Welcome to our dedicated page for Abeona Therapeut news (Ticker: ABEO), a resource for investors and traders seeking the latest updates and insights on Abeona Therapeut stock.
Abeona Therapeutics Inc. (Nasdaq: ABEO) is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, with a primary focus on recessive dystrophic epidermolysis bullosa (RDEB)ZEVASKYN® (prademagene zamikeracel), which Abeona describes as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB.
On this page, readers can follow ABEO news related to ZEVASKYN’s commercial rollout, including activation of new Qualified Treatment Centers, initial patient treatments, and updates on manufacturing and product release processes at the company’s cell and gene therapy cGMP facility in Cleveland, Ohio. Press releases also cover developments in reimbursement and market access, such as the assignment of a permanent HCPCS J-code (J3389) by the Centers for Medicare and Medicaid Services (CMS) and coverage decisions by commercial health plans.
Abeona’s news flow additionally features corporate and pipeline updates, including quarterly financial results, participation in investor conferences, and progress in its AAV-based gene therapy programs, such as the ABO-503 program for X-linked retinoschisis (XLRS) selected for the FDA’s Rare Disease Endpoint Advancement Pilot Program. Management appointments and employee equity inducement grants under Nasdaq Listing Rule 5635(c)(4) are also regular topics.
Investors, clinicians, and other stakeholders can use this ABEO news feed to review the company’s latest disclosures on commercial performance indicators, regulatory and payer milestones, treatment site expansion, and strategic pipeline initiatives in gene therapy.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced a securities purchase agreement to raise approximately $25 million through the sale of 1,000,006 shares of Series A and 250,005 shares of Series B convertible redeemable preferred stock at a discounted price of $19.00 each. These preferred stocks are convertible into common stock at an initial price of $0.45 per share, contingent on stockholder approval for a reverse stock split. The offerings are expected to close by May 2, 2022, subject to customary conditions.
Abeona Therapeutics (ABEO) has achieved target enrollment in its pivotal Phase 3 VIITAL™ study for EB-101, focusing on recessive dystrophic epidermolysis bullosa (RDEB), with topline results expected in Q3 2022. The company secured FDA alignment on Chemistry, Manufacturing, and Controls (CMC) for EB-101. Abeona plans to concentrate on EB-101 while seeking a commercialization partner and will discontinue development of ABO-101 for MPS IIIB. The company reported cash resources of $50.9 million as of December 31, 2021, down from $96 million in 2020, indicating a need to manage expenses to extend cash runway into mid-2023.
Abeona Therapeutics (Nasdaq: ABEO) announced CEO Vish Seshadri's participation in a panel at the Cantor Fitzgerald Virtual Rare Disease Summit on March 30, 2022, at 4:00 p.m. ET. The discussion will focus on the evolving definition of cell therapy and its applications for rare diseases.
Abeona is known for its gene and cell therapies aimed at serious diseases, including Phase 3 development of EB-101 for epidermolysis bullosa, and Phase 1/2 therapies ABO-102 and ABO-101 for Sanfilippo syndrome.
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.