Biotech Stocks Facing FDA Decision In October

Flexion Therapeutics
Flexion Therapeutics

The FDA decision on Flexion Therapeutics Inc.’s (FLXN) investigational product candidate Zilretta, also known as FX006, which is being evaluated as a new treatment option for patients with osteoarthritis of the knee, is slated for October 6, 2017.

Zilretta is a sustained-release corticosteroid polymer (PLGA) formulation intended to provide persistent concentrations of drug locally to amplify the magnitude and prolong the duration of pain relief in patients with osteoarthritis of the knee.

Opioids, immediate-release corticosteroid and hyaluronic acid intra-articular injections are the commonly prescribed treatment options for knee pain. But they have many limitations.

Therefore, drugs that deliver quick, significant and lasting analgesic effect having a strong safety profile with low incidence of adverse effects are unmet needs in the treatment of knee osteoarthritis.
According to Flexion, Zilretta fits the bill.

If approved, analysts expect Zilretta to generate $500 million in peak sales.

FLXN closed Thursday’s trading at $23.89, down 0.42%.