FDA Rejects Replimune's Blood Cancer Drug, Stock Sinks - Replimune Group (NASDAQ:REPL)

FDA Rejects Replimune’s Skin Cancer Treatment, Shares Sink

US regulators rejected a skin cancer treatment from Replimune Group Inc. in another sign of the agency’s new leadership taking a hard line on drug approvals.

Replimune skin cancer therapy rejected by FDA, a sign of regulators' hardened stance

The FDA's decision is the latest indication that the agency is taking a hardened stance on drug approvals under regulatory Vinay Prasad.

Replimune drug rejected by FDA; Omega raises $647M biotech fund

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.

FDA Rejects Replimune's Blood Cancer Drug, Stock Sinks - Replimune Group (NASDAQ:REPL)

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.

Replimune Stock Plummets 75% After FDA Rejects Application for Skin Cancer Treatment

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Nothing to See Here, Move Along

Anyone who has practiced food and drug law for a significant period will tell you that if the U.S. Food and Drug Administration (FDA) rejects your marketing application, your best bet is to regroup, perform some more studies, and try again, as judicial review is pointless. FDA has been approving new drug applications since the 1960s, and the leading casebook on food and drug law reports that no new drug applicant has successfully sought judicial…