Why Provention Bio (PRVB) Shares Are Trading Higher Premarket Today?

The FDA approved Provention Bio Inc’s PRVB Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes.
Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days.
Tzield’s safety and efficacy were evaluated in a 76-patient trial. The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo.
The therapy narrowly passed the vote at an FDA advisory committee meeting in May last year amid questions about the small study size and more.
The FDA hit teplizumab with a complete response letter, rejecting the application, in June last year.
After resubmitting the marketing application, the FDA extended the review period by three months.
In October, the company announced a co-promotion agreement for the U.S. launch of Tzield for the delay in the onset of clinical T1D in at-risk individuals with Sanofi SA SNY.
Teplizumab was previously developed by MacroGenics Inc MGNX, which PRVB licensed in May 2018.
Under the agreement, MacroGenics is entitled to receive $60 million upon FDA approval.
Price Action: PRVB shares are 4.37% higher at $8.60 premarket on the last check Friday.

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First Drug That Can Delay Onset of Type 1 Diabetes Gets FDA Approval After Multiple Regulatory Hurdles

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