FDA Denial of Replimune Drug Sparks Controversy
In a recent Senate hearing, Health Secretary Robert F. Kennedy Jr. distanced himself from the FDA's decision to reject Replimune's skin cancer drug. The agency cited issues with the company's reliance on a single-arm study. Replimune shares fell significantly but rebounded after Kennedy's comments were challenged in The Wall Street Journal.
During a Senate hearing, Health Secretary Robert F. Kennedy Jr. denied any involvement in the FDA's refusal to approve Replimune's drug for advanced skin cancer.
The FDA criticized the company's reliance on inadequate study data, resulting in declining shares of Replimune. However, the shares saw an upturn following critical comments in The Wall Street Journal.
The opinion piece attributed blame to the FDA's Vinay Prasad and called for leadership changes, while Replimune argued against the adequacy of the trial data, contradicting previous FDA positions.
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