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.
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Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the acceptance of three abstracts for presentation at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), scheduled for May 16-20, 2023, in Los Angeles, CA. The abstracts highlight preclinical data for investigational gene therapy candidates from its adeno-associated virus (AAV) ophthalmology program, including ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis, and ABO-505 for autosomal dominant optic atrophy. The company is submitting pre-IND meeting requests to the FDA and anticipates discussions in Q2 2023. This engagement is intended to advance their gene therapy programs aimed at addressing serious genetic eye diseases.
Abeona Therapeutics (ABEO) reported its 2022 financial results and outlined key corporate objectives in a press release dated March 29, 2023. The company plans to submit a Biologics License Application (BLA) for EB-101, aimed at treating recessive dystrophic epidermolysis bullosa (RDEB), to the FDA by late 2Q/early 3Q 2023, buoyed by positive Phase 3 VIITAL study results. Financial highlights include cash positions of $52.5 million and a net loss of $43.5 million for 2022. Abeona aims to advance drug candidates for eye diseases while strengthening its management team with new executive appointments.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the granting of equity awards to six new employees as part of an inducement for their employment. On March 23, 2023, a total of 131,750 restricted shares of common stock were awarded. These shares will vest one-quarter every year over four years, contingent on continued employment. The compensation committee approved these grants under Nasdaq Rule 5635(c)(4). Abeona focuses on developing cell and gene therapies for serious diseases, including its lead program EB-101 for recessive dystrophic epidermolysis bullosa.
Abeona Therapeutics Inc. (Nasdaq: ABEO) has announced that additional data from the Phase 3 VIITAL™ study of EB-101, targeting recessive dystrophic epidermolysis bullosa (RDEB), will be presented at the International Societies for Investigative Dermatology Meeting in Tokyo from May 10-13, 2023. The study's abstract, highlighting results from this trial, will be delivered by Dr. Jean Tang of Stanford University. EB-101 is an autologous gene therapy designed to correct the COL7A1 gene defect in RDEB patients, which currently has no approved treatment. EB-101 has received multiple designations from the U.S. FDA.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the advancement of three investigational gene therapy candidates aimed at treating serious genetic eye diseases: Stargardt Disease, X-linked Retinoschisis (XLRS), and Autosomal Dominant Optic Atrophy (ADOA). The company aims to submit its first pre-Investigational New Drug application meeting request this month. ABO-504, ABO-503, and ABO-505 have shown encouraging results in animal models, demonstrating the potential for successful therapeutic interventions. Abeona anticipates reporting further data at an upcoming scientific congress in the second quarter of 2023 and is preparing to align with the FDA on clinical development plans.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported positive topline data from its Phase 3 VIITAL study of EB-101 for treating recessive dystrophic epidermolysis bullosa (RDEB), meeting both co-primary endpoints related to wound healing and pain reduction. The company plans to submit a Biologics License Application (BLA) to the U.S. FDA in Q2 2023. With a cash position of $23.5 million and a recent $35 million private placement, Abeona is well-funded through Q3 2024. Despite a net loss of $9.5 million for Q3 2022, the outlook remains positive due to strong trial results and financial backing.
Abeona Therapeutics announced a private placement agreement to sell 7,065,946 shares at $4.60 each, along with pre-funded warrants for 543,933 shares and warrants for 7,609,879 shares, generating approximately $35 million in gross proceeds. The placement, set to close on November 7, 2022, involves institutional investors like Adage Capital and Armistice Capital. Proceeds will support development and working capital, with sufficient funding expected to last into Q3 2024. Abeona plans to file for the registration of the securities sold in the placement.
Abeona Therapeutics announced positive topline data from its pivotal Phase 3 VIITAL study for EB-101, a treatment for recessive dystrophic epidermolysis bullosa (RDEB). The study met co-primary endpoints, showing over 81.4% wound healing and significant pain reduction. EB-101 was well-tolerated, with no serious adverse events. The company plans to submit a Biologics License Application (BLA) to the FDA in Q2 2023, as EB-101 has received Orphan Drug and Rare Pediatric Disease designations.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the database lock for its pivotal Phase 3 VIITAL™ study of EB-101, an autologous, engineered cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), on October 18, 2022. The company expects to report topline results within two to three weeks. If successful, these results may support FDA approval for EB-101, which aims to address a significant unmet medical need for patients with RDEB. The therapy involves gene transfer to restore Type VII collagen production, crucial for skin integrity.