Shares of Alnylam Pharmaceuticals Inc. (ALNY) are rising over 6% Thursday morning, after the company reported positive topline results from HELIOS-A Phase 3 Study of Vutrisiran in patients with hATTR Amyloidosis with Polyneuropathy.
The stock has been trading in the range of $84.97 – $167.33 for the past one year, and is currently trading at $134.45, up $7.62 or 6.01%, with trading volume of 195K more versus an average volume of 500K shares.
The company announced that the HELIOS-A Phase 3 study of vutrisiran, met its primary and both secondary endpoints at nine months in patients with hATTR amyloidosis with polyneuropathy.
Vutrisiran is an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis.
Alnylam said that based on these positive results, it plans to submit a New Drug Application or NDA for vutrisiran with the U.S. Food and Drug Administration (FDA) in early 2021, and to follow with regulatory filings in additional countries, such as Brazil and Japan.
Alnylam also stated that it plans to submit a Marketing Authorisation Application or MAA in the EU upon obtaining the results of the 18-month analysis, which is expected in late 2021.
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