Acoramidis

Bridgebio Pharma's Attruby (acoramidis) gains FDA approval for ATTR-CM, challenging Pfizer's Vyndamax. Attruby, a next-gen oral TTR stabilizer, showed significant reduction in death and cardiovascular-related hospitalizations in a phase III study.

Acoramidis received FDA approval for treating transthyretin amyloid cardiomyopathy (ATTR-CM), based on significant results from the ATTRibute-CM study. The drug aims to reduce cardiovascular death and hospitalizations, showing a win ratio of 1.8 over placebo. Acoramidis stabilizes TTR proteins, improving outcomes and offering a new treatment option for ATTR-CM patients.

The FDA approved acoramidis (Attruby) for ATTR-CM, reducing cardiovascular death and hospitalization. It's the first near-complete TTR stabilizer, showing a 42% reduction in mortality and 50% in hospitalization events.

BridgeBio Pharma's acoramidis (Attruby) wins FDA approval for treating ATTR cardiomyopathy, competing with Pfizer's tafamidis. Attruby, a near-complete TTR stabilizer, aims to reduce cardiovascular death and hospitalization. Despite initial trial setbacks, 30-month data supported approval, positioning Attruby as the first oral stabilizer with near-complete stabilization claims. BridgeBio estimates a $15-20 billion market, dominated by Pfizer, with Alnylam and AstraZeneca also entering the space. Attruby's pricing is competitive but above cost-effectiveness benchmarks, with ongoing European review and a Bayer licensing deal.

FDA approves BridgeBio’s Attruby (acoramidis) for ATTR-CM, the first treatment to near-completely stabilize Transthyretin (TTR). Attruby demonstrated rapid benefits in Phase III studies, reducing mortality and hospitalizations, and improving quality of life. The approval is based on the ATTRibute-CM study, with a European Medicines Agency decision expected in 2025.

Acoramidis (Attruby) received FDA approval for treating wild-type or variant transthyretin amyloidosis cardiomyopathy (ATTR-CM), reducing cardiovascular death and hospitalization. It offers near-complete TTR stabilization in an oral tablet, competing with Tafamidis. The approval was based on the ATTRibute-CM trial, showing favorable safety and efficacy profiles, though some endpoints lacked significant reduction. Acoramidis is priced at just under $19,000 for a 28-day supply and is also under review in Europe, Japan, and Brazil.

The FDA approved BridgeBio's Attruby for ATTR-CM, a rare heart condition, offering a new treatment option. Priced at $18,759.12 for a 28-day supply, it competes with Pfizer's Vyndaqel. Attruby showed improved survival in trials but not in reducing overall deaths. BridgeBio partners with Bayer and AstraZeneca for European and Japanese markets.

BridgeBio Pharma's Attruby™ (acoramidis) receives FDA approval for treating ATTR-CM, reducing cardiovascular death and hospitalization. The ATTRibute-CM Phase 3 study showed significant benefits, with Attruby stabilizing Transthyretin (TTR) and improving patient outcomes. BridgeBio shares surged 25% post-approval. The company plans global expansion, with Europe, Japan, and Brazil as next targets. Scotiabank analyst Greg Harrison raised BridgeBio's price target to $48.00.

TD Cowen maintains Buy rating on BridgeBio Pharma (NASDAQ:) shares due to early approval of Attruby, a drug effective in reducing cardiovascular hospitalizations and deaths, priced 10% lower than competitor taf. A Key Opinion Leader survey indicates over 30% of first-line patients likely to be treated with Attruby, suggesting commercial success. BridgeBio's market capitalization is $5.63 billion, with analysts projecting sales growth, though the company is not yet profitable.