At least seven PDUFA dates on deck in May

At least seven therapies have PDUFA dates in May, four new therapies and three seeking label extensions. One of the new therapies is under priority review.

FDA is slated to make its first decision of the month on May 3 on a priority review of an NDA for Takecab vonoprazan fumarate from Phathom Pharmaceuticals Inc. (NASDAQ: PHAT) to treat Helicobacter pylori infection. In April 2021, Phathom announced that Takecab, an oral small molecule competitive blocker of the H+/K ATPase pump, met all primary and secondary endpoints, demonstrating both non-inferiority and superior eradication rates, versus Prevacid lansoprazole in a Phase III readout...