TIGITs took another tumble with GSK plc’s decision to end a development program and a collaboration with Iteos Therapeutics Inc. New top-line results from a phase II study in non-small-cell lung cancer using belrestotug, an anti-TIGIT monoclonal antibody, were disappointing so the companies are calling it a day.
Following last fall’s $1 billion development deal with Eli Lilly and Co., precision medicine company Haya Therapeutics SA has raised $65 million in a series A. It’s all part of increased validation from big pharmas that long noncoding RNAs, such as those being developed by Haya, have a strong future.
With positive phase IIa cardiovascular disease results in hand, Marea Therapeutics Inc. said it is ready to move on to a phase IIb study sometime in the second quarter of 2025. MAR-001, a monoclonal antibody targeting the protein coding gene ANGPTL4, produced an up to a 52.5% placebo-adjusted mean reduction in remnant cholesterol and up to a 52.7% placebo-adjusted mean reduction in triglycerides at 12 weeks.
Actuate Therapeutics Inc. said its lead candidate, elraglusib, in pancreatic cancer demonstrated a substantial improvement in median overall survival compared to data from the same phase II study released in December 2024, but it wasn’t enough to convince investors.
Less than a week after announcing it had a new CEO, privately held Creyon Bio Inc. began a licensing and research partnership with Eli Lilly and Co. Creyon is getting $13 million up front and could bring in more than $1 billion in milestone payments. The two plan to find, develop and commercialize RNA-targeted oligonucleotide treatments for a range of diseases.
The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the first oral GLP-1 for treating chronic weight management. So far, however, it has been injectables leading the way to approval.
Less than a week after announcing it had a new CEO, privately held Creyon Bio Inc. began a licensing and research partnership with Eli Lilly and Co. Creyon is getting $13 million up front and could bring in more than $1 billion in milestone payments. The two plan to find, develop and commercialize RNA-targeted oligonucleotide treatments for a range of diseases.
The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
Barely a year after the U.S. FDA shackled Abeona Therapeutics Inc.’s cell-based gene therapy with a complete response letter, the agency has approved it for treating a rare and genetic skin disease. Zevaskyn (prademagene zamikeracel), for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, will be priced in the U.S. at $3.1 million.
Early phase I data for Revolution Medicines Inc.’s RAS(ON) G12D-selective inhibitor zoldonrasib encouraged both the company and the analysts. Initial study data produced a 61% objective response rate in 11 solid tumor patients receiving the 1,200-mg dose once a day. The disease control rate for 16 patients came in at 89%.
