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Investing.com - Raymond James has reiterated an Outperform rating and $20.00 price target on AxoGen, Inc. (NASDAQ:AXGN), which has shown strong momentum with a 30% return over the past year. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $20 to $30, following the FDA’s extension of the PDUFA date for the company’s Avance Biologics License Application (BLA).
The FDA communicated late Friday that it has extended the review period by three months. While the timeline delay is not ideal, Raymond James notes that given the uniqueness of the filing, such a delay is not entirely unexpected.
AxoGen is expected to engage with the FDA this week to clarify remaining concerns. The research firm remains optimistic about final approval in December, viewing the delay as a "speed bump" in the decade-plus BLA journey.
Raymond James takes comfort that the FDA’s questions are manufacturing-related rather than clinical or safety-related data. The firm also notes that AxoGen’s manufacturing facilities have been audited by the FDA almost yearly throughout the process.
The delay will not impact AxoGen’s revenue, but it will shift an anticipated PSU-related stock-based compensation expense, which would be booked in cost of goods sold, from the third quarter to the fourth quarter of this year.
In other recent news, Axogen Inc . has reported its second-quarter 2025 financial results, showing revenue of $56.7 million. This figure surpasses both the estimate from Cantor Fitzgerald, which was $50.2 million, and the FactSet consensus of $53.0 million, marking a notable year-over-year growth of approximately 18.3%. Cantor Fitzgerald has reiterated an Overweight rating on Axogen, maintaining a $26.00 price target, following these strong financial results. Additionally, the U.S. Food and Drug Administration (FDA) has extended the review timeline for Axogen’s Biologics License Application for the Avance Nerve Graft by three months. The new decision date is set for December 5, 2025, due to a "Major Amendment" in the application, which included substantial new manufacturing and facility data. This extension was communicated to Axogen on August 22. These developments highlight the company’s ongoing regulatory processes alongside its financial performance.
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