NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Axogen, Inc. (“Axogen” or the “Company”) (NASDAQ: AXGN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Axogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On August 25, 2025, ...

Accessibility StatementSkip Navigation [Click here for information about joining the class action] Attorney advertising. Prior results do not guarantee similar outcomes. On August 25, 2025, Axogen issued a press release "announc[ing] 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." CONTACT:Danielle PeytonPomerantz LLP[email protected] ...

Company Overview - Axogen, Inc. (NASDAQ: AXGN) is a leader in developing and marketing surgical solutions aimed at restoring peripheral nerve function [3] - The company focuses on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [3] - Axogen's mission is to help restore peripheral nerve function and improve the quality of life for patients with nerve damage through innovative and clinically proven solutions [3] Product Portfolio - Axogen's product offerings include: - **Avance Nerve Graft**: A processed human nerve allograft for bridging severed peripheral nerves [4] - **Axoguard Nerve Connector**: An extracellular matrix coaptation aid for tensionless repair of severed nerves [4] - **Axoguard Nerve Protector**: A product used to wrap and protect damaged nerves while minimizing soft tissue attachments [4] - **Axoguard HA+ Nerve Protector™**: A next-generation technology designed to enhance nerve gliding and provide protection for peripheral nerve injuries [4] - **Axoguard Nerve Cap**: A product to protect nerve ends and reduce the development of painful neuromas [4] - **Avive+ Soft Tissue Matrix™**: An amniotic membrane allograft used to protect and separate tissues during healing [4] - The product portfolio is available in multiple countries including the United States, Canada, Germany, the United Kingdom, Spain, and South Korea [4] Upcoming Investor Conferences - Axogen management is scheduled to participate in several investor conferences: - **Cantor Global Healthcare Conference**: Fireside chat on September 3, 2025 [1] - **Wells Fargo Healthcare Conference**: 1x1 investor meetings on September 4, 2025 [2] - **Morgan Stanley Annual Global Healthcare Conference**: 1x1 investor meetings on September 10, 2025 [2] - **Lake Street Best Ideas Growth (BIG 9) Conference**: 1x1 investor meetings on September 11, 2025 [2] - Webcast events will be accessible live and archived for 90 days on Axogen's investor page [2]

Group 1 - U.S. stocks experienced mixed performance, with the Dow Jones index declining over 200 points on Monday [1] - Keurig Dr Pepper Inc. shares fell sharply by 7.8% to $32.38 following the announcement of its acquisition of JDE Peet's [1] - Valneva SE shares dropped 21% to $9.19 after the FDA suspended the license for IXCHIQ [3] Group 2 - DeFi Development Corp. saw its shares dip 18% to $16.51 after announcing a $125 million offering of 4.2 million shares at $12.50 per share [3] - Venu Holding Corporation's shares fell 13.3% to $15.56 after announcing an offering of 1.7 million shares [3] - Axogen, Inc. shares declined 10.2% to $14.60 due to an FDA Major Amendment designation delaying the Avance Nerve Graft decision to December 5, 2025 [3]

Core Insights - The FDA has extended the PDUFA goal date for Axogen's Biologics License Application for Avance Nerve Graft by three months to December 5, 2025 [1][2] - The extension is due to a Major Amendment designation, which allows additional time for the FDA to review substantial new manufacturing and facility data submitted by the company [2] - Feedback on product labeling is anticipated from the FDA in November 2025, aligning with standard PDUFA review procedures [3] Company Overview - Axogen, Inc. specializes in the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [4] - The company aims to restore nerve function and improve the quality of life for patients with peripheral nerve injuries through innovative and clinically proven solutions [4] - Axogen's product portfolio includes several products designed for nerve repair, including Avance® Nerve Graft, Axoguard Nerve Connector®, and Axoguard Nerve Protector®, among others [4]

Core Viewpoint - AxoGen (AXGN) shares have increased by 16.6% in the past four weeks, closing at $14.01, with a mean price target of $24.71 indicating a potential upside of 76.4% [1] Price Targets and Analyst Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $3.2, where the lowest estimate of $20.00 suggests a 42.8% increase, and the highest estimate of $30.00 indicates a 114.1% increase [2] - A low standard deviation signifies strong agreement among analysts regarding the stock's price movement, which can be a useful starting point for further research [9] Earnings Estimates and Analyst Optimism - Analysts show strong agreement in revising earnings per share (EPS) estimates higher, which correlates with potential stock price increases [11] - Over the last 30 days, two estimates have been revised upward, leading to a 27.1% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank and Investment Potential - AXGN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] - While consensus price targets may not be entirely reliable, the implied direction of price movement appears to be a good guide for potential investment [14]

Group 1 - Axogen (NASDAQ: AXGN) has experienced a continued selloff despite posting reasonably strong Q2 FY'25 numbers, indicating a wide distribution of potential outcomes for the company [1] Group 2 - The company operates within a framework that focuses on fundamental value drivers of business economics, aiming to identify high probability long-term compounders [2] - The research covers various investment securities and futures & options markets, indicating a broad approach to investment analysis [2] Group 3 - There is no indication of any stock, option, or similar derivative positions held by the analyst in the companies mentioned, suggesting an unbiased perspective [3] - The article expresses the author's own opinions without any compensation from the companies discussed, reinforcing the independence of the analysis [3] Group 4 - Seeking Alpha emphasizes that past performance does not guarantee future results, highlighting the inherent uncertainties in investment decisions [4] - The platform clarifies that it does not provide personalized investment advice, which is crucial for investors to consider [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to______________ Commission file number: 001-36046 Washington, D.C. 20549 FORM 10-Q (Mark One) Axogen, Inc. (Exact Name of Registrant as Specified in Its Charter) Minnesota (State or other j ...

分组1 - AxoGen reported quarterly earnings of $0.12 per share, exceeding the Zacks Consensus Estimate of $0.06 per share, and showing an increase from $0.05 per share a year ago, resulting in an earnings surprise of +100.00% [1] - The company achieved revenues of $56.66 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 7.11%, and up from $47.91 million year-over-year [2] - Over the last four quarters, AxoGen has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] 分组2 - The stock has underperformed, losing about 23.9% since the beginning of the year, while the S&P 500 has gained 7.6% [3] - The current consensus EPS estimate for the coming quarter is $0.07 on revenues of $55.93 million, and for the current fiscal year, it is $0.20 on revenues of $216.4 million [7] - The Zacks Industry Rank for Medical - Instruments is currently in the bottom 37% of over 250 Zacks industries, indicating potential underperformance compared to higher-ranked industries [8]

AxoGen (AXGN) Q2 2025 Earnings Call August 05, 2025 08:00 AM ET Speaker0Joining me on today's call is Michael Dale, AxoGen's Chief Executive Officer and Director and Lindsay Hartley, Chief Financial Officer. Michael will discuss second quarter twenty twenty five financial results and corporate highlights. Lindsay will then provide details on financial performance, guidance and overall outlook for the year. This will be followed by a question and answer session. Today's call is being broadcast live via webca ...