Provention Bio Inc. (PRVB) stock soars during after-hour session. Here’s to know why?

• The teplizumab Biologics License Application (“BLA”) was incomplete in its submitted form, and additional details would be needed to obtain FDA approval.
• As a result, the teplizumab BLA lacks the evidence-based support that PRVB had promised investors.
• PRVB had thus exaggerated the chances of the teplizumab BLA being approved and, as a result, the teplizumab commercialization timetable.
• As a result, PRVB’s public claims at all applicable times were materially inaccurate and misleading.

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However,

The significant increase occurred after the US Food and Drug Administration (FDA) released briefing papers ahead of a May 27 advisory committee meeting. This committee will look into Provention’s Biologics License Application (BLA) for teplizumab, which is used to prolong the initiation of chronic type 1 diabetes (T1D) in people who are at risk.

The FDA’s briefing papers couldn’t have come at a great time for prevention. The TN-10 pivotal trial “successfully showed the treatment effect of teplizumab in halting T1D diagnosis in at-risk relatives of T1D patients for a median period of approximately 2 years,” according to the department.

There are currently no accepted therapies for delaying the initiation of T1D, according to the FDA briefing papers. The department tended to persuade the advisory committee to consider Provention’s TN-10 report as hitting the threshold for proving feasibility because of the patient necessity and “the impracticality of running a second long-term clinical trial.”

Also,

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet in a few days to discuss the regulatory filing for teplizumab, which will be a major trigger for the biotech stock. Investors are betting that the advisory committee will not take a less friendly position than the FDA briefing materials suggest.