Acoramidis

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.

H.C. Wainwright raises BridgeBio Pharma's price target to $49.00 from $43.00, maintaining a Buy rating, following FDA approval of Attruby for ATTR-CM. Attruby, priced at $18,759.12 for a 28-day supply, is expected to generate sales early next year. BridgeBio's market cap is $4.43 billion, with negative operating income of -$516.2 million, highlighting the significance of Attruby's commercialization.

The FDA approved acoramidis (Attruby), an oral transthyretin stabilizer for adults with ATTR-CM, reducing cardiovascular death and hospitalization. This first-of-its-kind therapy, designed to mimic a natural TTR gene mutation, was supported by the ATTRibute-CM trial, showing improved outcomes in ATTR-CM patients.

FDA approves BridgeBio Pharma's acoramidis (Attruby) for ATTR-CM, setting up a market competition with Pfizer's Vyndamax/Vyndaqel/Vynmac. Attruby, priced at $18,759 for a 28-day supply, aims to reduce cardiovascular death and hospitalization in ATTR-CM patients. BridgeBio plans to pursue regulatory approvals in Europe, Japan, and Brazil. Analysts predict potential peak sales of $2 billion or more for Attruby.

Attruby, the first FDA-approved near-complete TTR stabilizer, significantly reduces cardiovascular death and hospitalizations in ATTR-CM patients, with rapid benefits seen in as few as 3 months. BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers extensive access programs. The company is set to receive $500 million under a royalty funding agreement and plans global expansion, with European approval expected in 2025.

BridgeBio Pharma's Attruby (acoramidis) approved by FDA for ATTR-CM, reducing cardiovascular death and hospitalization. Positive ATTRibute-CM Phase 3 results led to $500 million payment. European MAA submitted, with Bayer granted exclusive rights for commercialization.