Axogen Completes Submission of Biologics License Application to U.S. Food and Drug Administration for Avance Nerve Graft®
Axogen, Inc. (AXGN)
Last axogen, inc. earnings: 2/24 04:01 pm
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Source: GlobeNewswire
ALACHUA, Fla. and TAMPA, Fla., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®. “I am proud of the significant progress our team has made towards the regulatory transition of Avance from a tissue to a biologic,” said Michael Dale, CEO and Director of Axogen, Inc. “We will continue to collaborate closely with the FDA as they review our application.” The Company anticipates the FDA will notify the company regarding whether the submission is accepted for review and confirm the procedural review timeline (either standard or priority) within approximately the next 60 days. Avance Nerve Graft previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The RMAT d
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News
- AxoGen Reports Strong Q3 2024 Revenue Growth [Yahoo! Finance]Yahoo! Finance
- Axogen Inc (AXGN) Q3 2024 Earnings Call Highlights: Strong Revenue Growth and Strategic Advancements [Yahoo! Finance]Yahoo! Finance
- Axogen, Inc Reports Third Quarter 2024 Financial Results and Provides BLA UpdateGlobeNewswire
- Axogen, Inc. to report third quarter 2024 financial results and host conference call on November 7, 2024GlobeNewswire
- AxoGen, Inc. (NASDAQ: AXGN) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
AXGN
Earnings
- 11/7/24 - Beat
AXGN
Sec Filings
- 11/14/24 - Form SC
- 11/7/24 - Form SC
- 11/7/24 - Form 10-Q
- AXGN's page on the SEC website