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Acoramidis Significantly Reduces the Risk of All-Cause and Cardiovascular Mortality in Patients with ATTR-CM through Month 54

(Positive)
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BridgeBio (Nasdaq: BBIO) presented long-term data showing acoramidis provides sustained benefit through Month 54 in ATTR-CM. Continuous treatment reduced all-cause mortality by 44.7% and cardiovascular mortality by 49.3% (both p<0.0001) versus placebo-to-acoramidis.

Acoramidis mitigated NT-proBNP rise, stabilized KCCQ-OS heart-failure scores, was well tolerated long term, and is approved in the U.S., EU, Japan, Switzerland and the UK.

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Positive

  • ACM −44.7% risk reduction at Month 54 (p<0.0001)
  • CVM −49.3% risk reduction at Month 54 (p<0.0001)
  • Mitigation of NT-proBNP progression through Month 54
  • Sustained stabilization of KCCQ-OS heart-failure scores

Negative

  • Real-world survey: over one-third of ATTR-CM patients received no treatment

News Market Reaction – BBIO

-0.49%
2 alerts
-0.49% Session close to close
$14.39B Market Cap
0.1x Rel. Volume

In the Mar 30 session, BBIO declined 0.49%, reflecting a mild negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights robust, long-term efficacy and safety for acoramidis in ATTR-CM, with s...
Analysis

This announcement highlights robust, long-term efficacy and safety for acoramidis in ATTR-CM, with sustained mortality risk reductions through 54 months and near-complete TTR stabilization of ≥90%. Prior news flow shows a pattern of significant clinical wins and growing commercial traction for Attruby. Investors following this story may focus on how these results influence treatment guidelines, real-world uptake, and upcoming presentations, as well as whether future data continue to support durable quality-of-life and biomarker benefits for patients.

Key Figures

All-cause mortality reduction: 44.7% Cardiovascular mortality reduction: 49.3% Follow-up duration: 54 months +5 more
8 metrics
All-cause mortality reduction 44.7% Risk reduction in ACM at Month 54 vs placebo-to-acoramidis (p<0.0001)
Cardiovascular mortality reduction 49.3% Risk reduction in CVM at Month 54 vs placebo-to-acoramidis (p<0.0001)
Follow-up duration 54 months ATTRibute-CM open-label extension efficacy and safety data timeframe
ACM p-value p<0.0001 Statistical significance for 44.7% ACM risk reduction
CVM p-value p<0.0001 Statistical significance for 49.3% CVM risk reduction
TTR stabilization ≥90% Near-complete transthyretin stabilization specified on acoramidis labels
Early sTTR assessment Day 28 Early increase in serum TTR associated with slower KCCQ-OS decline
Follow-up KCCQ-OS timepoint Month 30 KCCQ-OS comparison vs placebo in ATTRibute-CM analysis

Historical Context

5 past events · Latest: Mar 23 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 23 Conference presentation Positive +1.6% Announced upcoming ACC late-breaking oral and poster presentations on acoramidis data.
Mar 20 Equity inducement Neutral +1.6% Granted 70,916 RSUs to new employees as standard Nasdaq Rule 5635(c)(4) inducements.
Mar 11 Phase 3 interim data Positive -3.9% Reported positive Phase 3 FORTIFY interim efficacy and safety data for BBP-418 in LGMD2I/R9.
Mar 4 Conference data update Positive +3.1% Flagged additional positive interim FORTIFY data to be presented at MDA 2026 conference.
Feb 24 Earnings and pipeline Positive -2.6% Reported strong 2025 revenue, Attruby sales growth, cash balance, and multiple positive Phase 3 readouts.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive clinical and earnings updates have produced mixed reactions, with several strong fundamental announcements followed by negative or muted moves, suggesting a history of occasional sell-the-news responses.

Recent Company History

Over the past months, BridgeBio has reported multiple clinically and commercially significant milestones. On Feb 24, it posted Q4 2025 revenue of $154.2M and full-year revenue of $502.1M, largely from Attruby sales, while also strengthening its balance sheet with $587.5M in cash and new $632.5M 2033 convertible notes. In March, positive Phase 3 FORTIFY interim data and multiple conference presentations highlighted pipeline strength. Today’s long-term acoramidis ATTRibute-CM OLE results extend this narrative of de‑risking key assets and reinforcing Attruby’s franchise durability.

Key Terms

open-label extension, NT-proBNP, KCCQ-OS, serum transthyretin, +2 more
6 terms
open-label extension medical
"Earliest timepoint in an open-label extension with this magnitude of risk reduction"
An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.
NT-proBNP medical
"Acoramidis mitigated the rise in NT-proBNP through Month 54 to an extent not seen"
A blood test marker released when the heart is under strain; higher NT‑proBNP levels indicate the heart is working harder or may be failing, similar to a dashboard warning light that signals engine stress. Investors watch NT‑proBNP because changes in the marker can drive clinical trial results, treatment approvals, hospital use, and insurance decisions for heart drugs and devices, all of which affect revenue, adoption and valuation in healthcare companies.
KCCQ-OS medical
"stabilized and maintained all measures of heart failure-related QOL scores (KCCQ-OS)"
A KCCQ-OS is the overall summary score from the Kansas City Cardiomyopathy Questionnaire, a patient-reported survey that quantifies how heart failure affects a person’s symptoms, physical ability, social limits and quality of life. For investors it acts like a customer satisfaction score for a therapy or device: higher KCCQ-OS values signal meaningful patient benefit, which can influence regulatory approval, guideline endorsements, market uptake and reimbursement decisions.
serum transthyretin medical
"benefits with Acoramidis on Serum Transthyretin Concentrations and Kansas City"
Serum transthyretin is a protein made mainly by the liver that carries thyroid hormone and a vitamin-carrying protein through the bloodstream; think of it as a delivery van that shuttles small but important cargo. For investors, its level in blood tests can signal nutritional status or the presence of diseases where the protein misfolds and forms deposits, so it matters for diagnostics, drug development, and the commercial prospects of treatments targeting those conditions.
sTTR medical
"maintained serum transthyretin (sTTR) levels through Month 54."
A Small Business Technology Transfer (STTR) award is a U.S. government research grant that funds early-stage technology development by requiring a small company to formally partner with a research institution, such as a university. For investors, STTRs matter because they provide non-dilutive money, independent technical validation and staged milestones—like a funded pilot program—reducing development risk and helping a company advance technologies toward commercial products.
transthyretin (TTR) stabilizer medical
"only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer."
A transthyretin (TTR) stabilizer is a drug that binds and steadies the TTR protein in the blood, preventing it from changing shape and forming damaging clumps (amyloid) in organs and nerves. For investors, these medicines matter because successful stabilizers can slow disease progression, drive clinical and regulatory milestones, and create significant commercial opportunities—like a brace that keeps a fragile structure from collapsing.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- Earliest timepoint in an open-label extension with this magnitude of risk reduction at 44.7% in ACM (p<0.0001) and 49.3% in CVM (p<0.0001) 

- Acoramidis mitigated the rise in NT-proBNP through Month 54 to an extent not seen in the era of disease modifying treatments

- Early and continuous acoramidis treatment stabilized and maintained all measures of heart failure-related QOL scores (KCCQ-OS), which demonstrates that the improvement in duration and quality of life in patients with ATTR-CM by acoramidis is sustained

PALO ALTO, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today presented long-term efficacy and safety data from the ATTRibute-CM open-label extension (OLE) trial, demonstrating sustained clinical benefit of acoramidis through Month 54 in patients with ATTR-CM. These data were presented at the American College of Cardiology (ACC) Annual Scientific Sessions & Expo in a late-breaking oral presentation by Prem Soman, M.D., Ph.D. of University of Pittsburgh School of Medicine and it was the only ATTR-CM presentation selected for the ACC late-breaker session. These data are now simultaneously published in JAMA Cardiology. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

“Despite dramatic therapeutic advances in the field, many patients with ATTR-CM still continue to suffer progressive heart failure, high mortality risk, and many have limited long-term treatment options,” said Dr. Soman. “The ATTRibute-CM long-term data show that early and continuous treatment with acoramidis can meaningfully change the trajectory of this disease, with sustained reductions in all-cause and cardiovascular mortality, cardiovascular hospitalization, continued mitigation of NT-proBNP progression, and a favorable long-term safety profile. These findings reinforce the importance of early diagnosis followed by prompt, durable treatment to deliver sustained clinical benefit for patients.”

The findings from the OLE trial included:

  • At Month 54, continuous acoramidis treatment led to a statistically significant risk reduction of 44.7% in all-cause mortality (ACM) (p<0.0001) and 49.3% in cardiovascular mortality (CVM) (p<0.0001) versus placebo-to-acoramidis, which is the earliest timepoint in an open-label extension with this magnitude of risk reduction in these events
  • Through Month 54, acoramidis mitigated the rise in NT-proBNP versus placebo-to-acoramidis to an extent not seen in the era of disease modifying treatments
  • Early and continuous acoramidis treatment stabilized and maintained all measures of heart failure-related QOL scores (KCCQ-OS), which demonstrates that the improvement in duration and quality of life in patients with ATTR-CM by acoramidis is sustained
  • Acoramidis continued to be well tolerated with no long-term safety concerns

Three acoramidis posters were also shared at the ACC Annual Scientific Sessions & Expo, which included:

  • Long-Term Benefits With Acoramidis on Serum Transthyretin Concentrations and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) Score in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM), presented by Sarah Cuddy, M.D. of Brigham and Women's Hospital
    • This analysis showed that early and continuous acoramidis treatment stabilized heart failure-related health status and maintained serum transthyretin (sTTR) levels through Month 54. These findings emphasize the need for early diagnosis followed by early treatment in patients with ATTR-CM
  • Association Between Early Increase in sTTR with Acoramidis and Long-Term Effects on Heart Failure – Related Health Status in ATTR-CM: Results from ATTRibute-CM, presented by Jan Griffin, M.D. of Medical University of South Carolina
    • This analysis showed that an early increase in sTTR at Day 28 with acoramidis was associated with clinically meaningful slower decline in KCCQ-OS score at Month 30 versus placebo in patients with ATTR-CM in ATTRibute-CM
  • Treatment Patterns and Preferences in ATTR-CM in the United States: Results from a Real-World Survey, presented by Jill Waldron, MSN, GNP, MS of University of Utah
    • This analysis showed that in a real-world survey, physicians were not fully satisfied with treatment for more than half of those prescribed, and more than one-third of patients did not receive treatment at all. Patients were most comfortable with the prospect of oral therapy. These data highlight unmet treatment needs for ATTR-CM patients and importance of shared decision making for therapy selection

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, and the UK Medicines and Healthcare Products Regulatory Agency with all labels specifying near-complete stabilization of TTR.

More data on the benefit of Attruby for ATTR-CM patients is planned for future medical meetings.

About Attruby™ (acoramidis)

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

IMPORTANT SAFETY INFORMATION

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

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

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. 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 and commercial benefits of acoramidis; acoramidis’ observed impact on reductions in all-cause and cardiovascular mortality and cardiovascular hospitalization; acoramidis’ mitigation of NT-proBNP progression; the durability of improvements in heart failure-related QOL scores; the long-term safety and tolerability profile of acoramidis; and BridgeBio’s ongoing and future development programs.Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the 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.

BridgeBio Media Contact:
Bubba Murarka, Executive Vice President, Corporate Development
contact@bridgebio.com   
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
ir@bridgebio.com 


FAQ

What mortality benefit did acoramidis (BBIO) show at Month 54 in ATTR-CM?

Acoramidis showed a 44.7% reduction in all-cause mortality and a 49.3% reduction in cardiovascular mortality at Month 54 versus placebo-to-acoramidis. According to the company, both findings reached statistical significance (p<0.0001) in the open-label extension.

How did acoramidis affect NT-proBNP progression through Month 54 for BBIO patients?

Acoramidis mitigated the rise in NT-proBNP through Month 54 versus placebo-to-acoramidis, indicating slower biomarker worsening. According to the company, this extent of NT-proBNP control is notable compared with prior disease‑modifying treatments.

Did continuous acoramidis treatment maintain patient quality of life (KCCQ-OS) in ATTR-CM?

Yes. Early and continuous acoramidis stabilized and maintained KCCQ-OS heart-failure quality-of-life scores through Month 54. According to the company, this demonstrates sustained improvement in both duration and quality of life for patients.

Is acoramidis (Attruby/Beyonttra) approved and available in major markets?

Acoramidis is approved as Attruby in the U.S. and as Beyonttra by EMA, Japan, Switzerland, and the UK. According to the company, all labels specify near-complete TTR stabilization.