Valeant Pharmaceuticals Intl Inc (NYSE:
Valeant Could be Circling FDA Green Light in the Next 2 Months
Valeant shares were surging forward 3% yesterday following the news that the biotech giant and its partner Nix S.A. have resubmitted their drug Vesneo (latanoprostene bunod), an intra-ocular pressure (IOP)-lowering single-agent eye drop product for treatment of open angle glaucoma or ocular hypertension, for FDA consideration.
Praising Vesneo’s “compelling” efficacy profile as well as a “favorable” competitive edge, Rodman & Renshaw analyst
For context, upon the first round of consideration, the FDA countered the original Vesneo New Drug Application (NDA), first submitted in July of 2016, with a Complete Response Letter (CRL) on back of deficiencies detected in the facility in Tampa, Florida where the drug was meant to be manufactured; specifically highlighting issues in Good Morning Practices (CGMP).
However, “Since the...