Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.
Corvus Pharmaceuticals Inc.’s success in treating a COVID-19 patient previously diagnosed with non-small-cell lung cancer (NSCLC) with CPI-006 helped boost shares (NASDAQ:CRVS) to $4.96, up $2.21, or 181%, as the Burlingame, Calif.-based company disclosed the start of a phase I study to investigate the anti-CD73 immunotherapy prospect.
Missing the primary endpoint along with key secondary endpoints in a phase III trial of Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating COVID-19 patients who need mechanical ventilation caused Regeneron Pharmaceuticals Inc. and Sanofi SA to halt the study.
Geneva-based Obseva SA’s top-line data from the pivotal phase III studies called Primrose 1 and 2 with GnRH antagonist Yselty (linzagolix) pleased the company, but Wall Street not so much.
DUBLIN – Idorsia Ltd. plans to file an NDA before the year-end for its insomnia drug, daridorexant, following a read-out of top-line data from a second phase III study, which the company said closely tracked an earlier phase III study, although it failed to meet one of two primary endpoints with statistical significance.
The failure of an experimental refractory chronic cough drug to yield statistically significant reductions in placebo-adjusted cough frequency sent shares of its developer, Bellus Health Inc. (NASDAQ:BLU), down 71.7% to $3.40 on July 7.