AxoGen's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by AxoGen (AXGN).
Over the past two years, AxoGen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Avance. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Avance Nerve Graft FDA Regulatory Timeline and Events
Avance Nerve Graft is a drug developed by AxoGen for the following indication: Biologically active off-the-shelf processed human nerve allograft.
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:
- Avance Nerve Graft
- Announced Date:
- December 3, 2025
- Indication:
- Biologically active off-the-shelf processed human nerve allograft
Announcement
Axogen, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has approved the Biologics License Application ("BLA") for AVANCE® (acellular nerve allograft-arwx).
AI Summary
Axogen, Inc. announced that the U.S. Food and Drug Administration has approved the Biologics License Application (BLA) for AVANCE® (acellular nerve allograft‑arwx). AVANCE is an acellular nerve scaffold intended to treat peripheral nerve discontinuities in adult and pediatric patients aged one month and older, including sensory, mixed, and motor nerve injuries.
The FDA granted approval for sensory nerve gaps >25 mm and for mixed and motor nerve discontinuities under the Accelerated Approval pathway. That decision was based on static two‑point discrimination (s2PD) results in sensory nerve gaps ≤25 mm, which the agency judged to reasonably predict clinical benefit. Continued approval for those indications depends on confirmatory clinical trials that verify and describe clinical benefit.
Axogen expects the licensed AVANCE product to be commercially available in early second quarter 2026; until then it remains available under the current tissue framework. Important safety information includes risks of procedural complications (pain, infection, swelling, neuroma, impaired function) and potential transmission of infectious agents from donor tissue. The most common adverse reactions reported were procedural pain and hyperesthesia.
Read Announcement- Drug:
- Avance Nerve Graft
- Announced Date:
- September 6, 2024
- Indication:
- Biologically active off-the-shelf processed human nerve allograft
Announcement
Axogen, Inc. announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®.
AI Summary
Axogen, Inc. announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its Avance Nerve Graft®. The submission marks a significant step in advancing the product, which is used in the repair of peripheral nerves. Michael Dale, the CEO, expressed pride in the progress made toward transitioning Avance from a traditional tissue product to a biologic. Axogen will now work closely with the FDA as they review the application. The company expects to receive confirmation on the submission’s acceptance for review, as well as details regarding the review timeline, within the next 60 days. This latest development underscores Axogen’s commitment to enhancing treatment options for patients suffering from nerve injuries through innovative product advancements.
Read Announcement- Drug:
- Avance Nerve Graft
- Announced Date:
- May 16, 2024
- Indication:
- Biologically active off-the-shelf processed human nerve allograft
Announcement
Axogen, Inc. announce that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for licensure of Avance Nerve Graft® on May 15, 2024.
AI Summary
Axogen, Inc. announced an important step forward in its regulatory process on May 15, 2024. The company has begun the rolling submission process with the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA). This application is for the licensure of its Avance Nerve Graft®, a product designed to address nerve injuries in patients. By using a rolling submission, Axogen is allowed to provide sections of its application to the FDA as they become ready, which could potentially lead to faster feedback and a quicker overall review process.
The decision to use a rolling submission demonstrates the company’s strategy to rapidly advance its medical solutions. This move by Axogen aims to help streamline the approval process, bringing innovative treatment options to patients who need them sooner while ensuring the product meets all safety and effectiveness standards set by the FDA.
Read Announcement
AxoGen FDA Events - Frequently Asked Questions
As of now, AxoGen (AXGN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, AxoGen (AXGN) has reported FDA regulatory activity for Avance Nerve Graft.
The most recent FDA-related event for AxoGen occurred on December 3, 2025, involving Avance Nerve Graft. The update was categorized as "FDA approved," with the company reporting: "Axogen, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has approved the Biologics License Application ("BLA") for AVANCE® (acellular nerve allograft-arwx)."
Currently, AxoGen has one therapy (Avance Nerve Graft) targeting the following condition: Biologically active off-the-shelf processed human nerve allograft.
More FDA Event Resources from MarketBeat
Companies With Recent 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
FDA progress for NASDAQ:AXGN last updated on 12/4/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
Free AXGN Stock Alerts