Thinly traded micro cap Flexion Therapeutics (FLXN -10.6%) slumps on a 6x surge in volume in response to the pricing of its public offering of 3.6M shares of common stock at $18. Underwriters over-allotment is an additional 540K shares. Closing date is November 21.
Results from a Phase 2 study assessing the effects on blood glucose levels of Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, Fast Track-tagged Zilretta (FX006), in adult type 2 diabetics with osteoarthritis (OA) of the knee showed a statistically significant and clinically relevant reduction in the rise of blood glucose compared to immediate-release (IR) triamcinolone acetonide (TCA) (synthetic corticosteroid).
The study randomized 33 patients 1:1 to receive either a single intra-articular injection of 40 mg Zilretta or 40 mg IR TCA. Blood glucose levels were evaluated for three weeks with a continuous glucose monitoring device. The primary endpoint was the change in average glucose values from baseline to 72 hours post dosing.
Complete results will be submitted for presentation at a future scientific conference.
Zilretta is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide based on microsphere technology that combines a polymer with a corticosteroid to provide long-term pain relief. In late-stage studies it has demonstrated clinically meaningful improvement in pain, stiffness and function in patients with knee OA. Immediate-release corticosteroids can cause a spike in blood glucose which can be problematic for diabetics.
The company plans to file a New Drug Application (NDA) with the FDA this quarter.
Thinly traded micro cap Flexion Therapeutics (NASDAQ:FLXN) is off 11% premarket on modest volume in response to its announcement that it has commenced a $60M public offering of common stock. Price, volume and terms have yet to be released.