FDA sends NovaVax back to the clinic; Stoke Therapeutics sets terms for upsized $101M IPO
→ A beleaguered NovaVax has run into a major hurdle on its RSV vaccine’s quest to market. The FDA is asking the company to conduct a whole new Phase III trial to confirm that ResVax can protect infants from “medically significant RSV disease” if their mothers were vaccinated. While it’s sorting out the situation in the US and Europe, NovaVax said it will continue working with its backers at the Bill & Melinda Gates Foundation to introduce the vaccine in low to middle income countries.
→ Calliditas Therapeutics and Everest Medicines have entered into a license agreement to develop and commercialize Calliditas’ lead drug candidate, Nefecon — which is currently being run in a global Phase III clinical trial for patients with chronic autoimmune kidney disease IgA Nephropathy (IgAN) — in Greater China and Singapore. Sweden-based Calliditas will receive an upfront payment of $15 million with potential milestones up to $106 million.
→ Diasome Pharmaceuticals, which is developing Hepatocyte Directed Vesicle (HDV) technology that is designed to be mixed with any commercially available insulin to lessen the instances of blood glucose highs and lows in patients living with diabetes, on Monday posted a snapshot of data from a six-month mid-stage study testing the drug, HDV-L, at the American Diabetes Association meeting.
“In patients with higher baseline HbA1C, HDV-L led to a HbA1C reduction equivalent to conventional Lispro treatment, but these HDV-L treated subjects reduced their mealtime insulin dose by 25% and experienced a trend towards a 73% reduction in time spent in hypoglycemia. Patients with lower baseline HbA1C levels did not change their bolus mealtime insulin doses and spent increased time in hypoglycemia. These results are consistent with the core hypothesis that improved liver glucose storage at mealtime should reduce both peripheral glucose exposure and peripheral insulin requirements,” said David Klonoff, the principal investigator of the study, in a statement.
→ Preclinical biotech Stoke Therapeutics has broken out the terms of its IPO. The Bedford, Massachusetts-based company plans to offer 6.7 million shares in the price range of $14 to $16 to raise $101 million, it said in a filing Friday. The company plans to list under the symbol $STOK.
→ The genome sequencing experts at Personalis have also announced an IPO. The company plans to offer 6.7 million shares in the price range of $14 to $16 to raise $100 million, it said in a filing Friday and will trade as $PSNL.