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.

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