Abeona Therapeutics Inc. develops and commercializes cell and gene therapies for serious diseases. Its updates center on ZEVASKYN (prademagene zamikeracel), an autologous cell-based gene therapy for wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa, including qualified treatment center activations, commercial launch activity, manufacturing and patient-treatment progress.
Company news also covers financial results, corporate progress, employee inducement equity awards under Nasdaq rules, board and committee changes, and development work involving AAV-based gene therapies and next-generation AAV capsids for ophthalmic and other serious diseases.
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.
Abeona Therapeutics (Nasdaq: ABEO) has announced a significant milestone in its Phase 3 VIITAL™ study, with the final patient completing their 6-month follow-up visit for the EB-101 therapy targeting recessive dystrophic epidermolysis bullosa (RDEB). Topline results are anticipated within a month, potentially paving the way for FDA approval if positive. The study assesses EB-101, which utilizes gene transfer to correct a defect in the COL7A1 gene, aiming to facilitate wound healing. RDEB currently has no approved treatments, making this development critical for affected patients.
Abeona Therapeutics announced CEO Vish Seshadri will participate in a fireside chat at the Jefferies Cell and Genetic Medicine Summit on September 30, 2022, at 8:30 a.m. ET. The company will also engage in one-on-one investor meetings during the event. A live webcast of the chat will be available on the Abeona website and archived for 30 days. Abeona Therapeutics is a clinical-stage biopharmaceutical firm focusing on cell and gene therapies for serious diseases, including its lead program EB-101 for recessive dystrophic epidermolysis bullosa, currently in Phase 3 development.
Abeona Therapeutics Inc. (Nasdaq: ABEO) will have its CEO, Vish Seshadri, participate in a panel at the Cantor Fitzgerald Cell and Genetic Medicines Conference on September 15, 2022, at 2:30 p.m. ET. The discussion is focused on late-stage gene and cell therapies. Additionally, Abeona will hold one-on-one investor meetings during the conference. The company is known for developing cell and gene therapies for serious diseases, including its lead program, EB-101, for recessive dystrophic epidermolysis bullosa, which is in Phase 3 development.