What happened
Shares of Provention Bio (PRVB) were soaring 20.4% as of 11:32 a.m. ET on Friday. The big jump came after the company announced that it plans to resubmit the Biologics License Application (BLA) for teplizumab in delaying type 1 diabetes.
So what
In July 2021, the Food and Drug Administration (FDA) issued a Complete Response Letter related to Provention's BLA filing for teplizumab. The biotech stock plunged nearly 30% on the news. With the overall stock market slide in recent weeks, shares of Provention fell even more.
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However, today's announcement gives investors hope that Provention could get back on track. The company said that its decision to refile the BLA for teplizumab came after a meeting with the FDA. Provention and the FDA agreed on changes to the data included in the regulatory package.
In particular, Provention will propose a modified 14-day course of therapy to address the FDA's concerns. The company also plans to address chemical, manufacturing, and controls issues raised by the FDA in a meeting held in August 2021.
Now what
Provention stated that it hopes to resubmit the BLA for teplizumab in the first quarter of 2022. There's no guarantee that the FDA will approve the drug. However, the company's prospects look better now than they've been in quite a while.