Provention Bio on course to file for US approval of teplizumab late 2020

Shares of clinical-stage US biotech Provention Bio (Nasdaq: PRVB) rose 6% in pre-market trading in reaction to reiteration of its registration plan for its Breakthrough Therapy-designated teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes in at-risk people.

Based on written communications from the US Food and Drug Administration and the agency’s - designation of PRV-031 as a breakthrough therapy, the company believes that existing clinical and non-clinical data for PRV-031 will be sufficient to support a Biologics License Application (BLA) submission for PRV-031 in the fourth quarter of 2020 for the at-risk indication.  The company expects to meet with the FDA in the fourth quarter of 2019 to discuss this expedited development plan.

Provention acquired rights to teplizumab from fellow US biotech MacroGenics (Nasdaq: MGNX) in May last year. The latter company had suspended its development in 2010 after a clinical trial run with partner Eli Lilly (NYSE: LLY) showed it failed to slow progression of diabetes.