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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) 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.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the advancement of three investigational gene therapy candidates aimed at treating serious genetic eye diseases: Stargardt Disease, X-linked Retinoschisis (XLRS), and Autosomal Dominant Optic Atrophy (ADOA). The company aims to submit its first pre-Investigational New Drug application meeting request this month. ABO-504, ABO-503, and ABO-505 have shown encouraging results in animal models, demonstrating the potential for successful therapeutic interventions. Abeona anticipates reporting further data at an upcoming scientific congress in the second quarter of 2023 and is preparing to align with the FDA on clinical development plans.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported positive topline data from its Phase 3 VIITAL study of EB-101 for treating recessive dystrophic epidermolysis bullosa (RDEB), meeting both co-primary endpoints related to wound healing and pain reduction. The company plans to submit a Biologics License Application (BLA) to the U.S. FDA in Q2 2023. With a cash position of $23.5 million and a recent $35 million private placement, Abeona is well-funded through Q3 2024. Despite a net loss of $9.5 million for Q3 2022, the outlook remains positive due to strong trial results and financial backing.
Abeona Therapeutics announced a private placement agreement to sell 7,065,946 shares at $4.60 each, along with pre-funded warrants for 543,933 shares and warrants for 7,609,879 shares, generating approximately $35 million in gross proceeds. The placement, set to close on November 7, 2022, involves institutional investors like Adage Capital and Armistice Capital. Proceeds will support development and working capital, with sufficient funding expected to last into Q3 2024. Abeona plans to file for the registration of the securities sold in the placement.
Abeona Therapeutics announced positive topline data from its pivotal Phase 3 VIITAL study for EB-101, a treatment for recessive dystrophic epidermolysis bullosa (RDEB). The study met co-primary endpoints, showing over 81.4% wound healing and significant pain reduction. EB-101 was well-tolerated, with no serious adverse events. The company plans to submit a Biologics License Application (BLA) to the FDA in Q2 2023, as EB-101 has received Orphan Drug and Rare Pediatric Disease designations.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the database lock for its pivotal Phase 3 VIITAL™ study of EB-101, an autologous, engineered cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), on October 18, 2022. The company expects to report topline results within two to three weeks. If successful, these results may support FDA approval for EB-101, which aims to address a significant unmet medical need for patients with RDEB. The therapy involves gene transfer to restore Type VII collagen production, crucial for skin integrity.
Abeona Therapeutics (Nasdaq: ABEO) has announced a significant milestone in its Phase 3 VIITAL™ study, with the final patient completing their 6-month follow-up visit for the EB-101 therapy targeting recessive dystrophic epidermolysis bullosa (RDEB). Topline results are anticipated within a month, potentially paving the way for FDA approval if positive. The study assesses EB-101, which utilizes gene transfer to correct a defect in the COL7A1 gene, aiming to facilitate wound healing. RDEB currently has no approved treatments, making this development critical for affected patients.
Abeona Therapeutics announced CEO Vish Seshadri will participate in a fireside chat at the Jefferies Cell and Genetic Medicine Summit on September 30, 2022, at 8:30 a.m. ET. The company will also engage in one-on-one investor meetings during the event. A live webcast of the chat will be available on the Abeona website and archived for 30 days. Abeona Therapeutics is a clinical-stage biopharmaceutical firm focusing on cell and gene therapies for serious diseases, including its lead program EB-101 for recessive dystrophic epidermolysis bullosa, currently in Phase 3 development.
Abeona Therapeutics Inc. (Nasdaq: ABEO) will have its CEO, Vish Seshadri, participate in a panel at the Cantor Fitzgerald Cell and Genetic Medicines Conference on September 15, 2022, at 2:30 p.m. ET. The discussion is focused on late-stage gene and cell therapies. Additionally, Abeona will hold one-on-one investor meetings during the conference. The company is known for developing cell and gene therapies for serious diseases, including its lead program, EB-101, for recessive dystrophic epidermolysis bullosa, which is in Phase 3 development.
Abeona Therapeutics reported its 2022 Q2 financial results, announcing a net loss of $12.1 million or $2.08 per share, improved from a $15.2 million loss in Q2 2021. Cash and equivalents stood at $26 million, with operating cash usage reduced to $9 million, down from $13.7 million in Q1 2022. The company entered an exclusive license agreement with Ultragenyx for ABO-102, allowing it to extend its cash runway, crucial for the upcoming Phase 3 VIITAL™ data readout of EB-101 expected in Q4 2022. Additionally, significant progress was noted in pain reduction and wound healing associated with EB-101.