Alnylam Stock Drops Despite FDA Approval of Qfitlia Ranking 461st in Trading Volume

On March 28, 2025, Alnylam Pharmaceuticals, Inc. (ALNY) experienced a significant decline, with its stock price dropping by 0.94% and a trading volume of 1.84 billion, ranking 461st in the day's market activity.

The U.S. Food and Drug Administration (FDA) has approved Qfitlia™ (fitusiran), an RNAi therapeutic developed by Alnylam. This approval marks the sixth RNAi therapeutic discovered by Alnylam to receive FDA approval and the first to treat hemophilia A or B, with or without inhibitors. Qfitlia is designed to lower antithrombin, a protein that inhibits blood clotting, aiming to promote thrombin generation and prevent bleeding episodes. It is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 and older with hemophilia A or B, with or without factor VIII or IX inhibitors.

Qfitlia's approval is a significant milestone for Alnylam, completing the "products" goal in its P5x25 strategy. The therapeutic has the potential to benefit the estimated one million people living with hemophilia A and B worldwide. Clinical studies have shown that Qfitlia can reduce annualized bleeding rates by 90% through a subcutaneous injection regimen administered once every two months. This unique mechanism of action makes Qfitlia an important non-factor option for patients with hemophilia.

Alnylam's RNAi therapeutics platform harnesses the natural cellular process of RNAi, a gene-silencing mechanism that has been recognized with the Nobel Prize in Physiology or Medicine. By silencing messenger RNA, RNAi therapeutics prevent the production of disease-causing proteins, offering a revolutionary approach to treating genetic and other diseases. Alnylam's commercial RNAi therapeutic products include ONPATTRO®, AMVUTTRA®, GIVLAARI®, and OXLUMO®, as well as Leqvio® and Qfitlia™, which are being developed and commercialized by partners Novartis and Sanofi, respectively.