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 clinical-stage biopharmaceutical leader advancing gene therapies for rare genetic diseases. This dedicated news hub provides investors and researchers with essential updates on ABEO’s therapeutic developments, regulatory milestones, and scientific partnerships.
Discover timely press releases detailing progress in AAV-based therapies, CRISPR/Cas9 research, and pivotal clinical trials for conditions like epidermolysis bullosa. Our curated collection includes FDA correspondence updates, manufacturing quality certifications, and strategic collaboration announcements – all critical for evaluating the company’s trajectory.
Key content categories feature BLA submission statuses, Phase 3 trial results, and technology licensing agreements. Bookmark this page for streamlined access to verified updates about ABEO’s pipeline candidates and operational developments, presented with clarity for both professional analysts and engaged stakeholders.
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.
Abeona Therapeutics reported its 2022 Q2 financial results, announcing a net loss of $12.1 million or $2.08 per share, improved from a $15.2 million loss in Q2 2021. Cash and equivalents stood at $26 million, with operating cash usage reduced to $9 million, down from $13.7 million in Q1 2022. The company entered an exclusive license agreement with Ultragenyx for ABO-102, allowing it to extend its cash runway, crucial for the upcoming Phase 3 VIITAL™ data readout of EB-101 expected in Q4 2022. Additionally, significant progress was noted in pain reduction and wound healing associated with EB-101.
Abeona Therapeutics (Nasdaq: ABEO) announced it regained compliance with Nasdaq's minimum bid price requirement as of July 18, 2022. The company needed its common stock to maintain a closing bid price of at least $1.00 for 10 consecutive trading days, which it successfully achieved. Abeona focuses on developing cell and gene therapies for serious diseases, including its lead program, EB-101, for epidermolysis bullosa, currently in Phase 3. The company also develops AAV-based gene therapies for ophthalmic conditions.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced its participation in the Jefferies Healthcare Conference on June 9, 2022, at 3:30 p.m. EDT. Management will present updates on the company's advancements in cell and gene therapy. A live webcast will be available on the Investors section of Abeona's website, and the presentation will be archived for 30 days. Abeona focuses on developing therapies for serious diseases, with its lead program, EB-101, in Phase 3 development for recessive dystrophic epidermolysis bullosa.
Abeona Therapeutics Inc. (Nasdaq: ABEO) has received an additional 180-day extension from Nasdaq until November 14, 2022, to meet the $1.00 minimum bid price requirement for continued listing. The stock must maintain a closing bid price of at least $1.00 for 10 consecutive trading days to demonstrate compliance. If successful, Nasdaq will confirm compliance; otherwise, the stock may face delisting. Abeona plans to propose a reverse stock split to help achieve this goal at a special stockholder meeting scheduled for June 14, 2022.