Provention Bio Shares Up After Update on Type 1 Diabetes Drug

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 [e-mail]

(END) Dow Jones Newswires

November 22, 2021 08:43 ET (13:43 GMT)

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