Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
Fourteen therapies to treat moderate to severe psoriasis are expected to enter the Chinese market in the next two years, according to Clarivate and BioWorld reports. Eleven of them are being developed by domestic biopharmaceutical firms.
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
