Phase II
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.
Roivant Sciences launches new subsidiary Hemavant that will develop Eisai-licensed asset for transfusion-dependent anemia in patients with low-risk MDS.
Six months after the one-time treatment, 47% of patients in Cohort 1 demonstrated a promising two-step or greater improvement in their diabetic retinopathy.
ProQR Therapeutics has reported that their drug sepofarsen failed to meet its primary and secondary endpoints in recent Phase II/III clinical trials.
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
PRESS RELEASES