ALACHUA, Fla. and TAMPA, Fla. - Axogen, Inc. (NASDAQ: AXGN), specializing in surgical solutions for peripheral nerve injuries, has finished the rolling submission for its Biologics License Application (BLA) for Avance Nerve Graft® to the U.S. Food and Drug Administration (FDA), as announced on September 6. The company's CEO, Michael Dale, expressed pride in the team's progress and confirmed their ongoing cooperation with the FDA during the review process.
The FDA is expected to notify Axogen about the acceptance of the submission for review and establish the review timeline, which could be either standard or expedited, within the next 60 days. Axogen has requested priority review status, which could shorten the standard 10-month review to six months once the submission is accepted.
Avance Nerve Graft has been designated as a Regenerative Medicine Advanced Therapy (RMAT) by the FDA, a status that facilitates the development of regenerative therapies for serious or life-threatening conditions. The company anticipates a decision on the product's approvability between April and September of the following year.
Axogen's portfolio for peripheral nerve repair includes a range of products such as Avance® Nerve Graft, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Avive+ Soft Tissue MatrixTM, and Axoguard Nerve Cap®, catering to various surgical specialties and procedures, both scheduled and emergent. These products are available in multiple markets, including the United States, Canada, the United Kingdom, South Korea, and other European and international regions.
The company's press release also contained forward-looking statements regarding expectations for FDA acceptance and approval of the BLA, as well as estimated review and regulatory action timelines. However, these statements are subject to factors such as global supply chain issues, hospital staffing, product development, and regulatory processes which could impact the actual results or events.
The information in this article is based on a press release statement from Axogen, Inc.
In other recent news, AxoGen (NASDAQ:AXGN), a nerve repair company, reported a substantial 25.6% increase in revenue for Q2 2024, reaching $47.9 million, largely due to a 22.4% rise in unit volume and mix, and a 3.2% price increase. The company's adjusted EBITDA for the quarter was $5.6 million, significantly improved from a loss of $0.2 million in the previous year. AxoGen has revised its full-year revenue guidance to between $182 million and $186 million, and expects to be net cash flow positive from April 1st through the end of the year. Despite higher costs at its new processing center affecting gross margins, the company anticipates margin improvements over time. Michael Dale has been appointed as the new CEO, succeeding Karen Zaderej. The company has also launched new products and is progressing with its biologics license application for Avance Nerve Graft, anticipating approval in mid-2025. These are among the key recent developments for AxoGen.
InvestingPro Insights
As Axogen, Inc. (NASDAQ: AXGN) reaches a pivotal moment with the completion of its BLA submission for Avance Nerve Graft®, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Axogen boasts a market capitalization of $580.74 million, reflecting the market's current valuation of the company. Despite not being profitable over the last twelve months, with a P/E ratio of -34.16, the company has shown impressive revenue growth of 17.26% over the last year.
InvestingPro Tips have highlighted several key points that could be of interest to investors considering Axogen's potential. The company has experienced a high return over the last year, indicating strong market confidence, which has culminated in the stock trading near its 52-week high. Additionally, Axogen's liquid assets exceed its short-term obligations, providing a cushion that may support ongoing operations and development efforts. This is particularly relevant given the critical phase the company is entering with the FDA review process for its nerve repair products.
For those looking to delve deeper into Axogen's performance and future outlook, there are additional InvestingPro Tips available at https://www.investing.com/pro/AXGN. These tips provide further analysis and insights that could help investors make more informed decisions.
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