Alnylam Scraps Interim Analysis For Heart Disease Trial, Rethinks Plans For Another Rare Disorder Program

Alnylam Scraps Interim Analysis For Heart Disease Trial, Rethinks Plans For Another Rare Disorder Program
  • Tucked Away in the Q3 earnings releaseAlnylam Pharmaceuticals Inc ALNY revealed it would scrap plans to launch a Phase 3 trial for vutrisiran in the rare Stargardt disease as it continues to evaluate the impact of the Inflation Reduction Act.
  • The Stargardt disease study was slated to begin before the end of the year.
  • Additionally, Alnylam has decided not to perform an optional interim analysis of the closely watched Helios-B trial in transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM). Instead, it will wait for a top-line readout that’s expected in early 2024.
  • In June, Amvuttra (vutrisiran) got its FDA approval in hereditary ATTR polyneuropathy, a neurological form of ATTR.
  • The drug just completed its first quarter on the market. 
  • Attained over 2,580 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of September 30, 2022, up from over 2,400 on commercial ONPATTRO as of June 30, 2022, representing 8% total TTR quarterly growth.
  • The company reported Q3 sales of $261.56 million, including royalty sales.
  • Price Action: ALNY shares are down 4.20% at $192.59 on the last check Thursday.
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