Axogen Provides Update on FDA Review Timeline for Avance Nerve Graft
Axogen (NASDAQ:AXGN) announced that the FDA has extended the PDUFA goal date for its Biologics License Application (BLA) for Avance Nerve Graft by three months to December 5, 2025. The extension follows the FDA's designation of Axogen's recent submission, which included new manufacturing and facility data, as a Major Amendment to its BLA.
The FDA plans to provide feedback on product labeling in November 2025. This extension allows the agency additional time to review the substantial new information submitted as part of the company's response to an FDA information request, supporting the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic.
Axogen (NASDAQ:AXGN) ha comunicato che la FDA ha posticipato di tre mesi la data obiettivo PDUFA per la sua Domanda di Autorizzazione Biologica (BLA) relativa a Avance Nerve Graft, fissandola ora al 5 dicembre 2025. L'estensione segue la classificazione, da parte della FDA, della recente documentazione inviata da Axogen 鈥� che comprende nuovi dati di produzione e relativi agli impianti 鈥� come una Major Amendment alla BLA.
La FDA prevede di fornire commenti sull'etichettatura del prodotto a novembre 2025. Questa proroga concede all'agenzia tempo aggiuntivo per esaminare le rilevanti nuove informazioni presentate nella risposta dell'azienda a una richiesta di chiarimenti della FDA, a supporto della transizione di Avance Nerve Graft da prodotto tissutale a biologico approvato tramite BLA.
Axogen (NASDAQ:AXGN) anunci贸 que la FDA ha ampliado en tres meses la fecha objetivo PDUFA para su Solicitud de Licencia Biol贸gica (BLA) del Avance Nerve Graft, estableci茅ndola ahora en 5 de diciembre de 2025. La extensi贸n se produce despu茅s de que la FDA designara la reciente presentaci贸n de Axogen 鈥攓ue inclu铆a nuevos datos de fabricaci贸n e instalaciones鈥� como una Major Amendment a la BLA.
La FDA tiene previsto ofrecer comentarios sobre el etiquetado del producto en noviembre de 2025. Esta pr贸rroga permite a la agencia disponer de tiempo adicional para revisar la importante informaci贸n nueva remitida en la respuesta de la compa帽铆a a una solicitud de informaci贸n de la FDA, apoyando la transici贸n de Avance Nerve Graft de producto tisular a biol贸gico aprobado mediante BLA.
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Axogen (NASDAQ:AXGN) a annonc茅 que la FDA a prolong茅 de trois mois la date cible PDUFA pour sa Demande d'Autorisation de Biologique (BLA) concernant Avance Nerve Graft, la repoussant au 5 d茅cembre 2025. Cette extension fait suite 脿 la qualification par la FDA de la r茅cente soumission d'Axogen 鈥� incluant de nouvelles donn茅es de fabrication et d'installations 鈥� comme une Major Amendment de la BLA.
La FDA pr茅voit de fournir des commentaires sur l'茅tiquetage du produit en novembre 2025. Cette prolongation permet 脿 l'agence de disposer de temps suppl茅mentaire pour examiner les nouvelles informations substantielles soumises en r茅ponse 脿 une demande d'informations de la FDA, favorisant la transition d'Avance Nerve Graft d'un produit tissulaire vers un biologique approuv茅 par BLA.
Axogen (NASDAQ:AXGN) gab bekannt, dass die FDA das PDUFA-Zieldatum f眉r seinen Antrag auf Zulassung eines biologischen Arzneimittels (BLA) f眉r das Avance Nerve Graft um drei Monate auf den 5. Dezember 2025 verschoben hat. Die Verl盲ngerung erfolgt, nachdem die FDA die k眉rzlich eingereichten Unterlagen von Axogen 鈥� einschlie脽lich neuer Herstellungs- und Anlagendaten 鈥� als Major Amendment zur BLA eingestuft hatte.
Die FDA plant, im November 2025 R眉ckmeldung zur Produktkennzeichnung zu geben. Diese Fristverl盲ngerung gibt der Beh枚rde zus盲tzliche Zeit, die umfangreichen neuen Informationen zu pr眉fen, die als Antwort des Unternehmens auf eine Informationsanforderung der FDA eingereicht wurden, und unterst眉tzt die Umstellung von Avance Nerve Graft von einem Gewebeprodukt auf ein per BLA zugelassenes Biologikum.
- Continued progress toward BLA approval for Avance Nerve Graft
- FDA maintains active engagement in review process
- Clear timeline provided for labeling feedback in November 2025
- Three-month delay in PDUFA goal date to December 5, 2025
- Additional review time needed for manufacturing and facility data
- Potential market launch delay due to extended review period
FDA PDUFA goal date extended by three months
ALACHUA, Fla. and TAMPA, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (Nasdaq: AXGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for Avance庐 Nerve Graft by three months to December 5, 2025.
On August 22, 2025, the Company received a communication from the FDA indicating that the information submitted by the Company in response to an FDA information request, which included substantial new manufacturing and facility data not previously reviewed by the Agency, was deemed a Major Amendment to its BLA. Under FDA guidelines, this designation allows for additional time to review the submission. As a result, the FDA has extended the PDUFA goal date to December 5, 2025.
The FDA also informed the Company that it now anticipates providing feedback on product labeling in November 2025, consistent with PDUFA review procedures.
鈥淲e appreciate the FDA's thorough review and look forward to continuing our engagement with the agency to complete the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic,鈥� said Michael Dale, Axogen鈥檚 Chief Executive Officer.
About Axogen
Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries by providing innovative, clinically proven and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. Axogen鈥檚 product portfolio includes Avance庐 Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector庐, a porcine (pig) submucosa extracellular matrix (鈥淓CM鈥�) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector庐, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while minimizing soft tissue attachments; Axoguard HA+ Nerve Protector鈩�, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to enhance nerve gliding and provide short- and long-term protection for peripheral nerve injuries; Axoguard Nerve Cap庐, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive+ Soft Tissue Matrix鈩�, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue healing. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea and several other countries. For more information, visit www.axogeninc.com.
Cautionary Statements Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential approval, timing of regulatory review and labeling feedback for Avance Nerve Graft. Words such as 鈥渁nticipate,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥減otential,鈥� and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Readers are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the timing and outcome of FDA review, potential requests for additional data or information, the possibility of delays, and other risks described in the 鈥淩isk Factors鈥� section of Axogen鈥檚 filings with the Securities and Exchange Commission (SEC).
Axogen undertakes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events, or otherwise, except as required by law.
Contact:
Axogen, Inc.
[email protected]
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