Provention Bio Inc. (PRVB) Misses Q4 EPS by 8c

Provention Bio Inc. (NASDAQ: PRVB) reported Q4 EPS of ($0.58), $0.08 worse than the analyst estimate of ($0.50).

"2020 was a pivotal year for Provention Bio and the type 1 diabetes (T1D) landscape," stated Ashleigh Palmer, CEO of Provention Bio. "The FDA's filing of our BLA for teplizumab represents a momentous achievement for Provention Bio in our mission to potentially deliver the first disease-modifying T1D therapy, which may catalyze a paradigm shift in how pre-symptomatic, at-risk patients are screened and treated before the clinical diagnosis of T1D. We look forward to working closely with the FDA to support the Agency's Priority Review, while we prepare for a potential commercial launch in the second half of this year."

Mr. Palmer continued, "In addition to the considerable progress being made on the teplizumab regulatory front, we're excited about the advancement of our portfolio of additional autoimmunology therapeutic candidates. Our recently initiated first-in-human study of our coxsackievirus B (CVB) polyvalent vaccine candidate, PRV-101, has the potential to be the first vaccine for the prevention of coxsackievirus B infection, a presumed trigger in the development of type 1 diabetes and celiac disease. In addition, our recent partnership agreement with Huadong Medicine not only aides the funding and execution of our PRV-3279 clinical development program in lupus, but we believe also provides external validation of our pioneering business model focused on intercepting and preventing serious, debilitating and life-threatening autoimmune diseases."

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

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