Flexion Therapeutics Granted Fast Track Status by the FDA for FX006 for Treatment of Osteoarthritis of the Knee

Go back to Flexion Therapeutics Granted Fast Track Status by the FDA for FX006 for Treatment of Osteoarthritis of the Knee

Northland Capital Markets Remains Bullish on Flexion Therapeutics (FLXN) After Being Granted Fast Track Status by FDA

September 2, 2015 9:37 AM EDT

Northland Capital Markets reiterated an Outperform rating and $40.00 price target on Flexion Therapeutics (NASDAQ: FLXN) as the company has been granted fast track status by the FDA for FX006. This reduces the NDA review time to approval to within 6 months versus the standard 10... More

Flexion Therapeutics' (FLXN) FX006 Granted Fast Track Status

September 1, 2015 4:02 PM EDT

Flexion Therapeutics, Inc. (Nasdaq: FLXN) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for FX006, Flexion's late-stage, lead drug candidate that is designed as a treatment for the more than four million U.S. patients receiving intra-articular (IA) injections for osteoarthritis (OA) of the knee. Flexion is currently studying FX006 in a Phase 2b pivotal trial, with top-line data expected to be announced soon, as well as in a Phase 3 clinical trial for which it expects to share data in the first quarter of... More