We're winding down to the end of 2022 but still have lots of major readouts left with year. This includes readouts from companies like TGTX, IPSEY, MDGL, IONS, and more! See below for a table full of major readouts you should keep an eye on.
Weekly Watchlist Highlights:
CHRS's asset Toripalimab has a PDUFA target action date of 12/23/2022 for the treatment of recurrent or metastatic Nasopharyngeal Carcinoma. Toripalimab previously received a CRL on 5/2/2022 and the BLA was resubmitted and accepted in July 2022.
TGTX's asset has a PDUFA target action date of 12/28/2022 for Ublituximab to treat Multiple Sclerosis. The PDUFA date was extended from September 28 to December 28 on 5/31/2022. Currently there are a handful of other MS assets in late stage trials in the BPIQ database.
IPSEY's asset Palovarotene has a PDUFA target action date of 12/29/2022 to treat fibrodysplasia ossificans progressiva (FOP). The NDA for palovarotene was previously withdrawn in August 2021 and then resubmitted in June 2022. An AdComm meeting was scheduled for 10/31/22 but was postponed to allow more time for review. The PDUFA date has not been changed but it is uncertain if the AdComm can be completed before the scheduled PDUFA date.
Ph3 MAESTRO-NASH trial topline results expected Q4 2022. MAESTRO-NASH & MAESTRO-NAFLD-1 studies are intended to serve as the foundation for a new drug application filing for resmetirom in the noncirrhotic NASH population in the first half of next year.
