Provention Bio may be waiting a bit longer for the FDA's decision on its diabetes prevention drug teplizumab, but at least the biotech has $60 million cash in the meantime to work through launch preparations.
At the end of June, the FDA told the biotech that more time is needed to make a decision regarding teplizumab after getting a look at some new information. The agency extended its review by three months, possibly delaying a decision until Nov. 17.
Now, the New Jersey biotech has sold off 13,318,535 shares of common stock to institutional investors in a private placement. The shares were sold at $6 apiece and will have a five-year term. Provention expects gross proceeds from the offering to be around $60 million.
The money will be used to prepare for the potential launch of teplizumab, though the drug’s future remains in the FDA’s hands. If the FDA doesn’t identify any major deficiencies, it plans to discuss proposed labeling and any postmarketing requirement or commitment requests with Provention by Oct. 17.
In January, Provention was given a green light from the FDA to resubmit the teplizumab application, which had been on hold as the agency questioned whether the planned commercial product was comparable to the product used in historical trials.
Teplizumab was granted a breakthrough-therapy designation, meaning the FDA is expected to make a decision within six months compared to the typical 10.
The drug is designed to help delay clinical Type 1 diabetes in at-risk people. Provention found in clinical trials that teplizumab delayed disease onset by a median of two years, which can help patients avoid diabetic ketoacidosis, a life-threatening complication of diabetes.