On the bad news front last week, USA-based Alkermes received a refuse-to file letter from the US Food and Drug Administration for its depression candidate ALKS-5461. Attracting attention on the deal-making scene was Germany’s Boehringer Ingelheim immuno-oncology collaboration with OSE Immunotherapeutics, and Switzerland’s Ferring agreeing to acquire microbiome specialist Rebiotix. Research news highlighted two failures. First, the disappointment of Phase III date on GenSight’s rare disease drug candidate GSO10, and then, more spectacular, the failure of Incyte Corp and Merck & Co’s combination trial of Keytruda and epacadostat in melanoma.
Alkermes suffers major setback for NDA filing of depression drug
The FDA on Monday gave Alkermes what is known as a refusal to file letter. That means that the FDA reviewed the company's application and determined that there wasn’t sufficient data to approve ALKS-5461 in its current form. This caused the stock to close lower by 21.96% to $45.23 per share, noted Terry Chrisomalis on the Seeking Alpha blog.
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