Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.
The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.
FAIRFIELD, N.J., July 30, 2015 /PRNewswire/ — Medimetriks Pharmaceuticals, Inc. announced today that its licensor, Ferrer, completed the second Phase III clinical study for Ozenoxacin, a novel bactericidal non-fluorinated quinolone in development for impetigo. Medimetriks owns the exclusive U.S. rights to Ozenoxacin 1% cream. The global trial, conducted at 44 centers with an emphasis on U.S. […]