AxoGen (AXGN) FDA Approvals $50.40 +3.96 (+8.53%) As of 08/21/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest AxoGen's Drug in the FDA Approval ProcessThis 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 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. FDA approved - December 3,2025Fda Approved Drug: Avance Nerve GraftAnnounced Date: December 3, 2025Indication: Biologically active off-the-shelf processed human nerve allograftAnnouncementAxogen, 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 SummaryAxogen, 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 AnnouncementRegulatory Update - September 6,2024Regulatory Update BLADrug: Avance Nerve GraftAnnounced Date: September 6, 2024Indication: Biologically active off-the-shelf processed human nerve allograftAnnouncementAxogen, 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 SummaryAxogen, 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 AxoGen FDA Events - Frequently Asked Questions Has AxoGen received FDA approval? As of now, AxoGen (AXGN) has not received any FDA approvals for its therapy in the last two years. What drugs has AxoGen submitted to the FDA? In the past two years, AxoGen (AXGN) has reported FDA regulatory activity for Avance Nerve Graft. What is the most recent FDA event for AxoGen? 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)." What conditions do AxoGen's current drugs treat? 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 FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Scholar Rock FDA EventsAC Immune FDA EventsAlector FDA EventsAlzamend Neuro FDA EventsArcutis Biotherapeutics FDA EventsBioNTech FDA EventsHarrow FDA EventsIonis Pharmaceuticals FDA EventsMilestone Pharmaceuticals FDA EventsRadiopharm Theranostics FDA EventsRein Therapeutics FDA EventsTurn Therapeutics FDA EventsNuvation Bio FDA EventsHumacyte FDA EventsModerna 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 Insulet FDA Events Teleflex FDA Events MiniMed Group FDA Events Haemonetics FDA Events Pulse Biosciences FDA Events TransMedics Group FDA Events NovoCure FDA Events Inspire Medical Systems FDA Events Artivion FDA Events Alpha Tau Medical FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:AXGN last updated on 12/4/2025 by MarketBeat.com Staff. 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FDA approved - December 3,2025Fda Approved Drug: Avance Nerve GraftAnnounced Date: December 3, 2025Indication: Biologically active off-the-shelf processed human nerve allograftAnnouncementAxogen, 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 SummaryAxogen, 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
Regulatory Update - September 6,2024Regulatory Update BLADrug: Avance Nerve GraftAnnounced Date: September 6, 2024Indication: Biologically active off-the-shelf processed human nerve allograftAnnouncementAxogen, 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 SummaryAxogen, 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
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