Abeona Therapeut Stock Price, News & Analysis

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.

Abeona Therapeutics (Nasdaq: ABEO) has announced its participation in the upcoming Leerink Partners Global Healthcare Conference in Miami, Florida. The company's CEO, Vish Seshadri, Ph.D., M.B.A., will deliver a presentation on Monday, March 10, 2025, at 3:00 p.m. Eastern Time.

Investors and interested parties can access a live webcast of the presentation through the 'Events' section of Abeona's investor relations website at https://investors.abeonatherapeutics.com/events. The presentation recording will remain available for replay on the website for 30 days following the event.

Abeona Therapeutics (Nasdaq: ABEO) has announced the granting of equity awards to five new non-executive employees. The awards, approved by the Compensation Committee under Nasdaq Listing Rule 5635(c)(4) on February 28, 2025, consist of an aggregate of 16,300 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 (Nasdaq: ABEO) has announced the granting of equity awards to eight new non-executive employees. The Compensation Committee approved these inducement grants on January 31, 2024, consisting of a total of 13,000 restricted shares of common stock. The equity awards were granted in compliance with Nasdaq Listing Rule 5635(c)(4).

The vesting schedule for these restricted stock awards is structured over three years, with one-third of the shares vesting annually on each grant date anniversary. Full vesting will occur on the third anniversary of the Grant Date, contingent upon continued employment with Abeona.

Abeona Therapeutics (Nasdaq: ABEO) has granted equity awards to five new non-executive employees as employment inducement. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of a total of 28,600 restricted shares of 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. The Compensation Committee of Abeona's Board of Directors approved these awards on December 30, 2024.

Abeona Therapeutics (Nasdaq: ABEO) has announced the granting of equity awards to nine new non-executive employees. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of 44,700 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. The equity awards were approved by the Compensation Committee of Abeona's Board of Directors on November 30, 2024, as material inducement to employment.

Abeona Therapeutics reported Q3 2024 financial results and corporate updates. The FDA accepted their BLA resubmission for pz-cel in recessive dystrophic epidermolysis bullosa, setting a PDUFA date of April 29, 2025. The company's cash position was $110.0 million as of September 30, 2024. Q3 net loss was $30.3 million, with R&D expenses of $8.9 million and G&A expenses of $6.4 million. CMS granted a product-specific procedure code for pz-cel and assigned it to Pre-MDC MS-DRG 018. The company secured new patents for pz-cel treatment and expanded its Cleveland facility for manufacturing capacity.