XBI - Provention Bio (PRVB): BLA Accepted; Downgrading To A Hold
- On March 26th, Provention Bio announced that the FDA accepted the BLA submission of Teplizumab for the delay of type 1 diabetes (T1D) indication for at-risk individuals.
- The goal date for PDUFA is August 17th. Until then, there is no meaningful catalyst, meaning the stock could trade lower for awhile.
- We stand by our previous view and remain bullish on Teplizumab’s success, and we believe re-entering near the catalyst date may be a wise low-risk strategy for investors.
- We maintain the target price of USD 10 (if no dilution happens).
- The key short-term risk would be a dilution of shares due to limited cash runway.
For further details see:
Provention Bio (PRVB): BLA Accepted; Downgrading To A Hold