ACADIA Pharmaceuticals Completes Sale of Rare Pediatric Disease Priority Review Voucher

Acadia Pharmaceuticals Inc. has officially finalized the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) following the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The sale, referred to as the Asset Sale, was completed on December 11, 2024.

The PRV was originally obtained by Acadia Pharmaceuticals Inc. as part of a U.S. Food and Drug Administration (FDA) program designed to foster the development of specific rare pediatric disease product applications. This voucher was awarded to the company in March 2023 in connection with the FDA’s approval of DAYBUE (trofinetide) to treat Rett syndrome.

The Asset Sale was executed according to the terms outlined in the Asset Purchase Agreement dated November 5, 2024, known as the PRV Transfer Agreement. The details of this agreement were previously disclosed by Acadia Pharmaceuticals Inc. in Part II, Item 5 of its Quarterly Report on Form 10-Q for the period ended September 30, 2024, which was filed with the Securities and Exchange Commission on November 7, 2024.

Upon the completion of the Asset Sale, Acadia Pharmaceuticals Inc. received $150.0 million. Per the terms of the Joint Venture and License Agreement established on July 13, 2023, with Neuren Pharmaceuticals Limited (Neuren), one-third of the proceeds from the PRV sale will be paid to Neuren.

It’s important to note that the above summary of the PRV Transfer Agreement may not cover all pertinent details and is subject to the full text of the agreement itself. A complete copy of the PRV Transfer Agreement will be included as an exhibit to Acadia Pharmaceuticals Inc.’s Annual Report on Form 10-K for the year ending December 31, 2024.

As of December 11, 2024, Jennifer J. Rhodes, the Executive Vice President, Chief Legal Officer, and Secretary of Acadia Pharmaceuticals Inc., has signed off on this report in compliance with the Securities Exchange Act of 1934.

This release is meant to inform interested parties about Acadia Pharmaceuticals Inc.’s recent transaction involving the sale of its Rare Pediatric Disease Priority Review Voucher.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read ACADIA Pharmaceuticals’s 8K filing here.

ACADIA Pharmaceuticals Company Profile

ACADIA Pharmaceuticals Inc, a biopharmaceutical company, focuses on the development and commercialization innovative medicines that address unmet medical needs in central nervous system (CNS) disorders and rare diseases in the United States. The company offers NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis; and DAYBUE, a novel synthetic analog of the amino-terminal tripeptide of insulin-like growth factor 1 for treatment of Rett Syndrome.