Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million
CLEVELAND, May 12, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million upon the closing of the transaction. Abeona was awarded the PRV following the U.S. Food and Drug Administration (FDA) approval of ZEVASKYN™ (prademagene zamikeracel) on April 28, 2025.
'With proceeds from this PRV sale, we have sufficient cash for more than two years of operating expenses without the need for capital infusion and not accounting for ZEVASKYN sales,' said Joe Vazzano, Chief Financial Officer of Abeona. 'Furthermore, with ZEVASKYN becoming available to treat patients beginning third quarter of 2025, we anticipate becoming profitable in early 2026.'
The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
Stifel was lead financial advisor to Abeona on the transaction. Jefferies also served as financial advisor on the transaction.
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 www.abeonatherapeutics.com.
ZEVASKYNTM, Abeona AssistTM, 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 successfully generate commercial sales of ZEVASKYN and generate future revenue; the successful closing of our sale transaction for the Priority Review Voucher; 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@abeonatherapeutics.comSign in to access your portfolio
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
15 minutes ago
- Yahoo
Personalis' NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO
FREMONT, Calif., June 03, 2025--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging. The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates. The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled "Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses." The results from this study were also simultaneously published in the journal Annals of Oncology. Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev's team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression. "Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA's potential to guide treatment decisions and personalize care in high-risk cervical cancer," said Dr. Mayadev. Key findings presented: Detection of ctDNA following CRT was independently prognostic of patient outcomes. Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT. Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans. High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death. "We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients." About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, clinical relevance or importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient's response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Personalis' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 6, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law. Not affiliated with or endorsed by ASCO. View source version on Contacts Investors: Caroline Cornerinvestors@ 415-202-5678 Media Contact pr@
Yahoo
25 minutes ago
- Yahoo
Why Guardant Health Stock Surged Nearly 9% Higher Today
The company's Shield multi-cancer detection test won an important designation from a top regulator. This should help bring it to market quicker. 10 stocks we like better than Guardant Health › Precision oncology specialist Guardant Health (NASDAQ: GH) was something of a stock market star on Tuesday. On the back of very positive news in the regulatory sphere, the company's shares jumped almost 9% higher today. This made it quite the outperformer on the exchange, as the bellwether S&P 500 index's gain was a relatively modest 0.6%. This morning before market open, Guardant announced that the U.S. Food and Drug Administration (FDA) had granted the healthcare company's Shield multi-cancer detection (MCD) test its Breakthrough Device designation. This instantly confers a high status on Shield, as the FDA's designation is given only to a small clutch of medical devices that can either diagnose or treat a disease more effectively than other products. In Shield's case, it is quite a versatile diagnostic device that can screen for a wide range of cancers, including colorectal, lung, and ovarian. It is designed to evaluate people 45 years of age or older who are at a typical average risk for cancer. According to Guardant, Shield has 98.6% specificity and 75% sensitivity in detecting certain cancers. In its news release touting the FDA's move, Guardant quoted its co-CEO AmirAli Talasaz as saying that it "shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw." "We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly," he added. Another big plus of the Breakthrough Device designation is that it's part of an FDA initiative aimed at getting useful medical products to market faster. Talasaz and his team at Guardant might just get their wish with Shield before long. Before you buy stock in Guardant Health, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Guardant Health wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $657,385!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $842,015!* Now, it's worth noting Stock Advisor's total average return is 987% — a market-crushing outperformance compared to 171% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 2, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy. Why Guardant Health Stock Surged Nearly 9% Higher Today was originally published by The Motley Fool 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
32 minutes ago
- Yahoo
Fundhost Selects SS&C to Power Fund Accounting & Registry Services
WINDSOR, Conn., June 03, 2025--(BUSINESS WIRE)--SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced Fundhost Limited, a boutique fund services provider to investment managers in Australia, has selected SS&C to support its fund services operations. Fundhost provides responsible entity, trustee, fund administration, registry, compliance, operations and support services to boutique Australian and international fund managers. The platform has AUD $2 billion in assets under management. Under the agreement, Fundhost will use SS&C's proprietary platform to streamline its unit registry and fund administration operations. As part of the transition, 10 Fundhost employees have joined SS&C's Sydney office to ensure continuity of service and a seamless onboarding process for Fundhost clients. "We are delighted to partner with SS&C Technologies, a global leader in fund administration and registry services," said Anne Monge, Fundhost founder and Joint-CEO. Drew Wilson, Joint-CEO of Fundhost, added: "We selected SS&C for their proven expertise across private markets, hedge funds, and active ETFs, as well as their global infrastructure. With access to SS&C's technology and operational resources, we're well-positioned to broaden our capabilities while maintaining the high level of service our clients rely on." The agreement expands SS&C's presence in Australia and reinforces its commitment to supporting the local investment management industry with flexible, scalable solutions. "We're excited to welcome our new colleagues and to deepen our presence in the Australian market," said Euan McLeod, Head of Transfer Agency, SS&C Global Investor & Distribution Solutions, Australia. "As demand for business process outsourcing continues to accelerate, we remain committed to delivering market-leading services to fund managers, custodians, and responsible entities across Australia." About Fundhost Fundhost is a leading integrated Responsible Entity offering responsible entity, trustee, accounting, administration, registry and via strategic relationship with HSBC, custody under one roof. A boutique itself, Fundhost has supported the development of some of Australia's most successful boutiques. About SS&C SS&C is a global provider of services and software for the financial services and healthcare industries. Founded in 1986, SS&C is headquartered in Windsor, Connecticut, and has offices around the world. More than 22,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale and technology. Additional information about SS&C (Nasdaq: SSNC) is available at Follow SS&C on X, LinkedIn and Facebook. View source version on Contacts Brian SchellChief Financial OfficerSS&C TechnologiesTel: +1-816-642-0915Email: InvestorRelations@ Justine StoneInvestor RelationsSS&C TechnologiesTel: +1- 212-367-4705Email: InvestorRelations@ Drew WilsonJoint-CEOFundhost LimitedTel: +61 414 755 954Email: dreww@ Media Contacts Sam Gentile | ProsekTel: +1-646-818-9195Email: pro-SSC@ 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
