Replimune Plans to Resubmit Skin Cancer Drug to FDA After 2 Rejections
Replimune Group plans to resubmit its application for an experimental skin cancer drug in the coming days after reaching an agreement with the US Food and Drug Administration, giving the biotech a third attempt to win approval for the melanoma treatment after two prior rejections.
The FDA had twice turned down the therapy after questioning its study design. Replimune representatives met with White House officials in early May, and by the end of the month the agency was planning to review the medication again.
From the sources (8 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
@wsjReplimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again.
@reutersReplimune gets third chance at US approval for skin cancer drug
@reuterslegalReplimune said on Friday it plans to resubmit the application for its experimental skin cancer drug in the coming days after reaching an agreement with the U.S. FDA, which previously declined to approve the therapy twice.