BridgeBio Pharma za měsíc od poslední výsledkové zprávy oslabil o 10,7 %. Výnosy ve 2. čtvrtletí vzrostly meziročně o 120 % na 243,7 milionu USD, ale ztráta činila 78 centů na akcii.
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.
Trump oznámil dohody s devíti středně velkými farmaceutickými firmami o snížení cen léků podle pravidla MFN. Společnosti se zároveň zavázaly investovat nejméně 19,6 miliardy USD do výroby v USA.
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.
BridgeBio uzavřela dobrovolnou dohodu s vládou USA, která rozšíří přístup pacientům Medicaid k jejímu již prodávanému léku prostřednictvím GENEROUS Model a sníží náklady. Attruby zůstane dostupný v rámci Medicare Part D bez budoucích cenových mandátů.
- 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 ve 2. čtvrtletí zvýšila tržby o 120 % na 243,7 milionu USD díky prudkému růstu prodejů Attruby. Akcie zároveň obchodují s EV/tržby 11,96, výrazně nad srovnatelnými společnostmi.
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.
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.
BridgeBio oznámila, že do studie ASCEND-ATTR fáze 3b/4 byl zařazen první účastník. Studie má prověřit dlouhodobý vliv acoramidisu na strukturu, funkci a amyloidní zátěž srdce u ATTR-CM.
- 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]
BridgeBio uvedla, že acoramidis ve studii ATTRibute-CM poprvé naznačil možnost zvrátit strukturální poškození srdce u ATTR-CM. Pacienti měli navíc o 65 dní více života mimo nemocnici po 36 měsících.
- 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.
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]
BridgeBio oznámila, že tržby z Attruby ve 2. čtvrtletí více než ztrojnásobily na více než 222 milionů USD. Celkové tržby firmy se téměř zdvojnásobily na téměř 244 milionů USD.
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).
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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.
BridgeBio Pharma oznámila cenu sekundární nabídky 5 milionů akcií od KKR Genetic Disorder L.P.; společnost sama žádné akcie neprodává a nezíská žádný výnos.
- 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.
BridgeBio Pharma zvýšila ve 2. čtvrtletí čisté tržby z Attruby na 222,4 mil. USD z 71,5 mil. USD před rokem. Firma zároveň posunula tři pozdní programy do regulačního přezkumu.
The Phase 3 Failure That Sent Biotech Winners and Losers in Opposite DirectionsBridgeBio Pharma NASDAQ: BBIO reported continued growth for its ATTR cardiomyopathy treatment Attruby in the second quarter of 2026, while advancing three late-stage programs into regulatory review and expanding commercial preparations for potential launches over the next year.
Chief Executive Officer Neil Kumar described the period as a transition point for the company, citing the commercial progress of Attruby, regulatory submissions for programs in limb-girdle muscular dystrophy type 2I, autosomal dominant hypocalcemia type 1 and achondroplasia, and the start of a Phase III trial in chronic hypoparathyroidism.
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Attruby Revenue Rises as First-Line Use Expands BridgeBio's Volatile Week Puts Biotech Stocks Under a MicroscopeAttruby generated $222.4 million in net product revenue during the second quarter, up from $71.5 million a year earlier and representing another sequential increase of more than $35 million. Chief Commercial Officer Matt Outten said growth was led by treatment-naive, first-line patients, while the pool of patients switching from Pfizer’s Vyndaqel had normalized after a period of elevated switching activity.
“The engine is the first-line,” Outten said, adding that BridgeBio’s first-line share increased in a market that was broadly stable sequentially. Kumar said Attruby was the fastest-growing brand in the category, with 23% growth during the quarter, while the overall market grew 19%.
Management said it expects clinical differentiation to remain central to Attruby’s commercialization. Kumar highlighted data published in Circulation: Heart Failure that BridgeBio said showed early and sustained kidney-protective effects for acoramidis, the active ingredient in Attruby, in patients with ATTR cardiomyopathy. The company said the analysis included improvement in chronic eGFR slope and reductions in urinary albumin-to-creatinine ratio.
BridgeBio also cited real-world analyses comparing Attruby with tafamidis. Kumar said an independent propensity score-matched study associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at six months versus tafamidis. A separate company analysis showed a 34% reduction in diuretic intensification, heart-failure hospitalization and mortality, according to Kumar.
Management said the failure of the CARDIO-TTRansform study’s primary endpoint, which evaluated eplontersen in ATTR cardiomyopathy, could reinforce stabilization therapy as a first-line standard. However, executives said they were awaiting fuller data from the study before updating expectations for Attruby’s long-term market share.
BridgeBio said it remains on track for acoramidis to reach blockbuster worldwide sales in 2026, including sales of Beyonttra outside the U.S. recorded by its partners. Outten emphasized that this target was not a forecast specifically for U.S. Attruby net product revenue.
Three Programs Move Toward Potential Approval BridgeBio said all three of its late-stage programs moved into regulatory review during the quarter.
BBP-418 for LGMD2I/R9: The FDA accepted the new drug application on May 27 with priority review. The PDUFA target action date is Nov. 27, 2026, and no advisory committee meeting is planned. Kumar said the treatment could become the first approved therapy for LGMD2I, which the company said affects more than 1,000 patients in the U.S. BridgeBio’s commercial team is already in the field, and the company said it has identified more than 1,500 genetically confirmed patients. Encaleret for ADH1: The FDA accepted the NDA on July 22 and granted priority review. The PDUFA target action date is May 8, 2027, with no advisory committee currently planned. BridgeBio also submitted a marketing authorization application to the European Medicines Agency. The company said more than 2,200 patients had been identified through ICD-10 claims data between October 2023 and June 2026. Infigratinib for achondroplasia: BridgeBio said it has submitted its NDA and is targeting FDA acceptance, potentially including priority review, in the fourth quarter of 2026, with a potential approval in mid-2027. The company said infigratinib could be the first oral FGFR3-targeted treatment for achondroplasia if approved. Kumar said infigratinib demonstrated a statistically significant improvement in arm span in the Phase III PROPEL 3 study, which was published in The New England Journal of Medicine. The company is building its commercial field organization for a market where injectable competitors are already available.
Chronic Hypoparathyroidism Trial Begins BridgeBio also began screening patients in RECLAIM-HP, its global Phase III trial of encaleret in chronic hypoparathyroidism. The company expects top-line results within approximately 18 months.
Management said chronic hypoparathyroidism affects about 200,000 people in the U.S. and Europe. Kumar argued that encaleret could offer an oral alternative designed to address both low serum calcium and excess urinary calcium. He cited a Phase II proof-of-concept study in which 80% of postsurgical hypoparathyroidism patients receiving encaleret achieved normal blood and urine calcium levels within five days.
Financial Results and Capital Position Total second-quarter revenue was $243.7 million, compared with $110.6 million in the year-earlier period. The increase was driven primarily by higher Attruby revenue. Royalty revenue rose to $15.4 million from $1.6 million, largely reflecting Beyonttra sales in Europe and Japan.
Operating expenses increased to $335.7 million from $241.2 million as BridgeBio expanded sales, marketing, medical affairs and pre-commercial supply activities. The company recorded a loss from operations of $107.1 million, an improvement from a $134.3 million operating loss a year earlier.
BridgeBio ended June with $720.2 million in cash, cash equivalents and marketable securities. After closing a $1 billion preferred equity investment led by Sixth Street on July 1, with participation from HealthCare Royalty Partners, the company said its cash balance was approximately $1.7 billion.
President and Chief Financial Officer Tom Trimarchi said the capital position is intended to support operating activities, continued Attruby investment and three potential launches over the next 12 months. Management said it expects operating results to remain relatively stable over the next several quarters before improving toward break-even as launch investments reach a steadier level and revenue grows.
About BridgeBio Pharma (NASDAQ:BBIO)BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside.
BridgeBio's pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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BridgeBio Pharma vykázala za čtvrtletí ztrátu 0,78 USD na akcii, což bylo horší než odhad analytiků na úrovni 0,64 USD. Tržby ve výši 243,68 milionu USD ale překonaly konsensus o 9,46 %.
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.
BridgeBio Pharma získala od Barclays opět doporučení overweight a cílovou cenu 157 USD, což znamená asi 95% potenciál růstu. Hlavním tahounem je lék Attruby, který ve 1. čtvrtletí 2026 přinesl v USA výnosy 180,6 milionu USD.
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.
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
AstraZeneca a Ionis Pharmaceuticals oznámily, že studie CARDIO-TTRansform u Wainua nesplnila primární cíl. Akcie Ionis v jeden den spadly o více než 9 %; AstraZeneca jen krátce klesla během intradenního obchodování.
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
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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
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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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BridgeBio Pharma vyskočila na 52týdenní maximum 93,42 USD poté, co rival AstraZeneca selhala ve fázi III studie CARDIO-TTRansform. Akcie BBIO v seanci přidaly 15 %.
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.
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BBIO currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BridgeBio závisí hlavně na Attruby, která v roce 2025 přinesla tržby 362,4 milionu USD a v 1. čtvrtletí roku 2026 téměř 181 milionů USD. Firma zároveň chystá tři možná uvedení na americký trh v příštích 12 měsících.
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.
BridgeBio získala až 1 mld. USD v preferenčním kapitálu od Sixth Street a HealthCare Royalty, což výrazně posiluje bilanci firmy. Financování má podpořit růst Attruby i tři potenciální uvedení na trh v USA během příštích 12 měsíců.
- 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.
