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Provention Bio Inc. (PRVB) Tops Q3 EPS by 5c

November 5, 2019 5:00 PM EST

Provention Bio Inc. (NASDAQ: PRVB) reported Q3 EPS of ($0.24), $0.05 better than the analyst estimate of ($0.29).

"The PRV-031 program continues to build momentum, with positive developments on the regulatory front that strengthen our confidence in the path forward for the prevention or delay of the onset of clinical type 1 diabetes (T1D) in at-risk individuals," stated Ashleigh Palmer, CEO, Provention Bio. "Recent Breakthrough Therapy and PRIME designations from the FDA and European Medicines Agency (EMA), respectively, recognize and confirm the unmet need of these individuals and we believe validate the transformative potential of this therapeutic candidate. Based on our interactions with the FDA, we believe that the existing clinical efficacy and safety, as well as non-clinical data, has the potential to support a BLA filing with the FDA in the fourth quarter of next year, and look forward to confirming this expedited regulatory path at a multi-function, Type B meeting with the Agency this quarter."

"We believe the progress of our PRV-031 T1D at-risk program not only represents a unique opportunity in its own right, but also more broadly validates Provention's founding strategic intent to develop other novel therapies that intercept or prevent immune-mediated diseases. We continue to advance our programs, including the ongoing PROTECT Phase 3 clinical study evaluating PRV-031 in newly diagnosed T1D patients and our ongoing Phase 1b PREVAIL clinical trial evaluating PRV-3279. PRV-3279 has the potential to intercept the pathophysiology of systemic lupus erythematosus (SLE) and other B cell-mediated autoimmune diseases, as well as manage clinically relevant immunogenicity associated with gene therapies and certain recombinant protein therapeutics."

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



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