Abeona Therapeut Stock Price, News & Analysis

Abeona Therapeutics announced the completion of target enrollment in its pivotal Phase 3 VIITAL™ study for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

The study aims to evaluate the safety and effectiveness of EB-101, a gene-corrected cell therapy.

Results are anticipated in the third quarter of 2022, focusing on wound healing and pain reduction. This milestone underscores the critical need for therapies in RDEB, as currently, no approved treatments exist.

Abeona Therapeutics (ABEO) announced significant progress in its gene and cell therapy development in a shareholder letter. The company is nearing completion of patient enrollment for its pivotal Phase 3 VIITAL™ study for EB-101, targeting roughly 35 patients. The anticipated top-line data is expected in Q3 2022. For ABO-102 targeting MPS IIIA, regulatory clarity has improved following an FDA Type B meeting. Additionally, the company has raised approximately $17.5 million, leading to more than $50 million in cash for 2022, positioning it for several upcoming milestones in its therapeutic development pipeline.

Abeona Therapeutics Inc. (Nasdaq: ABEO) has priced an underwritten public offering of 44.7 million shares of common stock and warrants at a combined price of $0.39 per share. The offering aims to raise approximately $17.5 million in gross proceeds, with the closing expected on December 21, 2021. Funds will support clinical development of its pipeline products and general corporate purposes. The securities are offered under a shelf registration statement declared effective by the SEC.

Abeona Therapeutics Inc. (Nasdaq: ABEO) announced an underwritten public offering of its common stock and warrants to purchase common stock, subject to market conditions. The offering will be conducted under an existing shelf registration statement. Abeona plans to utilize the net proceeds for clinical development, working capital, and corporate purposes. Cantor Fitzgerald & Co. serves as the sole book-running manager. Important details regarding the offering are included in the filed prospectus with the SEC.

Abeona Therapeutics (Nasdaq: ABEO) announced its sponsorship of the virtual event Venture Into Cures on November 18, 2021, supporting the EB Research Partnership's mission to find a cure for epidermolysis bullosa (EB). The event will feature stories from EB patients, world-renowned speakers, and celebrity performers to raise funds for research. Abeona is advancing its Phase 3 VIITAL™ study of EB-101, a promising treatment for recessive dystrophic epidermolysis bullosa, with the goal of addressing the urgent medical need faced by patients.

Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the presentation of data from its pivotal Transpher A study for ABO-102 gene therapy targeting Sanfilippo syndrome type A at the 14th International Congress of Inborn Errors of Metabolism (ICIEM) from November 21-23, 2021. The interim results will be shared by Dr. Nicholas Smith, highlighting a positive correlation between cognitive functioning measures in young children. This event underscores Abeona's commitment to advancing its gene therapy offerings for serious diseases.

Abeona Therapeutics Inc. (Nasdaq: ABEO) announced participation of CEO Vish Seshadri at the Jefferies London Healthcare Conference from November 16-19, 2021. A pre-recorded webcast will be accessible on their investor webpage starting November 18, 2021. Abeona, a clinical-stage biopharmaceutical company, focuses on gene and cell therapies for serious diseases, including its Phase 3 investigational therapy for epidermolysis bullosa and gene therapies for Sanfilippo syndromes. The company operates a cGMP manufacturing facility for its therapies.

Abeona Therapeutics Inc. (Nasdaq: ABEO) reported Q3 2021 results and progress on key projects. The Phase 3 VIITAL™ study for EB-101 is on track to finish patient enrollment in Q1 2022, with top-line data expected by Q3 2022. The company anticipates submitting Biologics License Applications (BLA) for both EB-101 and ABO-102 in late 2022 to early 2023. A settlement with REGENXBIO has been reached, resolving a dispute and allowing resource focus on pipeline advancement. As of September 30, 2021, cash was $67 million, with a net loss of $7 million for the quarter.

Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that CEO Vish Seshadri, Ph.D., M.B.A., will present at the Jefferies Gene Therapy/Editing Summit on October 27, 2021, at 3:30 p.m. ET. The presentation will be available live and archived on the company’s investor website. Abeona is focused on gene and cell therapies for serious diseases, with key projects including the Phase 3 autologous gene-corrected therapy EB-101 for epidermolysis bullosa, and AAV-based therapies for Sanfilippo syndrome types A and B, currently in Phase 1/2 development.