Plus, news about Ascendis Pharma, Korro Bio, Novo Nordisk and Medexus:
Nuvalent offers $350M in shares: The oncology biotech is looking to capitalize on a swell of investor interest, with its share price $NUVL up about 24% on Monday morning. At the European Society for Medical Oncology’s annual meeting over the weekend, Nuvalent announced that it now expects pivotal data from two clinical programs in 2025.
FDA lifts partial hold on Zentalis Pharmaceuticals’ main drug: The company said Monday that it can now continue enrolling in “all ongoing azenosertib clinical studies.” The FDA placed three trials on partial hold in June after two patient deaths were reported. Its stock $ZNTL was up about 30% on Monday morning.
Ascendis Pharma reports victory in dwarfism pivotal trial: The company said patients given a once-weekly dose of navepegritide had a higher annual growth rate than placebo, the primary endpoints of the trial. Wall Street responded in kind, with shares $ASND up about 18% on Monday morning. It plans to submit for FDA approval in the first three months of 2025.
RNA editing biotech inks Novo Nordisk pact worth up to $530M: Korro Bio will handle preclinical development for two candidates aimed at cardiometabolic diseases. Novo Nordisk will then have the option to take the lead on clinical trials.
Medexus’ FDA review extended by three months: The new PDUFA date for treosulfan is Jan. 30. The FDA told the company’s commercial partner, medac, that it needs more time to review a supplemental analysis of data that’s been deemed a “major amendment.” Medexus said the FDA has not requested additional clinical trial data.