Provention Bio Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
-U.S. Food and Drug Administration (FDA) filing of a Biologics License Application (BLA) and Priority Review for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals; PDUFA goal date of July 2, 2021-
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RED BANK, N.J., Feb. 25, 2021 /PRNewswire/ Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the fourth quarter and full year ended December 31, 2020. 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 cat
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- Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease
- First dosing of PRV-101 in the PROVENT Phase I clinical trial started in January 2021
BILTHOVEN, Netherlands, Jan. 19, 2021 /PRNewswire/
Intravacc, a world leader in translational research and development of vaccines, today announced that a candidate polyvalent inactivated coxsackievirus B (CVB) vaccine it developed and manufactured for Provention Bio in less than 36 months, has entered into a first in human Phase I clinical study called PROVENT (PROtocol for coxsackievirus Vaccine in healthy volunteers) .
Provention Bio is clinical stage biopharmaceutical company, that selected Intravacc in 2018 to lead product development and manufacturing of clinical study material for Provention s vaccine candidate (PRV-101). This CVB vaccine candidate is developed for the intended prevention of acute CVB infection and
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- Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of type 1 diabetes and celiac disease -
RED BANK, NJ, USA I December 15, 2020 I Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the initiation of PROVENT (
PROtocol for coxsackievirus
E in healthy volu
NTeers), a first-in-human study of its polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, PRV-101. Provention is developing PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease.
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RED BANK, N.J., Dec. 15, 2020 /PRNewswire/ Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the initiation of PROVENT (
PROtocol for coxsackievirus
E in healthy volu
NTeers), a first-in-human study of its polyvalent inactivated coxsackievirus B (CVB) vaccine candidate, PRV-101. Provention is developing PRV-101 for the prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease.
CVB is a common enterovirus that frequently causes acute morbidity such as respiratory disease, meningitis, pericarditis, otitis, and hand-foot-mouth disease. CVB is also the leading cause of viral myocarditis, a common condition that can cause fatal arrythmia and lead to a serious chronic myocarditis that often needs heart transplantation. CVB infection is significantly associated with the development of T1D an