Merck gets a PDUFA date for its chronic cough contender; Morphic shares skyrocket on the heels of PhI data rollout in IBD
Merck should know before the end of this year whether or not the FDA will approve its drug gefapixant for chronic cough. The regulator has set a PDUFA date of Dec. 21 for the drug, giving the pharma giant a regular review for a closely watched development program.
Gefapixant is the leader among a group of P2X3 receptor antagonists that are racing to compete for a share of this program. That’s one reason why the agency has informed Merck that it plans to hold an advisory committee for the review.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.