AxoGen, Inc. (AXGN) announced the initiation of rolling submission of a Biologics License Application (BLA) seeking licensure for its human nerve allograft candidate, Avance Nerve Graft, to the FDA on May 15.The initial submission includes the complete non-clinical data package. The company will submit the remaining Clinical and Chemistry, Manufacturing and Controls components in the upcoming months. The rolling submission is expected to be completed by the third quarter of 2024.Following a potential approv ...

ALACHUA, Fla. and TAMPA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, is pleased to announce that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for licensure of Avance Nerve Graft® on May 15, 2024. "Today's milestone represents a significant step in our regulatory transition of Avance Nerve Graft ...

ALACHUA, Fla. and TAMPA, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, chairman, chief executive officer, and president, will participate in a fireside chat at the Leerink Partners Healthcare Crossroads Conference in Austin, TX, on Wednesday, May 29, 2024, at 3:40 p.m. CT / 4:40 p.m. ET. Webcast events can be accessed live through the Investors pag ...

AxoGen, Inc. (NASDAQ:AXGN) Q1 2024 Earnings Conference Call May 2, 2024 8:00 AM ET Company Participants Harold Tamayo - VP, Finance and IR Karen Zaderej - Chairman, CEO and President Nir Naor - CFO Conference Call Participants Michael Sarcone - Jefferies Mike Kratky - Leerink Partners Caitlin Cronin - Canaccord Genuity Ross Osborn - Cantor Fitzgerald Operator Greetings, and welcome to the AxoGen, Inc. 2024 First Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conferenc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 Axogen, Inc. (Ex ...

AxoGen (AXGN) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 40%. A quarter ago, it was expected that this regenerative medicine company would post a loss of $0.09 per share when it actually produced a loss of $0.06, delivering a surprise of 33.33%.Over the last four quarters, the company ha ...

Axogen, Inc Reports First Quarter 2024 Financial Results ALACHUA and TAMPA, FL – May 2, 2024 – Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today reported financial results and business highlights for the first quarter ended March 31, 2024. First Quarter Financial Results • First quarter revenue was $41.4 million, a 12.9% increase compared to the first quarter of 2023. • In the first quarter of 2024, our gross margin in ...

ALACHUA, Fla. and TAMPA, Fla., April 29, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announces the first surgical implantations of its newest product, Avive+ Soft Tissue Matrix™. "We are excited to expand our offering in nerve protection with the introduction of this resorbable barrier to support the critical phases of healing for nerve injuries," said Karen Zaderej, chairman, CEO, and president ...

ALACHUA, Fla. and TAMPA, Fla., April 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will report first quarter 2024 financial results on Thursday, May 2, 2024, before the market opens. Axogen management will host an investment-community conference call and webcast at 8 a.m. ET following the release. Investors interested in participating in the conference call by phone may ...

AxoGen, Inc. (NASDAQ:AXGN) Q4 2023 Earnings Call Transcript March 5, 2024 8:00 AM ET Company Participants Harold Tamayo - VP, Finance and IR Karen Zaderej - Chairman, CEO and President Nir Naor - CFO Conference Call Participants Chris Pasquale - Nephron Mike Sarcone - Jefferies Mike Kratky - Leerink Partners Caitlin Cronin - Canaccord Genuity Dave Turkaly - Citizens JMP Ross Osborn - Cantor Fitzgerald Operator Hello, and welcome to the AxoGen, Inc. 2023 Fourth Quarter and Full Year Financial Results Confere ...