Anika announces submission of final PMA module for Hylofast cartilage repair.
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 05 2025
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PMA Application Submission: Anika Therapeutics has submitted the third and final module of its Premarket Approval application for Hyalofast, a resorbable scaffold for treating knee cartilage defects, to the FDA.
Clinical Trial Results: The submission includes data from the U.S. pivotal Phase III FastTRACK clinical trial, which evaluates the effectiveness of Hyalofast over a 24-month period, along with additional analyses and real-world data.
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Analyst Views on ANIK
Wall Street analysts forecast ANIK stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ANIK is 16.00 USD with a low forecast of 16.00 USD and a high forecast of 16.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 9.130
Low
16.00
Averages
16.00
High
16.00
Current: 9.130
Low
16.00
Averages
16.00
High
16.00
About ANIK
Anika Therapeutics, Inc. is engaged in the osteoarthritis pain management and regenerative solutions space focused on early intervention orthopedics. The Company is leveraging its core expertise in hyaluronic acid and implant solutions. It partners with clinicians to provide minimally invasive products that restore active living for people around the world. It is developing, manufacturing and commercializing products on its hyaluronic acid (HA) technology platform. It is focused on spaces within orthopedics, including osteoarthritis pain management and regenerative solutions, and its products are delivered in key sites of care, including ambulatory surgery centers. Its products include OA Pain Management, Regenerative Solutions, and others. The OA Pain Management product family consists of Cingal, Monovisc, Orthovisc, Orthovisc mini and Orthovisc-T. Its Regenerative Solutions include Integrity, Hyalofast, Tactoset and NanoFx.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Anika Therapeutics Faces Investor Lawsuit Over Securities Violations
- Legal Investigation Initiated: Bragar Eagel & Squire is investigating whether Anika Therapeutics has violated federal securities laws, which could impact the company's reputation and shareholder confidence.
- Poor Clinical Trial Results: Anika's July 30, 2025, announcement revealed that Hyalofast failed to meet its pre-specified primary endpoints, resulting in a 27.42% drop in stock price to $8.10 per share, raising concerns about product efficacy in the market.
- Investor Losses: The high dropout rate in the clinical trial and missed visits during COVID led to missing data, potentially causing long-term shareholders to face losses, increasing the necessity for legal action.
- Contact Law Firm: Investors who purchased Anika shares and suffered losses are encouraged to contact Bragar Eagel & Squire to understand their legal rights, indicating that the company's legal risks may affect future investment decisions.
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Anika Therapeutics Shares Plunge 27% After Clinical Trial Fails to Meet Primary Endpoints
- Clinical Trial Results: Anika Therapeutics announced on July 30, 2025, that its Hyalofast clinical trial showed improvements in pain and function but failed to meet its pre-specified primary endpoints, undermining investor confidence.
- Stock Price Reaction: Following the disappointing trial results, Anika's shares fell by $3.06, or approximately 27.42%, closing at $8.10 on July 30, 2025, reflecting market concerns about the company's future prospects.
- Ongoing Investigation: Kirby McInerney LLP is currently investigating potential violations of federal securities laws by Anika and its senior management, with no lawsuits filed yet, indicating increasing legal risks for the company.
- Investor Rights: Investors who purchased Anika securities or have relevant information are encouraged to contact Kirby McInerney LLP to discuss their rights, highlighting the firm's commitment to protecting investor interests.
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