Flexion Continues to Fall Post Clinical Hold on FX006

Flexion Therapeutics, Inc. (FLXN) fell 4.6% after the company announced that the FDA has placed a clinical hold on patient enrollment and dosing in an ongoing phase IIb study on FX006, a sustained-release, intra-articular steroid. The phase IIb study was evaluating the use of FX006 in patients with osteoarthritis (:OA) of the knee. Overall, the stock has fallen 7.7% to date.

At the time of issuing the press release the company stated that it was yet to receive any written notice from the FDA about the clinical hold on FX006. However, the company noted that the FDA has indicated that the clinical hold on the phase IIb study is due to a single occurrence of an infection in the injected knee joint of a patient in the study.

The company intends to work closely with the FDA to accelerate the review process. Once the FDA review is completed, the company will ascertain the future course of action for FX006.

We are disappointed with the clinical hold on FX006 and believe that investor focus will remain on the outcome of the FDA review process. Flexion Therapeutics’ pipeline includes other pain candidates – FX007 (post-operative pain, preclinical) and FX005 (end-Stage OA pain, phase IIa completed).

Flexion Therapeutics carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include Gilead Sciences Inc. (GILD), Johnson & Johnson (JNJ) and Amgen Inc. (AMGN). While Gilead is a Zacks Rank #1 (Strong Buy) stock, Amgen and Johnson & Johnson carry the same rank as Flexion Therapeutics.

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