Abeona Therapeutics

191 articles about Abeona Therapeutics

• Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - April 1, 2024

  4/1/2024

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company.

• Abeona Therapeutics Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections

  3/18/2024

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives.

• Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 05, 2024

  3/5/2024

  Abeona Therapeutics Inc. announced it has granted equity awards to new non-executive employees who joined the Company.

• Abeona Therapeutics Announces Progress Update on Pz-cel Biologics License Application (BLA)

  2/1/2024

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced, as part of the review process by the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB), completion by the FDA of both a Bioresearch Monitoring (BIMO) inspection of Abeona and the BLA mid-cycle review meeting.

• Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - February 01, 2024

  2/1/2024

  Abeona Therapeutics Inc. announced it has granted equity awards to new non-executive employees who joined the Company.

• Abeona Therapeutics Announces $50 Million Credit Facility

  1/8/2024

  Abeona Therapeutics Inc. announced that it has entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P.

• Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - December 15, 2023

  12/15/2023

  Abeona Therapeutics Inc. announced it has granted equity awards to new non-executive employees who joined the Company.

• Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)

  11/27/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel).

• Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments

  11/13/2023

  Abeona Therapeutics Inc. reported financial results for the third quarter of 2023 and provided corporate updates.

• Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

  11/1/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company.

• Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa

  9/26/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB).

• Abeona Therapeutics Appoints Madhav Vasanthavada, Ph.D., M.B.A. as Chief Commercial Officer

  9/12/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Madhav Vasanthavada, Ph.D., M.B.A. to the role of Chief Commercial Officer (CCO) and Head of Business Development (BD), effective immediately.

• Abeona Therapeutics Announces Participation in Upcoming Investor Conferences

  9/7/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in September 2023.

• Abeona Therapeutics Announces Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission

  8/30/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company’s intention to proceed with the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EB-101, its investigational autologous, engineered cell therapy, for patients with recessive dystrophic epidermolysis bullosa (RDEB) after the recent completion of a pre-BLA meeting with the FDA.

• Abeona Therapeutics Reports Second Quarter 2023 Financial Results

  8/8/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2023 and provided an update on progress toward achieving key corporate objectives.

• Abeona Therapeutics Announces Submission of Briefing Package for Pre-Biologics License Application (BLA) Meeting with FDA in August 2023

  7/28/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company’s pre-Biologics License Application (BLA) meeting in August 2023.

• Abeona Therapeutics Joins Rare Disease Company Coalition

  7/19/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has joined the Rare Disease Company Coalition (RDCC), an alliance of life science companies committed to discovering, developing, and delivering therapies for patients impacted by rare diseases.

• Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

  7/7/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents’ fees and other offering expenses.

• Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

  7/3/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has raised $25 million at-the-market from select existing investors, primarily to fund initiation of the Company’s launch preparations in anticipation of the EB-101 Biologics License Application (BLA) submission and potential approval.

• Abeona Therapeutics Announces Regulatory Update on Biologics License Application (BLA) for EB-101

  6/9/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency’s alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application (BLA).