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 (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.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for Q1 2022, highlighting a net loss of $20.8 million, or $0.14 per share. The company is focused on extending its cash runway, having off-loaded MPS assets and emphasizing the EB-101 pivotal Phase 3 study, with topline data expected in Q3 2022. Cash resources stood at $37.2 million. Recent developments include a $25 million private placement and a plan to regain Nasdaq compliance, which may involve a reverse stock split. Abeona will discuss these results in a conference call on May 17, 2022.
Abeona Therapeutics Inc. (Nasdaq: ABEO) presented new preclinical data on AAV204 at the ARVO Annual Meeting, showcasing its potential as a novel AAV capsid for ophthalmic applications. The study involved administering AAV204 to non-human primates, which demonstrated superior GFP expression in the macula and optic nerve compared to AAV8. This less invasive para-retinal administration method resulted in no clinically relevant inflammation. The AIM™ capsid library, which includes AAV204, targets various tissues for gene therapy, potentially improving treatment outcomes for serious diseases.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the presentation of preclinical data on AAV204 at the ARVO Annual Meeting, scheduled for May 1-4, 2022. The data highlights AAV204's superior ability to achieve robust transduction in the macula area of the eye through para-retinal administration in non-human primates, a method that avoids the need for subretinal detachment. The poster presentation is set for May 3, 2022, demonstrating the potential of Abeona's AIM™ capsid library to improve genetic therapy delivery.