Last week we saw the MDGL NASH data on Monday and it's up over +300%. This next week we see LOTS of PDUFA events happening to close out the year. See below for a table full of major readouts you should keep an eye on.
Weekly Watchlist Highlights:
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 The NDA for palovarotene was previously withdrawn in August 2021 and then resubmitted in June 2022.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.
Resubmitted BLA accepted on 8/3/22 and PDUFA target action date set at January 1, 2023. EMA accepted, expects a decision from the European Commission in the first quarter of 2023. Licensed from MediWound (MDWD).
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