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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 (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.
Abeona Therapeutics announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for pz-cel, an investigational autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The FDA set a PDUFA target action date of April 29, 2025. The BLA resubmission includes clinical data from the Phase 3 VIITAL™ study and a Phase 1/2a study with up to 8 years of follow-up. If approved, pz-cel would be the first autologous, cell-based gene therapy for RDEB, designed to provide collagen VII expression through COL7A1 gene integration.
Abeona Therapeutics (Nasdaq: ABEO) announced its management team's participation in two upcoming investor conferences in November 2024. The company will attend the Truist Securities BioPharma Symposium for investor meetings on November 7, and the Stifel 2024 Healthcare Conference on November 18, which includes a fireside chat at 4:10 p.m. ET and investor meetings. A live webcast of the fireside chat will be available on Abeona's website investor section, with a replay available for a time.
Abeona Therapeutics (Nasdaq: ABEO) has announced new equity awards for nine recently hired non-executive employees. The Compensation Committee approved restricted stock awards totaling 27,500 shares of common stock as employment inducements. These awards will vest over three years, with one-third of the shares vesting annually on the grant date anniversary. Full vesting will occur on the third anniversary, contingent on continued employment.
Abeona Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for pz-cel, its investigational gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). The resubmission addresses Chemistry Manufacturing and Controls items identified in the previous Complete Response Letter (CRL) from April 2024. The CRL did not identify any clinical efficacy or safety concerns, and no new clinical trials were requested. The BLA is supported by data from the Phase 3 VIITAL™ study and a Phase 1/2a study. The FDA's review period will be either 2 or 6 months, depending on classification as Class 1 or Class 2.
Abeona Therapeutics Inc. (Nasdaq: ABEO) has announced the granting of equity awards to new non-executive employees. The Compensation Committee of Abeona's Board of Directors approved these awards on September 30, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4). The awards, granted to eight new hires, consist of restricted stock equity awards totaling up to 23,100 restricted shares of Abeona common stock. The vesting schedule for these awards is as follows:
- One-third of the shares will vest yearly on each anniversary of the Grant Date
- Full vesting will occur on the third anniversary of the Grant Date
- Vesting is subject to continued employment with Abeona on the applicable dates