Abeona Therapeut Stock Price, News & Analysis

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.