Replimune Secures FDA Path to Resubmit Melanoma Drug Rejected Twice
Replimune Group said US regulators would reconsider its skin cancer treatment, allowing the biotech to resubmit the experimental melanoma drug for approval after two earlier rejections. The announcement sent the company’s shares sharply higher.
The Food and Drug Administration had previously rejected the treatment because it questioned the study design. The resubmission gives Replimune a renewed chance to win approval for a therapy whose regulatory path had been stalled by those setbacks.
From the sources (5 posts)
@wsjExperimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design.
@wallstengineWSJ: Replimune is expected to announce an agreement with the FDA to resubmit its advanced melanoma drug for approval, giving $REPL a 3rd shot after two prior rejections over study design and data concerns. The reversal comes less than three
@wsjExclusive: Replimune Group is expected to announce that it has reached an agreement with the FDA on a path to resubmit its experimental melanoma treatment for approval, people familiar with the matter said
@businessReplimune shares soared after the biotech company said that US regulators would reconsider its skin cancer treatment after two prior rejections
@cnbcReplimune to resubmit twice-rejected drug for approval after FDA shakeup