Flexion's Zilretta data sufficient for submission

Flexion Therapeutics Inc. (NASDAQ:FLXN) gained $5.78 (50%) to $17.23 after it said FDA endorsed the company's plans to submit an NDA for osteoarthritis (OA) pain therapy Zilretta ( FX006) based on existing data. In a letter to the company, Flexion said FDA wrote that data from Zilretta's registration program are "acceptable to support filing of an NDA submission." Flexion said a planned in-person pre-NDA meeting "has become unnecessary," and the company is on track to submit its NDA in 4Q16.

Zilretta, a sustained-release intra-articular formulation of triamcinolone acetonide (TCA), has Fast Track designation to treat OA knee pain. ...