Phase II
Marinus Pharmaceuticals reported that its Phase III RAISE trial of IV ganaxolone for status epilepticus will be delayed, thanks to the pandemic.
Shares of Kodiak Sciences plunged nearly 70% in premarket trading after its Phase II/III study of KSI-301 failed to demonstrate non-inferior visual acuity gains compared to Regeneron’s Eylea.
Veru’s enobosarm shows good proof of concept data even when 90% of patients have failed first-line therapies.
Weeks after announcing that its lead monoclonal antibody was demonstrating efficacy against the Omicron variant, Adagio Therapeutics CEO Tillman Gerngross steps down.
Synairgen watched its stock plummet 85% after reporting disappointing Phase III results for its inhaled COVID-19 treatment on Feb. 21.
The FDA asked Homology Medicines to modify the pheNIX gene therapy trial’s risk mitigation measures to prevent any serious issues that may arise.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Clinical Catch-Up for February 21
Biomarin indicated that the FDA had requested more data from non-clinical studies to evaluate the theoretical cancer risk to human trial participants. This is likely to take several quarters.
The NDA acceptance is based on positive results from the KRYSTAL-1 trial, which looked into the effect of using 600mg BID of adagrasib in patients.
PRESS RELEASES