Benevolentai Ltd. is betting on its oral phosphodiesterase 10 inhibitor BEN-8744 as having first-in-class potential for moderate to severe ulcerative colitis, after healthy volunteers in a phase Ia trial remained free of central nervous system-associated side effects.
Neuromuscular disease specialist NMD Pharma A/S has been given U.S. FDA approval for a phase IIb trial of NMD-670, after demonstrating proof of mechanism for the orally-available chloride ion channel-1 inhibitor in generalized myasthenia gravis.
China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors
Eledon Pharmaceuticals Inc.’s tegoprubart, an investigational anti-CD40 ligand antibody, was used as part of the immunosuppressive regimen after the first-ever transplant of a kidney from a genetically modified pig to a human. The tegoprubart procedure was done March 16 at Massachusetts General Hospital on a 62-year-old man with end-stage renal disease.
The Hodgkin lymphoma space found itself in the spotlight late last year when Affimed NV rolled out updated data with lead innate cell engager acimtamig when combined with allogeneic natural killer cells. Findings from the investigator-initiated trial became the topic of talk at the American Society of Hematology meeting, when Yago Nieto, professor at the University of Texas MD Anderson Cancer Center – and principal investigator of the study – spoke.
Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld.
Top-line data from Seelos Therapeutics Inc.’s phase II/III study of SLS-005 in amyotrophic lateral sclerosis (ALS) failed to meet statistical significance in its primary and secondary endpoints, continuing the stock’s nearly half-year downward trajectory.
Clearing the way for a U.S. regulatory bid in the second half of this year are positive top-line results from Pathfindr-2, the second of two successful phase III studies testing the efficacy and safety of Crinetics Pharmaceuticals Inc.’s oral, once-daily paltusotine for acromegaly.
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
China’s National Medical Products Administration (NMPA) approved Kechow Pharma Inc.’s MEK inhibitor, tunlametinib, for treatment of patients with NRAS-mutated advanced melanoma who were previously treated with PD-1/PD-L1 inhibitors. The Center for Drug Evaluation granted tunlametinib a priority review. The approval marks the first targeted therapy for this patient population and the first product that originated from Kechow, a privately held firm founded in 2014 to develop small-molecule therapeutics against cancer.
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