Shares of Prime Medicine, Inc. (PRME) are down over 17% today, after the company announced a strategic restructuring aimed at focusing on key areas such as large genetic liver diseases, cystic fibrosis, and partnered programs, along with a transition in CEO leadership.
As part of pipeline prioritization, the company will focus on in vivo programs for the treatment of Wilson's Disease and Alpha-1 Antitrypsin Deficiency (AATD), two of the largest genetic liver diseases.
Prime Medicine plans to submit an Investigational New Drug (IND) application or Clinical Trial Application (CTA) for the Wilson's Disease program in the first half of 2026, followed by the AATD program in mid-2026. Initial clinical data from both programs are anticipated in 2027.
The company will also continue its in vivo Cystic Fibrosis program with support from the Cystic Fibrosis Foundation.
Additionally, the company today announced promising initial clinical results from its ongoing Phase 1/2 trial of PM359, an investigational Prime Editing therapy for p47phox Chronic Granulomatous Disease (CGD).
p47phox deficiency is a specific type of Chronic Granulomatous Disease (CGD), an inherited immunodeficiency where phagocytes, like neutrophils, cannot effectively kill certain bacteria and fungi due to a defect in their NADPH oxidase enzyme system.
The Phase 1/2 study is evaluating the safety, biological activity, and preliminary efficacy of PM359, an ex vivo Prime Edited autologous hematopoietic stem cell or HSC therapy, designed to correct the most common disease-causing mutation or delGT in the NCF1 gene in patients with p47phox CGD.
Despite the promising results, Prime Medicine will not independently pursue further development of PM359 for CGD and is currently seeking external partners to continue advancing the program. The company will discontinue efforts in X-linked CGD.
In a bid to significantly reduce cash needs in advance of key data inflection points, the company is reducing its organizational workforce by approximately 25%.
The company also announced that Keith Gottesdiener is stepping down from his roles as CEO and as a member of Prime Medicine's Board of Directors, effective immediately. In light of this leadership transition, Allan Reine, who has been serving as the company's Chief Financial Officer, has now been appointed as the new CEO and will also join the Board of Directors. Additionally, Jeff Marrazzo, a current member of the Board, has been named Executive Chair.
Currently, PRME is trading at $1.30, down by 17.67 percent on the Nasdaq.
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