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Yahoo
13-05-2025
- Business
- Yahoo
Abeona secures cash runway with $155m priority review voucher sale
US-based Abeona Therapeutics has signed a deal to sell its priority review voucher for $155m, two weeks after picking up approval in the US for its first commercial product. The biotech company was eligible for the voucher upon securing a rare paediatric disease designation. A voucher was subsequently given to the biotech after winning approval from the US Food and Drug Administration (FDA) for gene therapy Zevaskyn (prademagene zamikeracel) late last month. Zevaskyn is a treatment for the rare disease recessive dystrophic epidermolysis bullosa (RDEB). Abeona did not disclose the voucher's buyer, saying only it had entered a definitive asset purchase agreement. Investors seemed happy with Abeona's decision, with the company's stock, listed on the Nasdaq exchange, peaking 16.8% higher in trading yesterday, from $5.27 a share at close on Friday (9 May) to a high of $6.16. The company's stock later settled at $5.60 a share at market close – a 6.26% increase on the previous trading day. This spike coincides with stock increases across the pharmaceutical sector on Monday after US President Donald Trump announced he would sign an executive order to bring down US drug prices. Abeona has a market cap of $273.27m. Priority review vouchers are awarded to pharmaceutical companies developing drugs for rare paediatric diseases, neglected tropical diseases, or material threat medical countermeasures – markets that companies are hesitant to enter due to weak financial performance. Biotechs can use the vouchers to slash the FDA review time of any drug application from the usual ten months to six months. This can be done in a more lucrative market, facilitating a recuperation of funds spent developing the original product. Alternatively, companies can sell their voucher for a quick cash injection – the route opted by Abeona. The company did not reveal how it plans to use the funds, with CEO Joe Vazzano commenting only that the $155m means the company has 'sufficient cash for more than two years of operating expenses without the need for capital infusion.' Vazzano added that cash projections neither account for sales of Zevaskyn, which has a planned commercial rollout in Q3 2025. It is likely, therefore, that at least part of the funds raised from the voucher sale will go towards the gene therapy's launch. Zevaskyn will be priced at $3.1m a dose and is a one-time treatment. Analysis by GlobalData's Pharma Intelligence Centre forecasts sales of $366m by 2031. GlobalData is the parent company of Pharmaceutical Technology. The figure achieved by Abeona in its voucher sale tallies with other recent deals. Zevra sold a voucher in February for $150m, also to an undisclosed party. In November 2024, PTC Therapeutics sold a voucher to an unnamed buyer for $150m. The highest fee for a voucher still stands at $350m, when AbbVie bought one from United Therapeutics in 2015. Though down from these heights, recent transactions are still a step up from a relatively stable $100m selling price average seen over the past seven years, perhaps a reflection that vouchers now hold more value in an uncertain US funding landscape. Rare disease development has hit rocky waters amid mass layoffs across US health agencies by the Trump administration. A big setback could arise from the failure to renew the priority review voucher programme for paediatric rare diseases, which expired, in part, due to shifting political priorities. This has cast a blanket of precariousness over future rare disease pipelines. "Abeona secures cash runway with $155m priority review voucher sale" 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. 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
12-05-2025
- Business
- Yahoo
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 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@ in to access your portfolio
