AxoGen (AXGN) FDA Events

AxoGen's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by AxoGen (AXGN). Over the past two years, AxoGen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Avance. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Avance Nerve Graft FDA Regulatory Events

Avance Nerve Graft is a drug developed by AxoGen for the following indication: Biologically active off-the-shelf processed human nerve allograft. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Regulatory Update - September 6,2024

BLA

• Drug: Avance Nerve Graft
• Announced Date: September 6, 2024
• Indication: Biologically active off-the-shelf processed human nerve allograft

Axogen, Inc. 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®.

Axogen, Inc. announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its Avance Nerve Graft®. The submission marks a significant step in advancing the product, which is used in the repair of peripheral nerves. Michael Dale, the CEO, expressed pride in the progress made toward transitioning Avance from a traditional tissue product to a biologic. Axogen will now work closely with the FDA as they review the application. The company expects to receive confirmation on the submission’s acceptance for review, as well as details regarding the review timeline, within the next 60 days. This latest development underscores Axogen’s commitment to enhancing treatment options for patients suffering from nerve injuries through innovative product advancements.

Regulatory Update - May 16,2024

BLA

• Drug: Avance Nerve Graft
• Announced Date: May 16, 2024
• Indication: Biologically active off-the-shelf processed human nerve allograft

Axogen, Inc. 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.

Axogen, Inc. announced an important step forward in its regulatory process on May 15, 2024. The company has begun the rolling submission process with the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA). This application is for the licensure of its Avance Nerve Graft®, a product designed to address nerve injuries in patients. By using a rolling submission, Axogen is allowed to provide sections of its application to the FDA as they become ready, which could potentially lead to faster feedback and a quicker overall review process.

The decision to use a rolling submission demonstrates the company’s strategy to rapidly advance its medical solutions. This move by Axogen aims to help streamline the approval process, bringing innovative treatment options to patients who need them sooner while ensuring the product meets all safety and effectiveness standards set by the FDA.

AxoGen FDA Events - Frequently Asked Questions

Has AxoGen received FDA approval?

As of now, AxoGen (AXGN) has not received any FDA approvals for its therapy in the last two years.

What drugs has AxoGen submitted to the FDA?

In the past two years, AxoGen (AXGN) has reported FDA regulatory activity for Avance Nerve Graft.

What is the most recent FDA event for AxoGen?

The most recent FDA-related event for AxoGen occurred on September 6, 2024, involving Avance Nerve Graft. The update was categorized as "Regulatory Update," with the company reporting: "Axogen, Inc. 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®."

What conditions do AxoGen's current drugs treat?

Currently, AxoGen has one therapy (Avance Nerve Graft) targeting the following condition: Biologically active off-the-shelf processed human nerve allograft.