June 20 Company Quick Takes: Priority Review for Alexion, Melinta therapies; plus Alimera, Denovo and more
Priority Review for Alexion's Ultomiris sBLA
FDA accepted and granted Priority Review to an sBLA from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) for Ultomiris ravulizumab-cwvz to block complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome. The sBLA's PDUFA date is Oct. 19. The news comes two days after Japan approved the long-acting C5 inhibitor for paroxysmal nocturnal hemoglobinuria.
Melinta leaps with Priority Review for Baxdela sNDA
Melinta Therapeutics Inc. (NASDAQ:MLNT) has gained nearly 170% to $5.28 since announcing Wednesday that FDA accepted and granted Priority Review to an sNDA for Baxdela delafloxacin to treat community-acquired bacterial pneumonia. The PDUFA date for the broad-spectrum fluoroquinolone antibiotic, which is approved for acute bacterial skin and skin structure infections, is Oct. 24. Baxdela has Qualified Infectious Disease Product status in both indications...