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Abeona Therapeutics Inc. (NASDAQ: ABEO) is a prominent clinical-stage biopharmaceutical company dedicated to the development of innovative gene therapies for life-threatening rare genetic disorders. By leveraging cutting-edge biotechnology, Abeona is making significant strides in transforming treatment paradigms for diseases with high unmet medical needs.
Core Business
Abeona's primary focus is on gene therapies and plasma-based products aimed at rare genetic diseases. The company's leading programs include pz-cel (prademagene zamikeracel, formerly known as EB-101), an investigational autologous gene-corrected epidermal graft for treating recessive dystrophic epidermolysis bullosa (RDEB), and several adeno-associated virus (AAV)-based gene therapies. These include therapies for Sanfilippo syndrome types A and B, juvenile Batten disease, infantile Batten disease, and Fanconi anemia.
Recent Achievements and Current Projects
In recent developments, Abeona completed its first U.S. Biologics License Application (BLA) submission for pz-cel in September 2023. The FDA's Priority Review of this application has a target action date of May 25, 2024. Moreover, the company has initiated commercial readiness activities, including discussions with treatment sites and payer engagements, anticipating a potential U.S. launch. Abeona's financial condition has been significantly bolstered by a $75 million underwritten offering in May 2024 and a $50 million credit facility obtained in January 2024.
Strategic Partnerships and Financial Highlights
Abeona's collaborations with institutional investors and organizations like Taysha Gene Therapies have been instrumental in advancing its clinical programs. With a robust balance sheet, the company raised an additional $25 million in July 2023 to support commercial preparations, and as of the latest financial reports, holds sufficient resources to fund operations into 2026.
Product Pipeline
Abeona's development portfolio includes:
- pz-cel for RDEB
- abo-102 for Sanfilippo syndrome type A
- abo-101 for Sanfilippo syndrome type B
- abo-201 and abo-202 for juvenile and infantile Batten disease
- abo-301 for Fanconi anemia
- abo-302 utilizing CRISPR/Cas9-based gene editing
- EB-201 for epidermolysis bullosa
Through its fully integrated cell and gene therapy cGMP manufacturing facility, Abeona is equipped to support both clinical and potential commercial production needs.
Looking Forward
With its strong pipeline and strategic financial maneuvers, Abeona Therapeutics is well-positioned to achieve critical milestones in the near future. The company remains committed to bringing transformative therapies to patients with unmet needs, driving forward its mission to change the landscape of gene therapy.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the acceptance of three abstracts for presentation at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), scheduled for May 16-20, 2023, in Los Angeles, CA. The abstracts highlight preclinical data for investigational gene therapy candidates from its adeno-associated virus (AAV) ophthalmology program, including ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis, and ABO-505 for autosomal dominant optic atrophy. The company is submitting pre-IND meeting requests to the FDA and anticipates discussions in Q2 2023. This engagement is intended to advance their gene therapy programs aimed at addressing serious genetic eye diseases.
Abeona Therapeutics (ABEO) reported its 2022 financial results and outlined key corporate objectives in a press release dated March 29, 2023. The company plans to submit a Biologics License Application (BLA) for EB-101, aimed at treating recessive dystrophic epidermolysis bullosa (RDEB), to the FDA by late 2Q/early 3Q 2023, buoyed by positive Phase 3 VIITAL study results. Financial highlights include cash positions of $52.5 million and a net loss of $43.5 million for 2022. Abeona aims to advance drug candidates for eye diseases while strengthening its management team with new executive appointments.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the granting of equity awards to six new employees as part of an inducement for their employment. On March 23, 2023, a total of 131,750 restricted shares of common stock were awarded. These shares will vest one-quarter every year over four years, contingent on continued employment. The compensation committee approved these grants under Nasdaq Rule 5635(c)(4). Abeona focuses on developing cell and gene therapies for serious diseases, including its lead program EB-101 for recessive dystrophic epidermolysis bullosa.
Abeona Therapeutics Inc. (Nasdaq: ABEO) has announced that additional data from the Phase 3 VIITAL™ study of EB-101, targeting recessive dystrophic epidermolysis bullosa (RDEB), will be presented at the International Societies for Investigative Dermatology Meeting in Tokyo from May 10-13, 2023. The study's abstract, highlighting results from this trial, will be delivered by Dr. Jean Tang of Stanford University. EB-101 is an autologous gene therapy designed to correct the COL7A1 gene defect in RDEB patients, which currently has no approved treatment. EB-101 has received multiple designations from the U.S. FDA.
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