing and providing medicines for rare genetic diseases.

Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the risk that the agreement may be implemented, interpreted or applied differently than BridgeBio currently expects; that federal or state laws, regulations, policies, reimbursement frameworks or government pricing programs may change or be implemented in a manner that adversely affects BridgeBio or its products; that BridgeBio may become subject to additional pricing mandates, requirements or restrictions notwithstanding its current expectations that the agreement may not result in the anticipated improvements in access, affordability or other expected benefits; that the agreement or future changes in government pricing or reimbursement policies may adversely affect BridgeBio’s business, results of operations or ability to continue investing in the development and commercialization of medicines for rare genetic diseases; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission.

Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-08-30 19:26 1mo ago
2026-08-25 14:36 2mo ago
Is BBIO a Buy as Fast Sales Growth Meets a Steep Valuation Premium?
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways BridgeBio's second-quarter 2026 revenues jumped 120%, driven by rapid growth in Attruby sales.Three potential U.S. launches could broaden BBIO's revenue base over the next 12 months.BBIO trades at a 11.96 EV-to-sales ratio, well above its comparison groups. BridgeBio Pharma (BBIO - Free Report) is entering a pivotal commercial stretch. Attruby is scaling quickly, while three late-stage candidates could widen the company’s revenue base over the next year.

The trade-off is a demanding valuation alongside continued losses, product concentration and launch risk. The investment case therefore depends on whether commercial expansion can justify BBIO’s premium to its comparison groups.

BBIO’s Growth Case Starts With AttrubySecond-quarter 2026 revenues jumped 120% year over year to $243.7 million, topping the Zacks Consensus Estimate of $222.6 million. Attruby generated $222.4 million in U.S. product sales, more than triple the $71.5 million reported a year earlier.

Attruby’s first-half 2026 U.S. sales reached $403 million. The Zacks Consensus Estimate calls for 2026 revenues of $1,008 million, while BridgeBio estimates that diagnosed U.S. ATTR-CM patients increased from fewer than 5,000 in 2019 to more than 50,000 in 2025. The expanding diagnosed population supports Attruby’s commercial opportunity.

BridgeBio’s Pipeline Could Broaden Revenue SourcesBridgeBio is preparing for three potential U.S. product launches over the next 12 months. BBP-418 is under FDA review for limb-girdle muscular dystrophy type 2I/R9, with a decision expected by Nov. 27, 2026. If approved, it could become the first therapy for this patient population.

Encaleret is under review for autosomal dominant hypocalcemia type 1, with an FDA decision expected by May 8, 2027. BridgeBio also submitted infigratinib for achondroplasia in the third quarter of 2026 and is targeting a potential launch in early to mid-2027. A $1 billion preferred equity financing closed July 1 to support current and planned launches.

BBIO’s Valuation Demands Strong ExecutionBBIO trades at a forward 12-month enterprise-value-to-sales ratio of 11.96 versus 2.87 for the Zacks sub-industry, 2.58 for the Zacks Medical sector and 4.84 for the S&P 500. Shares have gained 24% in the past three months and 71.4% in the past year.

The current multiple is below BBIO’s five-year median of 34.62, but the gap versus broader comparison groups remains substantial. That premium makes regulatory delays, slower product uptake or weaker-than-expected Attruby share gains more consequential for investors.

BridgeBio Still Faces Concentration and Launch RisksAttruby remains BridgeBio’s only approved commercial product. Pfizer Inc. (PFE - Free Report) continues to market Vyndamax for ATTR-CM, while Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) has Amvuttra approved for ATTR-CM. BridgeBio said Attruby’s estimated frontline share rose two to three percentage points in the second quarter, but payer access and continued clinical differentiation remain important for further gains.

Execution risk extends beyond Attruby. BridgeBio must build physician awareness, identify eligible patients and secure reimbursement for potential new products. The company also reported a second-quarter loss of 78 cents per share versus the consensus loss estimate of 64 cents, while research and development expenses rose 34% and selling, general and administrative expenses increased 44%.

BBIO’s Style Scores Favor Growth Over ValueThe balance of rapid sales expansion, a broader potential product base and a steep relative valuation supports a measured stance rather than an aggressive directional call. Commercial progress could strengthen the case, but regulatory and launch execution remain central to the outlook.

BBIO currently carries a Zacks Rank #3 (Hold), which supports a measured posture. Its Growth Score of B indicates relatively favorable growth characteristics. By contrast, its Value Score of F and Momentum Score of D point to weaker valuation and momentum characteristics, while its VGM Score of D shows that the combined style profile is not broadly favorable. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
2026-08-30 19:25 1mo ago
2026-08-25 14:36 2mo ago
Why BBIO Rose 24% in Three Months and Whether the Rally Can Continue
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways Attruby sales reached $403 million in the first half of 2026, supporting BBIO's growth.BBP-418, encaleret and infigratinib offer catalysts that could broaden BBIO's commercial base.BBIO's 12.0X forward EV/Sales valuation leaves less room for execution or regulatory setbacks. BridgeBio Pharma (BBIO - Free Report) shares have gained 24% in the past three months, far ahead of the S&P 500’s 0.7% rise over the same period. The move leaves investors weighing whether improving commercial and pipeline momentum can support further gains.

Attruby’s growth and multiple regulatory catalysts strengthen the fundamental case. Still, a rich valuation and meaningful execution risk leave less room for disappointment after the recent advance.

BBIO’s Three-Month Rally Sets a Higher BarThe stock’s three-month gain extends a much larger 71.4% advance over the past year. That compares with gains of 6.6% for its Zacks sub-industry and 12.4% for the Zacks Medical sector over three months.

Over the past year, the sub-industry and sector rose 32.5% and 13.1%, respectively. BBIO’s outperformance raises the bar for future results, making continued operating progress more important as investors assess the next leg of the stock’s move.

Attruby Growth Gives BBIO Fundamental SupportAttruby generated $403 million in U.S. sales during the first half of 2026 after producing $362.4 million in 2025. BridgeBio also said Attruby continued gaining share among treatment-naive patients in the second quarter, while diagnosed ATTR-CM patients in the United States exceeded 50,000 in 2025.

The competitive backdrop remains important. Pfizer Inc. (PFE - Free Report) remains an established competitor through the Vyndaqel family. Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) also competes with Amvuttra in ATTR-CM. Continued first-line adoption and broader diagnosis will therefore be key to sustaining Attruby’s growth.

BBIO’s Pipeline Adds Near-Term Upside CatalystsBBP-418 is the closest major regulatory event, with an FDA decision expected by Nov. 27, 2026, for limb-girdle muscular dystrophy type 2I/R9. If approved, it could become the first therapy for that patient population, and BridgeBio has said it is prepared to launch upon approval.

Encaleret has an FDA decision date of May 8, 2027, for autosomal dominant hypocalcemia type 1. Infigratinib adds another potential launch, with BridgeBio targeting early to mid-2027 in achondroplasia. Successful approvals would broaden the commercial base beyond Attruby.

Valuation Could Limit Further BBIO UpsideBBIO trades at 12.0X forward 12-month EV/Sales, well above 2.9X for its Zacks sub-industry and 2.6X for the Zacks Medical sector. The S&P 500 trades at 4.8X on the same measure.

That premium leaves less valuation support if commercial execution slows or regulatory outcomes disappoint. Continued Attruby growth and successful pipeline conversion may be needed for the stock to sustain a premium multiple after its recent rally.

BBIO’s Mixed Signals Keep Expectations in CheckThe bottom line is that BBIO has credible growth drivers, but the stock already discounts meaningful progress. Attruby is scaling quickly and several late-stage assets could diversify revenues, while competition, regulatory risk and valuation remain important offsets.

BBIO currently carries a Zacks Rank #3 (Hold), with a Growth Score of B, Value Score of F, Momentum Score of D and VGM Score of D. The favorable Growth Score points to stronger growth characteristics, but the weaker value, momentum and combined scores temper the near-term setup. That mix supports a measured view rather than assuming the three-month rally will continue at the same pace. 

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
2026-08-30 19:25 1mo ago
2026-08-25 14:42 2mo ago
BridgeBio Q2 Sales Jump 120% as Attruby Drives Commercial Momentum
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways BridgeBio's Q2 revenue reached $243.7 million, led by Attruby's $222.4 million in U.S. sales.Attruby's first-line share gained two to three points as patient switching from Pfizer normalized.BridgeBio had about $1.7 billion in cash after a July financing, supporting three potential launches. BridgeBio Pharma (BBIO - Free Report) entered the second half of 2026 with Attruby doing most of the commercial heavy lifting. Second-quarter revenues rose 120% year over year and topped the Zacks Consensus Estimate, but the company still posted a wider-than-expected loss as development and launch spending increased.

That split matters for investors. Attruby is scaling quickly while BridgeBio funds several late-stage programs and potential launches. The question for the rest of 2026 is whether first-line ATTR-CM share gains can keep revenue momentum moving.

BBIO’s Q2 Sales Beat Came From AttrubySecond-quarter revenues reached $243.7 million, above the Zacks Consensus Estimate of $222.6 million. Attruby generated $222.4 million in U.S. product sales, more than tripling from $71.5 million a year earlier and accounting for most of the quarter's top line.

Royalty revenues rose to $15.4 million from $1.6 million, mainly on Beyonttra sales in the European Union and Japan. License and services revenues fell more than 84% to $5.8 million because the year-earlier period included a $30 million regulatory milestone.

BridgeBio’s Loss Shows the Cost of ExpansionBridgeBio lost 78 cents per share, wider than the Zacks Consensus Estimate of a 64-cent loss, though the result improved from a 95-cent loss a year earlier. Revenue growth has not yet translated into profitability.

Research and development expenses increased 34% to $149.4 million as BridgeBio invested in late-stage programs. Selling, general and administrative expenses climbed 44% to $186.3 million as the company supported Attruby commercialization and pre-commercial work for upcoming launches.

BBIO’s First-Line Share Gains Matter for 2026Management sees treatment-naive patients as Attruby's key long-term growth source. The pool of patients switching from Pfizer's Vyndaqel/Vyndamax has begun to normalize after elevated activity in prior quarters. BridgeBio estimated that Attruby's first-line share rose two to three percentage points in the second quarter.

Pfizer Inc. (PFE - Free Report) competes through its Vyndaqel family, the therapy from which some Attruby patients have switched. Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) adds another ATTR-CM competitor through Amvuttra. Sustained first-line gains therefore matter as switching provides less incremental support.

BridgeBio’s Cash Position Supports More LaunchesBridgeBio ended June with $720.2 million of cash, cash equivalents and marketable securities, down from $940.2 million at the end of the prior quarter. That figure excluded the $1 billion preferred equity financing that closed July 1 and lifted the cash balance to about $1.7 billion.

The added liquidity supports a period in which BridgeBio is preparing for three potential U.S. product launches over the next 12 months. BBP-418 has an FDA decision date of Nov. 27, 2026. Encaleret is under review for a May 8, 2027 decision, while infigratinib is targeted for a potential early- to mid-2027 launch if approved.

BBIO’s Ratings Reflect Growth With Execution RiskThe bottom line is that commercial momentum is clear, but earnings pressure remains. Attruby delivered the sales beat, while BridgeBio continues to absorb high development and commercialization costs and relies heavily on one marketed product.

BBIO currently carries a Zacks Rank #3 (Hold). Within the Style Score framework, a #3 Rank sits between the stronger #1 (Strong Buy) and #2 (Buy) categories and the weaker #4 (Sell) and #5 (Strong Sell) categories. You can see the complete list of today’s Zacks #1 Rank stocks here.

The Growth Score of B is BBIO's strongest style signal, while the Momentum Score of D and Value Score of F are less favorable. Its VGM Score of D points to a mixed combined profile as BridgeBio works to sustain Attruby growth and execute on its launch pipeline.
2026-08-30 19:25 1mo ago
2026-08-26 07:30 1mo ago
BridgeBio Announces First Participant Dosed in ASCEND-ATTR, a Phase 3b/4 Study Evaluating the Long-Term Effects of Acoramidis on Disease Regression in ATTR-CM
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

- The ASCEND-ATTR study builds on the Phase 3 ATTRibute-CM CMR substudy results previously shared here, which indicated treatment with acoramidis may improve cardiac structure and function with evidence of amyloid regression in a subset of patients

- ATTR-CM has long been treated as a disease where progression can be slowed, but these findings raise the possibility that acoramidis may be capable of reversing progression and actively restoring heart health. TTR stabilization with acoramidis may allow the body's natural amyloid clearance mechanisms to outpace amyloid formation, thereby enabling cardiac remodeling and functional recovery

- ASCEND-ATTR will determine whether long-term acoramidis treatment is associated with sustained improvement in cardiac structural disease damage, function, and amyloid burden

- Additional data from the CMR substudy of ATTRibute-CM and its open-label extension compared to a natural history cohort will be shared at the ESC Congress 2026

PALO ALTO, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that the first participant has been dosed in ASCEND-ATTR, a Phase 3b/4 study designed to further characterize the long-term effects of acoramidis on the improvement of cardiac structure, function, and amyloid burden in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

“Serial cardiac imaging from the ATTRibute-CM CMR substudy gave us the first real signal that TTR stabilization can do more than slow disease progression, it may allow the heart to recover function and remodel favorably over time,” said Ahmad Masri, M.D., M.S. of Oregon Health and Science University. “ASCEND-ATTR will allow us to study these structural and functional changes prospectively and in far greater depth, across a notably larger patient cohort and with two complementary imaging modalities, to better understand the extent to which favorable remodeling can be achieved with long-term acoramidis treatment.”

ASCEND-ATTR is a single-arm, prospective, longitudinal, open-label study that will enroll approximately 150 participants with ATTR-CM. Cardiovascular magnetic resonance (CMR) and cardiac echocardiography will be performed annually over 36 months. The primary efficacy endpoint is responder status at Month 36 by CMR, based on improvement from baseline in LV systolic function. Secondary endpoints include CMR measures of cardiac function, structure, and amyloid burden at Month 36, along with echocardiographic measures, circulating biomarkers, and imaging assessments at Months 12 and 24. This study reflects BridgeBio's relentless pursuit in advancing care and addressing the unmet needs of the ATTR-CM community.

The previously presented CMR substudy of ATTRibute-CM found treatment with acoramidis suggested disease improvement across multiple measurements of cardiac structure and function through month 30, including mean improvement from baseline in Left Ventricular Mass Index (LVMi), Left Ventricular Stroke Volume Index (LVSVi), and Left Ventricular Ejection Fraction (LVEF) with evidence of amyloid regression in a subset of patients. TTR stabilization with acoramidis may allow the rate of innate amyloid clearance mechanisms to exceed the rate of amyloid formation, thereby enabling cardiac remodeling and functional recovery. These findings suggest acoramidis may be capable of altering the trajectory of this otherwise progressive disease and actively restoring heart health. Additional data from the CMR substudy of ATTRibute-CM and its open-label extension compared to a natural history cohort will be shared at the European Society of Cardiology (ESC) Congress 2026.

More information on ASCEND-ATTR (NCT07695701) can be found here on clinicaltrials.gov.

About Attruby™ (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding acoramidis, including the potential for acoramidis to improve cardiac structure and function, promote cardiac remodeling and functional recovery, alter or reverse the progression of ATTR-CM, and restore heart health; the potential for TTR stabilization with acoramidis to allow innate amyloid clearance mechanisms to exceed the rate of amyloid formation and thereby enable cardiac remodeling and functional recovery; the design, conduct, enrollment, timing, endpoints and anticipated ability of ASCEND-ATTR to further characterize the long-term effects of acoramidis on cardiac structure, function and amyloid burden, including whether long-term treatment with acoramidis is associated with sustained improvement in cardiac structural disease damage, function and amyloid burden; and BridgeBio’s plans to present additional data from the CMR substudy of ATTRibute-CM and its open-label extension at future medical meetings. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials, including ASCEND-ATTR; the risk that results from subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed improvements in cardiac structure, function or amyloid burden may not be replicated in additional analyses or studies or translate into improved long-term clinical outcomes; that mechanistic interpretations of observed data, including the potential relationship between TTR stabilization, innate amyloid clearance, cardiac remodeling and functional recovery, may not be borne out by further analyses or additional data; that ASCEND-ATTR may not demonstrate sustained improvement in cardiac structure, function or amyloid burden or otherwise confirm the findings or therapeutic implications suggested by prior analyses; that plans to present additional data may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact: 
Kaitlyn Reilly, Director, Communications
[email protected] 
(650)-789-8220 

BridgeBio Investor Contact: 
Kristen Kelleher, Director, Investor Relations 
[email protected] 
2026-08-30 19:25 1mo ago
2026-08-30 10:00 1mo ago
Acoramidis Demonstrates Reversal of Cardiac Structural Disease Progression and Functional Decline and Significantly Increases Days Alive and Free from Hospitalization in ATTR-CM
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

- Acoramidis is the first therapy shown to potentially reverse cardiac structural disease progression and functional decline through 42 months based on CMR imaging, with up to half of patients showing clinically meaningful improvement in cardiac function in the completer analysis

- Patients treated with acoramidis were observed to have an unprecedented 65 additional days alive and out of the hospital by Month 36 versus baseline placebo patients

- Acoramidis demonstrated long-term efficacy and safety through 54 months across variant ATTR-CM subgroups, including p.Val142Ile and non-p.Val142Ile. These findings were simultaneously published in the European Journal of Heart Failure

PALO ALTO, Calif., Aug. 30, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, presented new analyses from the Phase 3 ATTRibute-CM study of Attruby® (acoramidis) in transthyretin amyloid cardiomyopathy (ATTR-CM), including the cardiac magnetic resonance imaging (CMR) substudy and the open-label extension (OLE) at the European Society of Cardiology (ESC) Congress 2026. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

“The clinical community is excited about the potential to restore heart health found in these data. For a long time, patients living with ATTR-CM could only hope for a stop to the otherwise relentless progression of disease. These new CMR data from ATTRibute-CM shows evidence of reversal in a meaningful proportion of individuals treated with acoramidis, with roughly half showing improved left ventricular systolic function in the completer analysis, more than 2x the proportion observed in the natural history from a NAC cohort or in ATTRibute-CM participants treated with placebo. These findings support acoramidis as a therapy capable of altering the trajectory of this otherwise progressive disease,” said Marianna Fontana, M.D. of University College London, UK. “For patients and clinicians navigating ATTR-CM, this is an exciting signal that the treatment paradigm is shifting toward a therapy that could actively restore heart health rather than only manage decline.”

The CMR substudy of ATTRibute-CM and its open-label extension provide the first evidence from serial CMR that a therapy can potentially reverse disease progression through Month 42. The findings presented by Awais Sheikh, MBChB of the National Amyloidosis Centre, London, UK were evaluated using two complementary analytical approaches, which found:

In a completer analysis, clinically meaningful improvement from baseline in left ventricular (LV) systolic function was observed in 54% of acoramidis-treated patients versus 20% of placebo-treated patients at Month 30, and in 53% of continuous-acoramidis patients at Month 42For context, only 26% of completers in an independent natural history cohort demonstrated improved LV systolic function by Month 24 – approximately half the rate observed with acoramidis, suggesting that this magnitude of improvement falls outside the expected natural course of diseaseIn a conservative analysis, long-term acoramidis treatment was associated with clinically meaningful improvement from baseline in LV systolic function in approximately one-third of patients over 30-42 months. Improvement was observed in 34% of acoramidis-treated patients versus 9% of placebo-treated patients at Month 30 and in 30% of continuous-acoramidis patients at Month 42In addition, 46% of patients receiving continuous acoramidis demonstrated improvement from baseline in LV mass index at Month 42, providing evidence of favorable structural remodelingThese results provided sufficient evidence for BridgeBio to recently dose its first participant in ASCEND-ATTR, a Phase 3b/4 study designed to determine if acoramidis is associated with sustained improvement in myocardial structural disease progression, function and amyloid burden In a post-hoc analysis of ATTRibute-CM presented by Richard Wright, M.D. of the Pacific Heart Institute, U.S., acoramidis preserved significantly more time alive outside the hospital for patients with ATTR-CM. The analysis evaluated days lost to death and/or cardiovascular-related hospitalization (DLDCVH), a patient-centered measure that integrates all-cause mortality, cardiovascular-related hospitalizations, and length of stay into a single assessment of disease burden. Key findings included:

In participants with ATTR-CM, acoramidis reduced the estimated mean percentage of DLDCVH to 7.5% versus 11.7% with placebo through Month 30Acoramidis preserved more than one month of additional time alive and out of the hospital (38 days) over 30 months with the benefit nearly doubling to 65 days (observed) over three years, and nearly tripling to up to 94 days (modelled estimates) over three years, reflecting progressive divergence in outcomes over time The p.Val142Ile genetic variant is the most common ATTR-CM genetic variant globally, disproportionately affecting individuals of Western African ancestry, with a carrier frequency of 3-4% in the U.S. Black population. Findings in the ATTRibute-CM OLE presented by Kevin Alexander, M.D. of Stanford University School of Medicine, U.S. showed continued benefit of acoramidis in 56 variant ATTR-CM (ATTRv-CM) patients, including 35 p.Val142Ile and 21 non-p.Val142Ile patients through Month 54, demonstrating:

All-cause mortality (ACM) and cardiovascular mortality (CVM) were markedly lower in the continuous acoramidis arm versus placebo-to-acoramidis across both p.Val142Ile and non-p.Val142Ile variant subgroupsThrough Month 54, ACM was 30.4% with continuous acoramidis versus 66.7% with placebo-to-acoramidis in the p.Val142Ile subgroup, and 24.3% with continuous acoramidis versus 57.9% with placebo-to-acoramidis across the overall ATTRv-CM population, a consistent, more than two-fold difference in mortality favoring continuous treatmentThe ACM and CVM rates at Month 54 were notably high (~65%) in the p.Val142Ile group who were randomized to placebo in ATTRibute-CM, underscoring the substantial unmet medical need in this high-risk subgroupContinuous acoramidis achieved sustained increases in serum TTR (sTTR) and persistent attenuation of N-terminal pro-B-type natriuretic peptide (NT-proBNP) rise through Month 54 in both participants with p.Val142Ile or non-p.Val142Ile variantsThese Month 54 findings extend the survival benefit and favorable biomarker trends previously reported at Month 30, demonstrating the long-term durability of efficacy and safety of acoramidis in ATTRv-CM, including in the p.Val142Ile subgroupAcoramidis remained well tolerated through Month 54, with no new safety signals observed in the OLE In addition to the one oral presentation and two moderated posters highlighted, two additional moderated posters on acoramidis were shared at the ESC Congress 2026, including:

Acoramidis Improves Health-Related Quality of Life in Wild-Type and Variant Transthyretin Amyloid Cardiomyopathy: An EQ-5D-5L Subgroup Analysis from ATTRibute-CM, presented by Emer Joyce, M.D., Ph.D. of The Mater Misericordiae University Hospital, IE Treatment with acoramidis resulted in significant and clinically meaningful benefits in health-related quality of life (HRQoL) in both wild-type ATTR-CM (ATTRwt-CM) and ATTRv-CM. Greater impact on HRQoL versus placebo was observed in participants with ATTRv-CM Improvement of Health Status with Acoramidis in Patients with Wild-Type and Variant Transthyretin Amyloid Cardiomyopathy: KCCQ Domains Analysis from the ATTRibute-CM Study, presented by Nitasha Sarswat, M.D. of University of Chicago Medical Center, U.S. In ATTRibute-CM, acoramidis attenuated the decline in heart failure-related health status versus placebo in participants with ATTRwt-CM and ATTRv-CM, with consistent benefits observed across Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) and individual domain scores. A numerical improvement was observed across almost all KCCQ domains in acoramidis-treated participants with ATTRwt-CM and ATTRv-CM relative to placebo As part of BridgeBio's partnership with Yale's Cardiovascular Data Science (CarDS) Lab to advance AI networks for earlier detection of ATTR-CM, three posters were presented at the ESC Congress 2026. Findings from the partnership included:

A Novel AI-Derived Digital Biomarker for Monitoring Disease Progression in ATTR-CM: First-In-Trial Use of a Computer Vision AI-ECG Algorithm within a Phase 3 Pivotal Randomized Controlled Trial, presented by Rohan Khera, M.D. of Yale School of Medicine, U.S. This showed the first deployment of a computer vision AI-ECG algorithm, operating directly on ECG data, as a digital biomarker in a RCT (ATTRibute-CM). An image-based AI-ECG algorithm demonstrated discrimination across clinical subgroups at baseline and detected differential longitudinal changes between acoramidis and placebo over 30 months. These findings support the potential role of AI-ECG derived prediction scores as a scalable digital biomarker in clinical trials and potential routine cardiovascular care A Fully Decentralized, Patient-Led Digital Registry for ATTR-CM Integrating Multisystem EHR and Wearable Data: The DISCOVER-ATTR Study, presented by Aline Pedroso, Ph.D. of Yale School of Medicine A fully decentralized, patient-led digital registry can successfully aggregate longitudinal multisystem electronic health records (EHR) data and wearable physiologic signals in ATTR-CM. Early results show substantial data yield and feasibility of longitudinal mapping of care trajectories and multimodal risk prediction, providing a blueprint for next-generation registries in rare cardiovascular diseases Nationwide U.S. Federated Deployment of Artificial Intelligence for Multimodal Screening of ATTR Cardiomyopathy: First Multicenter Analysis from the TRACE-AI Network, presented by Bruno Batinica, MBChB of Yale School of Medicine In this largest-ever deployment of AI-electrocardiogram and AI-Echo models for opportunistic retrospective screening of individuals at risk of ATTR-CM, we demonstrate a large burden of probable undiagnosed ATTR-CM with prognostic implications. Leveraging this framework for screening holds promise for enabling broad, timely identification of patients to maximize the overall benefit of new therapies Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Additional data on the benefit of Attruby for individuals with ATTR-CM is planned for future medical meetings, including Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, taking place in Phoenix, Arizona on October 9-12, 2026.

About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data presented regarding acoramidis, including the potential clinical and therapeutic implications of observed changes in cardiac structure and function and the potential for acoramidis to alter the trajectory of ATTR-CM and restore heart health; the potential utility of AI-based tools and digital biomarkers for the detection, monitoring and screening of ATTR-CM in clinical trials and clinical practice; and BridgeBio’s plans to present additional data regarding Attruby at future medical meetings. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, the risk that results from post hoc analyses, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects, that observed improvements in cardiac structure, function or other measures may not be replicated in additional analyses or studies or translate into improved long-term clinical outcomes, that the potential utility of AI-based tools and digital biomarkers may not be demonstrated in further studies or translate into routine clinical use, that plans to present additional data may change, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected]
2026-08-24 14:07 2mo ago
2026-08-24 07:30 2mo ago
BridgeBio to Present New Acoramidis Data from Open-Label Extension Analyses in ATTR-CM at ESC Congress 2026
BBIO BridgeBio Pharma
FMP Stock News
Original source text
 | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, announced today that two oral presentations and three posters on new acoramidis data in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM) will be shared at the European Society of Cardiology (ESC) Congress 2026, taking place in Munich, Germany on August 28-31, 2026. The data will further strengthen the differentiated clinical profile of acoramidis, reinforcing it as the first-line treatment of choice for individuals with ATTR-CM. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

As part of BridgeBio's partnership with Yale's Cardiovascular Data Science (CarDS) Lab to advance AI networks for earlier detection of ATTR-CM, three additional posters will be presented at the ESC Congress 2026.

Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Oral Presentations:
Acoramidis Reduces Days Lost to Death and/or Cardiovascular-Related Hospitalization, Preserving Time Alive Outside the Hospital in Participants with ATTR-CM: Results from ATTRibute-CM
Presenter: Richard Wright, M.D., Pacific Heart Institute, U.S.
Date: Sunday, August 30 at 8:15 am CEST

Durable Survival Benefits of Acoramidis over 54 Months in Variant Transthyretin Amyloid Cardiomyopathy (ATTR-CM), Including p.V142I: Interim Findings from ATTRibute-CM and its Open-Label Extension
Presenter: Kevin Alexander, M.D., Stanford University School of Medicine, U.S.
Date: Sunday, August 30 at 10:55 am CEST

Moderated ePosters:
Long-term Improvement in Myocardial Structure and Function in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Treated with Acoramidis Compared with a Natural History Cohort
Presenter: Awais Sheikh, MBChB, National Amyloidosis Centre, London, UK
Date: Friday, August 28 at 4:15 pm CEST

Acoramidis Improves Health-Related Quality of Life in Wild-Type and Variant Transthyretin Amyloid Cardiomyopathy: An EQ-5D-5L Subgroup Analysis from ATTRibute-CM
Presenter: Emer Joyce, M.D., Ph.D., The Mater Misericordiae University Hospital, IE
Date: Sunday, August 30 at 3:15 pm CEST

Improvement of Health Status with Acoramidis in Patients with Wild-Type and Variant Transthyretin Amyloid Cardiomyopathy: KCCQ Domains Analysis from the ATTRibute-CM Study
Presenter: Nitasha Sarswat, M.D., University of Chicago Medical Center, U.S.
Date: Sunday, August 30 at 3:15 pm CEST

Yale-Partnered Moderated ePosters:
A Novel AI-Derived Digital Biomarker for Monitoring Disease Progression in ATTR-CM: First-In-Trial Use of a Computer Vision AI-ECG Algorithm within a Phase 3 Pivotal Randomized Controlled Trial
Presenter: Rohan Khera, M.D., Yale School of Medicine, U.S.
Date: Monday, August 31 at 11:15 am CEST

A Fully Decentralized, Patient-Led Digital Registry for ATTR-CM Integrating Multisystem EHR and Wearable Data: The DISCOVER-ATTR Study
Presenter: Aline Pedroso, Ph.D., Yale School of Medicine, U.S.
Date: Monday, August 31 at 1:15 pm CEST

Nationwide U.S. Federated Deployment of Artificial Intelligence for Multimodal Screening of ATTR Cardiomyopathy: First Multicenter Analysis from the TRACE-AI Network
Presenter: Bruno Batinica, MBChB, Yale School of Medicine, U.S.
Date: Sunday, August 30 at 1:35 pm CEST

About Attruby™ (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
[email protected]   
(650)-789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
[email protected] 
2026-08-14 17:14 2mo ago
2026-08-14 11:15 2mo ago
BridgeBio Stock Has Soared 29% in Just 3 Months. Here's Why Wall Street Thinks It Could Go Even Higher.
BBIO BridgeBio Pharma
FMP Stock News
Original source text
One of the more high-flying stocks in the U.S. biotech sector these days is genetic-disease-focused BridgeBio Pharma (BBIO -1.18%). That's due almost entirely to the outperformance of its Attruby heart medication.

If the generally bullish analyst sentiment on the company is anything to go by, Attruby is only at the start of a long, successful run. Also, BridgeBio is well on track to succeed with pipeline drugs in the near future.

Image source: Getty Images.

A new and popular treatment
Attruby received U.S. Food and Drug Administration (FDA) approval in late 2024 for the treatment of a rare progressive heart disease called transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a type of cardiac amyloidosis.

The drug is a state-of-the-art treatment for ATTR-CM and as such has seen significant growth in its short commercial life. In its recent second-quarter earnings report, BridgeBio disclosed that Attruby sales more than tripled year over year, to more than $222 million from $71.5 million in the year-ago period (its first full quarter on the market).

Since Attruby is far and away the primary contributor to overall revenue -- it's the only commercialized product currently producing sales -- BridgeBio's top line expanded admirably. Its total second-quarter tally was nearly $244 million, more than double the nearly $111 million in the second quarter of 2025.

The company also boasts quite a promising drug pipeline. In that recently completed quarter, it submitted New Drug Applications (NDAs) for all three of its late-stage developmental programs to the FDA; two were accepted for review.

The trio consists of the muscular dystrophy treatment BBP-418; encaleret, which targets a rare endocrine disorder, autosomal dominant hypocalcemia; and infigratinib, a drug that treats a form of short-stature skeletal dysplasia (commonly referred to as dwarfism).

Today's Change

(

-1.18

%) $

-0.96

Current Price

$

80.25

The power of the pipeline
That combination of a relatively new medication on a sharp rise and a lineup of high-potential drugs now under review is impressing analysts.

Following the earnings release, Piper Sandler's Biren Amin, to name one, raised his price target on the stock while maintaining his "overweight" (buy) recommendation. He believes the one developmental drug under review that's received a 2026 Prescription Drug User Fee Act (PDUFA) review date from the FDA, BBP-418, will earn approval and start generating revenue by the end of this year. Its PDUFA decision date is Nov. 27.

According to analyst tracking site TipRanks, 16 out of 17 pundits currently following BridgeBio's fortunes recommend it as a buy, with only one rating it a hold. Personally, I find that realistic. I'd go so far as to say that BridgeBio currently has one of the best combinations of a commercialized anchor drug and advanced developmental programs in the biotech sector.

That doesn't mean it's perfect, of course -- the company remains unprofitable. That's understandable, though, given the resources needed to support both the commercialization of Attruby and the late-stage development of three other drugs.

But to my mind, if any investor with some risk appetite is going to take a chance on a biotech, BridgeBio is a fine choice. Like most of those analysts, I think the stock can gain even more altitude.
2026-08-14 12:25 2mo ago
2026-08-14 07:30 2mo ago
BridgeBio Pharma Announces Pricing of Oversubscribed Secondary Offering that Diversifies its Institutional Shareholder Base
BBIO BridgeBio Pharma
FMP Stock News
Original source text
- The transaction supports the evolution of the Company’s shareholder base toward further high-quality, long-term ownership

PALO ALTO, Calif., Aug. 14, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today the pricing of a secondary offering of 5,000,000 shares of its common stock by the selling stockholder KKR Genetic Disorder L.P. The Company is not selling any shares and will not receive any of the proceeds of the offering. The offering is expected to close on August 17, 2026, subject to customary closing conditions.

William Blair, Goldman Sachs & Co. LLC and KKR Capital Markets LLC are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-297701) that was previously filed by the Company with the Securities and Exchange Commission (the “SEC”) and automatically became effective upon filing on July 24, 2026.

A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. A copy of the prospectus supplement and accompanying prospectus can be obtained, when available, by contacting William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, by telephone at 1-800-621-0687 or by email at [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; KKR Capital Markets LLC, 30 Hudson Yards, Suite 7500, NY, NY 10001; or by accessing the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described above, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market.

BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2025, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the SEC on August 10, 2026 and our other filings with the SEC. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
2026-08-13 21:59 2mo ago
2026-08-13 17:42 2mo ago
BridgeBio Pharma Announces Launch of Secondary Offering of Common Stock on Behalf of an Existing Shareholder
BBIO BridgeBio Pharma
FMP Stock News
Original source text
PALO ALTO, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today the launch of a secondary public offering of 5,000,000 shares of its common stock by the selling stockholder KKR Genetic Disorder L.P. The Company is not selling any shares and will not receive any of the proceeds of the offering.
2026-08-12 12:17 2mo ago
2026-08-12 03:37 2mo ago
BridgeBio Pharma Q2 Earnings Call Highlights
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Posted by Defense World Staff on Aug 12th, 2026

BridgeBio Pharma (NASDAQ:BBIO) reported continued growth for its ATTR cardiomyopathy treatment Attruby in the second quarter of 2026, while advancing three late-stage programs into regulatory review and expanding commercial preparations for potential launches over the next year.

Chief Executive Officer Neil Kumar described the period as a transition point for the company, citing the commercial progress of Attruby, regulatory submissions for programs in limb-girdle muscular dystrophy type 2I, autosomal dominant hypocalcemia type 1 and achondroplasia, and the start of a Phase III trial in chronic hypoparathyroidism.

Attruby Revenue Rises as First-Line Use Expands Attruby generated $222.4 million in net product revenue during the second quarter, up from $71.5 million a year earlier and representing another sequential increase of more than $35 million. Chief Commercial Officer Matt Outten said growth was led by treatment-naive, first-line patients, while the pool of patients switching from Pfizer’s Vyndaqel had normalized after a period of elevated switching activity.

“The engine is the first-line,” Outten said, adding that BridgeBio’s first-line share increased in a market that was broadly stable sequentially. Kumar said Attruby was the fastest-growing brand in the category, with 23% growth during the quarter, while the overall market grew 19%.

Management said it expects clinical differentiation to remain central to Attruby’s commercialization. Kumar highlighted data published in Circulation: Heart Failure that BridgeBio said showed early and sustained kidney-protective effects for acoramidis, the active ingredient in Attruby, in patients with ATTR cardiomyopathy. The company said the analysis included improvement in chronic eGFR slope and reductions in urinary albumin-to-creatinine ratio.

BridgeBio also cited real-world analyses comparing Attruby with tafamidis. Kumar said an independent propensity score-matched study associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at six months versus tafamidis. A separate company analysis showed a 34% reduction in diuretic intensification, heart-failure hospitalization and mortality, according to Kumar.

Management said the failure of the CARDIO-TTRansform study’s primary endpoint, which evaluated eplontersen in ATTR cardiomyopathy, could reinforce stabilization therapy as a first-line standard. However, executives said they were awaiting fuller data from the study before updating expectations for Attruby’s long-term market share.

BridgeBio said it remains on track for acoramidis to reach blockbuster worldwide sales in 2026, including sales of Beyonttra outside the U.S. recorded by its partners. Outten emphasized that this target was not a forecast specifically for U.S. Attruby net product revenue.

Three Programs Move Toward Potential Approval BridgeBio said all three of its late-stage programs moved into regulatory review during the quarter.

BBP-418 for LGMD2I/R9: The FDA accepted the new drug application on May 27 with priority review. The PDUFA target action date is Nov. 27, 2026, and no advisory committee meeting is planned. Kumar said the treatment could become the first approved therapy for LGMD2I, which the company said affects more than 1,000 patients in the U.S. BridgeBio’s commercial team is already in the field, and the company said it has identified more than 1,500 genetically confirmed patients. Encaleret for ADH1: The FDA accepted the NDA on July 22 and granted priority review. The PDUFA target action date is May 8, 2027, with no advisory committee currently planned. BridgeBio also submitted a marketing authorization application to the European Medicines Agency. The company said more than 2,200 patients had been identified through ICD-10 claims data between October 2023 and June 2026. Infigratinib for achondroplasia: BridgeBio said it has submitted its NDA and is targeting FDA acceptance, potentially including priority review, in the fourth quarter of 2026, with a potential approval in mid-2027. The company said infigratinib could be the first oral FGFR3-targeted treatment for achondroplasia if approved. Kumar said infigratinib demonstrated a statistically significant improvement in arm span in the Phase III PROPEL 3 study, which was published in The New England Journal of Medicine. The company is building its commercial field organization for a market where injectable competitors are already available.

Chronic Hypoparathyroidism Trial Begins BridgeBio also began screening patients in RECLAIM-HP, its global Phase III trial of encaleret in chronic hypoparathyroidism. The company expects top-line results within approximately 18 months.

Management said chronic hypoparathyroidism affects about 200,000 people in the U.S. and Europe. Kumar argued that encaleret could offer an oral alternative designed to address both low serum calcium and excess urinary calcium. He cited a Phase II proof-of-concept study in which 80% of postsurgical hypoparathyroidism patients receiving encaleret achieved normal blood and urine calcium levels within five days.

Financial Results and Capital Position Total second-quarter revenue was $243.7 million, compared with $110.6 million in the year-earlier period. The increase was driven primarily by higher Attruby revenue. Royalty revenue rose to $15.4 million from $1.6 million, largely reflecting Beyonttra sales in Europe and Japan.

Operating expenses increased to $335.7 million from $241.2 million as BridgeBio expanded sales, marketing, medical affairs and pre-commercial supply activities. The company recorded a loss from operations of $107.1 million, an improvement from a $134.3 million operating loss a year earlier.

BridgeBio ended June with $720.2 million in cash, cash equivalents and marketable securities. After closing a $1 billion preferred equity investment led by Sixth Street on July 1, with participation from HealthCare Royalty Partners, the company said its cash balance was approximately $1.7 billion.

President and Chief Financial Officer Tom Trimarchi said the capital position is intended to support operating activities, continued Attruby investment and three potential launches over the next 12 months. Management said it expects operating results to remain relatively stable over the next several quarters before improving toward break-even as launch investments reach a steadier level and revenue grows.

About BridgeBio Pharma (NASDAQ:BBIO) BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.

BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.

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2026-08-11 21:50 2mo ago
2026-08-11 16:01 2mo ago
BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
BBIO BridgeBio Pharma
FMP Stock News
Original source text
PALO ALTO, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that on August 8, 2026, the compensation committee of BridgeBio's board of directors approved equity grants to 56 new employees in restricted stock units for an aggregate of 66,705 shares of the Company's common stock. One-fourth of the shares underlying each employee's restricted stock units will vest on August 16, 2027, with one-twelfth of the remaining shares underlying each such employee's restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee's continued employment with the Company or one of its subsidiaries on such vesting dates.
2026-08-11 19:25 2mo ago
2026-08-11 13:46 2mo ago
BridgeBio Q2 Earnings Miss, Revenues Beat as Attruby Sales Surge
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways BridgeBio's Q2 revenues surged 120% to $243.7 million, driven mainly by surging Attruby sales.BridgeBio's Attruby U.S. sales more than tripled to $222.4 million, aided by first-line share gains.BridgeBio filed for infigratinib approval in achondroplasia, targeting a mid-2027 commercial launch. BridgeBio Pharma (BBIO - Free Report) reported a second-quarter 2026 loss of 78 cents per share, wider than the Zacks Consensus Estimate of a loss of 64 cents. Despite the miss, the figure improved compared to the year-ago loss of 95 cents.

Revenues surged 120% year over year to $243.7 million, beating the Zacks Consensus Estimate of $222.6 million. This growth was primarily driven by its sole marketed drug, Attruby.

Year to date, BridgeBio’s shares have gained 11% compared with the industry’s 7% growth.

Image Source: Zacks Investment Research

BBIO's Attruby Sales Drive the Top LineAttruby, which is approved for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM), generated $222.4 million from product sales in the United States. The figure more than tripled from the $71.5 million recorded in the year-ago period.

Per BridgeBio, Attruby continued to gain share among treatment-naive patients, which management views as the key long-term growth driver for the franchise. Meanwhile, the pool of patients switching from Pfizer’s (PFE - Free Report) Vyndaqel/Vyndamax, a key competing ATTR-CM therapy, has begun to normalize after elevated switching activity in prior quarters. Management expects continued first-line share gains to support sales growth going forward.

Royalty revenues increased to $15.4 million from $1.6 million, primarily reflecting Attruby sales in the EU and Japan, where it is marketed as Beyonttra.

License and services revenues fell 84% year over year to $5.8 million, as the prior-year period benefited from a $30 million regulatory milestone.

BBIO's Costs Rise on Commercial InvestmentsResearch and development expenses increased 34% year over year to $149.4 million, reflecting continued investment in late-stage programs.

Selling, general and administrative expenses climbed 44% to $186.3 million as the company supported Attruby commercialization and pre-commercial work for upcoming launches.

As of June 30, 2026, cash, cash equivalents and marketable securities totaled $720.2 million, down from $940.2 million in the previous quarter. The figure excludes the $1 billion preferred equity financing that closed July 1, which lifted the company's cash balance to about $1.7 billion.

BBIO Advances Third Program Toward Commercial LaunchAlongside the earnings results, BridgeBio announced that it has submitted a regulatory filing with the FDA for oral infigratinib in achondroplasia. If approved, the company expects a commercial launch in mid-2027.

This marks the third regulatory filing submitted to the FDA. BridgeBio already has two filings under review — BBP-418 for limb-girdle muscular dystrophy (LGMD) type 2I/R9 (LGMD2I/R9) and encaleret for autosomal dominant hypocalcemia type 1 (ADH1). A final decision on BBP-418 is expected by Nov. 27, 2026, and on encaleret by May 8, 2027.

Commercial and medical teams are being built across the programs. More than 2,200 ADH patients had been identified under the dedicated ICD-10 code through June 2026, with about 70 new diagnoses per month.

BridgeBio Expands Late-Stage PipelineBeyond ADH1, the company has begun screening patients in the phase III RECLAIM-HP study on encaleret for chronic hypoparathyroidism, a condition that affects roughly 200,000 patients across the United States and Europe. Top-line data from the study are expected in late 2027 or early 2028.

Infigratinib development is also extending into hypochondroplasia, with a phase II update expected in the second half of 2026.

BridgeBio also plans to advance a transthyretin depleter, with an investigational new drug (IND) filing targeted for next year.

BBIO Zacks RankBridgeBio currently carries a Zacks Rank #3 (Hold).

Our Key Picks Among Biotech StocksSome better-ranked stocks in the biotech sector are Harmony Biosciences (HRMY - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.65 for 2026. Over the same period, EPS estimates have increased from $3.64 to $4.04 for 2027. HRMY shares have risen about 4% year to date.

Harmony Biosciences missed on earnings in three of the trailing four quarters and met on one occasion, delivering an average negative surprise of 13.97%.

Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 164% so far this year.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%.
2026-08-11 17:01 2mo ago
2026-08-11 11:05 2mo ago
4 Biotech Stocks With Major Second-Half Pipeline Catalysts This Year
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways Vertex Pharmaceuticals awaits a Nov. 30 FDA decision on povetacicept filing for IgA nephropathy.Amylyx expects third-quarter 2026 phase III LUCIDITY results for avexitide in post-bariatric hypoglycemia.Praxis expects an FDA decision on relutrigine for DEEs by Dec. 27, followed by EMERALD study data in Q4. The pharmaceutical sector differs from many industries as stock performance often depends less on near-term results and more on the success of products in development. For biotech companies, clinical and regulatory developments can sharply alter valuations by changing expectations for a drug's safety, efficacy and commercial potential.

Pipeline milestones are therefore key stock catalysts. Clinical data can validate or undermine a candidate, while regulatory decisions can bring it closer to commercialization. Late-stage data and regulatory milestones generally have a significant impact on stock prices as they offer more clarity on a drug's approval prospects.

Against this backdrop, Vertex Pharmaceuticals (VRTX - Free Report) , Amylyx Pharmaceuticals (AMLX - Free Report) , Praxis Precision Medicines (PRAX - Free Report) and BridgeBio Pharma (BBIO - Free Report) stand out for having notable pipeline/regulatory developments during the second half of 2026. With multiple clinical and regulatory milestones spanning pain, metabolic disorders, neurological diseases and rare genetic conditions, these companies offer several potentially meaningful catalysts, making the four biotech stocks particularly compelling investment opportunities.

Vertex PharmaceuticalsThe key near-term catalyst for Vertex is the FDA’s pending decision on a biologics license application for accelerated approval of povetacicept in adults with IgA nephropathy (IgAN), scheduled for Nov. 30, 2026. Acquired from Alpine Immune Sciences, povetacicept is being developed as a potential best-in-class therapy for multiple B-cell-mediated diseases and could help Vertex expand beyond its established cystic fibrosis franchise.

Year to date, VRTX shares have gained 15.6% compared with the industry’s 5.2% growth.

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The upcoming FDA decision could be particularly important given povetacicept’s potential role in establishing Vertex’s presence in nephrology. If approved, povetacicept would become Vertex’s first commercialized therapy in nephrology, creating a potential new source of product revenues and growth. The company is also advancing povetacicept in primary membranous nephropathy, another B-cell-mediated disease, and has completed the phase IIB portion of the mid- to late-stage program. Conversely, a regulatory setback could delay the candidate’s commercial prospects and weaken expectations for its contribution to Vertex’s longer-term growth. VRTX currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Amylyx PharmaceuticalsAmylyx's lead candidate, avexitide, a GLP-1 receptor antagonist, is being developed for post-bariatric hypoglycemia, a condition for which there are currently no FDA-approved therapies. The key near-term catalyst is top-line results from the phase III LUCIDITY study, which Amylyx expects to report in the third quarter of 2026. The study has completed enrollment, with its primary endpoint being the reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16.

Year to date, AMLX shares have soared 87.6% against the industry’s 1.5% decline.

Image Source: Zacks Investment Research

The upcoming readout could be particularly important given avexitide’s central role in Amylyx’s pipeline. Earlier clinical studies have demonstrated consistent, dose-dependent effects, providing a supportive backdrop ahead of the pivotal readout. If the phase III study is successful and avexitide is subsequently approved, Amylyx aims to launch the drug commercially in 2027. This would give the company its first marketed drug and a potential recurring source of product revenues, making the LUCIDITY outcome a significant inflection point. Conversely, an unfavorable result could materially weaken avexitide’s regulatory and commercial prospects. Amylyx is also exploring avexitide in congenital hyperinsulinism. AMLX currently carries a Zacks Rank #3.

Praxis Precision MedicinesA potential FDA approval for relutrigine in genetically defined developmental epileptic encephalopathies (DEEs) is Praxis' most prominent second-half catalyst. The new drug application (NDA) is supported by positive results from the registrational cohort of the phase II/III EMBOLD study, which met its primary efficacy objective, demonstrating a 53% placebo-adjusted reduction in monthly motor seizures over 16 weeks in patients with SCN2A- and SCN8A-related DEEs. Although the drug initially received priority review with a Sept. 27, 2026, decision date, the FDA extended the review period by three months, establishing a new Dec. 27, 2026, target action date. The mid-cycle meeting was completed without major safety or efficacy concerns identified to date, and no advisory committee meeting is planned.

Year to date, PRAX shares have rallied 24.6% compared with the industry’s 5.3% growth.

Image Source: Zacks Investment Research

The catalyst is not limited to the regulatory decision. The EMERALD study, evaluating relutrigine in patients with broader DEEs, has completed recruitment and is expected to report top-line results in the fourth quarter of 2026. If positive, the study could support a supplemental NDA in 2027, potentially expanding the commercial opportunity beyond the genetically defined SCN2A- and SCN8A-DEE populations covered by the initial application. PRAX currently carries a Zacks Rank #3.

BridgeBio PharmaFDA action on BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) represents BridgeBio's major second-half catalyst. BBP-418 is an investigational oral glycosylation substrate therapy with a unique mechanism of action that could improve muscle, ambulatory and cardiopulmonary function. Its differentiated proposition is particularly notable because, if approved, BBP-418 could become the first and only approved therapy for LGMD2I/R9 and potentially the first approved therapy for any form of limb-girdle muscular dystrophy.

Year to date, BridgeBioshares have gained 10.7% compared with the industry’s 6.8% growth.

Image Source: Zacks Investment Research

The candidate has already cleared a major clinical hurdle. In the phase III FORTIFY study, BBP-418 met all primary and secondary endpoints at the prespecified 12-month interim analysis, with treated participants improving while placebo recipients declined across key measures. The FDA subsequently accepted BridgeBio's NDA for Priority Review and assigned a decision date of Nov. 27, 2026. The agency is not currently planning an advisory committee meeting, further focusing attention on the regulatory decision itself. BridgeBio also intends to initiate studies in younger LGMD2I/R9 patients and in additional LGMD subtypes, providing potential avenues for label expansion if the initial regulatory outcome is favorable. BBIO currently carries a Zacks Rank #3.
2026-08-11 17:01 2mo ago
2026-08-11 12:49 2mo ago
BridgeBio: Attruby Delivers In Q2, Expect Three New Launches In 12 Months
BBIO BridgeBio Pharma
FMP Stock News
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HomeStock IdeasLong IdeasHealthcare 

SummaryBridgeBio delivered a Q2 beat, reaffirmed $1B+ 2026 Attruby/Beyonttra global sales guidance, and expectations for three product launches by mid-2027.Attruby’s U.S. net sales surged 311% Y/Y, with ex-U.S. Beyonttra royalties up 62% sequentially as they continue to gain TTR stabilizer market share.BBIO’s $1B preferred equity raise addresses balance sheet concerns, supporting accelerated commercial and pipeline investment.I expect BBIO to achieve cash flow positivity within 3-4 quarters and significant profitability by early 2028, unlocking operating leverage, additional share repurchase potential, and business development.I do much more than just articles at Growth Stock Forum: Members get access to model portfolios, regular updates, a chat room, and more. Learn More » imaginima/iStock via Getty Images

BridgeBio Pharma (BBIO) reported strong second quarter results, beating the analyst consensus by $24 million and reiterating expectations for worldwide net sales of Attruby/Beyonttra exceeding $1 billion this year. The submissions to the FDA for three late-stage

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Analyst’s Disclosure: I/we have a beneficial long position in the shares of BBIO, ARWR either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

This article reflects the author's opinion and should not be regarded as a buy or sell recommendation or investment advice in any way.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.
2026-08-11 02:35 2mo ago
2026-08-10 20:58 2mo ago
BridgeBio Pharma, Inc. (BBIO) Q2 2026 Earnings Call Transcript
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma, Inc. (BBIO) Q2 2026 Earnings Call Transcript
2026-08-11 00:10 2mo ago
2026-08-10 18:04 2mo ago
BridgeBio Pharma Q2 Earnings Call Highlights
BBIO BridgeBio Pharma
FMP Stock News
Original source text
The Phase 3 Failure That Sent Biotech Winners and Losers in Opposite DirectionsBridgeBio Pharma NASDAQ: BBIO reported continued growth for its ATTR cardiomyopathy treatment Attruby in the second quarter of 2026, while advancing three late-stage programs into regulatory review and expanding commercial preparations for potential launches over the next year.

Chief Executive Officer Neil Kumar described the period as a transition point for the company, citing the commercial progress of Attruby, regulatory submissions for programs in limb-girdle muscular dystrophy type 2I, autosomal dominant hypocalcemia type 1 and achondroplasia, and the start of a Phase III trial in chronic hypoparathyroidism.

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Attruby Revenue Rises as First-Line Use Expands BridgeBio's Volatile Week Puts Biotech Stocks Under a MicroscopeAttruby generated $222.4 million in net product revenue during the second quarter, up from $71.5 million a year earlier and representing another sequential increase of more than $35 million. Chief Commercial Officer Matt Outten said growth was led by treatment-naive, first-line patients, while the pool of patients switching from Pfizer’s Vyndaqel had normalized after a period of elevated switching activity.

“The engine is the first-line,” Outten said, adding that BridgeBio’s first-line share increased in a market that was broadly stable sequentially. Kumar said Attruby was the fastest-growing brand in the category, with 23% growth during the quarter, while the overall market grew 19%.

Management said it expects clinical differentiation to remain central to Attruby’s commercialization. Kumar highlighted data published in Circulation: Heart Failure that BridgeBio said showed early and sustained kidney-protective effects for acoramidis, the active ingredient in Attruby, in patients with ATTR cardiomyopathy. The company said the analysis included improvement in chronic eGFR slope and reductions in urinary albumin-to-creatinine ratio.

BridgeBio also cited real-world analyses comparing Attruby with tafamidis. Kumar said an independent propensity score-matched study associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at six months versus tafamidis. A separate company analysis showed a 34% reduction in diuretic intensification, heart-failure hospitalization and mortality, according to Kumar.

Management said the failure of the CARDIO-TTRansform study’s primary endpoint, which evaluated eplontersen in ATTR cardiomyopathy, could reinforce stabilization therapy as a first-line standard. However, executives said they were awaiting fuller data from the study before updating expectations for Attruby’s long-term market share.

BridgeBio said it remains on track for acoramidis to reach blockbuster worldwide sales in 2026, including sales of Beyonttra outside the U.S. recorded by its partners. Outten emphasized that this target was not a forecast specifically for U.S. Attruby net product revenue.

Three Programs Move Toward Potential Approval BridgeBio said all three of its late-stage programs moved into regulatory review during the quarter.

BBP-418 for LGMD2I/R9: The FDA accepted the new drug application on May 27 with priority review. The PDUFA target action date is Nov. 27, 2026, and no advisory committee meeting is planned. Kumar said the treatment could become the first approved therapy for LGMD2I, which the company said affects more than 1,000 patients in the U.S. BridgeBio’s commercial team is already in the field, and the company said it has identified more than 1,500 genetically confirmed patients. Encaleret for ADH1: The FDA accepted the NDA on July 22 and granted priority review. The PDUFA target action date is May 8, 2027, with no advisory committee currently planned. BridgeBio also submitted a marketing authorization application to the European Medicines Agency. The company said more than 2,200 patients had been identified through ICD-10 claims data between October 2023 and June 2026. Infigratinib for achondroplasia: BridgeBio said it has submitted its NDA and is targeting FDA acceptance, potentially including priority review, in the fourth quarter of 2026, with a potential approval in mid-2027. The company said infigratinib could be the first oral FGFR3-targeted treatment for achondroplasia if approved. Kumar said infigratinib demonstrated a statistically significant improvement in arm span in the Phase III PROPEL 3 study, which was published in The New England Journal of Medicine. The company is building its commercial field organization for a market where injectable competitors are already available.

Chronic Hypoparathyroidism Trial Begins BridgeBio also began screening patients in RECLAIM-HP, its global Phase III trial of encaleret in chronic hypoparathyroidism. The company expects top-line results within approximately 18 months.

Management said chronic hypoparathyroidism affects about 200,000 people in the U.S. and Europe. Kumar argued that encaleret could offer an oral alternative designed to address both low serum calcium and excess urinary calcium. He cited a Phase II proof-of-concept study in which 80% of postsurgical hypoparathyroidism patients receiving encaleret achieved normal blood and urine calcium levels within five days.

Financial Results and Capital Position Total second-quarter revenue was $243.7 million, compared with $110.6 million in the year-earlier period. The increase was driven primarily by higher Attruby revenue. Royalty revenue rose to $15.4 million from $1.6 million, largely reflecting Beyonttra sales in Europe and Japan.

Operating expenses increased to $335.7 million from $241.2 million as BridgeBio expanded sales, marketing, medical affairs and pre-commercial supply activities. The company recorded a loss from operations of $107.1 million, an improvement from a $134.3 million operating loss a year earlier.

BridgeBio ended June with $720.2 million in cash, cash equivalents and marketable securities. After closing a $1 billion preferred equity investment led by Sixth Street on July 1, with participation from HealthCare Royalty Partners, the company said its cash balance was approximately $1.7 billion.

President and Chief Financial Officer Tom Trimarchi said the capital position is intended to support operating activities, continued Attruby investment and three potential launches over the next 12 months. Management said it expects operating results to remain relatively stable over the next several quarters before improving toward break-even as launch investments reach a steadier level and revenue grows.

About BridgeBio Pharma (NASDAQ:BBIO)BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.

BridgeBio's pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-08-11 00:10 2mo ago
2026-08-10 18:11 2mo ago
BridgeBio Pharma (BBIO) Reports Q2 Loss, Tops Revenue Estimates
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (BBIO - Free Report) came out with a quarterly loss of $0.78 per share versus the Zacks Consensus Estimate of a loss of $0.64. This compares to a loss of $0.95 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -21.88%. A quarter ago, it was expected that this rare disease drug developer would post a loss of $0.7 per share when it actually produced a loss of $0.84, delivering a surprise of -20%.

Over the last four quarters, the company has not been able to surpass consensus EPS estimates.

BridgeBio Pharma, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $243.68 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 9.46%. This compares to year-ago revenues of $110.57 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

BridgeBio Pharma shares have added about 10.5% since the beginning of the year versus the S&P 500's gain of 13.3%.

What's Next for BridgeBio Pharma?While BridgeBio Pharma has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for BridgeBio Pharma was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.57 on $249.98 million in revenues for the coming quarter and -$2.31 on $965.61 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Generic Drugs is currently in the bottom 12% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, Assembly Biosciences (ASMB - Free Report) , is yet to report results for the quarter ended June 2026.

This biotech drug developer is expected to post quarterly loss of $0.70 per share in its upcoming report, which represents a year-over-year change of +47.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Assembly Biosciences' revenues are expected to be $9.2 million, down 4.5% from the year-ago quarter.
2026-08-04 14:10 2mo ago
2026-08-04 04:13 2mo ago
California State Teachers Retirement System Boosts Stock Position in BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Posted by Defense World Staff on Aug 4th, 2026

California State Teachers Retirement System boosted its stake in shares of BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 23.7% in the first quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The firm owned 165,703 shares of the company’s stock after acquiring an additional 31,797 shares during the quarter. California State Teachers Retirement System owned about 0.08% of BridgeBio Pharma worth $12,305,000 as of its most recent filing with the Securities and Exchange Commission.

Other institutional investors have also modified their holdings of the company. Commonwealth Equity Services LLC raised its stake in shares of BridgeBio Pharma by 4.9% during the fourth quarter. Commonwealth Equity Services LLC now owns 5,179 shares of the company’s stock worth $396,000 after purchasing an additional 244 shares during the last quarter. Farther Finance Advisors LLC grew its position in BridgeBio Pharma by 91.4% in the 4th quarter. Farther Finance Advisors LLC now owns 513 shares of the company’s stock valued at $39,000 after buying an additional 245 shares during the last quarter. State of New Jersey Common Pension Fund D raised its position in BridgeBio Pharma by 0.5% during the 4th quarter. State of New Jersey Common Pension Fund D now owns 51,896 shares of the company’s stock worth $3,970,000 after buying an additional 246 shares during the last quarter. CWM LLC raised its position in BridgeBio Pharma by 4.3% during the 4th quarter. CWM LLC now owns 6,444 shares of the company’s stock worth $493,000 after buying an additional 265 shares during the last quarter. Finally, Xponance LLC lifted its stake in shares of BridgeBio Pharma by 2.2% in the 4th quarter. Xponance LLC now owns 12,536 shares of the company’s stock worth $959,000 after acquiring an additional 272 shares during the period. Institutional investors and hedge funds own 99.85% of the company’s stock.

Analyst Upgrades and Downgrades BBIO has been the topic of several analyst reports. Truist Financial lifted their target price on shares of BridgeBio Pharma from $95.00 to $102.00 and gave the company a “buy” rating in a report on Wednesday, April 29th. HC Wainwright raised their price objective on shares of BridgeBio Pharma from $110.00 to $120.00 and gave the company a “buy” rating in a research report on Monday, July 13th. Weiss Ratings reaffirmed a “sell (d)” rating on shares of BridgeBio Pharma in a report on Friday, May 15th. Royal Bank Of Canada assumed coverage on BridgeBio Pharma in a research note on Thursday, April 9th. They set an “outperform” rating and a $100.00 target price for the company. Finally, Morgan Stanley lifted their price target on BridgeBio Pharma from $94.00 to $98.00 and gave the company an “overweight” rating in a research note on Thursday, May 28th. Twenty analysts have rated the stock with a Buy rating, two have assigned a Hold rating and one has issued a Sell rating to the company’s stock. According to MarketBeat, the company has an average rating of “Moderate Buy” and a consensus target price of $95.21.

Check Out Our Latest Stock Analysis on BridgeBio Pharma

Insider Buying and Selling In other news, CAO Maricel Apuli sold 2,000 shares of the stock in a transaction that occurred on Thursday, July 30th. The shares were sold at an average price of $80.06, for a total value of $160,120.00. Following the sale, the chief accounting officer directly owned 127,401 shares in the company, valued at $10,199,724.06. This represents a 1.55% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO Neil Kumar sold 40,000 shares of the firm’s stock in a transaction that occurred on Thursday, June 4th. The stock was sold at an average price of $67.46, for a total transaction of $2,698,400.00. Following the transaction, the chief executive officer directly owned 535,686 shares of the company’s stock, valued at approximately $36,137,377.56. This trade represents a 6.95% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last ninety days, insiders have sold 432,117 shares of company stock valued at $32,650,700. 14.23% of the stock is owned by company insiders.

BridgeBio Pharma Price Performance NASDAQ BBIO opened at $79.96 on Tuesday. BridgeBio Pharma, Inc. has a 1-year low of $42.09 and a 1-year high of $93.42. The company has a market capitalization of $15.63 billion, a P/E ratio of -21.38 and a beta of 0.96. The business has a 50 day moving average price of $74.44 and a 200 day moving average price of $72.80.

BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last posted its earnings results on Thursday, May 7th. The company reported ($0.84) EPS for the quarter, missing analysts’ consensus estimates of ($0.70) by ($0.14). The business had revenue of $194.51 million during the quarter, compared to the consensus estimate of $178.07 million. During the same quarter last year, the firm posted ($0.88) EPS. The business’s quarterly revenue was up 66.8% compared to the same quarter last year. On average, research analysts expect that BridgeBio Pharma, Inc. will post -2.27 earnings per share for the current fiscal year.

BridgeBio Pharma Profile (Free Report)

BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.

BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.

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2026-08-03 11:43 2mo ago
2026-08-03 07:30 2mo ago
BridgeBio to Report Second Quarter 2026 Financial Results and Commercial Updates on August 10, 2026 at 4:30 pm ET
BBIO BridgeBio Pharma
FMP Stock News
Original source text
PALO ALTO, Calif., Aug. 03, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it will release its second quarter 2026 financial results and business update after the market closes on Monday, August 10, 2026. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day.
2026-08-02 10:40 2mo ago
2026-08-02 05:55 2mo ago
1 Top Wall Street Analyst Thinks This Stock Could Soar 95% Over the Next 12 Months. Here's Why I Agree.
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (BBIO -2.50%) has already been one of biotech's biggest winners over the past two years (up 209% as of July 31). Yet Barclays analyst Eliana Merle believes the rally may not be over.

Merle recently reiterated her overweight rating and $157 price target, implying roughly 95% upside from where the stock is trading now. The bullish thesis here seems to center around the company's newly launched heart drug, Attruby, which could become a much larger commercial success than Wall Street currently expects.

Indeed, this is a reasonable expectation.

Image source: Getty Images.

Attruby is off to a strong start BridgeBio received FDA approval for Attruby in late 2024 to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive disease in which abnormal proteins accumulate in the heart, eventually leading to heart failure. Commercial adoption has been encouraging.

During the first quarter of 2026, BridgeBio generated $180.6 million in Attruby revenue in the U.S., helping total company revenue climb to $194.5 million. Management has also said more than 7,800 unique patients had received prescriptions from over 1,850 prescribers. And as awareness of the drug improves, the addressable market could expand well beyond today's treated population.

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Barclays may still be underestimating the opportunity Barclays' optimism is based partly on its belief that Attruby's commercial launch is outperforming Wall Street expectations. The firm projects $912 million in U.S. sales for 2026, roughly 10% above the consensus estimate of $826 million.

And BridgeBio isn't just a one-product company, either. It also has two potential approvals on the horizon. The FDA is reviewing BBP-418 for limb-girdle muscular dystrophy, with a decision expected by Nov. 27, 2026, and Encaleret, designed to treat autosomal dominant hypocalcemia type 1 (a rare condition caused by mutations in the CASR gene), which is scheduled for an FDA decision by May 8, 2027. Those programs could further diversify revenue while reducing reliance on a single commercial asset.

The valuation still leaves room for upside It's no secret that biotech stocks often look expensive before they become profitable, and BridgeBio is no exception. Yes, the company remains unprofitable today as it continues investing heavily in commercialization and late-stage development. That said, Wall Street expects revenue to nearly double this year to roughly $960 million, followed by another sharp increase in 2027 as Attruby sales continue ramping up. Analysts also expect BridgeBio to reach profitability next year.

Of course, that doesn't guarantee Barclays' $157 price target will be reached. Execution still matters. Attruby must continue gaining market share, additional pipeline programs need to deliver, and management has to prove it can successfully transition from a development-stage biotech into a multiproduct commercial company.

Still, I think Barclays' optimism is understandable. BridgeBio now has an approved blockbuster candidate generating meaningful revenue, several late-stage pipeline assets approaching important milestones, and analysts projecting rapid top-line growth over the next two years. If the company continues executing as it has so far, a significantly higher share price doesn't look unreasonable.
2026-07-28 15:17 2mo ago
2026-07-28 11:06 2mo ago
BridgeBio Pharma (BBIO) Expected to Beat Earnings Estimates: Should You Buy?
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (BBIO - Free Report) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.

The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.

While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.

Zacks Consensus EstimateThis rare disease drug developer is expected to post quarterly loss of $0.63 per share in its upcoming report, which represents a year-over-year change of +33.7%.

Revenues are expected to be $223.36 million, up 102% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.53% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for BridgeBio Pharma?For BridgeBio Pharma, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +13.69%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination indicates that BridgeBio Pharma will most likely beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that BridgeBio Pharma would post a loss of$0.7 per share when it actually produced a loss of -$0.84, delivering a surprise of -20.00%.

The company has not been able to beat consensus EPS estimates in any of the last four quarters.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

BridgeBio Pharma appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
2026-07-25 17:38 3mo ago
2026-07-25 04:05 3mo ago
Affinity Asset Advisors LLC Has $11.14 Million Stock Holdings in BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Posted by Defense World Staff on Jul 25th, 2026

Affinity Asset Advisors LLC cut its stake in shares of BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 53.1% during the 1st quarter, according to the company in its most recent disclosure with the Securities & Exchange Commission. The institutional investor owned 150,000 shares of the company’s stock after selling 170,000 shares during the quarter. Affinity Asset Advisors LLC owned approximately 0.08% of BridgeBio Pharma worth $11,139,000 at the end of the most recent quarter.

A number of other large investors have also bought and sold shares of BBIO. Global Retirement Partners LLC increased its position in shares of BridgeBio Pharma by 271.5% during the fourth quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock worth $39,000 after acquiring an additional 372 shares in the last quarter. Farther Finance Advisors LLC boosted its stake in shares of BridgeBio Pharma by 91.4% in the 4th quarter. Farther Finance Advisors LLC now owns 513 shares of the company’s stock worth $39,000 after buying an additional 245 shares during the last quarter. Kemnay Advisory Services Inc. purchased a new position in shares of BridgeBio Pharma in the 4th quarter worth approximately $41,000. Cary Street Partners Investment Advisory LLC grew its holdings in shares of BridgeBio Pharma by 861.0% in the fourth quarter. Cary Street Partners Investment Advisory LLC now owns 567 shares of the company’s stock valued at $43,000 after acquiring an additional 508 shares in the last quarter. Finally, Eurizon Capital SGR S.p.A. bought a new position in shares of BridgeBio Pharma in the fourth quarter valued at approximately $44,000. 99.85% of the stock is currently owned by institutional investors and hedge funds.

Analyst Upgrades and Downgrades BBIO has been the topic of a number of research reports. Weiss Ratings restated a “sell (d)” rating on shares of BridgeBio Pharma in a research note on Friday, May 15th. Citigroup raised their price objective on shares of BridgeBio Pharma from $82.00 to $93.00 and gave the stock a “neutral” rating in a report on Thursday, July 16th. Canaccord Genuity Group initiated coverage on shares of BridgeBio Pharma in a research note on Wednesday, June 3rd. They issued a “buy” rating and a $104.00 price objective for the company. Mizuho lowered their target price on shares of BridgeBio Pharma from $106.00 to $96.00 and set an “outperform” rating on the stock in a report on Tuesday, June 16th. Finally, Royal Bank Of Canada started coverage on BridgeBio Pharma in a research report on Thursday, April 9th. They set an “outperform” rating and a $100.00 target price on the stock. Twenty equities research analysts have rated the stock with a Buy rating, two have assigned a Hold rating and one has issued a Sell rating to the stock. According to data from MarketBeat.com, BridgeBio Pharma has an average rating of “Moderate Buy” and a consensus price target of $95.21.

Read Our Latest Stock Analysis on BridgeBio Pharma

BridgeBio Pharma Stock Up 1.3% Shares of NASDAQ:BBIO opened at $84.02 on Friday. The company’s 50-day moving average price is $72.69 and its 200 day moving average price is $72.53. The company has a market cap of $16.46 billion, a PE ratio of -22.47 and a beta of 0.95. BridgeBio Pharma, Inc. has a fifty-two week low of $42.09 and a fifty-two week high of $93.42.

BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last announced its quarterly earnings results on Thursday, May 7th. The company reported ($0.84) EPS for the quarter, missing the consensus estimate of ($0.70) by ($0.14). The business had revenue of $194.51 million for the quarter, compared to the consensus estimate of $178.07 million. The company’s revenue for the quarter was up 66.8% compared to the same quarter last year. During the same quarter in the prior year, the firm earned ($0.88) EPS. As a group, equities analysts anticipate that BridgeBio Pharma, Inc. will post -2.27 EPS for the current year.

Insider Buying and Selling In other news, Director Jennifer E. Cook sold 148,589 shares of the company’s stock in a transaction dated Thursday, July 9th. The stock was sold at an average price of $88.54, for a total transaction of $13,156,070.06. Following the completion of the sale, the director owned 8,383 shares in the company, valued at approximately $742,230.82. This represents a 94.66% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Andrea Ellis sold 17,167 shares of BridgeBio Pharma stock in a transaction dated Thursday, July 9th. The stock was sold at an average price of $84.00, for a total value of $1,442,028.00. Following the completion of the transaction, the director owned 22,579 shares in the company, valued at $1,896,636. The trade was a 43.19% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last three months, insiders sold 432,117 shares of company stock valued at $32,633,740. 14.23% of the stock is owned by company insiders.

BridgeBio Pharma Company Profile (Free Report)

BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.

BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.

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2026-07-24 12:48 3mo ago
2026-07-24 04:11 3mo ago
California Public Employees Retirement System Grows Stock Holdings in BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Posted by Defense World Staff on Jul 24th, 2026

California Public Employees Retirement System raised its holdings in BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 21.9% in the 1st quarter, according to its most recent 13F filing with the SEC. The fund owned 253,479 shares of the company’s stock after acquiring an additional 45,596 shares during the period. California Public Employees Retirement System owned 0.13% of BridgeBio Pharma worth $18,823,000 at the end of the most recent reporting period.

Other large investors also recently made changes to their positions in the company. Global Retirement Partners LLC grew its position in shares of BridgeBio Pharma by 271.5% in the fourth quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock valued at $39,000 after purchasing an additional 372 shares during the period. Farther Finance Advisors LLC lifted its position in BridgeBio Pharma by 91.4% during the fourth quarter. Farther Finance Advisors LLC now owns 513 shares of the company’s stock worth $39,000 after buying an additional 245 shares during the period. Kemnay Advisory Services Inc. purchased a new position in BridgeBio Pharma during the fourth quarter worth about $41,000. Cary Street Partners Investment Advisory LLC boosted its stake in BridgeBio Pharma by 861.0% in the 4th quarter. Cary Street Partners Investment Advisory LLC now owns 567 shares of the company’s stock worth $43,000 after buying an additional 508 shares during the last quarter. Finally, Eurizon Capital SGR S.p.A. acquired a new stake in BridgeBio Pharma in the 4th quarter worth about $44,000. Hedge funds and other institutional investors own 99.85% of the company’s stock.

Insider Activity In related news, CEO Neil Kumar sold 40,000 shares of BridgeBio Pharma stock in a transaction on Thursday, June 4th. The shares were sold at an average price of $67.46, for a total transaction of $2,698,400.00. Following the transaction, the chief executive officer owned 535,686 shares in the company, valued at approximately $36,137,377.56. The trade was a 6.95% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CFO Thomas Trimarchi sold 13,651 shares of the company’s stock in a transaction dated Monday, May 18th. The stock was sold at an average price of $65.08, for a total value of $888,407.08. Following the completion of the sale, the chief financial officer directly owned 359,194 shares of the company’s stock, valued at $23,376,345.52. The trade was a 3.66% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold a total of 432,117 shares of company stock valued at $32,633,740 over the last quarter. 14.23% of the stock is owned by insiders.

BridgeBio Pharma Price Performance Shares of NASDAQ:BBIO opened at $82.93 on Friday. The business has a 50-day moving average of $72.33 and a two-hundred day moving average of $72.45. The firm has a market capitalization of $16.24 billion, a PE ratio of -22.17 and a beta of 0.95. BridgeBio Pharma, Inc. has a 12 month low of $42.09 and a 12 month high of $93.42.

BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last released its quarterly earnings data on Thursday, May 7th. The company reported ($0.84) earnings per share for the quarter, missing the consensus estimate of ($0.70) by ($0.14). The firm had revenue of $194.51 million during the quarter, compared to analyst estimates of $178.07 million. BridgeBio Pharma’s quarterly revenue was up 66.8% on a year-over-year basis. During the same quarter in the prior year, the company earned ($0.88) earnings per share. As a group, research analysts anticipate that BridgeBio Pharma, Inc. will post -2.29 earnings per share for the current year.

Analyst Ratings Changes Several analysts have commented on BBIO shares. HC Wainwright lifted their price target on BridgeBio Pharma from $110.00 to $120.00 and gave the company a “buy” rating in a report on Monday, July 13th. Weiss Ratings reissued a “sell (d)” rating on shares of BridgeBio Pharma in a research report on Friday, May 15th. Royal Bank Of Canada assumed coverage on shares of BridgeBio Pharma in a research report on Thursday, April 9th. They issued an “outperform” rating and a $100.00 target price on the stock. Canaccord Genuity Group assumed coverage on shares of BridgeBio Pharma in a report on Wednesday, June 3rd. They issued a “buy” rating and a $104.00 target price for the company. Finally, Truist Financial upped their price target on shares of BridgeBio Pharma from $95.00 to $102.00 and gave the stock a “buy” rating in a research report on Wednesday, April 29th. Twenty analysts have rated the stock with a Buy rating, two have assigned a Hold rating and one has assigned a Sell rating to the stock. According to data from MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and an average price target of $95.21.

View Our Latest Report on BridgeBio Pharma

BridgeBio Pharma Profile (Free Report)

BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.

BridgeBio’s pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.

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