Soleno Therapeutics Inc.’s phase III DESTINY PWS (C601) trial evaluating once-daily diazoxide choline controlled-release tablets for treating patients with Prader-Willi syndrome (PWS) missed its primary endpoint of change from baseline in hyperphagia, or insatiable hunger, which is the disease’s predominant syndrome.
In a big day of setting up IPOs for launch, the charge is being led by Royalty Pharma, a buyer of biopharmaceutical royalties and an industry funder, which is aiming at a $2 billion offering. That massive number is more than half of the total biotech offerings brought in through May.
The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
Athira Pharma Inc. closed on an $85 million series B financing designed to advance its small molecule, NDX-1017, into a phase II/III trial for treating Alzheimer’s disease later this year. The company is using positive data generated last year from its phase Ia/b trial in patients with mild to moderate Alzheimer’s disease as a springboard to the clinic.
New interim phase II data from Replimune Group Inc., of Woburn, Mass., show RP-1 and Opdivo (nivolumab, Bristol-Meyers Squibb Co.) produced multiple complete responses and a high rate of deep responses in anti-PD-1/anti-CTLA-refractory melanoma.
The juggernaut that is Daiichi Sankyo Co. Ltd.’s Enhertu continued to roll into this weekend’s American Society of Clinical Oncology virtual meeting, bringing momentum from its December FDA approval for HER2-positive breast cancer, along with fresh data from three new studies in other indications.
Aduro Biotech Inc. and privately held Chinook Therapeutics Inc., will merge to focus mainly on kidney diseases. Two complementary drugs are involved in the deal.
In data taken from three expansion cohorts of Exelixis Inc.’s phase Ib study of Cabometyx and Tecentriq in patients with locally advanced or metastatic solid tumors, a 27% objective response rate was seen in those with immune checkpoint inhibitor-pretreated non-small-cell lung cancer.
Two phase III stumbles of Iterum Therapeutics plc’s sulopenem have cast the company’s future in doubt. The latest problem is the failure of the penem anti-infective compound, with oral and I.V. formulations, failing to achieve statistical noninferiority relative to ertapenem in treating complicated urinary tract infection (cUTI).
