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2026-09-09 23:04 4h ago
2026-09-09 18:47 8h 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 9h ago
2026-09-09 12:31 15h 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 16h ago
2026-09-09 04:00 23h 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
Original source text
- 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 2d ago
2026-09-07 04:20 2d 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 7d ago
2026-09-02 07:30 7d 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 8d ago
2026-09-01 13:35 8d 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 8d ago
2026-09-01 12:01 8d 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 8d ago
2026-09-01 07:30 8d 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 9d ago
2026-08-31 15:44 9d 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 10d ago
2026-08-25 14:36 15d 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 10d ago
2026-08-25 14:36 15d 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 10d ago
2026-08-25 14:42 15d 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 10d ago
2026-08-26 07:30 14d 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 10d ago
2026-08-30 10:00 10d 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 16d ago
2026-08-24 07:30 16d 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 26d ago
2026-08-14 11:15 26d 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 26d ago
2026-08-14 07:30 26d 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 27d ago
2026-08-13 17:42 27d 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 28d ago
2026-08-12 03:37 28d 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 29d ago
2026-08-11 16:01 29d 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 29d ago
2026-08-11 13:46 29d 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 29d ago
2026-08-11 11:05 29d 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.

Image Source: Zacks Investment Research

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 29d ago
2026-08-11 12:49 29d ago
BridgeBio: Attruby Delivers In Q2, Expect Three New Launches In 12 Months
BBIO BridgeBio Pharma
FMP Stock News
Original source text
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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2026-08-11 02:35 30d ago
2026-08-10 20:58 30d ago
BridgeBio Pharma, Inc. (BBIO) Q2 2026 Earnings Call Transcript
BBIO BridgeBio Pharma
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Original source text
BridgeBio Pharma, Inc. (BBIO) Q2 2026 Earnings Call Transcript
2026-08-11 00:10 30d ago
2026-08-10 18:04 30d ago
BridgeBio Pharma Q2 Earnings Call Highlights
BBIO BridgeBio Pharma
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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.

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2026-08-11 00:10 30d ago
2026-08-10 18:11 30d ago
BridgeBio Pharma (BBIO) Reports Q2 Loss, Tops Revenue Estimates
BBIO BridgeBio Pharma
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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 1mo ago
2026-08-04 04:13 1mo ago
California State Teachers Retirement System Boosts Stock Position in BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
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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 1mo ago
2026-08-03 07:30 1mo 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 1mo ago
2026-08-02 05:55 1mo 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 1mo ago
2026-07-28 11:06 1mo 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 1mo ago
2026-07-25 04:05 1mo 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 1mo ago
2026-07-24 04:11 1mo 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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2026-07-23 20:00 1mo ago
2026-07-23 14:16 1mo ago
FDA Accepts BridgeBio's Filing for Rare Genetic Disease Drug
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways BridgeBio's filing for encaleret in ADH1 was accepted by the FDA, with a decision due by May 8, 2027.BBIO's filing is backed by phase III data showing restored blood and urine calcium and PTH production.BridgeBio says encaleret could expand its portfolio beyond Attruby alongside BBP-418 and infigratinib. BridgeBio Pharma (BBIO - Free Report) announced that the FDA has accepted its regulatory filing seeking approval for the investigational oral candidate encaleret to treat individuals living with a rare genetic endocrine disorder called autosomal dominant hypocalcemia type 1 (ADH1).

A final decision is expected by May 8, 2027. If approved, encaleret would become the first FDA-approved therapy specifically indicated for ADH1, offering a disease-targeted treatment for a condition that is currently managed with calcium and active vitamin D supplementation rather than therapies that address its underlying cause.

The FDA also notified BridgeBio that it is not currently planning to hold an advisory committee meeting, suggesting that the agency does not presently see the need for external expert review of the application. While this is generally viewed as a positive procedural development, it should not be interpreted as an indication of the FDA's ultimate approval decision.

The filing is supported by results from the phase III CALIBRATE study, which showed that encaleret led to the simultaneous restoration of blood and urine calcium, as well as the restoration of physiologic parathyroid hormone (PTH) production. Per BridgeBio, the findings support the drug’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1.

BBIO Stock’s Price PerformanceYear to date, the company’s shares have gained 8% against the industry’s 5% fall.

Image Source: Zacks Investment Research

BridgeBio Takes a Step Closer to Becoming a Multi-Product CompanyThe FDA's acceptance of encaleret marks another regulatory milestone for BridgeBio as it continues to expand its product portfolio beyond Attruby, which is currently its only marketed product. The drug is approved for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM).

However, the company has several late-stage candidates that could significantly diversify its revenue base over the next 12 months. Encaleret is one of three near-term commercialization opportunities, alongside BBP-418 and infigratinib.

A filing for BBP-418 is already under FDA review for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a final decision expected by Nov. 27, 2026. On the other hand, BridgeBio is on track to submit a filing to the agency for infigratinib as a potential treatment for achondroplasia in the third quarter of 2026.

Together with encaleret, BBP-418 and infigratinib could significantly diversify BridgeBio's revenue base. If approved, these candidates would transform the company from a single-product business into a diversified rare disease commercial player, reducing its dependence on Attruby as its primary growth driver.

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

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

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share (EPS) have increased from $2.97 to $3.02. Over the same period, EPS estimates for 2027 have also increased from $4.81 to $4.92. LQDA shares have skyrocketed more than 150% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed once, with the average surprise being 54.40%.

Over the past 60 days, estimates for Harmony Biosciences’ 2026 EPS have increased from $3.20 to $3.30. Over the same period, EPS estimates for 2027 have risen from $3.64 to $3.87. HRMY shares have lost nearly 7% year to date.

Harmony Biosciences’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 25.16%.
2026-07-22 12:44 1mo ago
2026-07-22 07:30 1mo ago
BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1
BBIO BridgeBio Pharma
FMP Stock News
Original source text
July 22, 2026 07:30 ET  | Source: BridgeBio Pharma, Inc.

- PDUFA target action date of May 8, 2027

- If approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1, representing a potential blockbuster opportunity for BridgeBio

- Encaleret demonstrated consistent efficacy across all pre-specified primary and key secondary efficacy endpoints normalizing key markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile

- BridgeBio is also currently enrolling CALIBRATE-PEDS, a registrational Phase 2/3 trial to study encaleret in pediatric ADH1 and intends to initiate the RECLAIM-HP Phase 3 registrational study of encaleret in chronic hypoparathyroidism later this summer; successful development could extend encaleret’s utility to a broader patient population

PALO ALTO, Calif., July 22, 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) for encaleret for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027, and BridgeBio is prepared to launch encaleret upon approval, representing a potential blockbuster opportunity for the Company. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.

"The FDA's acceptance of our NDA is a powerful validation of encaleret’s differentiated clinical profile and enables a major step forward for the ADH1 community. We believe encaleret has the potential to transform care for patients who currently have no indicated treatment options, and we're moving with urgency to bring it to them,” said Ananth Sridhar, Chief Executive Officer of BridgeBio Endocrinology.

CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints, supporting encaleret’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1. The topline results can be found here. Additional results were presented at the European Congress of Endocrinology (ECE) 2026 and the Endocrine Society 2026 annual meeting (ENDO) in oral presentations, with data showing simultaneous restoration of blood and urine calcium, as well as restoration of physiologic parathyroid hormone (PTH) production.

"For too long, ADH1 has been an invisible condition, that disrupts several systems in the body, from the kidneys to the nervous system to the muscles and often goes unrecognized for years. The path to diagnosis is frequently a long and exhausting one, especially for patients with a genetic disorder. Patients often cycle through specialists before anyone connects the dots to their diagnosis. The FDA's acceptance of this NDA is a moment of real hope for ADH1 patients and a signal that the medical and regulatory community understand the seriousness of this condition and that an orally administered option may finally be on the horizon for those in need," said Patty Keating, Executive Director of the HypoPARAthyroidism Association.

As of April 2026, over 2,100 individuals have been diagnosed in the U.S. with autosomal dominant hypocalcemia since October 2023 based on claims data, suggestive of a growing marketplace and elevated diagnostic suspicion. The Company also intends to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1 in the second half of 2026.

BridgeBio is currently enrolling CALIBRATE-PEDS (NCT07080385), a global registrational Phase 2/3 study of encaleret in pediatric ADH1. The Company also plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism later this summer, building on the positive Phase 2 proof-of-concept findings of PTH-independent effects of encaleret on renal calcium handling and expanding the potential applications of encaleret beyond ADH1. Successful development could extend encaleret’s utility to a broader patient population.

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, 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 express and implied statements relating to the Company’s expectations regarding the regulatory review process for encaleret in ADH1, including the FDA’s review of the NDA and the potential for approval; the Company’s preparedness to launch encaleret upon approval; the potential for encaleret to become the first and only approved therapy specifically indicated for individuals living with ADH1 and to transform care for patients with ADH1; the potential for encaleret to be a disease-modifying therapy by targeting the underlying genetic cause of ADH1; the potential commercial opportunity for encaleret in ADH1, including as a potential blockbuster opportunity for the Company; the timing of a potential Marketing Authorization Application submission to the European Medicines Agency for encaleret in ADH1; the Company’s plans to initiate RECLAIM-HP, a global Phase 3 study of encaleret in chronic hypoparathyroidism, and the potential expansion of encaleret beyond ADH1, including the potential for encaleret to become a multi-billion-dollar opportunity for the Company. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. 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, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, regulatory submissions not being accepted or approved on anticipated timelines or at all, encaleret not becoming the first and only approved therapy specifically indicated for individuals living with ADH1, the Company not being successful in launching encaleret on anticipated timing or at all, the potential commercial opportunity for encaleret not being realized, the Company’s plans for RECLAIM-HP not proceeding as expected, 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 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:
Bubba Murarka, Executive Vice President
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
[email protected]
2026-07-18 12:37 1mo ago
2026-07-18 03:11 1mo ago
Allspring Global Investments Holdings LLC Sells 104,864 Shares of BridgeBio Pharma, Inc. $BBIO
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Posted by Defense World Staff on Jul 18th, 2026

Allspring Global Investments Holdings LLC cut its holdings in BridgeBio Pharma, Inc. (NASDAQ:BBIO – Free Report) by 10.5% during the 1st quarter, according to its most recent disclosure with the Securities & Exchange Commission. The institutional investor owned 889,356 shares of the company’s stock after selling 104,864 shares during the quarter. Allspring Global Investments Holdings LLC owned approximately 0.45% of BridgeBio Pharma worth $66,213,000 at the end of the most recent reporting period.

A number of other hedge funds and other institutional investors have also recently bought and sold shares of BBIO. Harvest Fund Management Co. Ltd bought a new position in BridgeBio Pharma in the 3rd quarter valued at approximately $34,000. Jones Financial Companies Lllp acquired a new position in BridgeBio Pharma during the 1st quarter worth about $35,000. Farther Finance Advisors LLC grew its position 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 valued at $39,000 after buying an additional 245 shares during the last quarter. Global Retirement Partners LLC grew its position in shares of BridgeBio Pharma by 271.5% in the 4th quarter. Global Retirement Partners LLC now owns 509 shares of the company’s stock valued at $39,000 after buying an additional 372 shares during the last quarter. Finally, Kemnay Advisory Services Inc. acquired a new stake in shares of BridgeBio Pharma in the fourth quarter valued at about $41,000. Institutional investors own 99.85% of the company’s stock.

Analysts Set New Price Targets A number of equities analysts have recently issued reports on the company. Weiss Ratings restated a “sell (d)” rating on shares of BridgeBio Pharma in a research report on Friday, May 15th. HC Wainwright increased their target price 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. Mizuho decreased their target price on shares of BridgeBio Pharma from $106.00 to $96.00 and set an “outperform” rating for the company in a research report on Tuesday, June 16th. Morgan Stanley raised their price target on shares of BridgeBio Pharma from $94.00 to $98.00 and gave the stock an “overweight” rating in a report on Thursday, May 28th. Finally, Truist Financial boosted 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 given a Hold rating and one has assigned a Sell rating to the stock. Based on data from MarketBeat, the company has an average rating of “Moderate Buy” and a consensus target price of $95.21.

View Our Latest Research Report on BBIO

BridgeBio Pharma Price Performance NASDAQ:BBIO opened at $81.38 on Friday. BridgeBio Pharma, Inc. has a one year low of $42.09 and a one year high of $93.42. The company has a market cap of $15.94 billion, a PE ratio of -21.76 and a beta of 0.95. The firm has a 50-day moving average of $71.13 and a 200-day moving average of $72.32.

BridgeBio Pharma (NASDAQ:BBIO – Get Free Report) last announced its quarterly earnings results 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 company had revenue of $194.51 million for the quarter, compared to analyst estimates of $178.07 million. The business’s quarterly revenue was up 66.8% compared to the same quarter last year. During the same quarter last year, the firm posted ($0.88) earnings per share. On average, equities research analysts expect that BridgeBio Pharma, Inc. will post -2.29 earnings per share for the current fiscal year.

Insider Activity In other news, CEO Neil Kumar sold 40,000 shares of the company’s stock in a transaction on Thursday, June 4th. The shares were sold at an average price of $67.46, for a total value of $2,698,400.00. Following the completion of the sale, the chief executive officer owned 535,686 shares in the company, valued at $36,137,377.56. This represents a 6.95% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which is available 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 the firm’s 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 transaction, the director directly 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. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last ninety days, insiders sold 432,117 shares of company stock worth $32,633,740. Company insiders own 14.23% of the company’s stock.

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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2026-07-13 17:25 1mo ago
2026-07-13 12:25 1mo ago
The Phase 3 Failure That Sent Biotech Winners and Losers in Opposite Directions
BBIO BridgeBio Pharma
FMP Stock News
Original source text
When a late-stage clinical trial misses a primary endpoint, the market reaction rarely distributes evenly across the board. The fallout often reveals undeniable fundamental truths about single-asset exposure, pipeline diversification, and the competitive moats protecting established treatments. The July 9 announcement from AstraZeneca NYSE: AZN and Ionis Pharmaceuticals NASDAQ: IONS regarding the CARDIO-TTRansform Phase 3 trial provides a real-time masterclass in these market dynamics.

The investigational use of Wainua, also known as eplontersen, failed to achieve statistical significance on its primary composite endpoint of cardiovascular mortality and recurrent cardiovascular events at 140 weeks. The treatment targets transthyretin-mediated amyloid cardiomyopathy. This fatal disease causes misfolded proteins to build up in the heart muscle.

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The clinical failure removes an anticipated competitor from a highly lucrative market and triggers an immediate capital rotation across the broader biotech sector.

Unmasking the Trial: Stabilizers Block the PathTo truly understand why the market repriced these assets so aggressively, investors must look beneath the headline failure and evaluate the underlying subgroup data. The treatment landscape relies heavily on stabilizer medications like Vyndamax, manufactured by Pfizer NYSE: PFE. In the CARDIO-TTRansform trial, patients already taking these baseline stabilizers accounted for 57% of the study population at the start of the program, and that proportion rose to roughly 80% by the conclusion of the study.

Wainua failed to demonstrate an additive treatment effect in this specific stabilizer subgroup. The drug did not improve outcomes for patients who were already receiving standard-of-care treatments.

In the monotherapy subgroup, which includes patients not taking any stabilizers, Wainua demonstrated a hazard ratio of 0.71, translating to a 29% risk reduction. While that figure aligns closely with competitor benchmarks, it offers very little commercial utility. A pharmaceutical product cannot successfully capture meaningful market share if it only works for the rapidly shrinking fraction of patients who are completely naive to standard-of-care treatments.

This data exposes a fundamental disparity between antisense oligonucleotides like Wainua and RNA interference therapies developed by competitors. Alnylam Pharmaceuticals NASDAQ: ALNY previously validated its competing RNA interference therapy, Amvuttra, across both monotherapy and combination with a stabilizer subgroup in its HELIOS-B trial. By failing to show that essential additive benefit, Wainua is effectively locked out of the most lucrative and pre-treated segment of the total addressable market.

Asymmetric Damage: Single Asset SqueezeThe financial damage stemming from this clinical miss was distributed quite unevenly, highlighting the stark contrast between concentrated pipeline risk and structural business diversification.

Ionis Pharmaceuticals Today

IONS

Ionis Pharmaceuticals

$56.31 -1.94 (-3.33%)

As of 01:25 PM Eastern

This is a fair market value price provided by Massive. Learn more.

52-Week Range$40.03▼

$86.74Price Target$96.05

Ionis Pharmaceuticals absorbed the brunt of the impact. Shares fell by more than 9% in a single day, pushing the stock down more than 26% since the start of the year and compressing its total market capitalization to $9.63 billion.

Ionis Pharmaceuticals faces acute vulnerability due to its reliance on expanding the addressable market for Wainua. The current regulatory approval for ATTR-polyneuropathy covers fewer than 50,000 patients globally.

The cardiomyopathy indication would have unlocked a total addressable market of 300,000 to 500,000 patients.

Without that expansion, Ionis Pharmaceuticals faces a difficult fundamental reality. The developer currently generates negative earnings, with an earnings-per-share loss of 56 cents. First-quarter 2026 revenue surged to $246 million, an 87% increase year-over-year, but rapid commercial infrastructure expansion kept profit margins compressed, resulting in a net loss of $93 million.

While the company's trailing return on equity remained deeply negative at -58.65%, its balance sheet risk softened substantially after Ionis eliminated $633 million in convertible debt using restricted escrow cash on April 1, 2026.

Astrazeneca Today

$168.76 -2.85 (-1.66%)

As of 01:25 PM Eastern

This is a fair market value price provided by Massive. Learn more.

52-Week Range$137.23▼

$212.71Dividend Yield2.57%

P/E Ratio25.35

Price Target$211.00

AstraZeneca tells a completely different fundamental story. AstraZeneca's stock price fell briefly intraday before institutional buyers stepped in to support it. A $266.54 billion pharmaceutical sector giant does not live or die by a single indication expansion.

AstraZeneca generates $60.44 billion in annual sales, supported by blockbuster oncology franchises such as Tagrisso and Imfinzi. The company operates with a healthy 17.19% net margin, a robust 30.86% return on equity, and a conservative debt-to-equity ratio of 0.52.

Pre-trial models projected Wainua could reach peak sales of up to $6.5 billion with the ATTR-CM approval.

Analysts have since revised those estimates down to approximately $4 billion. Erasing a $2.5 billion premium certainly adjusts near-term valuation models, but it barely registers against AstraZeneca's stated $80 billion top-line revenue target for 2030. The institutional market accurately perceived the drop as a temporary mispricing rather than a structural downgrade.

The Vultures Circle: Rivals Catch the TailwindsMarkets dislike a vacuum. When Wainua was removed as an imminent competitive threat, capital immediately rotated into the rival drugmakers positioned to capture that unaddressed market share. The trial failure preserves the current duopoly and triopoly pricing power within the disease space.

BridgeBio NASDAQ: BBIO emerged as the most direct beneficiary, with shares up 16% to touch new 52-week highs following the initial announcement. BridgeBio is actively launching its newly approved therapy, Attruby.

Without Wainua entering the market to compress margins and force aggressive discounting, BridgeBio enjoys a heavily cleared commercial runway. BridgeBio recently secured a $1 billion Series A convertible preferred equity raise led by Sixth Street and KKR. This infusion provides a substantial capital buffer to execute an aggressive, unopposed commercial launch, funding sales force deployment without immediate dilution concerns.

Pfizer and Alnylam Pharmaceuticals also experienced immediate bid support. Pfizer maintains its multi-billion-dollar stronghold with Vyndamax, resting easy knowing that physicians will not have to weigh the transition of stable patients to a competing therapy. Alnylam Pharmaceuticals sustains its clinical momentum, as its RNA interference mechanism remains the only proven combination therapy that effectively stacks on top of existing stabilizers.

Discharging the Risk: Portfolio Lessons LearnedThe failure of the CARDIO-TTRansform trial fundamentally rewrites the competitive map for amyloidosis treatments. It draws a hard line between therapies that can improve the standard of care and those that merely match it in isolation.

For the entities involved, the data reinforces the protective power of a diversified revenue base. AstraZeneca easily absorbs the setback through its oncology and metabolic divisions, while Ionis Pharmaceuticals faces prolonged fundamental pressure as it navigates elevated debt levels and stalled growth drivers. Investors evaluating biotech allocations might consider prioritizing developers with validated combination therapies or deeply diversified pipelines to mitigate these specific clinical risks.

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2026-07-12 15:02 1mo ago
2026-07-12 09:55 1mo ago
BridgeBio: "Strong Buy" Attruby Differentiation And Several NDA Submissions In Play
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (BBIO) remains a "Strong Buy," driven by regulatory approvals, robust pipeline progress, and significant commercial momentum for Attruby in ATTR-CM. Company has achieved U.S. and international approvals for acoramidis, with Q1 2026 U.S. net product revenue reaching $180.6 million, and is pursuing further pipeline expansion. Positive phase 3 PROPEL 3 data for oral infigratinib in achondroplasia supports an NDA submission in Q3 2026, targeting a $2.9B global market.
2026-07-10 22:15 1mo ago
2026-07-10 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
July 10, 2026 16:01 ET  | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., July 10, 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 July 7, 2026, the compensation committee of BridgeBio’s board of directors approved equity grants to 37 new employees in restricted stock units for an aggregate of 83,283 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.

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:
Bubba Murarka, Executive Vice President, Corporate Development
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
[email protected]
2026-07-10 19:51 1mo ago
2026-07-10 13:25 1mo ago
How a Rival's Clinical Setback Sent BBIO Stock to a 52-Week High
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways BridgeBio Pharma surged after a rival's phase III ATTR-CM trial failed its primary endpoint.BBIO's Attruby is its only marketed drug and posted strong U.S. sales after its FDA approval.BridgeBio sees a large ATTR-CM opportunity as diagnoses rise and the market remains underdiagnosed. Shares of BridgeBio Pharma (BBIO - Free Report) climbed to a 52-week high of $93.42 on Thursday after rival AstraZeneca's (AZN - Free Report) late-stage clinical setback boosted investor confidence in the company's sole marketed drug, Attruby. Although the stock did not hold on to its intraday high, it still ended the session 15% higher, adding roughly $2.3 billion to its market value.

The rally followed AstraZeneca’s announcement that the phase III CARDIO-TTRansform study evaluating Wainua in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) failed to meet its primary endpoint. Investors viewed the setback as a favorable development for BridgeBio's Attruby because it could strengthen the drug’s competitive position in the ATTR-CM space.

Attruby is currently BridgeBio's only marketed product and the primary driver of the company's revenues. Approved by the FDA in November 2024 for adults with ATTR-CM, the drug has enjoyed a strong commercial launch. BridgeBio generated $362.4 million in U.S. Attruby sales in 2025, its first full year on the market, followed by nearly $181 million in the first quarter of 2026 alone.

Attruby's long-term opportunity remains substantial because the target market continues to be significantly underdiagnosed. BridgeBio estimates that the number of diagnosed ATTR-CM patients in the United States grew from fewer than 5,000 in 2019 to more than 50,000 in 2025, while the global market opportunity for ATTR therapies could ultimately exceed $20 billion.

Another company that benefited from AstraZeneca’s clinical setback is Pfizer (PFE - Free Report) , whose shares also rose 1% yesterday. The U.S.-based pharma giant currently dominates the ATTR-CM market with its Vyndaqel family, comprising Vyndaqel, Vyndamax and Vynmac. The franchise generated approximately $1.6 billion in global sales in first-quarter 2026, up 8% year over year, underscoring its leadership in the space. In April, Pfizer entered into a settlement with generic drug manufacturers that extends the effective U.S. patent protection for Vyndamax until June 1, 2031, delaying generic competition and supporting the drug's long-term commercial outlook.

BBIO’s Price Performance, Valuation & EstimatesShares of BridgeBio have risen 18% year to date, outperforming the industry’s 3% growth.

Image Source: Zacks Investment Research

From a valuation standpoint, the company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 13.46 times forward 12-month sales, higher than the industry average of 1.95 times.

Image Source: Zacks Investment Research

Estimates for BridgeBio’s 2026 and 2027 bottom line have declined over the past 30 days.

Image Source: Zacks Investment Research

BBIO currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
2026-07-10 12:39 1mo ago
2026-07-10 06:36 1mo ago
BridgeBio Pharma (BBIO) Moves 15.1% Higher: Will This Strength Last?
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (BBIO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
2026-07-08 19:53 2mo ago
2026-07-08 13:31 2mo ago
BridgeBio Stock Taps Rare Disease Trends and New Diagnosis Growth
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma (BBIO - Free Report) is building its investment case around rare diseases where diagnosis, targeted treatment and commercial access are changing quickly.

Attruby's launch in transthyretin amyloid cardiomyopathy gives the company a commercial base, while late-stage programs could widen its reach in genetic diseases with limited approved options.

Attruby Shows BridgeBio Demand ExpansionAttruby is already BridgeBio's main revenue driver. The drug generated $362.4 million in U.S. sales in 2025, its first full year on the market, and nearly $181 million in first-quarter 2026 sales.

The demand backdrop matters as much as the product launch. BridgeBio estimates diagnosed ATTR-CM patients in the United States increased from fewer than 5,000 in 2019 to more than 50,000 in 2025 as awareness improved and non-invasive diagnostic tools gained wider use.

This makes Attruby part of a broader market-expansion story. A larger identified patient pool can support continued adoption if BridgeBio converts diagnosis growth into prescriptions and maintains access against entrenched alternatives.

BBIO Targets First-in-Class OpportunitiesBridgeBio's late-stage pipeline is aimed at rare diseases where established therapies remain limited. BBP-418 is under FDA review for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a decision expected by Nov. 27, 2026.

If approved, BBP-418 would become the first therapy for that patient group and potentially the first approved treatment for any form of limb-girdle muscular dystrophy. Encaleret offers a similar first-in-class angle in autosomal dominant hypocalcemia type 1 (ADH1), with a possible U.S. launch in early 2027.

The strategy fits BridgeBio's broader focus on genetically defined diseases. It also gives investors multiple regulatory catalysts beyond Attruby, although approval timing and label breadth remain key variables.

How Oral Drugs Shape BridgeBio's PositioningProduct format is part of BBIO's competitive pitch. Infigratinib is an orally administered therapy being developed for achondroplasia, with a U.S. filing planned for the third quarter of 2026.

That oral profile could matter in a market that already includes injectable options. BioMarin Pharmaceutical (BMRN - Free Report) markets Voxzogo in achondroplasia, while Ascendis Pharma (ASND - Free Report) adds another competitive reference point through Yuviwel.

Attruby also operates in a competitive field. Pfizer (PFE - Free Report) remains the established player in ATTR-CM through its Vyndaqel family, which means BridgeBio must compete on clinical relevance, access and physician adoption rather than diagnosis growth alone.

BridgeBio Builds Beyond a One-Product StoryBridgeBio is still highly dependent on Attruby, but its portfolio points beyond a single commercial win. The company is preparing for three potential U.S. launches over the next 12 months, supported by a $1 billion preferred equity financing.

Earlier-stage assets add a longer runway. BBP-812 is being developed for Canavan disease, while a next-generation ATTR-CM depleter program could extend BridgeBio's presence in the same cardiac amyloidosis market over time.

Minority interests in GondolaBio and BridgeBio Oncology Therapeutics add rare disease and oncology optionality. These assets are not central to the near-term thesis, but they reinforce the company's effort to build a broader genetic-disease platform.

How BBIO Signals Trend Strength to InvestorsThe bottom line is that BridgeBio gives investors credible exposure to rare disease diagnosis growth, targeted therapy development and underpenetrated patient populations. Attruby validates the commercial side, while BBP-418, encaleret and infigratinib could determine whether BBIO becomes a broader launch story.

BBIO currently carries a Zacks Rank #3 (Hold). That rank is consistent with a balanced view in which launch execution and market expansion are offset by competition, regulatory risk and valuation pressure. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

For now, the investment debate rests less on the attractiveness of rare disease trends and more on execution. Attruby must keep gaining share, and the pipeline needs approvals that can diversify revenues without adding avoidable launch risk.
2026-07-08 17:29 2mo ago
2026-07-08 13:25 2mo ago
Is BBIO Stock a Buy Now or Too Expensive for the Risk Ahead
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio Pharma BBIO has become a harder stock to judge after its sharp rare-disease run. Attruby is ramping quickly, yet the valuation already assumes a good deal of future success.
2026-07-08 17:29 2mo ago
2026-07-08 13:25 2mo ago
BridgeBio Stock Outlook Hinges on Attruby & New Drug Catalysts
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Key Takeaways BridgeBio's Attruby became its main revenue driver after strong early sales following FDA approval.BBIO targets three potential U.S. launches over 12 months, led by BBP-418 under priority review.BBIO boosted liquidity with $1B financing, but debt, competition and pipeline risks remain. BridgeBio Pharma (BBIO - Free Report) is moving from a launch-driven story toward a broader commercial execution test. Attruby has quickly become the company’s financial backbone, while late-stage pipeline assets could add new revenue streams.

The stock’s outlook now depends on whether BridgeBio can scale Attruby, convert upcoming regulatory catalysts into launches and manage risks tied to a leveraged rare disease growth model.

Why Attruby Drives BBIO GrowthAttruby is BridgeBio’s key marketed product and main revenue driver. The drug was approved by the FDA in November 2024 for adults with transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive heart disease caused by transthyretin amyloid buildup.

U.S. Attruby sales were $362.4 million in 2025, its first full year on the market, and nearly $181 million in the first quarter of 2026. That performance made the therapy BBIO’s financial backbone.

Growth is tied to rising diagnosis rates, physician adoption and patient uptake. BridgeBio estimates that diagnosed U.S. ATTR-CM patients rose from fewer than 5,000 in 2019 to more than 50,000 in 2025, helped by greater awareness and wider use of non-invasive diagnostic tools.

How BridgeBio Can Broaden RevenueBridgeBio’s next challenge is reducing its dependence on Attruby. The company is preparing for three potential U.S. product launches over the next 12 months, led by BBP-418, encaleret and infigratinib.

BBP-418 is the closest catalyst. The FDA accepted the filing for priority review in limb-girdle muscular dystrophy type 2I/R9, with a decision expected by Nov. 27, 2026. Approval would make it the first therapy for this patient population.

Encaleret adds another possible first-in-class launch. BridgeBio submitted the filing in May 2026 for autosomal dominant hypocalcemia type 1 (ADH1) and anticipates a U.S. launch in early 2027 if approved.

Infigratinib could follow in achondroplasia. BridgeBio intends to file in the third quarter of 2026 and is targeting a potential launch in early to mid-2027. Together, these programs could shift BBIO toward a broader rare disease platform.

BBIO Balance Sheet Supports Launch PlansBridgeBio recently raised $1 billion through preferred equity financing to support current and potential product launches. The capital gives the company more flexibility as it funds Attruby commercialization.

Liquidity looks adequate for near-term needs. BridgeBio ended the first quarter of 2026 with $940.2 million in cash, cash equivalents and marketable securities, up from $587.5 million at the end of 2025.

Debt remains part of the investment case. Long-term debt was approximately $1.93 billion as of March 31, 2026, while short-term debt was around $547 million. The cash balance covers near-term obligations, but BBIO remains a leveraged growth story.

Where BBIO Investors Should Stay CautiousThe biggest risk is concentration. Attruby is BridgeBio’s only approved product in its commercial portfolio, leaving near-term financial performance highly dependent on one therapy.

Competition is another constraint. Pfizer (PFE - Free Report) markets the established Vyndaqel family in ATTR-CM, and BridgeBio must keep proving Attruby’s clinical and access position to gain further share.

Pipeline risk is also material. An FDA delay, rejection, request for more data or narrower-than-expected label for BBP-418, encaleret or infigratinib could push out the diversification timeline.

In achondroplasia, BioMarin Pharmaceutical (BMRN - Free Report) markets Voxzogo, an injectable treatment option. That backdrop means infigratinib’s oral profile may help, but uptake would still depend on data, reimbursement and physician adoption.

How BBIO Fits a Neutral Rating SetupBBIO fits a balanced setup because the positives and risks are both clear. Attruby has delivered meaningful early revenue, the late-stage pipeline offers multiple catalysts and the balance sheet has been strengthened.

At the same time, one-product reliance, regulatory uncertainty and competition keep the risk-reward profile from being one-sided. The stock trades at 12.3X forward 12-month EV/Sales, above the Zacks sub-industry multiple of 2.7X.

A Neutral stance is consistent with a Zacks Rank #3 (Hold) style setup, where investors may prefer to watch execution rather than assume a straight-line growth path. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
2026-07-02 12:57 2mo ago
2026-07-02 07:30 2mo ago
Acoramidis Associated with First-Ever Early and Sustained Direct Kidney-Protective Effects in ATTR-CM
BBIO BridgeBio Pharma
FMP Stock News
Original source text
July 02, 2026 07:30 ET  | Source: BridgeBio Pharma, Inc.

- Acoramidis initiation was associated with rapid kidney-protective activity as exhibited in a hemodynamically mediated, reversible eGFR dip and a placebo-corrected 15.5% reduction in UACR by Day 28 (P<0.05), with no kidney-related adverse events observed in these post-hoc analyses

-Treatment with acoramidis provided a sustained, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year; p<0.001) sustained UACR reduction (13.7%; p=0.026) through Month 30

- Acoramidis demonstrated a profile consistent with drugs that act directly on the kidney, such as ACE inhibitors, ARBs, and SGLT2 inhibitors, which has not previously been observed with any other approved ATTR-CM therapy and supports a direct kidney mechanism that is potentially independent of TTR-stabilization

-The magnitude of the acute eGFR dip in participants treated with acoramidis was positively associated with a reduction in early cardiovascular outcomes; the opposite was observed with placebo

- The acute, reversible eGFR dip following acoramidis initiation reflects a favorable hemodynamic renal response that may help explain the early separation in cardiovascular outcomes versus placebo. Kidney function is especially important in heart failure, where a progressive decline in kidney function compounds mortality risk

PALO ALTO, Calif., July 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, today announced the publication of new analyses in Circulation: Heart Failure, examining kidney function in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM) treated with acoramidis. This publication was based on post-hoc analyses of data from randomized, double blind, placebo-controlled trials including the Phase 2 study and the Phase 3 ATTRibute-CM study. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

“In these data, we observed early and sustained cardiorenal benefits of acoramidis treatment with a pattern similar to what we see with drugs such as ACE inhibitors, ARBs, and SGLT2 inhibitors, suggesting acoramidis may have a direct effect on kidney function. These effects have not been reported with other ATTR-CM medications. Acoramidis appears to have a protective effect on the heart and the kidney simultaneously, with potentially meaningful implications for long-term survival and reduced cardiovascular hospitalizations. Kidney dysfunction is pervasive in this population and an independent predictor of mortality from ATTR-CM. For a patient population that is older, sicker, and increasingly surviving long enough for organ preservation to matter, these cardiorenal observations represent an important advancement in the care of patients living with ATTR-CM,” said Professor Jeffrey Testani, M.D., M.T.R. of the Yale School of Medicine, U.S., and first author on the Circulation: Heart Failure manuscript.

The post-hoc analyses shared in the publication demonstrated that acoramidis initiation was associated with direct kidney-protective effects in patients with ATTR-CM, with both early and sustained improvements in kidney function, resembling the pattern seen with drugs acting directly on the kidney. Findings included:

Acoramidis was associated with an early, reversible estimated glomerular filtration rate (eGFR) dip of 8.5±0.48 mL/min/1.73 m2 (95% CI: 7.57, 9.44), which was accompanied by a reduction in placebo-corrected urinary albumin to creatinine ratio (UACR) by 15.5% by Day 28 (P<0.05); such a reduction in UACR may suggest a direct impact on kidney healthA sustained, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year; p<0.001) and sustained UACR reduction (13.7%; p=0.026) were observed through Month 30, resembling the pattern seen with drugs acting directly on the kidney, such as ACE inhibitors, ARBs, and SGLT2 inhibitorsThe acute dip in eGFR following initiation of acoramidis may represent a beneficial kidney effect that could be relevant to the previously reported, observed early separation within the first 3 months between acoramidis and placebo in adverse clinical outcomes and the cumulative cardiovascular-related mortality or recurrent cardiovascular-related hospitalizations (CVH) curves, with a numerical difference in events within 1 monthParticipants with dips larger than the overall population median experienced a 58% lower risk of death or cardiovascular hospitalization (HR: 0.42; 95% CI, 0.22–0.78; P=0.006) and 66% lower risk of hospitalization alone (HR: 0.34; 95% CI, 0.17–0.66; P=0.002) in the first year of treatment. Within the placebo arm, eGFR dips were associated with worse outcomes 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.

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 of acoramidis’ observed effects on kidney function, including eGFR and UACR; the potential for acoramidis to have direct kidney-protective effects or a direct effect on kidney function that may be independent of TTR stabilization; the potential relationship between the acute, reversible eGFR dip following initiation of acoramidis and beneficial kidney effects or early separation in cardiovascular outcomes; and the potential implications of these observations for long-term survival and reduced cardiovascular hospitalizations. 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, future regulatory filings, approvals and/or sales, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the risk that post hoc analyses may not be predictive of future clinical outcomes or treatment effect, that mechanistic interpretations of observed data may not be borne out by further analyses or additional data, and that observed effects on kidney function may not translate into improved long-term clinical outcomes, 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:
Bubba Murarka, Executive Vice President
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
[email protected]
2026-07-01 13:01 2mo ago
2026-07-01 07:30 2mo ago
BridgeBio Raises $1 Billion in Preferred Equity to Accelerate Present and Upcoming Launches
BBIO BridgeBio Pharma
FMP Stock News
Original source text
- Preferred equity investment led by Sixth Street and with participation from HealthCare Royalty, a business of KKR, with an initial conversion price of approximately $138 per share (more than 100% premium to Company’s 30-day VWAP)

- The financing significantly strengthens the Company’s balance sheet, enabling it to efficiently allocate capital across its highest return opportunities

- The financing comes at a pivotal moment for the Company, as Attruby® continues to grow into a multi-billion-dollar blockbuster drug, and as BridgeBio prepares for three additional potential blockbuster U.S. product launches over the next 12 months across BBP-418 for LGMD2I/R9, encaleret for ADH1, and infigratinib for achondroplasia

PALO ALTO, Calif., July 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 it has entered into an agreement with funds managed by Sixth Street (“Sixth Street”) and funds managed by HealthCare Royalty, a business of KKR (“HCRx” and, together with Sixth Street, the “Purchasers”) under which the Purchasers have invested up to $1 billion in newly issued convertible preferred equity of the Company.

The Series A Cumulative Convertible Participating Preferred Stock has the following principal terms:

7.00% initial dividend, payable in kind or in cash at the Company’s electionInitial conversion price of $137.79 per share (more than 100% premium to BridgeBio’s 30-day volume-weighted average price), increasing to $153.10 per share (more than 125% premium) from the fifth anniversaryPermanent equity with no scheduled maturity and no redemption at the holder’s optionBridgeBio may redeem the preferred stock for cash or, in certain circumstances, convert it into common stock, in each case on the terms set forth in the definitive agreements Sixth Street funded $800M as the lead investor, and HealthCare Royalty funded $133.9M at today’s close of the preferred equity investment.

“We are privileged to be partnering with Sixth Street and HealthCare Royalty at this pivotal time in BridgeBio’s trajectory. This financing represents the best of our dual mission – 1) to put patients first and ensure that we have the resources to do so, and 2) that we execute those responsibilities in a manner that maximizes the economic value of our Firm. Access to this type and quantum of capital ensures we can deliver on the promise of our launching medicines and beyond,” said Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio.

“Sixth Street is proud to support BridgeBio’s mission of bringing meaningful medicines to patients during this exciting stage as the company is on the cusp of potential approval and launch of three important new therapies,” said Jeff Pootoolal, Partner at Sixth Street. “Providing flexible capital at scale to leading developers of transformative medicines is central to what we do, and we look forward to a long and productive partnership with the BridgeBio team."

“The BridgeBio management team has a proven track record in launching and developing life-changing therapies, and we are pleased to partner with them on this transaction,” said Clarke Futch, Chairman and CEO of HealthCare Royalty. “This capital support reaffirms our belief in the company’s growth and ability to bring to market multiple products that serve high unmet medical needs.”

Latham & Watkins LLP served as legal advisor to BridgeBio. Evercore served as financial advisor and Sullivan & Cromwell LLP and Mintz LLP served as legal advisors to Sixth Street. Gibson, Dunn & Crutcher LLP served as legal advisor to HealthCare Royalty.

Additional details about the transaction and the related definitive agreements will be included in a Current Report on Form 8-K to be filed by the Company.

About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio; Nasdaq: BBIO) 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, and YouTube.

About Sixth Street
Sixth Street is a global investment firm with over $130 billion in assets under management and committed capital. Sixth Street uses its long-term flexible capital, data-enabled capabilities, and One Team culture to develop themes and offer solutions to companies across all stages of growth. Sixth Street Healthcare and Life Sciences invests thematically throughout the healthcare ecosystem, providing flexible capital solutions to companies addressing our most pressing healthcare challenges and improving patient outcomes. Investments in the sector include Apellis Pharmaceuticals, Arrowhead Pharmaceuticals, Arsenal Biosciences, Beam Therapeutics, Biohaven, Blueprint Medicines, Caris Life Sciences, Chroma Medicine, ConcertAI, Datavant, Essential Pharma, Immunogen, Ironwood, Mammoth Biosciences, Paratek Pharmaceuticals, and Velocity Clinical Research, among many others. Founded in 2009, Sixth Street has more than 750 team members including approximately 300 investment professionals around the world. For more information, visit https://www.sixthstreet.com/, or follow Sixth Street on LinkedIn.

About HealthCare Royalty
HealthCare Royalty (“HCRx”) is a leading royalty acquisition company founded in 2006 that is majority owned by KKR & Co. Inc. (NYSE: KKR). Over two decades, the HCRx team has developed a strong track record of investing in commercial-stage and near-commercial-stage biopharmaceutical assets, committing $7+ billion in over 110 biopharmaceutical products. With offices in New York, Stamford, San Francisco, Boston, London and Miami, HCRx continues to advance biopharmaceutical innovation by providing innovative capital solutions to counterparties. For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY®, HEALTHCARE ROYALTY PARTNERS® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC

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 express and implied statements relating to the Company’s expectations regarding its anticipated growth and expected product launches and intentions for investing in indication expansions. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. 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, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, 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 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.
2026-06-28 20:19 2mo ago
2026-06-28 16:00 2mo ago
BridgeBio Announces Publication in the New England Journal of Medicine of Phase 3 PROPEL 3 Trial of Oral Infigratinib in Children Living with Achondroplasia
BBIO BridgeBio Pharma
FMP Stock News
Original source text
- Phase 3 PROPEL 3 data published today in NEJM were simultaneously presented at ICCBH in a late-breaking oral presentation; presentation includes new arm span Z-score data showing a statistically significant improvement versus placebo (LS mean +0.37 SD; p<0.0001), the first and only statistically significant placebo-controlled arm span result reported for an achondroplasia trial at 52 weeks

- This is the first and only Phase 3 data for an achondroplasia clinical study published in The New England Journal of Medicine (NEJM), marking BridgeBio’s second NEJM publication in achondroplasia and fourth NEJM publication overall in the last three years

- The data includes the largest mean increase in AHV compared to placebo reported in any Phase 3 achondroplasia study (+2.1 cm/year observed mean improvement)

- Oral infigratinib is the only therapy to demonstrate statistically significant improvement in body proportionality in a Phase 3 achondroplasia study, with a LS mean treatment difference of –0.05 in children ages 3 to 8 years (p<0.05)

- Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug

- BridgeBio intends to submit an NDA to the FDA in the third quarter of 2026 with launch anticipated in early to mid 2027, and an MAA to the EMA in the second half of 2026

PALO ALTO, Calif., June 28, 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 positive results from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, were published as an original research article in the New England Journal of Medicine (NEJM). These data were also presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation by Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute, Melbourne, AUS, and global lead investigator for PROPEL 3.

"The publication of our pivotal trial data (PROPEL 3) in the New England Journal of Medicine is a defining milestone for the field of skeletal dysplasia that reflects the years of rigorous clinical investigation from investigators and dedication from children and their families to make this breakthrough science possible. These remarkable data establish oral infigratinib as the first therapy to directly target FGFR3, deliver the highest treated annualized growth velocity and greatest improvement in body proportionality reported for any current therapy for children with achondroplasia. Presenting these late-breaking data at ICCBH reflects the significance of having an orally administered, mechanistically distinct treatment option that addresses achondroplasia and hypochondroplasia at their very source,” said Dr. Savarirayan. “I believe that we are on a clear path toward a best-in-class therapy for children with achondroplasia that families seeking better options are excited to have available to them.”

The positive results shared in NEJM from PROPEL 3 include:

PROPEL 3 successfully met the primary endpoint of change from baseline in annualized height velocity, with a LS mean treatment difference against placebo of +1.74 cm/yr (p<0.0001). The observed mean difference was +2.10 cm/yr (p<0.0001). Both values are the largest observed in a Phase 3 clinical study in achondroplasiaPROPEL 3 successfully met the key secondary endpoint of change from baseline in height Z-score (achondroplasia reference population) at Week 52 (p<0.0001), with an LS mean increase on the treatment arm of +0.41 SDIn a pre-specified exploratory analysis of the key secondary endpoint, oral infigratinib achieved the first statistically significant improvement in body proportionality against placebo in achondroplasia, demonstrating an LS mean treatment difference of -0.05 (p<0.05) against placebo in children younger than 8 years old (>50% of the participants)Infigratinib was well-tolerated, with: No discontinuations related to study drugNo serious adverse events related to study drug3 cases (4%) of hyperphosphatemia, all mild, transient, asymptomatic, and not requiring dose reductions or discontinuationsNo adverse events associated with inhibition of FGFR1 or FGFR2 (e.g., retinal or corneal)
Additional data presented at ICCBH showed infigratinib improved arm span vs. placebo by +0.37 SD (p<0.0001), marking the first statistically significant improvement in arm span from a placebo-controlled achondroplasia trial In addition to the late-breaking oral presentation at ICCBH 2026, one oral presentation, one poster, and three encore posters were shared. The new details shared included:

Health-Related Quality of Life in Children with Achondroplasia: Findings from the Observational PROPEL Study, presented by Marie-Eve Robinson, M.D., of Shriners Hospital for Children Canada, McGill University, Montreal, CA Results from the global observational PROPEL study demonstrated that children with achondroplasia experience reduced health-related quality of life across multiple patient-reported measures, particularly in physical functioning, reinforcing the significant day-to-day burden of the condition and providing important baseline context for future studies of oral infigratinib Qualitative Research to Evaluate the Content Validity and Relevance of Patient-Reported Outcome Measures for Children and Parents of Children with Hypochondroplasia, presented by Chandler Crews of The Chandler Project, U.S. Findings from interviews with children and parents affected by hypochondroplasia demonstrated that commonly used patient-reported outcome measures were clear, relevant, and reflective of the real-world physical, cognitive, and quality-of-life challenges experienced by children living with the condition, supporting their use in future clinical research and care BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia. The Company intends to submit an NDA for achondroplasia to the FDA in the third quarter of 2026, and an MAA for achondroplasia to the EMA in the second half of 2026. The Company anticipates a U.S. launch in early to mid 2027.

Oral infigratinib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (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 infigratinib is approved, BridgeBio may qualify for a Priority Review Voucher.

Information about PROPEL Infant & Toddler 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 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 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, 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. 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, including express and implied statements relating to our expectations regarding the potential approval of oral infigratinib for achondroplasia; the timing of a potential NDA submission to the FDA and MAA submission to the EMA for achondroplasia and a potential launch of oral infigratinib; the potential of oral infigratinib to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia; the potential of oral infigratinib to address achondroplasia, hypochondroplasia and other skeletal dysplasia conditions at their source and with respect to wider medical and functional impacts; the potential use of findings from our observational and qualitative research in future clinical research and care; and our potential qualification for a Priority Review Voucher if oral infigratinib is approved, 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, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for our product candidates, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, our ability to obtain additional funding, potential volatility in our share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from the hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on our overall business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the U.S. Securities and Exchange Commission. 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.

BridgeBio Media Contact:
Bubba Murarka, Executive Vice President
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
[email protected]
2026-06-24 15:23 2mo ago
2026-06-22 07:30 2mo ago
BridgeBio to Present Primary Results from Phase 3 PROPEL 3 Trial of Oral Infigratinib for Children Living with Achondroplasia at ICCBH 2026
BBIO BridgeBio Pharma
FMP Stock News
Original source text
June 22, 2026 07:30 ET  | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., June 22, 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 positive data from PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children living with achondroplasia, will be shared in a late breaking oral presentation at the International Congress of Children’s Bone Health (ICCBH) 2026 taking place in Montreal, Canada on June 27-30, 2026.

BridgeBio will also share an oral presentation and four posters at the meeting highlighting quality of life, early intervention research, observational study findings, and educational resources through MyAchonJourney for individuals with achondroplasia and related skeletal dysplasias. Additionally, the Company will share an autosomal dominant hypocalcemia type 1 (ADH1) poster on findings from CLARIFY, its disease monitoring study of autosomal dominant hypocalcemia (ADH) type 1 and type 2.

Late-Breaking Oral Presentation:
A Randomized Controlled Trial of Oral Infigratinib in Children with Achondroplasia
Presenter: Ravi Savarirayan, M.D., Ph.D. of Murdoch Children’s Research Institute, Melbourne, AU, and Global Lead Investigator for PROPEL 3
Date & Time: Sunday, June 28 at 3:45 pm EDT

Oral Presentation:
Health-Related Quality of Life in Children with Achondroplasia: Findings from the Observational PROPEL Study
Presenter: Marie-Eve Robinson, M.D., M. Sc., Shriners Hospital for Children Canada, McGill University, CA
Date & Time: Monday, June 29 at 11:00 am EDT

Skeletal Dysplasia Posters:
A Phase 2/2b Study of Infigratinib in Children Under 3 Years Old with Achondroplasia: Design of PROPEL Infant and Toddler
Presenter: Julie Hoover-Fong, M.D., Ph.D., Johns Hopkins University, U.S.
Date & Time: Sunday, June 28 at 12:00 pm EDT

The ACCEL Observational Study: Diagnostic Features, Medical History, and Baseline Characteristics of Children with Hypochondroplasia
Presenter: Marie-Eve Robinson, M.D., M. Sc., Shriners Hospital for Children Canada, McGill University, CA
Date & Time: Monday, June 29 at 12:00 pm EDT

MyAchonJourney: An Online Educational Resource for Individuals with Achondroplasia and Their Families, Developed by Advocacy Leaders and Healthcare Providers
Presenter: Kirsten Kiefer, BridgeBio Skeletal Dysplasias, U.S.
Date & Time: Monday, June 29 at 12:00 pm EDT

Qualitative Research to Evaluate the Content Validity and Relevance of Patient-Reported Outcome Measures for Children and Parents of Children with Hypochondroplasia
Presenter: Chandler Crews, The Chandler Project, U.S.
Date & Time: Monday, June 29 at 12:00 pm EDT

ADH1 Poster:
Autosomal Dominant Hypocalcemia Type 1 and Type 2: Baseline Burden of Disease and Quality of Life in Pediatric Participants in the CLARIFY Disease Monitoring Study
Presenter: Raja Padidela, M.D., Royal Manchester Children's Hospital, University of Manchester, UK
Date & Time: Monday, June 29 at 12:00 pm EDT

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:
Bubba Murarka, Executive Vice President
[email protected]
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
[email protected]
2026-06-24 15:23 2mo ago
2026-06-23 16:31 2mo ago
BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
BBIO BridgeBio Pharma
FMP Stock News
Original source text
June 23, 2026 16:31 ET  | Source: BridgeBio Pharma, Inc.

PALO ALTO, Calif., June 23, 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 June 18, 2026, the compensation committee of BridgeBio’s board of directors approved equity grants to 30 new employees in restricted stock units for an aggregate of 66,810 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on May 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:
Bubba Murarka, Executive Vice President, Corporate Development
[email protected]   
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
[email protected]
2026-06-12 13:57 2mo ago
2026-04-29 11:01 4mo ago
Amphastar Pharmaceuticals (AMPH) Expected to Beat Earnings Estimates: Should You Buy?
BBIO BridgeBio Pharma
FMP Stock News
Original source text
Amphastar Pharmaceuticals (AMPH - Free Report) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 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 specialty pharmaceutical company is expected to post quarterly earnings of $0.70 per share in its upcoming report, which represents a year-over-year change of -5.4%.

Revenues are expected to be $170.71 million, up 0.1% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 6.15% 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 Amphastar?For Amphastar, 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 +2.37%.

On the other hand, the stock currently carries a Zacks Rank of #2.

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

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. 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 Amphastar would post earnings of $0.97 per share when it actually produced earnings of $0.73, delivering a surprise of -24.74%.

Over the last four quarters, the company has beaten consensus EPS estimates three times.

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.

Amphastar 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.

An Industry Player's Expected ResultsBridgeBio Pharma (BBIO - Free Report) , another stock in the Zacks Medical - Generic Drugs industry, is expected to report loss per share of $0.71 for the quarter ended March 2026. This estimate points to a year-over-year change of +19.3%. Revenues for the quarter are expected to be $179.6 million, up 54% from the year-ago quarter.

Over the last 30 days, the consensus EPS estimate for BridgeBio Pharma has been revised 3.9% down to the current level. Nevertheless, the company now has an Earnings ESP of -4.23%, reflecting a lower Most Accurate Estimate.

When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that BridgeBio Pharma will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once.

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2026-06-12 13:57 2mo ago
2026-04-29 17:58 4mo ago
BridgeBio: Attruby's Early Dominance Makes The Bull Case Hard To Ignore
BBIO BridgeBio Pharma
FMP Stock News
Original source text
BridgeBio remains a compelling Buy, driven by Attruby's strong U.S. launch and favorable competitive dynamics following Pfizer's patent settlements. Attruby's peak annual sales are conservatively modeled at $2.2B, with sensitivity up to $4B, underpinned by a protected branded market through mid-2031. BBIO's late-stage pipeline—infigratinib, encaleret, and BBP-418—offers potential for additional blockbusters, supporting long-term value beyond Attruby.