PTC Therapeutics, Inc. (NASDAQ: PTCT) has announced the sale of its rare pediatric priority review voucher (PRV) for $150 million. The company was granted the PRV on November 13, 2024, along with the U.S. Food and Drug Administration (FDA) approval of Kebilidi™ (eladocagene exuparvovec-tneq) for the treatment of children and adults with AADC deficiency.
The sale of the PRV represents a significant financial transaction for PTC Therapeutics, highlighting the value of the voucher in the pharmaceutical industry. The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
The FDA awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. The program is intended to encourage the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
PTC Therapeutics, Inc. is a global biopharmaceutical company with a focus on the discovery, development, and commercialization of clinically differentiated medicines for individuals living with rare disorders. The company's ability to innovate and identify new therapies has led to a robust and diversified pipeline of transformative medicines, supporting its mission to provide access to best-in-class treatments for patients with limited treatment options.
This announcement reflects the company's strategic efforts to leverage its scientific and clinical expertise, as well as its global commercial infrastructure, to bring therapies to patients and maximize value for all stakeholders. The market has reacted to these announcements by moving the company's shares -0.2% to a price of $45.94. If you want to know more, read the company's complete 8-K report here.