Abeona Therapeutics

181 articles about Abeona Therapeutics

• 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).

• Abeona Therapeutics to Present at the Jefferies Healthcare Conference - June 1, 2023

  6/1/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 9, 2023 at 9:00 a.m. Eastern time.

• Abeona Therapeutics Announces Date Change for First Quarter 2023 Portfolio Update Conference Call to May 24, 2023

  5/22/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has changed the date of its previously announced First Quarter 2023 Portfolio Update conference call and webcast to Wednesday, May 24, 2023, at 8:30 a.m. ET. The call was previously scheduled for Tuesday, May 23, 2023, at 8:30 a.m. ET.

• Abeona Therapeutics Announces New Preclinical Data from its AAV Ophthalmology Program at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

  5/16/2023

  Abeona Therapeutics Inc. announced new data regarding three internally developed preclinical gene therapy product candidates from its adeno-associated virus ophthalmology program that will be presented at the 26th Annual Meeting of the American Society of Gene & Cell Therapy, taking place from May 16-20, 2023 in Los Angeles, CA.

• Abeona Therapeutics Reports First Quarter 2023 Financial Results

  5/11/2023

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

• Abeona Therapeutics Announces Additional Phase 3 VIITAL™ Study Results for EB-101 Presented at the International Societies for Investigative Dermatology 2023 Meeting

  5/11/2023

  Abeona Therapeutics Inc. announced an oral presentation of additional data from the Company's pivotal Phase 3 VIITAL™ study evaluating its investigational EB-101 for recessive dystrophic epidermolysis bullosa.

• Abeona Therapeutics Announces Multiple Abstracts Accepted from its AAV Ophthalmology Program at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

  4/10/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the acceptance of three abstracts at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place from May 16-20, 2023 in Los Angeles, CA.

• Abeona Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update

  3/29/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2022 and provided an update on progress toward achieving key corporate objectives.

• Abeona Therapeutics Announces Acceptance of Abstract on EB-101 Phase 3 VIITAL™ Study Results for Oral Presentation at International Societies for Investigative Dermatology (ISID) 2023 Meeting

  3/16/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that additional data from its pivotal Phase 3 VIITAL™ study of EB-101 for recessive dystrophic epidermolysis bullosa (RDEB) has been accepted for an oral presentation at the inaugural International Societies for Investigative Dermatology (ISID) Meeting, being held May 10-13, 2023 in Tokyo, Japan.

• Abeona Therapeutics Announces Update on AAV Ophthalmology Program

  3/14/2023

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced three internally developed investigational preclinical gene therapy product candidates from its ophthalmology program.

• Abeona Therapeutics Reports Third Quarter 2022 Financial Results

  11/14/2022

  Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced financial results for the third quarter of 2022.