Provention Bio Shares Up After Update on Type 1 Diabetes Drug
November 22 2021 - 7:58AM
Dow Jones News
By Michael Dabaie
Shares of Provention Bio Inc. were higher in premarket trading
after the biopharmaceutical company provided a regulatory update
for the approval pathway of teplizumab in at-risk Type 1
diabetes.
Provention shares were up 11% to $6.95 in premarket trading
Monday.
Provention updated on its efforts to address U.S. Food and Drug
Administration considerations cited in an FDA rejection letter. The
letter pertained to comparability between the company's planned
teplizumab commercial product and clinical drug product used in
historical trials of teplizumab.
Provention said that last Thursday it had a meeting with the FDA
to discuss the population pharmacokinetic model to be used for
planned commercial and clinical drug product comparison. In
preliminary meeting comments, the FDA approved the company
proceeding to populate the popPK model with data collected from
patients receiving therapeutic doses of teplizumab in a substudy of
the Protect Phase 3 trial in newly diagnosed type 1 diabetes.
Teplizumab is an investigational antibody being developed for
the delay of clinical type 1 diabetes in at-risk individuals.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
November 22, 2021 08:43 ET (13:43 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Provention Bio (NASDAQ:PRVB)
Historical Stock Chart
From Jun 2024 to Jul 2024
Provention Bio (NASDAQ:PRVB)
Historical Stock Chart
From Jul 2023 to Jul 2024
Real-Time news about Provention Bio Inc (NASDAQ): 0 recent articles
More Provention Bio Inc News Articles