Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company, develops gene and cell therapies for life-threatening rare genetic diseases. Its lead programs include EB-101, an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa; ABO-102, an adeno-associated virus-based gene therapy for Sanfilippo syndrome type A; and ABO-101, an AAV-based gene therapy for Sanfilippo syndrome type B. The company also develops ABO-201 to treat CLN3 disease; ABO-401 for the treatment of cystic fibrosis; and ABO-5OX for the treatment of genetic eye disorders. In addition, it is developing AAV-based gene therapy through its AIM vector platform programs. The company was formerly known as PlasmaTech Biopharmaceuticals, Inc. and changed its name to Abeona Therapeutics Inc. in June 2015. Abeona Therapeutics Inc. was founded in 1974 and is headquartered in New York, New York.
IPO Year:
Exchange: NASDAQ
Website: abeonatherapeutics.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 6/2/2025 | $19.00 | Outperform | Oppenheimer |
| 3/5/2025 | $16.00 | Outperform | Oppenheimer |
| 7/3/2024 | $15.00 | Buy | H.C. Wainwright |
| 5/30/2024 | $21.00 | Buy | Stifel |
| 11/30/2021 | $5.00 → $1.00 | Outperform → Market Perform | SVB Leerink |
| 11/29/2021 | $5.00 → $4.00 | Buy | HC Wainwright & Co. |
| 7/19/2021 | $8.00 → $5.00 | Buy | HC Wainwright & Co. |
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4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
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4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)
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Oppenheimer resumed coverage of Abeona Therapeutics with a rating of Outperform and set a new price target of $19.00
Oppenheimer initiated coverage of Abeona Therapeutics with a rating of Outperform and set a new price target of $16.00
H.C. Wainwright initiated coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $15.00
Stifel initiated coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $21.00
SVB Leerink downgraded Abeona Therapeutics from Outperform to Market Perform and set a new price target of $1.00 from $5.00 previously
HC Wainwright & Co. reiterated coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $4.00 from $5.00 previously
HC Wainwright & Co. reiterated coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $5.00 from $8.00 previously
HC Wainwright resumed coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $8.00
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8-K - ABEONA THERAPEUTICS INC. (0000318306) (Filer)
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8-K - ABEONA THERAPEUTICS INC. (0000318306) (Filer)
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10-Q - ABEONA THERAPEUTICS INC. (0000318306) (Filer)
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- Received FDA approval for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch on track and first ZEVASKYN patient treatment expected in 3Q 2025, momentum building with strong patient interest at qualified treatment centers and referrals, positive insurance coverage established with multiple national and regional payers - - $226M in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025, expected to fund operations for over two years before accounting for anticipated ZEVASKYN revenue beginn
CLEVELAND, Aug. 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 July 30, 2025, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to 14 individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 34,679 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 sha
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 th
- Lucile Packard Children's Hospital Stanford is ready to accept patients for ZEVASKYN treatment - - Abeona Therapeutics® and Stanford Medicine conducted research collaboration for more than a decade, culminating in U.S. Food and Drug Administration (FDA) approval of ZEVASKYN in April 2025 - - ZEVASKYN is the only FDA-approved therapy to treat RDEB wounds with a single application - CLEVELAND, July 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced activation of the newest Qualified Treatment Center (QTC) for FDA-approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets. This first-of-its-kind therapy, an outcome of a decade of research b
MINNEAPOLIS, July 14, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH) today announced that its Simple Western™ Technology played a key role in supporting the FDA approval of ZEVASKYN™ (prademagene zamikeracel), the first autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), developed by Abeona Therapeutics® (NASDAQ:ABEO). Throughout clinical development, Simple Western enabled precise identification and quantification of Collagen VII, a complex therapeutic target critical to ZEVASKYN's potency, supporting lot release testing for the viral vector and the cell therapy in a GMP setting. Abeona selected Simple Western over competing met
CLEVELAND, July 02, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million on June 27, 2025. Including net proceeds from the sale of the PRV, the Company reported that unaudited cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025 were approximately $225 million. "We have reached another key milestone: the successful sale of our PRV has closed," said Joe Vazzano, Chief Financial Officer of Abeona. "The PRV proceeds, combined with our existing cash, provides Abeona with robust financial flexibility, ensuring over
CLEVELAND, July 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced that Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, has exercised its option to license Abeona's patented AAV204 capsid for use in potential gene therapies for a range of prevalent and rare retinal diseases that result in blindness. This worldwide, non-exclusive license is pursuant to the agreement between Abeona and Beacon, announced in July 2024, to evaluate the therapeutic potential of AAV204. AAV204, a novel AAV capsid from the AIM™ capsid library licensed by Abeona from the University of North Carolina at Chapel Hill, has been shown to achieve hi
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 sha
CLEVELAND, June 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced that it was added as a member of the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index as part of the reconstitution of the Russell stock indexes, effective at the open of the U.S. equity markets today. "Abeona's addition to the Russell 2000 and 3000 indexes, on the heels of ZEVASKYN™'s FDA approval, represents a pivotal moment for the company," said Joe Vazzano, Chief Financial Officer of Abeona. "This inclusion amplifies our positive momentum as we progress with ZEVASKYN's commercial launch and provides an opportunity to engage with a broader audience of invest
- RDEB is a lifelong debilitating, blistering skin disease associated with large and painful wounds that often remain open for years and cause significant clinical burden, including pain, itch, and risk of squamous cell carcinoma - - ZEVASKYN™ (prademagene zamikeracel) demonstrated significant wound healing and pain reduction after a single treatment with a favorable safety profile in large chronic RDEB wounds - - ZEVASKYN is the first and only autologous cell-based gene therapy FDA-approved to treat RDEB wounds in adult and pediatric patients - CLEVELAND, June 24, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced that The Lancet has published r
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CLEVELAND, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced the appointment of Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD as new independent members to its Board of Directors. Dr. Zeiher brings more than 20 years of drug development experience where, in various roles, he oversaw the approval of 15 new treatments that addressed unmet needs in serious diseases with few to no treatment options. Dr. Crombez currently serves as Chief Medical Officer of Ultragenyx Pharmaceutical Inc. and brings extensive expertise in the development and execution of clinical development programs for rare genetic disorders. Michael Amoroso, Chairman of Abeon
CLEVELAND, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced the appointment of Madhav Vasanthavada, Ph.D., M.B.A. to the role of Chief Commercial Officer (CCO) and Head of Business Development (BD), effective immediately. In this capacity, in addition to his current BD responsibilities, Dr. Vasanthavada will oversee all aspects of commercial strategy, planning and operations as Abeona prepares for a potential launch of EB-101, its investigational, genetically engineered autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). Dr. Vasanthavada is a seasoned commercial executive bringing over 20 years of experience with leadershi
NEW YORK and CLEVELAND, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Jon Voss as Vice President, Head of Quality. Mr. Voss, who has been advising the Company as a consultant, will now serve in a leadership role to further strengthen Abeona's quality system and oversee all quality functions. "Jon is a proven technical leader with a strong track record of successful quality oversight that includes chemistry, manufacturing and control (CMC)-related and clinical functions for gene therapies," said Dr. Vish Seshadri, Ph.D., M.B.A., Head of Research & Clinical Development and CEO-
Steven H. Rouhandeh to retire as Chairman of the Board; Michael Amoroso appointed Chairman of the Board Vishwas Seshadri, Ph.D., M.B.A. to become Chief Executive Officer Brendan M. O'Malley, J.D., Ph.D. promoted to General Counsel, Brian Kevany, Ph.D. promoted to Chief Technical Officer, Scott Nogi, M.B.A., Head of Business Operations to expand role and lead operations at Abeona's Cleveland facility Regulatory veterans in AAV-based gene therapy, Carl Denny and Kate Imhoff, added to team in preparation for two upcoming Biologics License Application submissions NEW YORK and CLEVELAND, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integ
NEW YORK and CLEVELAND, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Edward Carr as Chief Financial Officer and Principal Financial Officer, effective immediately. Mr. Carr had served as Abeona's Chief Accounting Officer since January 2019. "I look forward to working together with Ed to meet our near-term clinical and regulatory milestones, as well as set Abeona on a course for longer-term success for patients and shareholders," said Michael Amoroso, Chief Executive Officer of Abeona. "Ed's financial leadership and deep understanding of our business helps position Abeona for
NEW YORK and CLEVELAND, May 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Vishwas Seshadri, Ph.D., M.B.A., as Senior Vice President, Head of Research & Clinical Development, effective June 1, 2021. Dr. Seshadri joins the company from Celgene Corporation, now a subsidiary of Bristol-Myers Squibb Company (BMS), and brings more than 20 years of experience including in academia and various senior and executive leadership roles in the life sciences industry overseeing product development, regulatory submissions, and commercialization for novel therapies including personalized, autologou
Patient enrollment ongoing for EB-101 pivotal Phase 3 VIITAL™ study Positive interim MPS III data presented at 17th Annual WORLDSymposium; additional neurocognitive assessments of patients treated in high dose cohort 3 in MPS IIIA Transpher A study and additional clinical data from MPS IIIB Transpher B study expected in 2021 Strengthened management and board to support the company's focus on driving future growth, enhancing corporate governance, and creating additional shareholder value Conference call scheduled for Tuesday, May 25, 2021 at 8:30 a.m. ET NEW YORK and CLEVELAND, May 18, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and
NEW YORK and CLEVELAND, April 19, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Dr. Leila Alland and Mr. Donald Wuchterl as new independent members to its Board of Directors. "Leila and Donald bring a collective wealth of diverse biologics experience to Abeona that spans clinical development and manufacturing of cell therapy and gene therapy products, as we continue to focus on the mission of bringing our novel gene and cell therapies to patients who currently have no approved treatment options," said Steven H. Rouhandeh, Chairman of Abeona's Board of Directors. "Their relevant ex
NEW YORK and CLEVELAND, March 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of two new independent members to its Board of Directors with significant biotechnology and life sciences experience: Faith L. Charles, Partner, Corporate Transactions and Securities at Thompson Hine LLP and Mark Alvino, President at life sciences strategic advisory firm Hudson Square Capital LLC. “In addition to the experience and backgrounds of the current Abeona directors, our two new board members represent a group of highly qualified and diverse executives who bring fresh perspectives, relevant exper
NEW YORK and CLEVELAND, March 22, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Michael Amoroso, Executive Vice President, Chief Operating Officer (COO) and principal executive officer at Abeona, has been promoted to President, Chief Executive Officer (CEO) and a member of the company’s Board of Directors, effective immediately. “Michael’s promotion to CEO reflects his unwavering commitment and outstanding operational leadership during a period of important transition for the company, and the Board fully supports him and the Abeona senior management team,” said Steven H. Rouhandeh, Chairman of Ab
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- Received FDA approval for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch on track and first ZEVASKYN patient treatment expected in 3Q 2025, momentum building with strong patient interest at qualified treatment centers and referrals, positive insurance coverage established with multiple national and regional payers - - $226M in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025, expected to fund operations for over two years before accounting for anticipated ZEVASKYN revenue beginn
- Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adultand pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) - - Entered into sales agreement for priority review voucher (PRV) for $155 million - CLEVELAND, May 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress. "ZEVASKYN's appr
- ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile - - ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025 - - Abeona Assist™ patient services program offers personalized support for eligible patients and families throughout their treatment journey with ZEVASKYN - - Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA - - Abeona Therapeutics® to host conference call today, Tuesday, April 29, 20
FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025 Launch preparations on track toward goal to treat first patient in 3Q 2025 CLEVELAND, March 20, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2024, and announced progress in the ongoing review with the U.S. Food and Drug Administration (FDA) regarding prademagene zamikeracel (pz-cel) and plans for the U.S. commercial launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), if approved. The Company will host a conference call and webcast today at
FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commercialization of pz-cel in 2025; Builds momentum with payor discussions and target treatment centers CLEVELAND, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the third quarter ended September 30, 2024, and recent corporate updates. "With the acceptance of our Biologics License Application (BLA) resubmission for pz-cel, we are ramping up our commercial readiness efforts, especially with respect to onboarding potential pz-cel treatment
Significant progress addressing CMC items noted in CRL BLA resubmission remains on track for 2H 2024 CLEVELAND, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the second quarter of 2024 and recent corporate progress. "Having completed data generation for nearly all of the Chemistry Manufacturing and Controls deliverables outlined in the Complete Response Letter that we received in April 2024, we are on track to resubmit our Biologics License Application for pz-cel this year and, if approved, bring a treatment option to patients with recessive dystrophic epidermolysis bullosa," said Vish Seshadri, Chief Executive Offic
BLA resubmission anticipated in second half of 2024 Closed $75 million underwritten offering in May, extending expected cash runway into 2026 CLEVELAND, May 15, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the first quarter of 2024 and recent corporate progress. "We are grateful to our existing as well as new investors who have demonstrated their support through the recent financing, which has extended our cash runway into 2026, well beyond anticipated regulatory milestones," said Vish Seshadri, Chief Executive Officer of Abeona. "We now remain focused on working with the FDA to address the CMC deficiencies noted in the CRL and mak
Receives FDA Complete Response Letter (CRL) based on need for additional CMC information CRL did not identify deficiencies related to clinical efficacy or clinical safety data in BLA, and no new clinical studies requested by FDA to support approval Anticipates completing and submitting requested CMC information in 3Q 2024 Conference call and webcast on Tuesday, April 23, 2024 at 8:30 a.m. ET to provide details on the requested CMC information CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Lett
CLEVELAND, March 18, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives. Abeona also announced today that the U.S. Food and Drug Administration (FDA) has completed a Pre-License Inspection (PLI) of its Cleveland, Ohio manufacturing facility related to the Company's Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB). During the inspection, the FDA reviewed the facilities, systems, and processes at the Cleveland site. The FDA also observed the manufacturing process for
CLEVELAND, May 22, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has changed the date of its previously announced First Quarter 2023 Portfolio Update conference call and webcast to Wednesday, May 24, 2023, at 8:30 a.m. ET. The call was previously scheduled for Tuesday, May 23, 2023, at 8:30 a.m. ET. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 885338 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona's website at www.abeonatherapeutics.com. The archived webcast replay will be availabl