Anika Therapeutics (ANIK) FDA Approvals $14.57 -0.03 (-0.21%) Closing price 04:00 PM EasternExtended Trading$14.57 0.00 (0.00%) As of 06:21 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Anika Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Anika Therapeutics (ANIK). Over the past two years, Anika Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Hyalofast. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Hyalofast FDA Regulatory Events Hyalofast is a drug developed by Anika Therapeutics for the following indication: Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - November 5,2025Provided Update Drug: HyalofastAnnounced Date: November 5, 2025Indication: Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. AnnouncementAnika Therapeutics, Inc. 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.AI SummaryAnika Therapeutics announced it has submitted the third and final module of its Premarket Approval application (PMA) for Hyalofast to the U.S. Food and Drug Administration. This resorbable, hyaluronic acid–based scaffold is used with a patient’s own bone marrow aspirate concentrate (BMAC) to repair knee cartilage defects. The PMA submission includes 24-month data from the FastTRACK Phase III trial, plus new post-hoc analyses and real-world evidence. The FastTRACK study compared Hyalofast plus BMAC against microfracture, the then-standard treatment. While the trial missed its original co-primary endpoints, post-hoc results showed a 23% improvement in pain relief with Hyalofast (p=0.02) and significant gains in sports activity scores, quality of life, and overall knee function. A higher proportion of Hyalofast patients achieved meaningful pain reductions at 10-, 15-, and 20-point thresholds versus microfracture. Anika believes these comprehensive data reinforce Hyalofast’s potential as a single-stage, off-the-shelf cartilage repair solution for U.S. patients. The company looks forward to advancing FDA review and making Hyalofast available in the United States.Read AnnouncementTop-line results - July 30,2025Top-Line Results Drug: HyalofastAnnounced Date: July 30, 2025Indication: Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. AnnouncementAnika Therapeutics, Inc. announced topline results from its U.S. pivotal clinical trial of Hyalofast, a resorbable, hyaluronic acid scaffold used in conjunction with autologous bone marrow aspirate concentrate (BMAC) for cartilage repair.AI SummaryAnika Therapeutics announced topline results from its U.S. pivotal trial of Hyalofast, a resorbable hyaluronic acid scaffold used with bone marrow aspirate concentrate (BMAC) for knee cartilage repair. The FastTRACK study was a randomized trial comparing Hyalofast plus BMAC against microfracture surgery. Despite consistent gains in pain and function, the trial missed its co-primary endpoints of percent change in KOOS Pain and IKDC function due to higher dropout and missed visits. Hyalofast showed statistically significant improvements in secondary endpoints including KOOS Sports and Recreation and Quality of Life and Total KOOS. Safety was comparable to microfracture. Hyalofast has treated over 35,000 patients worldwide since 2009, demonstrating a strong safety and effectiveness profile in independent studies. Based on these results and global data, Anika plans to submit the final PMA module in the second half of 2025 to seek FDA approval.Read Announcement Anika Therapeutics FDA Events - Frequently Asked Questions Has Anika Therapeutics received FDA approval? As of now, Anika Therapeutics (ANIK) has not received any FDA approvals for its therapy in the last two years. What drugs has Anika Therapeutics submitted to the FDA? In the past two years, Anika Therapeutics (ANIK) has reported FDA regulatory activity for Hyalofast. What is the most recent FDA event for Anika Therapeutics? The most recent FDA-related event for Anika Therapeutics occurred on November 5, 2025, involving Hyalofast. The update was categorized as "Provided Update," with the company reporting: "Anika Therapeutics, Inc. 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." What conditions do Anika Therapeutics' current drugs treat? Currently, Anika Therapeutics has one therapy (Hyalofast) targeting the following condition: Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Actuate Therapeutics FDA EventsAlterity Therapeutics FDA EventsErnexa Therapeutics FDA EventsKymera Therapeutics FDA EventsMicrobot Medical FDA EventsPalisade Bio FDA EventsRedhill Biopharma FDA EventsScienture FDA EventsTG Therapeutics FDA EventsGenmab A/S FDA EventsMediciNova FDA EventsMetaVia FDA EventsNeurocrine Biosciences FDA EventsPureTech Health FDA EventsSepterna FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Cerus FDA Events Align Technology FDA Events Merit Medical Systems FDA Events Haemonetics FDA Events QuidelOrtho FDA Events Geron FDA Events Sana Biotechnology FDA Events Aura Biosciences FDA Events CorMedix FDA Events Design Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ANIK last updated on 11/5/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Provided Update - November 5,2025Provided Update Drug: HyalofastAnnounced Date: November 5, 2025Indication: Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. AnnouncementAnika Therapeutics, Inc. 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.AI SummaryAnika Therapeutics announced it has submitted the third and final module of its Premarket Approval application (PMA) for Hyalofast to the U.S. Food and Drug Administration. This resorbable, hyaluronic acid–based scaffold is used with a patient’s own bone marrow aspirate concentrate (BMAC) to repair knee cartilage defects. The PMA submission includes 24-month data from the FastTRACK Phase III trial, plus new post-hoc analyses and real-world evidence. The FastTRACK study compared Hyalofast plus BMAC against microfracture, the then-standard treatment. While the trial missed its original co-primary endpoints, post-hoc results showed a 23% improvement in pain relief with Hyalofast (p=0.02) and significant gains in sports activity scores, quality of life, and overall knee function. A higher proportion of Hyalofast patients achieved meaningful pain reductions at 10-, 15-, and 20-point thresholds versus microfracture. Anika believes these comprehensive data reinforce Hyalofast’s potential as a single-stage, off-the-shelf cartilage repair solution for U.S. patients. The company looks forward to advancing FDA review and making Hyalofast available in the United States.Read Announcement
Top-line results - July 30,2025Top-Line Results Drug: HyalofastAnnounced Date: July 30, 2025Indication: Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. AnnouncementAnika Therapeutics, Inc. announced topline results from its U.S. pivotal clinical trial of Hyalofast, a resorbable, hyaluronic acid scaffold used in conjunction with autologous bone marrow aspirate concentrate (BMAC) for cartilage repair.AI SummaryAnika Therapeutics announced topline results from its U.S. pivotal trial of Hyalofast, a resorbable hyaluronic acid scaffold used with bone marrow aspirate concentrate (BMAC) for knee cartilage repair. The FastTRACK study was a randomized trial comparing Hyalofast plus BMAC against microfracture surgery. Despite consistent gains in pain and function, the trial missed its co-primary endpoints of percent change in KOOS Pain and IKDC function due to higher dropout and missed visits. Hyalofast showed statistically significant improvements in secondary endpoints including KOOS Sports and Recreation and Quality of Life and Total KOOS. Safety was comparable to microfracture. Hyalofast has treated over 35,000 patients worldwide since 2009, demonstrating a strong safety and effectiveness profile in independent studies. Based on these results and global data, Anika plans to submit the final PMA module in the second half of 2025 to seek FDA approval.Read Announcement
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