Anika Therapeutics Inc. ANIK announced that it has enrolled the first patient in the pivotal HyaloFast FastTRACK phase III study for the treatment of articular knee cartilage defect lesions.
The prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study will enroll patients (n=200) at up to 30 sites in the U.S. and the EU. The study is being evaluated to establish the superiority of a hyaluronan-based scaffold (HyaloFast) with autologous bone marrow aspirate concentrate (BMAC).
We note that HyaloFast has CE Marking in the EU and is commercialized in 18 countries with over 6,000 individuals treated with the product.
Meanwhile, earlier this month, the company announced that the FDA’s Office of Combination Products has assigned Cingal to the Center for Drug Evaluation and Research (CDER) as the lead center for premarket review.
The company is evaluating Cingal for the treatment of joint pain associated with osteoarthritis. In Nov 2015, Cingal was approved in Canada as a medical device to treat pain associated with osteoarthritis of the knee. Cingal is currently under review in the EU.
In addition, the company is working on the label expansion of Monovisc to treat pain associated with osteoarthritis of the hip. Monovisc is currently approved in the U.S. to treat joint pain caused by osteoarthritis.
Anika Therapeutics currently carries a Zacks Rank #1 (Strong Buy). Other favorably ranked stocks in the health care sector include Horizon Pharma plc HZNP, Arena Pharmaceuticals, Inc. ARNA and Achillion Pharmaceuticals, Inc. ACHN, each sporting a Zacks Rank #1.
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