Abeona Therapeut Stock Price, News & Analysis

Abeona Therapeutics (NASDAQ: ABEO) announced that CEO Vish Seshadri and CCO Madhav Vasanthavada will participate in a fireside chat at the upcoming Jefferies Global Healthcare Conference. The presentation is scheduled for June 4, 2025, at 11:40 a.m. Eastern Time. Investors can access the live webcast through the company's investor relations website, and a replay will be available for 30 days following the event.

Abeona Therapeutics (NASDAQ: ABEO) reported Q1 2025 financial results and major milestones. The company received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating RDEB wounds. Following approval, Abeona activated its first qualified treatment center at Lurie Children's Hospital, with the first patient expected in Q3 2025. The company entered into a sales agreement for its priority review voucher for $155 million. Financial highlights include: cash position of $84.5 million as of March 31, 2025, Q1 net loss of $12.0 million ($0.24 per share), and R&D expenses of $9.9 million. Notably, about 30 patients have started registering in the Abeona Assist program, and the company has secured value-based agreements with payers covering approximately 100 million commercially-insured lives.

Abeona Therapeutics (NASDAQ: ABEO) and Lurie Children's Hospital announced the activation of the first Qualified Treatment Center (QTC) for ZEVASKYN, a groundbreaking gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN, recently FDA-approved on April 29, 2025, is the first and only autologous cell-based gene therapy for RDEB wounds treatment with a single application.

Lurie Children's, a top-ranked hospital caring for over 150 epidermolysis bullosa patients, will begin patient identification with treatments expected to start in Q3 2025. The first patient is scheduled for biopsy in July 2025 and treatment in August 2025. To support patient access, Abeona has launched Abeona Assist, a comprehensive support program offering insurance benefits guidance, financial assistance, and travel logistics support.

Abeona Therapeutics announced that Ann & Robert H. Lurie Children's Hospital of Chicago has become the first Qualified Treatment Center for ZEVASKYN, their newly FDA-approved gene therapy for treating recessive dystrophic epidermolysis bullosa (RDEB) wounds. ZEVASKYN, approved on April 29, 2025, is the first and only autologous cell-based gene therapy for RDEB wounds treatment with a single application. Lurie Children's, a top-ranked hospital caring for over 150 EB patients, expects to begin treatments in Q3 2025, with the first patient scheduled for biopsy in July 2025. The hospital has been offering FDA-approved gene therapies since 2019, and ZEVASKYN will be their tenth gene therapy treatment. Abeona has launched Abeona Assist™, a comprehensive patient support program offering insurance benefits guidance and logistical assistance for eligible patients.

Abeona Therapeutics (NASDAQ: ABEO) has announced an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $155 million. The company received the PRV following FDA approval of ZEVASKYN™ (prademagene zamikeracel) on April 28, 2025. According to CFO Joe Vazzano, the proceeds will provide sufficient cash for over two years of operating expenses without requiring additional capital, excluding ZEVASKYN sales revenue.

ZEVASKYN is scheduled to become available for patient treatment in Q3 2025, with the company projecting profitability by early 2026. The PRV sale transaction remains subject to standard closing conditions, including Hart-Scott Rodino Antitrust Improvements Act waiting period expiration. Stifel led the financial advisory role, with Jefferies also serving as advisor.

Abeona Therapeutics (NASDAQ: ABEO) has granted equity awards to seven new non-executive employees as inducement for their employment. The awards, approved by the Compensation Committee on April 30, 2025, consist of a total of 21,500 restricted shares of Abeona common stock. The shares will vest in three equal annual installments, with full vesting occurring on the third anniversary of the Grant Date, contingent upon continued employment with the company.

Abeona Therapeutics has received FDA approval for ZEVASKYN, the first cell-based gene therapy for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB). The therapy, approved for both adult and pediatric patients, demonstrated significant results in the Phase 3 VIITAL study:

• 81% of treated wounds showed 50% or more healing after 6 months
• Single application provides long-term wound healing and pain reduction
• Treatment will be available through Qualified Treatment Centers in Q3 2025

The therapy uses patients' own skin cells, modified to produce Type VII collagen, treating a condition that causes severe blistering and wounds covering up to 80% of patients' bodies. The FDA granted a Rare Pediatric Disease Priority Review Voucher with the approval. Abeona Assist program will provide patient support, including insurance and logistics assistance.

Abeona Therapeutics (Nasdaq: ABEO) has announced new equity awards for six recently hired non-executive employees. The awards, approved under Nasdaq Listing Rule 5635(c)(4) by the Compensation Committee on March 31, 2025, consist of a total of 23,700 restricted shares of Abeona common stock.

The restricted stock awards feature a three-year vesting schedule, with one-third of the shares vesting annually on each anniversary of the Grant Date. Full vesting will occur on the third anniversary, contingent upon continued employment with Abeona.

Abeona Therapeutics reported its full year 2024 financial results and provided updates on pz-cel regulatory progress. The FDA's priority review of pz-cel BLA is advancing with a PDUFA date of April 29, 2025, with the company targeting first patient treatment in Q3 2025 if approved.

Financial highlights include cash position of $98.1 million as of December 31, 2024, up from $52.6 million year-over-year. The company reported a net loss of $63.7 million ($1.55 per share) compared to $54.2 million ($2.53 per share) in 2023. R&D expenses increased to $34.4 million from $31.1 million, while G&A expenses rose to $29.9 million from $19.0 million.

The company has secured additional facility space in Cleveland for manufacturing expansion and obtained two patents extending protection for pz-cel treatment to 2037 and transport system to 2040. Current cash runway is expected to fund operations into 2026.