Anika Therapeutics IncANIK announced that Cingal met its primary endpoint in a Phase 3 Study (Cingal 19-01), demonstrating superiority over triamcinolone hexacetonide (TH) steroid alone at 26 weeks post-treatment.
Cingal is a combination product of cross-linked hyaluronic acid (HA) proven to provide long-lasting pain relief through 6 months plus TH steroid to provide fast, short-term pain relief to treat the pain of knee osteoarthritis (OA).
Cingal is currently sold in more than 35 countries outside the U.S.
Anika will engage with the FDA on the next steps for U.S. regulatory approval in the coming months.
In parallel, Anika is exploring the potential to advance Cingal through commercial partnerships in the U.S. and select Asian markets.
In addition, Cingal demonstrated strong performance for pain reduction with 66% improvement in Pain Index (-44.3mm from baseline), and 90% of subjects were deemed to be OMERACT-OARSI Responders, a recognized method of evaluating responder rates based on improvement in pain and function.
Cingal was well-tolerated in the study, with only transient and non-serious adverse events (e.g., arthralgia, injection site pain, swelling, stiffness) related to the study injections.
Price Action: ANIK shares are up 1.86% at $28.95 on the last check Tuesday.
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