FDA Meeting Outcome Boosts Pain Therapeutics (PTIE); Upcoming Key Date for Valeant Pharmaceuticals’ (VRX) Unit
Pain Therapeutics, Inc. (Nasdaq:PTIE) shares soared over 40% in the extended session Monday after the company said that it has reached an agreement with the U.S. Food and Drug Administration (FDA) – during a recent positive meeting with the government agency – about the additional studies that are needed to obtain approval for its drug Remoxy ER, a proprietary abuse-deterrent oral formulation of oxycodone for pain relief.
PTIE stock closed at $0.68, down $0.016 (or -2.26%) and 275,414 of its shares changed hands during the day.
Pain Therapeutics, which is focused on drug development efforts on disorders of the nervous system, such as chronic pain, has 46.14M shares outstanding and PTIE stock 52-week range is between $0.51 and $3.00 per share. At close on Monday, the biopharmaceutical company had a market capitalization of $31.38M
Valeant Pharmaceuticals International, Inc.‘s (NYSE:VRX) subsidiary Bausch + Lomb and Nicox S.A. (EPA:COX) said after the closing bell Monday that the FDA will make a decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% by August 24, 2017 – the Prescription Drug User Fee Act (PDUFA) date -.
Latanoprostene bunod, an intraocular pressure lowering single-agent eye drop for open-angle glaucoma or ocular hypertension patients, was licensed by Nicox to Bausch + Lomb in 2010, but four years later the France-based international ophthalmic company exercised an option to co-promote the drug in the U.S.
VRX stock finished the regular session in negative territory by 3.54% (or -$0.39) at $10.64 with a total volume of 17.83M shares traded.
Valeant Pharmaceuticals International, which develops, manufactures, and markets pharmaceuticals, OTC products, and medical devices worldwide, has 341.19M shares outstanding, market capitalization (intraday) of $3.57B and VRX stock one-year range is from $10.50 and $38.50 per share.
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