Roth Capital Partners launched coverage of Acer Therapeutics (NASDAQ:ACER) with a “buy” rating and price target of $70. The stock closed at $17.28 on Feb. 23.Read More
Maxim Group initiated coverage of Atossa Genetics (NASDAQ:ATOS) with a “buy” rating and 12-month price target of $2. The stock closed at 33 cents on Jan. 25.Read More
Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) is partnering with a major manufacturer of controlled active pharmaceutical ingredients in the U.S. to manufacture Dronabinol XL AdVersa as part of the company’s plans to submit a 505(b)(2) NDA for the treatment of chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.Read More
IntelGenx (OTCQX:IGXT; TSXV:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) resubmitted the 505(b)(2) NDA to the FDA for RIZAPORT 10 mg, an oral thin-film formulation of rizatriptan for the treatment of acute migraines.Read More
IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.Read More
IntelGenx (OTCQX:IGXT; TSX-V:IGX) has signed a binding term sheet to license Eli Lilly's tadalafil dosing patent. Any exclusivity associated with the tadalafil compound patent is not affected by the agreement.Read More
The FDA has provided written feedback to Titan Pharmaceuticals (NASDAQ:TTNP) on the initial development plan for its proprietary ropinirole hydrochloride implant for Parkinson’s disease.
Based on the FDA’s feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support a potential IND submission in the fourth quarter of 2016, followed by an initial pharmacokinetic and proof-of-concept clinical study. Titan is pursuing a 505(b)(2) registration pathway for the implant.Read More