Acoramidis

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.

Attruby, approved by the FDA, is the first near-complete stabilizer of TTR for ATTR-CM treatment, showing rapid benefits in reducing cardiovascular death and hospitalizations. BridgeBio offers Attruby free for life to U.S. trial participants and plans global approvals. The drug preserves TTR's native function and improves quality of life.

The FDA approved acoramidis (Attruby), a drug developed at Stanford Medicine for treating transthyretin amyloid cardiomyopathy (ATTR-CM). Developed by Isabella Graef and Mamoun Alhamadsheh, with key clinical roles by Ron Witteles and Michaela Liedtke, it stabilizes transthyretin, improving survival and quality of life. Supported by Stanford's SPARK program, it marks a rare academic achievement in drug development.

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.

BridgeBio’s Attruby, an oral drug for transthyretin amyloid cardiomyopathy (ATTR-CM), has been approved by the FDA, priced at $18,759.12 for a 28-day supply. It significantly improves survival and reduces heart disease-related hospitalizations but lacks a mortality benefit. BridgeBio partners with Bayer for European marketing and AstraZeneca’s Alexion for Japan. Analysts predict limited uptake due to Pfizer’s established Vyndaqel, but potential for $2.5 billion in global sales by 2035.

BridgeBio secures FDA approval for acoramidis (Attruby) for ATTR-CM, showing 42% reduction in mortality/cardiovascular events and 50% reduction in cumulative events at 30 months. The drug stabilizes transthyretin protein, reducing amyloid fibril build-up and disease progression.

The FDA approved Attruby, an oral treatment reducing heart-related deaths and hospital visits in adults with transthyretin amyloid cardiomyopathy (ATTR-CM). Attruby stabilizes weak TTR protein, slowing disease progression and improving heart health faster than standard treatments. A clinical trial showed Attruby reduced deaths and hospital visits by 42% and heart failure risk by 50%. Mild side effects were noted, but resolved easily. BridgeBio offers a patient support program for Attruby users.