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%.
Bioxodes SA is gearing up fundraising for a follow-up study to the newly released interim phase IIa results of its lead asset in preventing secondary damage after an intracerebral hemorrhagic stroke. Data from the first 16 patients in the phase IIa study show BIOX-101 hit its primary safety and secondary endpoints in an indication that has no approved treatment.