Positive phase III data from the Advocate trial by Chemocentryx Inc. and Vifor Fresenius Medical Care Renal Pharma caused Chemocentryx’s stock (NASDAQ:CCXI) to dramatically rise 281% on Tuesday, clearing the way to an NDA filing for the star small-molecule attraction, avacopan, an oral, selective complement 5a receptor inhibitor.
La Jolla Pharmaceutical Co. discontinued its study LJ401-BT01 due to lack of efficacy and will reassess further development of LJPC-401 (synthetic human hepcidin) based on recent mixed clinical results.
The research challenge facing the scientific founders of newly launched Immunitas Therapeutics Inc. was getting human samples to deeply analyze in their quest to understand autoimmunity. While the research continued slowly, the science raced ahead.
Harpoon Therapeutics Inc. and Abbvie Inc. have cut their second deal in little more than two years as they embark upon an exclusive worldwide option and license transaction for HPN-217, Harpoon’s B-cell maturation antigen T-cell engagers targeting solid tumors and hematologic malignancies.
Even though November’s full moon had come and gone more than a week previous, Werewolf Therapeutics Inc. came out of the shadows Wednesday with a $56 million series A fundraiser to state its plans to develop immune-stimulatory therapeutics to trigger immune responses to cancer.
While Burt Adelman has been in Boston since 1991, it wasn’t until he joined Novo Ventures Inc. about four years ago that he realized there was often no way to tie the area’s drug development together into something resembling a cohesive whole.
Dicerna Pharmaceuticals Inc. kept adding major partners to its CV Monday as it and Novo Nordisk A/S struck a deal to discover and develop therapies to treat liver-related cardiometabolic diseases, including chronic liver disease, nonalcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases.
Restorbio Inc.'s PROTECTOR 1 phase III study failed to meet its primary endpoint and the company shares tracked deeply downward Friday. The trial was designed to evaluate RTB-101 in preventing clinically symptomatic respiratory illness (CSRI) in adults ages 65 and older.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) unanimously concluded Thursday that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular (CV) events in adults with elevated triglyceride levels (≥135 mg/dL) and other risk factors for CV disease. The 16-0 vote followed a day's discussion about potential effects of mineral oil, about the proper age population and the value of labeling. EMDAC's conclusion is only an advisory, as the FDA makes the final decision. FDA representatives at the panel discussion noted the study provided convincing data and waived off most concerns about mineral oil's impact on LDL cholesterol levels and blood pressure.
Merck & Co. Inc. acquired Calporta Therapeutics Inc. for an up-front payment and milestone payments that could total $576 million. Calporta is a build-to-buy spinout of La Jolla, Calif.-based COI Pharmaceuticals Inc. Calporta develops selective small-molecule agonists to TRPML1, foremost in the mammalian mucolipin TRP channel subfamily.
