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Investing.com -- Shares of Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) climbed 4% following the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation to extend the marketing authorization for its drug Amvuttra. The positive opinion, announced on April 25, 2025, supports the use of Amvuttra in treating both wild-type and hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adults.
Amvuttra, which is already approved for hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN), has now broadened its therapeutic reach, potentially increasing its market presence in the European Union. The CHMP’s endorsement is a significant step towards full marketing authorization for this new indication, which is expected to enhance Alnylam’s product portfolio and revenue streams.
The CHMP’s positive opinion is part of a broader set of recommendations for extensions of therapeutic indications for ten medicines already authorized in the EU. The committee’s recognition of Amvuttra’s potential in treating ATTR-CM is anticipated to bolster confidence in Alnylam’s capabilities in addressing rare diseases and expanding treatment options for patients with serious conditions.
While Alnylam has not released an official statement regarding the financial impact of the CHMP’s recommendation, investors have responded favorably to the news. The stock’s upward movement reflects optimism about the potential for increased sales and market penetration for Amvuttra in the EU.
The market’s reaction underscores the importance of regulatory approvals in shaping pharmaceutical companies’ growth trajectories. As Alnylam awaits the final decision on the marketing authorization for Amvuttra’s new indication, the company’s stock performance will likely continue to be influenced by regulatory developments and the drug’s commercial success in the European market.
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