What happened
Shares of Provention Bio (PRVB) were soaring 21.6% as of 10:56 a.m. EDT on Tuesday. The big jump came after the U.S. Food and Drug Administration (FDA) released briefing documents in advance of an advisory committee meeting scheduled for May 27. This advisory committee will review Provention's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
So what
Provention couldn't have asked for better news in the FDA's briefing documents. The agency stated that the company's TN-10 pivotal study "successfully demonstrated the treatment effect of teplizumab in delaying T1D diagnosis in at-risk relatives of T1D patients for a median time of approximately 2 years."
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The FDA briefing documents also noted that there aren't any approved therapies currently for delaying the onset of T1D. Because of the medical need and "the impracticality of conducting a second long-term clinical trial," the agency appeared to encourage the advisory committee to accept Provention's TN-10 study as meeting the threshold for showing effectiveness.
Now what
The next key catalyst for the biotech stock will come in just a couple of days when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meets to review the regulatory filing for teplizumab. Although the advisory committee could take a less favorable stance than the FDA briefing documents do, investors are betting that won't be the case.
