Latest news with #VishSeshadri
Associated Press
3 days ago
- Business
- Associated Press
Abeona Therapeutics® to Present at the Jefferies Global Healthcare Conference
CLEVELAND, May 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Ph.D., Chief Executive Officer, and Madhav Vasanthavada, Ph.D., Chief Commercial Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025 at 11:40 a.m. Eastern Time. A live webcast of the fireside chat can be accessed on the Investors section of the Abeona website under 'Events' at The webcast will be archived for 30 days. About Abeona Therapeutics Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company's fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company's development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona's novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. For more information, visit ZEVASKYN™, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc. Forward-Looking Statements Investor and Media Contact: Greg Gin VP, Investor Relations and Corporate Communications Abeona Therapeutics [email protected]
Yahoo
3 days ago
- Business
- Yahoo
Abeona Therapeutics® to Present at the Jefferies Global Healthcare Conference
CLEVELAND, May 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Ph.D., Chief Executive Officer, and Madhav Vasanthavada, Ph.D., Chief Commercial Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025 at 11:40 a.m. Eastern Time. A live webcast of the fireside chat can be accessed on the Investors section of the Abeona website under "Events" at The webcast will be archived for 30 days. About Abeona TherapeuticsAbeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company's fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company's development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona's novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. For more information, visit ZEVASKYN™, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc. Forward-Looking Statements This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as 'may,' 'will,' 'believe,' 'anticipate,' 'expect,' 'intend,' 'potential,' and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, our ability to commercialize ZEVASKYN, the therapeutic potential of ZEVASKYN, whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company's expectations, continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with and inspections from the FDA or other regulatory agencies, including those relating to preclinical programs; the ability to achieve or obtain necessary regulatory approvals; the impact of any changes in the financial markets and global economic conditions; risks associated with data analysis and reporting; and other risks disclosed in the Company's most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws. CONTACT: Investor and Media Contact: Greg Gin VP, Investor Relations and Corporate Communications Abeona Therapeutics ir@
Yahoo
30-04-2025
- Business
- Yahoo
FDA approves Abeona's $3.1m cell therapy for rare skin disease
Abeona Therapeutics has secured US Food and Drug Administration (FDA) approval for Zevaskyn (prademagene zamikeracel), a gene-corrected cell therapy designed to treat recessive dystrophic epidermolysis bullosa (RDEB). The approval follows years of clinical development and regulatory setbacks, and positions Abeona as the second company to bring a therapy for this condition to the US market. Also known as pz-cel, Zevaskyn is indicated for both paediatric and adult patients with RDEB. The therapy is administered as credit card-sized sheets of skin made from the patient's own keratinocytes, which are harvested, genetically modified to express the functional COL7A1 gene, and surgically applied to chronic wounds. The COL7A1 gene encodes a type of collagen essential for anchoring skin layers – something patients with RDEB lack due to genetic mutations. The FDA had previously rejected an application from Abeona last year, citing outstanding manufacturing and quality control (QC) concerns. Following a complete response (CR) letter and further chemistry, manufacturing and controls (CMC) submissions, the agency granted approval based on results from a pivotal Phase III study (NCT04227106). Despite a partial clinical hold in 2019, the study met both co-primary endpoints of wound healing and pain reduction, with no serious treatment-related adverse events (AEs) reported. The company also provided confirmatory evidence from a Phase I/IIa trial (NCT01263379), which supported the durability of healing after a single application. Zevaskyn is priced at $3.1m, placing it among the most expensive therapies in the US but in line with other rare disease gene and cell therapies. Abeona expects to make the product available commercially in Q3 2025. The company raised $35m in late 2022 after announcing the Phase III data, followed by a $25m financing round in July 2024 to support manufacturing and launch readiness. Krystal Biotech's Vyjuvek (beremagene geperpavec), a topical gene therapy gel for DEB, was approved in 2023 and generated $290.5m in revenue in 2024. Unlike Zevaskyn, which is applied once through surgery, Vyjuvek is dosed weekly and costs around $631,000 per patient per year. Vyjuvek also delivers a functional COL7A1 gene, though via a re-dosable, non-integrating viral vector. In the 29 April announcement, Abeona's CEO Vish Seshadri, said: 'We have heard from the RDEB community that there is a persistent unmet need to reliably address RDEB wounds, especially those that are chronic and prone to infection. Through a single surgical application, Zevaskyn can now offer people with RDEB the opportunity for wound healing and pain reduction in even the most severe wounds, as evidenced by the results from our pivotal Phase III study.' In connection with the approval, Abeona received a rare paediatric disease priority review voucher (PRV), which the company said it plans to monetise. The PRV programme, which grants expedited FDA review for a future drug application, is set to expire soon unless renewed by Congress. Rare disease advocates have warned that the programme's lapse, combined with existing FDA resource constraints, could deter future investment in paediatric rare disease research and development. "FDA approves Abeona's $3.1m cell therapy for rare skin disease" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Epoch Times
29-04-2025
- Health
- Epoch Times
FDA Approves First Cell-Based Treatment for Rare Skin Disorder
The Food and Drug Administration (FDA) has approved Zevaskyn, a gene therapy for a rare skin disorder, the company that makes the product said on April 29. Regulators approved Zevaskyn for adults and children with recessive dystrophic epidermolysis bullosa, a disorder that leaves skin fragile and prone to blistering. Severe cases of the disorder can result in loss of vision and other serious medical issues, according to the National Library of Medicine. Recessive dystrophic epidermolysis bullosa has no cure. Zevaskyn is the first cell-based gene therapy to receive approval for the condition. Abeona Therapeutics, which makes the therapy, said it only requires one application. 'Through a single surgical application, Zevaskyn can now offer people with [the condition] the opportunity for wound healing and pain reduction in even the most severe wounds,' Vish Seshadri, Abeona's CEO, Related Stories 10/28/2024 4/28/2025 Seshadri thanked participants in the company's clinical studies, including a phase 3 trial that showed people who received the therapy experienced statistically significant improvement in healing, compared with a control group that received the standard of care. Adverse events included itching. 'Zevaskyn was well-tolerated and efficacious in clinical studies, providing clinically meaningful improvements in wound healing, pain reduction, and other associated symptoms,' Dr. Jean Tang, a professor of dermatology who was the trial's principal investigator, said in a statement. Zevaskyn involves taking a patient's skin cells and genetically modifying the cells to produce collagen. Up to 12 of the resulting cellular sheets are then surgically applied to a patient's wounds. The FDA did not return a request for comment. Brett Kopelan, the executive director of Debra of America, which advocates for people with epidermolysis bullosa, expressed support for Zevaskyn, saying in a statement released by Abeona that the therapy 'can significantly increase the quality of life of patients.' Abeona said it expects Zevaskyn to be available starting in the third quarter of 2025. Patients seeking the therapy can receive it through Zevaskyn-qualified treatment centers. About 3.3 per million people are affected by recessive and dominant dystrophic epidermolysis bullosa, Two treatments are currently available. The Food and Drug Administration approved Vyjuvek, a gene therapy from Krystal Biotech, in 2023. The gel is applied to wounds regularly, typically once a week. Filsuvez, also approved in 2023, and made by Chiesi Global Rare Diseases, can also be used. The gel, which contains birch bark, is also applied to wounds.
