Anika Therapeutics Reports Filing of Final PMA Module for Hyalofast® Cartilage Repair Scaffold and Data from U.S. Pivotal FastTRACK Phase III Study
Anika Therapeutics Inc. (ANIK)
Last anika therapeutics inc. earnings: 2/20 04:05 pm
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US:NASDAQ Investor Relations:
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Source: GlobeNewswire
BEDFORD, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global leader in joint preservation and regenerative solutions, announced that it filed the third and final module of its Premarket Approval application (PMA) for Hyalofast—its resorbable, hyaluronic acid-based scaffold used with autologous bone marrow aspirate concentrate (BMAC) for treating articular cartilage defects in the knee. The Company also reported results from its U.S. pivotal Phase III FastTRACK clinical trial evaluating Hyalofast. On October 31, 2025, Anika submitted the third and final module of its Hyalofast PMA to the U.S. Food and Drug Administration (FDA). The PMA includes FastTRACK 24-month data and incorporates additional post-hoc analyses and real-world data. “We are pleased to announce the filing of the PMA for Hyalofast and to provide the results of the pivotal FastTRACK Phase III study. We believe the comprehensive results of the FastTRACK study reinforce Hyalofast’
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News
- Are Investors Undervaluing Anika Therapeutics, Inc. (NASDAQ:ANIK) By 39%? [Yahoo! Finance]Yahoo! Finance
- Anika Therapeutics (NASDAQ:ANIK) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Anika Therapeutics (NASDAQ:ANIK) had its price target raised by analysts at Barrington Research from $15.00 to $16.00. They now have an "outperform" rating on the stock.MarketBeat
- Anika Reports Third Quarter 2025 Financial ResultsGlobeNewswire
- Anika Therapeutics (NASDAQ:ANIK) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
ANIK
Earnings
- 11/5/25 - Beat
ANIK
Sec Filings
- 11/21/25 - Form SCHEDULE
- 11/7/25 - Form SCHEDULE
- 11/5/25 - Form S-8
- ANIK's page on the SEC website