FDA requests more data from Provention; plus Iterum, Seagen-Genmab, Pfizer and Gilead
Shares of Provention Bio Inc. (NASDAQ:PRVB) regained a small bit of the ground they lost Friday, when the stock tumbled 18% to $8 after the company revealed FDA wants more data on its BLA for teplizumab to delay or prevent Type I diabetes. The company said the agency identified deficiencies in the application “that preclude discussion of labeling and post-marketing requirements/commitments at this time” and that additional PK/PD data will be required. Provention gained $0.23 Monday. The company said that FDA still plans to hold an advisory committee meeting to discuss the BLA on May 27.
Adcomm for Iterum’s UTI candidate postponed
Antibiotic play Iterum Therapeutics plc (NASDAQ:ITRM) said FDA has postponed a meeting of its antimicrobial drugs advisory committee, previously set for June 2, to discuss the company’s NDA for sulopenem etzadroxil-probenecid to treat uncomplicated urinary tract infections in patients with quinolone non-susceptible pathogen. A new date has not been confirmed...