Latest news with #ZEVASKYN
Yahoo
02-08-2025
- Business
- Yahoo
Abeona Therapeutics, AscellaHealth Partner for Commercialization of ZEVASKYN Gene Therapy
Abeona Therapeutics Inc. (NASDAQ:ABEO) is one of the stocks under $10 to buy now. On July 29, AscellaHealth announced its successful HUB partnership with Abeona Therapeutics in the pre- and post-launch commercialization of ZEVASKYN (prademagene zamikeracel), which is an FDA-approved cell-based gene therapy. The collaboration addresses the clinical, operational, and reimbursement needs of this novel autologous cell-based gene therapy by designing and executing patient-centric, end-to-end solutions. An outcome of this partnership was the development and launch of AbeonaAssist, which is a customized patient support program designed to provide a seamless experience for patients, caregivers, and healthcare providers. A close-up of a staff member counting pills in a pharmaceutical warehouse. ZEVASKYN is the first and only autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa/RDEB. Abeona Therapeutics Inc. (NASDAQ:ABEO) is a clinical-stage biopharmaceutical company that develops gene and cell therapies for life-threatening diseases. While we acknowledge the potential of ABEO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-07-2025
- Business
- Yahoo
AscellaHealth HUB Partnership with Abeona Therapeutics® Supports Launch Success of Novel Cell-Based Gene Therapy and Access to Treatment for Rare Disease Patients
BERWYN, Pa., July 29, 2025 (GLOBE NEWSWIRE) -- AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, highlights the value of its HUB partnership with Abeona Therapeutics Inc. (Nasdaq: ABEO) in the successful pre-and-post launch commercialization of ZEVASKYN™, an FDA-approved cell-based gene therapy. Working as a collaborative partner, AscellaHealth designed and executed patient-centric, end-to-end solutions to address unique clinical, operational and reimbursement needs for a new-to-world autologous cell-based gene therapy. By focusing on the requirements of patients throughout the entire therapeutic journey, AscellaHealth led the collaborative effort to build and launch AbeonaAssist™, a highly customized patient support program that creates a seamless experience for patients, caregivers and healthcare providers. "Abeona's groundbreaking cell-based gene therapy demanded a HUB partner who could build tailored infrastructure from the ground up,' said William White, Vice President of Market Access at Abeona Therapeutics. 'AscellaHealth's comprehensive expertise in navigating this complex journey, from patient and provider engagement to optimizing reimbursement for this first-of-its-kind treatment, made them the unequivocal partner of choice. Since launch, their unwavering commitment to a patient-centric model, which perfectly aligns with our program's vision, has proven invaluable.' Bill Oldham, Chairman and President, AscellaHealth, says, 'We value our strategic partnership with Abeona which is built upon an aligned vision, a foundation of shared goals and a clear understanding of what can be achieved through collaboration. Together, we have created synergies that not only benefit both organizations, but most importantly, patient access to treatment and optimized clinical outcomes. Abeona epitomizes our description of an ideal partner that is committed to open communications, trust and transparency.' AscellaHealth's integrated patient services and HUB model are proving instrumental in achieving optimal results for life science manufacturers launching specialty pharmaceuticals, and cell and gene therapies for individuals with complex, chronic conditions and rare disease. The results highlight enhanced compliance, retention and satisfaction rates, underscoring the effectiveness of AscellaHealth's tailored programs that consistently deliver measurable outcomes:About ZEVASKYN™ (prademagene zamikeracel) gene-modified cellular sheets ZEVASKYN is the first and only autologous cell sheet-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a severe skin disease caused by a defect in both copies of the COL7A1 gene resulting in the inability to produce functional type VII collagen. Without functional type VII collagen and anchoring fibrils, the skin is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Patients often have large open wounds that can lead to serious life-threatening complications. ZEVASKYN incorporates the functional type VII collagen-producing COL7A1 gene into a patient's own skin cells, ex vivo, using a replication-incompetent retroviral vector to produce functional type VII collagen in treated wounds. ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application. For more information, visit Indication ZEVASKYN™ (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). Important Safety Information Serious allergic reactions to ZEVASKYN can occur. Patients should get medical help right away if they experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen. There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer. ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated. The most common side effects are pain from the procedure and itching. This is not a complete list of side effects. Patients should call their care team for medical advice about side effects. Side effects may be reported to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or See full Prescribing Information. About AscellaHealth AscellaHealth is a global partner that delivers proven end-to-end solutions to both life sciences and healthcare companies to enhance the quality of life for patients with complex, chronic conditions. A dedicated team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma. Visit 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 cGMP cell and gene therapy 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. Media: Caroline Chambers CPR Communicationscchambers@ x 21 A photo accompanying this announcement is available at This press release was published by a CLEAR® Verified in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
01-07-2025
- Business
- Yahoo
Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CLEVELAND, July 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On June 30, 2025, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to 21 individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 48,715 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee's continued employment with Abeona on the applicable vesting dates. 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 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, the timing and outcome of the FDA's review of our BLA resubmission for pz-cel; the FDA's grant of a Priority Review Voucher upon pz-cel approval; continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with 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@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
02-06-2025
- Business
- Associated Press
Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CLEVELAND, June 02, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On May 31, 2025, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to five individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 11,500 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee's continued employment with Abeona on the applicable vesting dates. 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 ZEVASKYNTM, Abeona AssistTM, 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]
Associated Press
30-05-2025
- 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]
