Anika Reports Top Line Data From CINGAL Study, Shares Slump

Shares of Anika Therapeutics Inc (NASDAQ:ANIK) 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. (NASDAQ:ILMN) , Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . 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.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.86 for 2018 and from $5.34 to $5.61 for 2019 over the past 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters with an average beat of 23.17%. The stock has rallied 32.2% so far this year.

Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 101.3% so far this year.

ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 3.9% so far this year.

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