Anika Therapeutics' Drug in the FDA Approval Process
This 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.
- Drug:
- Hyalofast
- Announced Date:
- November 5, 2025
- 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.
Announcement
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.
AI Summary
Anika 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- Drug:
- Hyalofast
- Announced Date:
- July 30, 2025
- 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.
Announcement
Anika 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 Summary
Anika 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
As of now, Anika Therapeutics (ANIK) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Anika Therapeutics (ANIK) has reported FDA regulatory activity for Hyalofast.
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."
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..
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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
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.
