Pharmaceutical Industry Roundup: Mergers, Clinical Trials, and Manufacturing Expansions

In a week of significant developments across the pharmaceutical landscape, companies are making strategic moves in clinical trials, mergers, and manufacturing capabilities. From promising cancer treatments to COVID-19 vaccine updates, the industry continues to evolve rapidly.

Akeso's Cancer Immunotherapy Shows Promise in Phase 3 Trial

Akeso, in collaboration with Summit Therapeutics, has announced positive interim results from a Phase 3 trial of ivonescimab, their experimental PD-1/VEGF inhibitor for lung cancer. The study, conducted in China, compared a combination of chemotherapy and ivonescimab to chemotherapy plus a PD-1 inhibitor alone. While specific details were not disclosed, the company reported that the ivonescimab combination significantly slowed tumor progression. A global study comparing this regimen to the current standard of care, Keytruda plus chemotherapy, is expected to report results in 2027.

In related news, Gilead Sciences reported that a combination of its antibody-drug conjugate Trodelvy, chemotherapy, and Merck & Co.'s Keytruda significantly delayed disease progression in women with newly diagnosed, metastatic triple-negative breast cancer expressing PD-L1. The company noted a "statistically significant and clinically meaningful improvement" in progression-free survival and an "early trend in improvement" in overall survival compared to Keytruda and chemotherapy alone.

Novavax Addresses FDA Request for Additional COVID-19 Vaccine Data

Novavax's shares rose significantly following an announcement that the U.S. Food and Drug Administration (FDA) has requested additional clinical data for its COVID-19 vaccine. This request comes after the FDA missed an April 1 deadline to convert the company's emergency use authorization to traditional approval. Novavax stated that the agency has called for a commitment to accrue study results post-approval, and the company is working "expeditiously" to address this request.

Pharmaceutical Manufacturing Expansions and Mergers

Regeneron Pharmaceuticals is set to nearly double its commercial drug manufacturing capacity in the United States through a new $3 billion deal with FUJIFILM Diosynth Biotechnologies. The ten-year agreement will see drugs produced at a new facility in Holly Springs, North Carolina, which is scheduled to open later this year. This expansion is part of Regeneron's broader investment strategy, which includes a $3.6 billion expansion of its Tarrytown, New York campus and new facilities in Rensselaer and Saratoga Springs.

In merger news, Alumis and Acelyrin have revised the terms of their planned combination. Under the new agreement, Alumis shareholders will own 52% of the combined company, up from the originally proposed 55%, while Acelyrin stockholders will now own 48%, an increase from the initial 45%. This adjustment follows discussions with stockholders and is intended to provide Acelyrin's equity holders with "greater interest in Alumis' long-term upside potential," according to Acelyrin board chair Bruce Cozadd.

Industry Restructuring and Leadership Changes

Several pharmaceutical companies are undergoing significant organizational changes. Tempest Therapeutics announced plans to lay off 21 of its 26 full-time employees by April 30, incurring $1.5 million in expenses, primarily for severance payments. This decision comes shortly after the company began exploring strategic alternatives to secure funding for advancing a liver cancer drug into Phase 3 testing.

Immunovant has replaced its CEO and CFO as part of a broader strategic transition that gives majority owner Roivant Sciences increased operational involvement and strategic oversight. Eric Venker, Roivant's president and chief operating officer, will take over as CEO, while Tiago Girao, an executive from another Roivant affiliate, will assume the role of CFO. These changes reflect Roivant's growing influence over Immunovant, which it spun out in 2019 and still owns 57% of.