Provention Bio Inc. (PRVB) Tops Q4 EPS by 2c

Provention Bio Inc. (NASDAQ: PRVB) reported Q4 EPS of ($0.22), $0.02 better than the analyst estimate of ($0.24).

"2019 was a transformational year for Provention Bio and the type 1 diabetes (T1D) landscape," stated Ashleigh Palmer, CEO of Provention Bio. "Data from the 'At-Risk' study published in the New England Journal of Medicine in June highlights the potential of PRV-031 (teplizumab) to prevent or delay onset of clinical T1D in individuals at risk of end-stage, insulin-dependent disease. Our receipt of Breakthrough Therapy and PRIME designations from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), respectively, recognizes and confirms the unmet T1D need and validates the transformative therapeutic potential of teplizumab."

Mr. Palmer continued, "Based on our discussions with the FDA late last year, we are now moving forward with preparing the various modules of our Biologics License Application (BLA), including generating the necessary drug substance comparability data to support our chemistry, manufacturing and controls (CMC) module. We remain on track to complete our rolling BLA submission in the fourth quarter of this year. In parallel with these efforts, in the first few months of 2020 we have commenced the build-out of our commercial leadership organization to support a potential launch of teplizumab as the first disease-modifying drug approved for T1D since insulin therapy in 1922."

For earnings history and earnings-related data on Provention Bio Inc. (PRVB) click here.

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