Axogen Completes Submission of Biologics License Application to U.S. Food and Drug Administration for Avance Nerve Graft®
Axogen (NASDAQ: AXGN) has completed the rolling submission process for its Biologics License Application (BLA) to the FDA for Avance Nerve Graft®. This marks a significant step in transitioning Avance from a tissue to a biologic. The company expects FDA notification on submission acceptance and review timeline within 60 days. Avance Nerve Graft has previously received Regenerative Medicine Advanced Therapy (RMAT) designation, potentially streamlining the development process. Axogen has requested priority review status, which could reduce the review timeline from 10 months to 6 months. The company anticipates an FDA determination of approvability between April and September of next year.
Axogen (NASDAQ: AXGN) ha completato il processo di presentazione continua per la sua Domanda di Licenza per Prodotti Biologici (BLA) presso la FDA per Avance Nerve Graft®. Questo rappresenta un passo significativo nella transizione di Avance da un tessuto a un biologico. L'azienda si aspetta una notifica dalla FDA sull'accettazione della presentazione e sulla tempistica della revisione entro 60 giorni. Avance Nerve Graft ha precedentemente ricevuto la designazione di Terapia Avanzata per la Medicina Rigenerativa (RMAT), che potrebbe semplificare il processo di sviluppo. Axogen ha richiesto un stato di revisione prioritario, il che potrebbe ridurre il tempo di revisione da 10 mesi a 6 mesi. L'azienda prevede una determinazione da parte della FDA in merito all'approvazione tra aprile e settembre del prossimo anno.
Axogen (NASDAQ: AXGN) ha completado el proceso de presentación continua para su Solicitud de Licencia de Productos Biológicos (BLA) ante la FDA para Avance Nerve Graft®. Esto marca un paso significativo en la transición de Avance de tejido a biológico. La compañía espera una notificación de la FDA sobre la aceptación de la presentación y la línea de tiempo de revisión dentro de 60 días. Avance Nerve Graft ha recibido anteriormente la designación de Terapia Avanzada en Medicina Regenerativa (RMAT), lo que podría agilizar el proceso de desarrollo. Axogen ha solicitado un estado de revisión prioritaria, lo que podría reducir el tiempo de revisión de 10 meses a 6 meses. La empresa anticipa una determinación de aprobabilidad por parte de la FDA entre abril y septiembre del próximo año.
Axogen (NASDAQ: AXGN)은 연속 제출 과정을 완료하였으며, FDA에 Avance Nerve Graft®에 대한 생물학적 제품 라이센스 신청서(BLA)를 제출했습니다. 이는 Avance를 조직에서 생물학적으로 전환하는 중요한 단계입니다. 회사는 제출 수락 및 검토 일정에 대한 FDA의 통지를 60일 이내에 받을 것으로 예상하고 있습니다. Avance Nerve Graft는 이전에 재생 의학 고급 치료(RMAT) 지정을 받아 개발 과정을 간소화할 수 있습니다. Axogen은 우선 심사 지위를 요청했으며, 이는 검토 기간을 10개월에서 6개월로 단축할 수 있습니다. 회사는 내년 4월과 9월 사이에 FDA의 승인 가능성 결정을 예상하고 있습니다.
Axogen (NASDAQ: AXGN) a complété le processus de soumission continue pour sa Demande de Licence de Produits Biologiques (BLA) auprès de la FDA pour Avance Nerve Graft®. Cela constitue une étape significative dans la transition d'Avance d'un tissu à un produit biologique. L'entreprise s'attend à recevoir une notification de la FDA concernant l'acceptation de la soumission et la chronologie de l'examen dans un délai de 60 jours. Avance Nerve Graft a précédemment reçu la désignation de Thérapie Avancée en Médecine Régénérative (RMAT), ce qui pourrait simplifier le processus de développement. Axogen a demandé un statut d'examen prioritaire, ce qui pourrait réduire le délai de révision de 10 mois à 6 mois. L'entreprise prévoit une détermination de l'approbabilité par la FDA entre avril et septembre de l'année prochaine.
Axogen (NASDAQ: AXGN) hat den laufenden Einreichungsprozess für seinen Antrag auf biologisches Produkt (BLA) bei der FDA für Avance Nerve Graft® abgeschlossen. Dies stellt einen bedeutenden Schritt bei der Umstellung von Avance von einem Gewebe zu einem biologischen Produkt dar. Das Unternehmen erwartet innerhalb von 60 Tagen eine Benachrichtigung von der FDA über die Annahme der Einreichung und den Zeitplan für die Überprüfung. Avance Nerve Graft hat zuvor die Bezeichnung für Fortgeschrittene Therapie der regenerativen Medizin (RMAT) erhalten, was den Entwicklungsprozess potenziell vereinfachen könnte. Axogen hat Prioritätsprüfungsstatus angefordert, der den Überprüfungszeitraum von 10 Monaten auf 6 Monate verkürzen könnte. Das Unternehmen erwartet eine Entscheidung der FDA über die Genehmigungsfähigkeit zwischen April und September nächsten Jahres.
- Completed BLA submission for Avance Nerve Graft to FDA
- Avance Nerve Graft has RMAT designation, potentially streamlining development
- Requested priority review status, which could reduce review timeline to 6 months
- None.
The completion of Axogen's BLA submission for Avance Nerve Graft® marks a significant milestone in the company's regulatory journey. This transition from tissue to biologic status could potentially expand market opportunities and enhance reimbursement prospects. The RMAT designation previously granted by the FDA is a positive indicator, suggesting the therapy's potential to address unmet medical needs in nerve repair.
If granted priority review, the approval process could be expedited, potentially leading to earlier market access. However, investors should note that FDA approval is not guaranteed and the timeline for determination (April to September next year) introduces a period of regulatory uncertainty. The outcome will be important for Axogen's future growth trajectory in the peripheral nerve repair market.
This regulatory milestone could have substantial financial implications for Axogen. A successful transition to biologic status for Avance Nerve Graft® may lead to improved pricing power and expanded insurance coverage, potentially driving revenue growth. However, the extended timeline for FDA determination introduces a period of financial uncertainty.
Investors should closely monitor the company's cash burn rate and R&D expenses during this regulatory phase. The potential for accelerated review, if granted, could result in earlier commercialization opportunities, positively impacting the company's financial outlook. Conversely, any delays or setbacks in the approval process could strain financial resources and impact investor confidence.
The completion of the BLA submission is a critical legal and regulatory step for Axogen. The transition from tissue to biologic classification brings both opportunities and challenges. If approved, Avance Nerve Graft® would be subject to more stringent regulatory oversight, potentially requiring additional compliance measures and ongoing post-market studies.
The RMAT designation provides certain regulatory advantages, including increased FDA interaction and potential for accelerated approval. However, it's important to note that this designation does not guarantee approval. Investors should be aware of potential legal and regulatory risks associated with the approval process, including the possibility of requests for additional data or clinical trials, which could impact timelines and costs.
ALACHUA, Fla. and TAMPA, Fla., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, 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®.
“I am proud of the significant progress our team has made towards the regulatory transition of Avance from a tissue to a biologic,” said Michael Dale, CEO and Director of Axogen, Inc. “We will continue to collaborate closely with the FDA as they review our application.”
The Company anticipates the FDA will notify the company regarding whether the submission is accepted for review and confirm the procedural review timeline (either standard or priority) within approximately the next 60 days. Avance Nerve Graft previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The RMAT designation, under the 21st Century Cures Act, aims to streamline the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions. The Company has requested priority review status for this BLA which, if granted, could reduce the review timeline from the standard 10-month to a priority 6-month review timeline from the date the submission is accepted by FDA. Based on this process, we believe we are on track for FDA determination of approvability between April and September of next year.
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 helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care 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's platform for peripheral nerve repair features a comprehensive portfolio of products used across various applications and surgical specialties, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and the surgical treatment of pain. These applications encompass both scheduled and emergent procedures. Specifically, scheduled procedures are often pursued by patients seeking relief from conditions caused by a nerve defect or previous surgical interventions. Such procedures include providing sensation for women undergoing breast reconstruction following a mastectomy, nerve reconstruction after the surgical removal of painful neuromas, and oral and maxillofacial procedures, as well as nerve decompression. Conversely, emergent procedures typically arise from injuries that initially present in an emergency room, with specialists intervening either immediately or within a few days following the initial injury. This broad range of applications underscores Axogen’s vital role in addressing diverse patient needs in peripheral nerve repair.
Axogen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, a biologically active processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector®, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector™, 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; Avive+ Soft Tissue MatrixTM, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue repair; and Axoguard Nerve Cap®, 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. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, and several other European and international markets.
For more information, visit www.axogeninc.com
Cautionary Statements Concerning Forward-Looking Statements
This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events, or results based on various assumptions and management's estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include, without limitation, the Company’s expectations that the FDA will accept its BLA submission, and that the FDA will ultimately approve the BLA for Avance Nerve Graft, as well as the Company’s estimated review and regulatory action timelines. Actual results or events could differ materially from those described in any forward-looking statements as a result of various factors, including, without limitation, global supply chain issues, hospital staffing issues, product development, product potential, clinical outcomes, regulatory process and approvals, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia’s invasion of Ukraine and related sanctions, recent geopolitical conflicts in the Middle East, potential disruptions due to management transitions, as well as those risk factors described under Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements.
Contact:
Axogen, Inc.
InvestorRelations@axogeninc.com
FAQ
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