BEYONTTRA™ (acoramidis), the First Near-Complete TTR Stabilizer (≥90%), Approved by ANVISA to Treat ATTR-CM in Brazil

- The approval of Beyonttra in Brazil is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date, including:

- By Month 1, numerically fewer cumulative cardiovascular events, including CVM or recurrent CVH, were observed with acoramidis compared to placebo

- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30

- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30

- Acoramidis is the first and only approved ATTR-CM treatment in the U.S., EU, UK, Switzerland, Japan, and Brazil that all have a label specifying near-complete stabilization (≥90%)

PALO ALTO, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization for acoramidis, under the brand name BEYONTTRA, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer.

"The ATTRibute-CM results represent a major advance for patients with ATTR-CM, who often face an earlier and more aggressive course of disease," said Fábio Fernandes, M.D., Ph.D., Director at the Heart Institute of the Clinical Hospital of the University of São Paulo Medical School (HCFMUSP), and investigator in the trial. "For too long, this community has lived with limited options and delayed recognition of their condition. Seeing a therapy like acoramidis deliver significant reductions in cardiovascular-related hospitalizations, improvements in survival, and preservation of functional capacity and quality of life is profoundly encouraging. These results signal a transformative shift in how we can care for patients across Brazil."

The approval in Brazil is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at Month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients.

"The ANVISA approval of BEYONTTRA marks an important step forward for Brazilian patients living with ATTR-CM. It is a particularly meaningful advance for patients living in Brazil who have long faced limited options for this progressive, life-threatening disease," said Jonathan Fox, M.D., Chief Medical Officer of BridgeBio Cardiorenal. "This authorization brings new hope to communities where ATTR-CM is increasingly recognized. This also reflects our commitment to ensuring that as many patients as possible in as many countries as possible have access to transformative care. We are profoundly grateful to the patients, families, investigators, and clinical partners whose courage and partnership made this milestone possible."

Acoramidis was approved as Attruby^® by the U.S. FDA in November 2024 and was approved as BEYONTTRA by the European Commission in February 2025, the Japanese Ministry of Health, Labour, and Welfare (MHLW) Agency in March 2025, and the UK Medicines and Healthcare Products Regulatory Agency in April 2025 with all labels specifying near-complete stabilization of TTR. Acoramidis is also currently under review by other global regulatory agencies.

BridgeBio will work in partnership with Biopas, a Swixx BioPharma company with an established pharmaceutical commercialization platform in Latin America, to commercialize BEYONTTRA in Brazil. Commercialization efforts are expected to begin in the second half of 2026, ensuring that Brazilian patients with ATTR-CM gain access to acoramidis as quickly as possible.

About BEYONTTRA

BEYONTTRA is an orally administered near-complete (≥90%) stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Full prescribing information for Brazil will be available through ANVISA.

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 Pharma, Inc. ((BridgeBio, NASDAQ:BBIO) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio's pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, and YouTube.

BridgeBio Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "continues," "estimates," "expects," "hopes," "intends," "may," "plans," "projects," "remains," "seeks," "should," "will," and variations of such words or similar expressions, or the negative of these terms or other comparable terminology. These words are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.These forward-looking statements, including statements regarding the potential clinical and commercial benefits of acoramidis and the potential outcomes; expected timing of commercialization efforts; potential patient access to acoramidis; and expected timing and outcome of regulatory reviews and approvals by other global regulatory agencies, are based on the information currently available to BridgeBio and on assumptions BridgeBio has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies as reflected in or suggested by these forward-looking statements are reasonable, BridgeBio can give no assurance that such 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, risks associated with the continued development and commercialization of acoramidis; the occurrence of adverse safety events; the ability to maintain regulatory approvals; the need for additional clinical data or analyses requested by regulatory authorities; whether future results will be consistent with prior clinical findings; BridgeBio's reliance on third parties, including commercialization partners, and their ability to execute on commercialization and distribution activities; manufacturing, supply continuity, and quality obligations; pricing, reimbursement, market access, and adoption in Brazil and other markets; and the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, and increasing rates of inflation and changing interest rates, on BridgeBio's business operations and expectations. Additional risks are set forth in the "Risk Factors" section of BridgeBio's most recent Annual Report on Form 10-K and other subsequent filings with the U.S. Securities and Exchange Commission. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Bubba Murarka, Executive Vice President, Corporate Development

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