Apr 27, 20211 min
$SLGL -12.7% Sol-Gel received no notification from FDA of approval of EPSOLAY; pre-approval inspection still needs to be conducted. source
$YMAB -1% Omburtamab MAA submitted to EMA. source
$PRVB -2.6% FDA ongoing review of teplizumab BLA; review will further be mentioned at 5/27 committee meeting. source
$SRNE +4.9% Phase 2 trial cleared to proceed. source
$RVVTF -3.6% Orphan Drug Designation for Psilocybin filed with FDA. source
$CYCN -18% Presents update on CY6463 trials; MELAS trial enrolling slowly and ADv trial to begin enrolling in mid year. source
$LUMO -4.6% Phase 2 LUM-201 data presented at webinar. source
$ZGNX -0.6% Global access program launched for FINTEPLA. source
$ESPR -4.3% Publication of CLEAR trial rationale and design evaluating NEXLETOL. source
$RVNC -0.8% First patient enrolled in Phase 3 trials of DaxibotulinumtoxinA. source
$PTGX -0.4% Enrollment in Phase 2 trial of rusfertide completed. source
$ALKS +0.1% Phase 2 ARTISTRY-6 trial initiated in patients with melanoma. source
$ALDX +33.7% Phase 3 INVIGORATE clinical trial achieves primary endpoint and all secondary endpoints. source
$RMTI -6.3% Triferic AVNU receives marketing approval in Canada. source
$ARAV +11.1% First patient dosed in Phase 3 AVB-500 trial. source
$VRNA -1.5% Phase 2b results published in International Journal of Chronic Obstructive Pulmonary Disease. source
$OBSV -2.9% PRIMROSE 3 bone mineral density study initiated for previous participants. source