The FDA advisory panel voted 10-3 in favor of Replimune Group's experimental melanoma treatment, despite concerns regarding the trial's design and data reliability. This decision comes after nearly two years of regulatory scrutiny, following recent criticisms that influenced a significant drop in the company's stock price.

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https://www.wsj.com/health/pharma/fda-panel-votes-in-favor-of-replimunes-melanoma-treatment-5d4e2c41

FDA Panel Votes In Favor of Replimune’s Melanoma Treatment

Independent experts voted 10-3 despite regulators’ concern about the design of the company’s pivotal cancer trial

Xavier Martinez

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The US Food and Drug Administration headquarters building. The U.S. Food and Drug Administration building in Silver Spring, Md. Replimune's first two applications for the melanoma therapy were rejected.Valerie Plesch/Bloomberg News

A Food and Drug Administration advisory panel voted 10-3 Thursday for Replimune Group’s experimental melanoma therapy, after a contentious meeting in which experts raised doubts about whether the company’s data and trial design could be trusted to show the skin- cancer drug works.

Thursday’s recommendation is the latest turn in a regulatory saga that has stretched nearly two years. Earlier this week, a critical FDA analysis of the company’s results triggered a more than 30% drop in its stock price.

FDA Panel Votes In Favor of Replimune’s Melanoma Treatment

FDA Panel Votes In Favor of Replimune’s Melanoma Treatment

Independent experts voted 10-3 despite regulators’ concern about the design of the company’s pivotal cancer trial

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