Vericel (VCEL) FDA Approvals $40.02 -0.01 (-0.02%) Closing price 09/18/2026 04:00 PM EasternExtended Trading$40.02 +0.00 (+0.01%) As of 09/18/2026 07:30 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 EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest Vericel's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Vericel (VCEL). Over the past two years, Vericel has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NexoBrid. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. NexoBrid FDA Regulatory Timeline and Events NexoBrid is a drug developed by Vericel for the following indication: Enzymatically removes nonviable burn tissue. 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. Peer-reviewed publication - December 10,2025Peer-Reviewed Publication Drug: NexoBridAnnounced Date: December 10, 2025Indication: Enzymatically removes nonviable burn tissueOther Companies Involved: NASDAQ:MDWD AnnouncementMediWound Ltd announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid® substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries.AI SummaryMediWound announced a peer-reviewed study showing that NexoBrid® can greatly reduce embedded particles that cause traumatic tattoos after abrasion and blast injuries. The prospective study at Sheba Medical Center treated 15 patients who first had standard scrubbing, then received NexoBrid within 24 hours. Photographs and computer analysis measured pigment before and after enzymatic debridement. Results showed mean pigmented wound area fell from 37.5% to 2.1% after NexoBrid, a 92.5% reduction versus the post-scrub baseline. Abrasive injuries lost about 96% of visible pigment and blast injuries about 84%. Treatment was done at the bedside, was well tolerated, and no treatment-related adverse events were reported in the early post-procedure period. Investigators say NexoBrid’s selective enzymatic action helps remove damaged tissue and reveal a clean wound bed, but note the study’s small size and short follow-up and call for larger controlled trials to confirm long-term cosmetic benefits.Read AnnouncementMarketing authorization - September 25,2025Marketing Authorization Australian TGA ApprovalDrug: NexoBridAnnounced Date: September 25, 2025Indication: Enzymatically removes nonviable burn tissueOther Companies Involved: NASDAQ:MDWD AnnouncementMediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns.AI SummaryMediWound Ltd. announced that Australia’s Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, its enzymatic therapy for removing eschar in adults and children with deep partial- and full-thickness thermal burns. This marks Australia as the 45th country to approve NexoBrid, underlining its growing role as a non-surgical standard of care in burn management. Balance Medical, MediWound’s exclusive partner in Australia, plans to launch NexoBrid in the fourth quarter of 2025. To meet rising global demand, MediWound is expanding its manufacturing capacity, with the new facility scheduled for completion by the end of 2025. Ofer Gonen, MediWound’s CEO, said the TGA approval expands access to advanced burn treatments across Australia and opens opportunities throughout the Asia-Pacific region. Dr. Jason Brown of the Royal Brisbane and Women’s Hospital noted that NexoBrid’s rapid, selective eschar removal preserves healthy tissue and offers clinicians a valuable non-surgical option for better patient outcomes.Read AnnouncementPublication - February 25,2025Publication Phase 3Drug: NexoBridAnnounced Date: February 25, 2025Indication: Enzymatically removes nonviable burn tissueOther Companies Involved: NASDAQ:MDWD AnnouncementMediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI).AI SummaryMediWound Ltd. recently announced that its Phase III Children Innovative Debridement Study (CIDS) has been published in Burns, the peer‐reviewed journal of the International Society for Burn Injuries (ISBI). This study, conducted in multiple centers across the US, EU, Israel, and India, focused on evaluating the safety and effectiveness of NexoBrid® compared to standard care in pediatric patients with deep partial- and full-thickness thermal burns. The results demonstrated that NexoBrid provided faster removal of eschar, reduced the need for surgical intervention, and preserved healthy tissue, offering a rapid non-surgical alternative for young burn victims. These findings supported the recent label expansion for pediatric use in key regions including the U.S., E.U., and Japan and further underline NexoBrid’s clinical benefits and potential to transform burn care for children.Read Announcement Vericel FDA Events - Frequently Asked Questions Has Vericel received FDA approval? As of now, Vericel (VCEL) has not received any FDA approvals for its therapy in the last two years. What drugs has Vericel submitted to the FDA? In the past two years, Vericel (VCEL) has reported FDA regulatory activity for NexoBrid. What is the most recent FDA event for Vericel? The most recent FDA-related event for Vericel occurred on December 10, 2025, involving NexoBrid. The update was categorized as "Peer-reviewed publication," with the company reporting: "MediWound Ltd announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid® substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries." What conditions do Vericel's current drugs treat? Currently, Vericel has one therapy (NexoBrid) targeting the following condition: Enzymatically removes nonviable burn tissue. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AbCellera Biologics FDA EventsAquestive Therapeutics FDA EventsHemab Therapeutics FDA EventsAdherex Technologies FDA EventsMIRA Pharmaceuticals FDA EventsNeuroOne Medical Technologies FDA EventsQuince Therapeutics FDA EventsSol-Gel Technologies FDA EventsAbbVie FDA EventsBristol Myers Squibb FDA EventsNuvation Bio FDA EventsAbeona Therapeutics FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsFate Therapeutics 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 Alkermes FDA Events Rhythm Pharmaceuticals FDA Events Scholar Rock FDA Events Mirum Pharmaceuticals FDA Events Travere Therapeutics FDA Events Oruka Therapeutics FDA Events Kiniksa Pharmaceuticals International FDA Events Cogent Biosciences FDA Events Ligand Pharmaceuticals FDA Events Xenon Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:VCEL last updated on 12/10/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Peer-reviewed publication - December 10,2025Peer-Reviewed Publication Drug: NexoBridAnnounced Date: December 10, 2025Indication: Enzymatically removes nonviable burn tissueOther Companies Involved: NASDAQ:MDWD AnnouncementMediWound Ltd announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid® substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries.AI SummaryMediWound announced a peer-reviewed study showing that NexoBrid® can greatly reduce embedded particles that cause traumatic tattoos after abrasion and blast injuries. The prospective study at Sheba Medical Center treated 15 patients who first had standard scrubbing, then received NexoBrid within 24 hours. Photographs and computer analysis measured pigment before and after enzymatic debridement. Results showed mean pigmented wound area fell from 37.5% to 2.1% after NexoBrid, a 92.5% reduction versus the post-scrub baseline. Abrasive injuries lost about 96% of visible pigment and blast injuries about 84%. Treatment was done at the bedside, was well tolerated, and no treatment-related adverse events were reported in the early post-procedure period. Investigators say NexoBrid’s selective enzymatic action helps remove damaged tissue and reveal a clean wound bed, but note the study’s small size and short follow-up and call for larger controlled trials to confirm long-term cosmetic benefits.Read Announcement
Marketing authorization - September 25,2025Marketing Authorization Australian TGA ApprovalDrug: NexoBridAnnounced Date: September 25, 2025Indication: Enzymatically removes nonviable burn tissueOther Companies Involved: NASDAQ:MDWD AnnouncementMediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns.AI SummaryMediWound Ltd. announced that Australia’s Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, its enzymatic therapy for removing eschar in adults and children with deep partial- and full-thickness thermal burns. This marks Australia as the 45th country to approve NexoBrid, underlining its growing role as a non-surgical standard of care in burn management. Balance Medical, MediWound’s exclusive partner in Australia, plans to launch NexoBrid in the fourth quarter of 2025. To meet rising global demand, MediWound is expanding its manufacturing capacity, with the new facility scheduled for completion by the end of 2025. Ofer Gonen, MediWound’s CEO, said the TGA approval expands access to advanced burn treatments across Australia and opens opportunities throughout the Asia-Pacific region. Dr. Jason Brown of the Royal Brisbane and Women’s Hospital noted that NexoBrid’s rapid, selective eschar removal preserves healthy tissue and offers clinicians a valuable non-surgical option for better patient outcomes.Read Announcement
Publication - February 25,2025Publication Phase 3Drug: NexoBridAnnounced Date: February 25, 2025Indication: Enzymatically removes nonviable burn tissueOther Companies Involved: NASDAQ:MDWD AnnouncementMediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI).AI SummaryMediWound Ltd. recently announced that its Phase III Children Innovative Debridement Study (CIDS) has been published in Burns, the peer‐reviewed journal of the International Society for Burn Injuries (ISBI). This study, conducted in multiple centers across the US, EU, Israel, and India, focused on evaluating the safety and effectiveness of NexoBrid® compared to standard care in pediatric patients with deep partial- and full-thickness thermal burns. The results demonstrated that NexoBrid provided faster removal of eschar, reduced the need for surgical intervention, and preserved healthy tissue, offering a rapid non-surgical alternative for young burn victims. These findings supported the recent label expansion for pediatric use in key regions including the U.S., E.U., and Japan and further underline NexoBrid’s clinical benefits and potential to transform burn care for children.Read Announcement
