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:
- 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 July 30, 2025, involving Hyalofast. The update was categorized as "Top-line results," with the company reporting: "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."
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 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
This page (NASDAQ:ANIK) was last updated on 8/2/2025 by MarketBeat.com Staff