Gilead Streamlines R&D Pipeline, Dropping MASH and Cancer Programs

Gilead Sciences, the California-based biopharmaceutical giant, has announced significant changes to its research and development pipeline, cutting several programs across multiple therapeutic areas. The move comes on the heels of the company's recent success with its HIV prophylactic, Yeztugo, and appears to be part of a strategic realignment of its drug development efforts.

MASH Program Termination

In a notable development, Gilead has discontinued its collaboration with Novo Nordisk on a combination treatment for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). The program, which was evaluating Gilead's cilofexor and firsocostat in combination with Novo's semaglutide, concluded a phase 2 trial with 457 patients in December 2024. However, Gilead has not publicly disclosed any data from this study.

The decision to terminate this program marks the end of Gilead's pursuits in the fibrotic disease space, leaving its pipeline in this area entirely empty. The company had previously acquired cilofexor and firsocostat through buyouts of Phenex and Nimbus, respectively. Despite showing promise in a small trial of 20 patients, the combination had faced challenges, including the occurrence of grade 3 adverse events.

Oncology Asset Cuts

Gilead has also made cuts to its oncology portfolio, dropping two early-stage cancer candidates. The first is GS-9911, a DGKα inhibitor that was being tested alone and in combination with an anti-PD-1 monoclonal antibody for advanced solid tumors. The second is zamzetoclax (GS-9716), an MCL1 inhibitor that was being evaluated both as a monotherapy and in combination with other chemotherapies for advanced solid malignancies.

Both of these oncology programs were in phase 1 trials at the time of their discontinuation. Gilead has not provided specific reasons for the termination of these studies or commented on the current status of the trials.

Strategic Pipeline Review

A Gilead spokesperson emphasized that the company's portfolio is under constant review to ensure the progression of the most promising and potentially impactful programs. This latest round of cuts appears to be part of a broader strategy to focus resources on areas with the highest potential for success.

The streamlining of Gilead's pipeline follows the recent approval and launch of Yeztugo, a twice-yearly HIV prophylactic, suggesting that the company may be redirecting its efforts towards areas where it has demonstrated recent success.

As the pharmaceutical landscape continues to evolve, Gilead's strategic decisions reflect the ongoing challenges and opportunities in drug development, particularly in complex disease areas such as MASH and oncology.