ALACHUA, Fla. and TAMPA, Fla. - Axogen, Inc. (NASDAQ: AXGN), a company specializing in surgical solutions for peripheral nerve injuries, has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for its Avance Nerve Graft®. The company announced on Wednesday that it submitted the non-clinical data package, marking the first step in the application process.
The rolling submission, which began on May 15, 2024, allows Axogen to submit individual sections of the BLA as they are completed, potentially expediting the FDA's review process. Avance Nerve Graft has previously received the Regenerative Medicine Advanced Therapy (RMAT) designation, which could further streamline its development and review.
The RMAT designation is part of the 21st Century Cures Act, designed to accelerate the availability of regenerative medicine therapies for serious diseases. This status could grant Axogen benefits like FDA guidance on the drug development process and the possibility of a priority review, which could shorten the standard 10-month review period to six months.
Axogen expects to complete the BLA filing in the third quarter of 2024, with the potential for FDA approval around mid-2025. The company plans to submit the remaining Clinical and Chemistry, Manufacturing, and Controls components in the upcoming months.
The Avance Nerve Graft is part of Axogen's broader portfolio aimed at peripheral nerve regeneration and repair, addressing conditions ranging from traumatic injuries to scheduled procedures for nerve reconstruction. Axogen's products are available in the United States, Canada, the United Kingdom, South Korea, and other international markets.
InvestingPro Insights
As Axogen, Inc. (NASDAQ: AXGN) progresses with its BLA submission for Avance Nerve Graft, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Axogen has a market capitalization of $260.04 million and has shown a revenue growth of 13.51% over the last twelve months as of Q1 2024. This growth is a positive signal for the company's ability to expand its operations and potentially increase market share.
Despite not being profitable over the last twelve months, Axogen has demonstrated a robust gross profit margin of 80.62%, indicating a strong ability to control the cost of goods sold and maintain profitability at the gross level. However, the company faces challenges as reflected by an operating income margin of -11.41%, which suggests that expenses beyond the cost of goods sold are currently outweighing revenues.
InvestingPro Tips for Axogen highlight that analysts do not expect the company to be profitable this year, which is consistent with the negative P/E ratio of -12.22. Moreover, the company's liquid assets exceed short-term obligations, providing some financial flexibility in the near term. It's also worth noting that the stock price has experienced a significant decline over the last three months, which may present a buying opportunity for long-term investors who believe in the company's future prospects. Axogen does not pay a dividend, indicating that the company is likely reinvesting earnings back into growth initiatives.
For those interested in a deeper dive into Axogen's financials and stock performance, InvestingPro offers additional insights. There are currently 4 more InvestingPro Tips available for Axogen at https://www.investing.com/pro/AXGN. To access these valuable insights and make more informed investment decisions, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.