Flexion's Zilretta bound for NDA submission

Flexion Therapeutics Inc. (NASDAQ:FLXN) rose $3.10 (28%) to $14 in early after-hours trading Tuesday after it said Zilretta ( FX006) met the primary endpoint in a Phase III trial to treat moderate to severe osteoarthritis (OA) knee pain. The therapy showed statistically significant analgesia vs. placebo at week 12 (p<0.0001).

Flexion plans to submit an NDA to FDA in 2H16 for the sustained-release intra-articular formulation of triamcinolone acetonide (TCA). FDA has granted Fast Track designation to the therapy. ...