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BPIQ Biotech Catalyst Watchlist - 11/13/22

There are a number of biotech catalyst events left in November, including FDA/PDUFA events, data readouts, and biomedical meetings. See the table below highlighting the events in the next 2 weeks:

November BiopharmIQ Catalyst Calendar (FDA Biotech Calendar)
Catalyst Calendar

PRVB - Provention Bio

PRVB's asset PRV-031 (Teplizumab) has a PDUFA target action date of November 17, 2022 for the treatment of Type 1 diabetes. The teplizumab BLA previously received a CRL on July 6, 2021 and the BLA was resubmitted on February 22, 2022. The BLA was accepted in March and a PDUFA date was originally set for August 17, 2022, but was extended to 11/17/2022 in June 2022. Positive data had previously been reported throughout 2020 and 2021 and an AdComm meeting for the first submission had a vote of 10-7 that the benefits outweighed the risks of teplizumab. Sanofi will be joining forces with Provention Bio to bring Teplizumab to market.


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