All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
Selecta Biosciences Inc., of Watertown, Mass., and Stockholm’s Swedish Orphan Biovitrum AB (Sobi) signed a licensing agreement for SEL-212, which is designed to control serum uric acid, reduce immunogenicity and allow for repeated monthly dosing when treating chronic refractory gout.
In a bid to expand its presence in the cardiometabolic disease space and strengthen its core business in diabetes and obesity, Novo Nordisk A/S is buying Corvidia Therapeutics Inc., of Waltham, Mass., for $2.1 billion, which includes a $725 million up-front payment.
Checkmate Pharmaceuticals Inc., of Cambridge, Mass., completed an $85 million series C to continue developing CMP-001, a differentiated Toll-like receptor 9 (TLR9) agonist, for treating anti-PD-1-refractory melanoma and to study additional indications that include front-line melanoma and head and neck squamous cell carcinoma.
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.
