FDA PDUFA goal date extended by three monthsALACHUA, 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® 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 ...

Company Overview - Axogen, Inc. is a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function [1] - The company focuses specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [2] - Axogen's products address the needs of patients suffering from traumatic injuries or surgical procedures that impact peripheral nerve function [2] Product Portfolio - Axogen offers a comprehensive portfolio of products for peripheral nerve repair, including: - Avance Nerve Graft®, a biologically active processed human nerve allograft for bridging severed peripheral nerves [2] - Axoguard Nerve Connector®, a porcine submucosa extracellular matrix coaptation aid for tensionless repair of severed peripheral nerves [2] - Axoguard Nerve Protector®, a product used to wrap and protect damaged peripheral nerves [2] - Axoguard HA+ Nerve Protector™, designed to enhance nerve gliding and provide protection for peripheral nerve injuries [2] - Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft for tissue protection during repair [2] - Axoguard Nerve Cap®, used to protect a peripheral nerve end and reduce the development of symptomatic neuroma [2] Market Presence - Axogen's products are available in multiple markets, including the United States, Canada, the United Kingdom, South Korea, and several European and international markets [2] - The company plays a vital role in addressing diverse patient needs in peripheral nerve repair across various applications and surgical specialties [2]

Company Overview - Axogen, Inc. (NASDAQ: AXGN) is a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function [1][3] - The company focuses specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [3] Product Portfolio - Axogen offers a comprehensive portfolio of products for peripheral nerve repair, including: - Avance Nerve Graft®, a biologically active processed human nerve allograft for bridging severed peripheral nerves [3] - Axoguard Nerve Connector®, a porcine submucosa extracellular matrix coaptation aid for tensionless repair of severed peripheral nerves [3] - Axoguard Nerve Protector®, a product used to wrap and protect damaged peripheral nerves [3] - Axoguard HA+ Nerve Protector™, designed to enhance nerve gliding and provide protection for peripheral nerve injuries [3] - Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft for tissue repair [3] - Axoguard Nerve Cap®, used to protect a peripheral nerve end and reduce the development of symptomatic or painful neuroma [3] Market Applications - Axogen's products are utilized across various applications and surgical specialties, including: - Traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and surgical treatment of pain [3] - The company addresses both scheduled procedures, such as nerve reconstruction after surgical removal of painful neuromas, and emergent procedures arising from injuries [3] Upcoming Financial Reporting - Axogen will report its 2025 second quarter financial results on August 5, 2025, before the market opens [1] - An investment-community conference call and webcast will follow the release at 8 a.m. ET [1]

Company Overview - Axogen, Inc. (NASDAQ: AXGN) is a leader in developing and marketing surgical solutions for peripheral nerve injuries [1][3] - The company focuses on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [3] - Axogen's products aim to restore peripheral nerve function and improve the quality of life for patients with nerve damage [3] Product Portfolio - Axogen offers a comprehensive portfolio of products for various applications, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and pain treatment [3] - Key products include: - Avance Nerve Graft®: a processed human nerve allograft for bridging severed peripheral nerves [3] - Axoguard Nerve Connector®: an extracellular matrix coaptation aid for tensionless repair of severed nerves [3] - Axoguard Nerve Protector®: a product used to protect damaged nerves and reinforce reconstruction [3] - Axoguard HA+ Nerve Protector™: designed to enhance nerve gliding and provide protection for peripheral nerve injuries [3] - Avive+ Soft Tissue Matrix™: an amniotic membrane allograft for tissue protection during repair [3] - Axoguard Nerve Cap®: used to protect a peripheral nerve end and reduce the development of painful neuromas [3] Market Presence - Axogen's products are available in the United States, Canada, the United Kingdom, South Korea, and several other international markets [3] - The company addresses both scheduled and emergent procedures, highlighting its vital role in peripheral nerve repair [3]

Core Viewpoint - Axogen, Inc. reported strong financial results for Q1 2025, highlighting robust revenue growth and progress towards long-term objectives, with a focus on enhancing sales productivity and commercial execution [3][5]. Financial Results - Q1 2025 revenue reached $48.6 million, marking a 17.4% increase compared to Q1 2024 [6]. - Gross margin for Q1 2025 was 71.9%, down from 78.8% in Q1 2024, attributed to increased product costs and inventory write-offs [6][7]. - The net loss for the quarter was $3.8 million, or $0.08 per share, an improvement from a net loss of $6.6 million, or $0.15 per share, in Q1 2024 [6][20]. - Adjusted net loss for the quarter was $0.9 million, or $0.02 per share, compared to $2.7 million, or $0.06 per share, in Q1 2024 [6][20]. - Adjusted EBITDA was $2.9 million for the quarter, up from $1.0 million in Q1 2024 [6][20]. Business Highlights - Revenue growth was broad-based across the product portfolio, with double-digit growth in all markets, including Extremities, Oral Maxillofacial & Head and Neck, and Breast [7]. - The FDA accepted the filing of the Biologics License Application (BLA) for Avance® Nerve Graft, with a goal date for approval set for September 5, 2025 [7]. - Regulatory milestones completed in Q1 2025 included a mid-cycle meeting with the FDA and clinical trial site inspections [7]. - Lindsey Hartley, CPA, was appointed as the new Chief Financial Officer effective May 12, 2025, succeeding Nir Naor [7]. 2025 Financial Guidance - The company maintains its full-year revenue growth guidance in the range of 15% to 17% and expects gross margin to be between 73% and 75% [5]. - The company anticipates being net cash flow positive for the full year [5].

Core Viewpoint - Axogen, Inc. is set to report its first quarter financial results for 2025 on May 8, 2025, and will host a conference call for the investment community shortly after the release [1]. Company Overview - Axogen, Inc. is a leader in developing and marketing surgical solutions specifically for peripheral nerve injuries, focusing on restoring nerve function and improving patients' quality of life [3]. - The company offers a comprehensive portfolio of products for peripheral nerve repair, including Avance Nerve Graft®, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Avive+ Soft Tissue Matrix™, and Axoguard Nerve Cap® [3]. - Axogen's products are utilized across various surgical specialties and applications, addressing both scheduled and emergent procedures related to peripheral nerve damage [3]. Product Applications - Scheduled procedures include nerve reconstruction for conditions caused by nerve defects, such as breast reconstruction post-mastectomy and oral and maxillofacial surgeries [3]. - Emergent procedures typically arise from traumatic injuries, requiring immediate or timely intervention by specialists [3]. - The company's products are available in multiple markets, including the United States, Canada, the United Kingdom, South Korea, and several European and international markets [3].