Abeona Therapeut Stock Price, News & Analysis

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

Abeona Therapeutics (Nasdaq: ABEO) has announced its participation in three upcoming investor conferences in September 2024:

• Wells Fargo Healthcare Conference on September 5, featuring investor meetings
• H.C. Wainwright Annual Global Investment Conference on September 10, including a company presentation at 1:30 p.m. ET and investor meetings
• Cantor Global Healthcare Conference on September 19, featuring a fireside chat at 9:45 a.m. ET and investor meetings

Live webcasts of the presentation and fireside chat will be available on the Investors section of Abeona's website under 'Events'. Replays will also be accessible for a time after the events.

Abeona Therapeutics (Nasdaq: ABEO) has announced new employee inducement grants in accordance with Nasdaq Listing Rule 5635(c)(4). On August 31, 2024, the company's Compensation Committee granted restricted stock equity awards to four new non-executive employees, totaling up to 8,600 restricted shares of Abeona common stock. These awards are designed as a material inducement to employment.

The vesting schedule for these restricted stock 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, subject to each employee's continued employment with Abeona on the applicable vesting dates.

Abeona Therapeutics (Nasdaq: ABEO) has appointed two new independent members to its Board of Directors: Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD. Dr. Zeiher brings over 20 years of drug development experience, having overseen the approval of 15 new treatments for serious diseases. Dr. Crombez, currently Chief Medical Officer at Ultragenyx Pharmaceutical, offers extensive expertise in clinical development programs for rare genetic disorders.

The appointments come at a important time for Abeona as it focuses on bringing pz-cel to patients with recessive dystrophic epidermolysis bullosa and seeks to advance its pipeline. Both new board members bring diverse drug development expertise that could prove valuable for Abeona's future strategies and growth.

Abeona Therapeutics (Nasdaq: ABEO) announced favorable Medicare reimbursement decisions for its investigational gene therapy, pz-cel, for recessive dystrophic epidermolysis bullosa (RDEB). The Centers for Medicare and Medicaid Services (CMS) granted a product-specific procedure code ICD-10-PCS and assigned Medicare reimbursement to Pre-MDC MS-DRG 018, one of the highest inpatient hospital reimbursement levels for cell and gene therapies. Both codes will be effective from October 1, 2024.

These decisions are expected to simplify inpatient hospital billing across all payers and increase speed to access of pz-cel after potential FDA approval. Abeona's Chief Commercial Officer, Madhav Vasanthavada, expressed confidence in securing strong access and reimbursement for all RDEB patients, citing positive feedback from commercial payers as well.

Abeona Therapeutics (NASDAQ: ABEO) reported Q2 2024 financial results and progress on its pz-cel BLA resubmission for RDEB treatment. Key points:

1. Completed Type A meeting with FDA, addressing most CRL deficiencies.
2. BLA resubmission on track for 2H 2024.
3. Q2 financials: $123M cash position, $7.4M net income.
4. Cash runway into 2026, excluding potential pz-cel revenue.
5. R&D expenses: $9.2M, G&A expenses: $8.6M.
6. New long-term safety data presented at SID and SPD meetings.
7. Non-exclusive agreement with Beacon Therapeutics for AAV204 capsid evaluation.

Abeona continues commercial preparations for potential pz-cel launch.