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 clinical-stage biopharmaceutical leader advancing gene therapies for rare genetic diseases. This dedicated news hub provides investors and researchers with essential updates on ABEO’s therapeutic developments, regulatory milestones, and scientific partnerships.
Discover timely press releases detailing progress in AAV-based therapies, CRISPR/Cas9 research, and pivotal clinical trials for conditions like epidermolysis bullosa. Our curated collection includes FDA correspondence updates, manufacturing quality certifications, and strategic collaboration announcements – all critical for evaluating the company’s trajectory.
Key content categories feature BLA submission statuses, Phase 3 trial results, and technology licensing agreements. Bookmark this page for streamlined access to verified updates about ABEO’s pipeline candidates and operational developments, presented with clarity for both professional analysts and engaged stakeholders.
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.
Abeona Therapeutics (Nasdaq: ABEO) has announced new employee inducement grants in accordance with Nasdaq Listing Rule 5635(c)(4). On July 31, 2024, the company's Compensation Committee approved restricted stock equity awards for two new non-executive employees. These awards total up to 4,500 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
These equity awards are designed to serve as a material inducement for employment at Abeona Therapeutics.
Abeona Therapeutics (Nasdaq: ABEO) and Beacon Therapeutics have signed a non-exclusive agreement for Beacon to evaluate Abeona's AAV204 capsid for ophthalmology gene therapies. AAV204, part of Abeona's AIM™ capsid library, shows promising transduction levels in macular and optic nerve tissues. Beacon has a 12-month evaluation period with options for a worldwide license covering up to five gene targets. Abeona stands to receive upfront payments, milestone payments, and royalties on net sales of licensed products. Beacon will handle development and commercialization of the therapies, which address distinct targets from Abeona's current projects.
Abeona Therapeutics (Nasdaq: ABEO) will participate in the Stifel Virtual Cell Therapy Forum on July 9, 2024. The company's CEO, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will engage in a virtual fireside chat at 9:45 a.m. Eastern Time.
A live webcast of the discussion will be accessible on the Investors section of Abeona's website under the 'Events' tab. The webcast will also be archived for 30 days for later viewing.
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