Shares of Anika Therapeutics Inc slumped 37% after the company reported disappointing data from its phase III Cingal 16-02 study. The 16-02 trial compared Cingal, a combination of cross-linked HA and triamcinolone hexacetonide (TH), with TH alone and cross-linked HA in treating patients with osteoarthritis (OA) in the knee.
The primary endpoint was a comparison of the pain reduction of Cingal compared with TH alone at 26-weeks. While Cingal achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks did not reach statistical significance.
Year to date, share price of the company decreased 16.3% compared with the industry’s decline of 5.7%.
The study showed a strong safety profile which matched with the previous clinical studies (13-01 phase III study). The duration of pain reduction was also similar to the previous study as patient improvement after Cingal injection was maintained near peak levels throughout the 26-week duration of the study.
Though the company expected Cingal to perform like it did in the other study, the difference in pain reduction seen in this study did not reach statistically significant levels at six months. Anika is currently following up with the patients in a prospectively designed extension phase of the trial, which will collect data through 39 weeks.
Cingal is the first and only commercially-available combination viscosupplement, and it is currently being used successfully by physicians to provide rapid and long-lasting relief from pain and discomfort caused by OA for patients in a growing number of countries.
The company will continue to monitor the results of the ongoing 3-month extension study and is actively reviewing the data and plans to work closely with regulators to come to an understanding of the next steps required to gain U.S. regulatory approval of Cingal.
Zacks Rank & Stocks to Consider
Anika has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Illumina, Inc. (ILMN - Free Report) , Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . While Illumina sports a Zacks Rank#1 (Strong Buy), Aeglea and ANI Pharmaceuticals carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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