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.
Just shy of four years ago, MEI Pharma Inc. and Helsinn Group hashed out a $464 million deal to develop and commercialize pracinostat. Now an interim futility analysis has persuaded them to halt their phase III study in acute myeloid leukemia (AML) while, pending further evaluation, patients enrolled in other pracinostat studies continue their treatment.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Abivax, Apellis, Biocardia, Menarini, Moleculin, Pfizer, Vaccibody.
Strongly positive histological data from Akero Therapeutics Inc. is being seen as setting a potentially new high bar in treating nonalcoholic steatohepatitis (NASH), but 89bio Inc.’s NASH treatment, on a similar development timeline, is sharing in the success.
LONDON – Biontech SE announced positive preliminary data from the ongoing phase I/II trial of one of the four COVID-19 vaccines it is developing with Pfizer Inc., with participants in each of three dose groups mounting immune responses that were greater than seen in patients who recovered from COVID-19 infections.
Zynerba Pharmaceuticals Inc.’s stock was slashed nearly in half June 30 as the company’s pivotal Connect-FX study for treating fragile X syndrome behavioral symptoms failed to achieve statistical significance in its primary and three key secondary endpoints.
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