Welcome to our dedicated page for Axogen news (Ticker: AXGN), a resource for investors and traders seeking the latest updates and insights on Axogen stock.
Axogen Inc. (AXGN) delivers innovative solutions for peripheral nerve repair through clinically validated medical technologies. This dedicated news hub provides investors and healthcare professionals with essential updates on the company developments shaping surgical nerve regeneration.
Access real-time announcements including quarterly earnings reports, regulatory milestones, product launch details, and strategic partnerships. Our curated collection features press releases about Avance Nerve Graft advancements, Axoguard product line expansions, and clinical study outcomes that demonstrate Axogen's leadership in nerve repair innovation.
Bookmark this page for centralized access to financial performance data, research breakthroughs, and market expansion initiatives. Stay informed about Axogen's contributions to improving surgical outcomes through cutting-edge ECM technologies and nerve regeneration solutions.
Axogen (NASDAQ:AXGN) announced that the FDA has extended the PDUFA goal date for its Biologics License Application (BLA) for Avance Nerve Graft by three months to December 5, 2025. The extension follows the FDA's designation of Axogen's recent submission, which included new manufacturing and facility data, as a Major Amendment to its BLA.
The FDA plans to provide feedback on product labeling in November 2025. This extension allows the agency additional time to review the substantial new information submitted as part of the company's response to an FDA information request, supporting the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic.
Axogen (NASDAQ: AXGN), a leader in peripheral nerve function restoration, reported strong Q2 2025 financial results with revenue of $56.7 million, up 18.3% year-over-year. The company achieved profitability with net income of $0.6 million ($0.01 per share), compared to a net loss in Q2 2024.
Key highlights include improved gross margin of 74.2%, adjusted EBITDA of $9.3 million, and expanded insurance coverage for nerve repair procedures. The FDA's review of Avance® Nerve Graft's Biologics License Application is progressing with a decision date of September 5, 2025.
Following strong H1 2025 performance, Axogen raised its full-year revenue guidance to at least 17% growth ($219 million) and maintains its gross margin forecast of 73-75%, despite anticipated one-time BLA approval costs.
Axogen (NASDAQ: AXGN), a leader in peripheral nerve function restoration solutions, has announced its participation in the Canaccord Genuity 45th Annual Growth Conference. The company's management team will be conducting one-on-one meetings with investors on Tuesday, August 12, 2025.
Axogen (NASDAQ: AXGN), a global leader in peripheral nerve function surgical solutions, has scheduled its 2025 second quarter financial results announcement for Tuesday, August 5, 2025, before market opening.
The company will host an investment-community conference call and webcast at 8:00 AM ET on the same day. Investors can participate via phone using the toll-free number (877) 407-0993 or direct dial (201) 689-8795. The webcast will be accessible through the Investors section of Axogen's website.
Axogen (NASDAQ: AXGN), a global leader in peripheral nerve injury surgical solutions, announced that Michael Dale, their CEO, president, and board director, will participate in a fireside chat at the Goldman Sachs Global Healthcare Conference. The event is scheduled for June 11, 2025, at 2:00 p.m. ET. Investors can access the live webcast through Axogen's investor relations webpage, with a replay available for 90 days afterward.
[]Axogen (NASDAQ: AXGN) has announced the appointment of Lindsey Hartley, CPA, as Chief Financial Officer, effective May 12, 2025. Hartley, currently serving as Vice President, Corporate Controller at Axogen, will succeed Nir Naor, who is departing to pursue other opportunities but will remain as an advisor until July 1, 2025.
Hartley brings 19 years of financial leadership experience, particularly in healthcare and medical devices. Since joining Axogen in October 2021, she has improved financial reporting processes, reduced month-end close time by 40%, and enhanced cash forecasting capabilities. Her previous experience includes roles at VERO Biotech, Brookhaven Medical, and EY.
Axogen (NASDAQ: AXGN), a global leader in peripheral nerve injury surgical solutions, has scheduled its 2025 first quarter financial results announcement for Thursday, May 8, 2025, before market opening. The company will host an investment-community conference call and webcast at 8:00 AM ET following the release.
Investors can participate via phone by dialing (877) 407-0993 (toll-free) or (201) 689-8795 (direct). The webcast will be accessible through the Investors page on www.axogeninc.com. A replay will be available in the Investors section post-call.
Axogen (NASDAQ: AXGN) has appointed Rick Ditto as Vice President of Global Health Economics, Reimbursement & Policy. Reporting to CEO Michael Dale, Ditto will spearhead coverage and reimbursement strategies to establish peripheral nerve function restoration as a standard of care.
Ditto brings over 15 years of medical device industry leadership experience from Zimmer Biomet, Johnson & Johnson, and Lumere. He holds degrees in Biomedical Engineering, Bioengineering, and Applied Health Economics & Outcomes Research.
As part of his employment package starting March 24, 2025, Ditto will receive an inducement grant on April 1, 2025, consisting of 45,000 Restricted Stock Units (RSUs) of Axogen common stock. The RSUs will vest over 4 years, with 50% vesting after two years and 25% vesting annually for the following two years.
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, has announced its upcoming Analyst & Investor Day scheduled for March 4, 2025, from 9am to 12pm Eastern time.
The event will feature presentations from key leadership including Chief Executive Officer Michael Dale, Chief Financial Officer Nir Naor, and other senior team members. Attendees can expect comprehensive insights into Axogen's business overview, strategic initiatives, growth plans, financial results, and future objectives.
For those unable to attend in person, a live webcast will be available on Axogen's investor relations website under "Axogen Virtual Analyst & Investor Day." A replay of the webcast will remain accessible for 90 days following the event.