Acoramidis

CHMP recommended EU approval of acoramidis based on ATTRibute-CM Phase 3 study results, showing rapid benefits in ATTR-CM patients. Acoramidis, a near-complete TTR stabilizer, was FDA-approved as Attruby™ in 2024 for reducing cardiovascular death and hospitalization in ATTR-CM. European Commission approval expected soon, with Bayer planning a 2025 European launch.

EU decision on marketing approval for 13 new products, including BridgeBio’s acoramidis, is imminent.

November 2024 FDA updates include approval of VARIPULSE for atrial fibrillation, removal proposal for oral phenylephrine in nasal decongestants, CRL for Ocaliva in PBC, acceptance of pz-cel gene therapy BLA for RDEB, approval of Emrosi for rosacea, acceptance of dupilumab sBLA for CSU, CRL for IZERVAY in GA, Gildeuretinol for Stargardt disease receiving Rare Pediatric and Fast Track status, approval of bimekizumab for HS, acceptance of HLX14 biosimilar BLA for denosumab, approval of Attruby for ATTR-CM, and acceptance of vutrisiran sNDA for ATTR-CM.

Continuous use of acoramidis over 42 months significantly reduced risks of all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), according to data from the ATTRibute-CM trial and its open-label extension. The FDA approved acoramidis for ATTR-CM treatment, highlighting its efficacy in early diagnosis and prompt initiation of treatment.

The FDA approved acoramidis (Attruby), developed at Stanford Medicine, for treating transthyretin amyloid cardiomyopathy (ATTR-CM). Originally AG10, it stabilizes transthyretin, preventing misfolding and aggregation in the heart, offering improved survival rates and quality of life for patients. The drug's development was supported by Stanford's SPARK program.

BridgeBio Pharma's BBIO surged on FDA approval of Attruby for ATTR-CM, while Cassava Sciences' SAVA plummeted as simufilam failed in Alzheimer's study. Amgen's AMGN reported positive data on MariTide for obesity but saw stock decline. Applied Therapeutics' APLT faced a CRL for govorestat in galactosemia treatment.

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FDA approves acoramidis (Attruby), a drug developed at Stanford Medicine for ATTR-CM, offering improved survival rates and quality of life. The drug, originally AG10, was developed through the SPARK program and clinical trials showed better efficacy than existing treatments.

BridgeBio Pharma's Attruby (acoramidis) approved by FDA for ATTR-CM, significantly reducing cardiovascular death and hospitalization in Phase 3 study. Attruby stabilizes TTR, mimicking a natural rescue mutation, and improves quality of life for patients with amyloidosis.

BridgeBio's acoramidis (Attruby) approved by FDA for transthyretin amyloid cardiomyopathy, leading to a fair value estimate increase to $36.40 from $35.20 and a 16% surge in shares.