Merck wins priority review for rare carcinoma drug belzutifan, the centerpiece of $1B+ Peloton buyout

The program that was once the crown jewel in Merck’s 2019 buyout of Peloton Therapeutics is one step closer to winning an FDA approval.

Belzutifan, formerly known as PT2977, has snared a priority review as it seeks to win the agency’s greenlight in von Hippel-Lindau (VHL) disease-associated renal cell carcinoma that doesn’t require immediate surgery. Regulators have slotted the candidate in for a Sept. 15 PDUFA date.