Shares of Provention Bio Inc. (NASDAQ:PRVB) closed March 13 at $24.10, up $17.40, or 259%, after Wall Street learned that collaborator Sanofi SA intends to acquire the firm for $25 per share in cash, which works out to an equity value of about $2.9 billion. The transaction brings Paris-based Sanofi the type 1 diabetes (T1D) therapy Tzield (teplizumab-mzwv), approved by the U.S. FDA in 2022 as the first and only therapy to delay the onset of stage 3 disease in adults and in pediatric patients ages 8 and older with T1D that has reached stage 2.
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
By next June or July, Swedish firm Atrogi AB expects to have data from a first-in-human phase Ia/Ib trial of its novel beta-2 adrenergic receptor agonist, ATR-258, which is in development for type 2 diabetes. The study has completed single ascending and multiple ascending-dose arms in 52 healthy volunteers and recently started recruiting 24 patients onto the phase Ib portion.
Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle.
After raising an undisclosed sum in a series A round, French biotech company Adipopharma LLC aims to progress its make-or-break targeted insulin resistance peptide into a phase I trial in type 2 diabetes patients by the end of 2023.
Leveraging a computational platform designed to exploit the full potential of a widely studied pharma target has proved successful in attracting venture investors in the last few years to Structure Therapeutics Inc. The company now is giving the public markets a go, aiming to raise up to $100 million in what marks the first biopharma U.S. IPO filing for 2023.
Oramed Pharmaceuticals Inc. has had a lot of success with testing its oral insulin, until now. The company will discontinue it oral insulin clinical work in treating type 2 diabetes after ORMD-0801 failed to hit its phase III study’s primary and secondary endpoints. The late-stage stumble clobbered the company stock (NASDAQ:ORMP), which lost 76% of its value on Dec. 12 to close at $2.54 each.
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes.
Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. And research into the drug class is continuing apace.
Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D.
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