NEW HAVEN — A bio-pharmaceutical company based in the city said in a regulatory filing last week that the federal Food and Drug Administration has accepted its new drug application for treatment and prevention of migraine headaches.
The Oct. 3 filing with the federal Securities and Exchange Commission also indicates that the review process for Biohaven’s drug candidate, Rimegepant, had priority review status by the FDA. That means the FDA’s goal is to take action on an application within six months and a decision on whether the drug should be approved could come by the end of the first quarter of 2020.
More than 38 million people in the United States suffer from some sort of migraine headaches, according to the Migraine Research Foundation.
Vlad Coric, the company’s chief executive officer, said the company has about 140 workers and that approval of Rimegepant “will result in a significantly higher employee count.”
The company has about 75 employees in New Haven’s Science Park complex. Its headquarters is at 234 Church St.
Sumant Kulkarni, an investment analyst with Boston-based Canaccord Genuity, said in a note to investors after Biohaven’s filing last week that he was “encouraged by the information in the company’s SEC filing because the FDA’s communications with the company indicate there are no major safety concerns identified with Rimegepant; and there there is no anticipated need for a risk evaluation and mitigation strategy associated with the agency’s review of the drug.
“(There) are no specific issues that require Biohaven’s input at this time,”Kulkarni wrote. “These comments are preliminary but lead us to be more confident in our 90 percent probability of approval assumption for Rimegepant for the acute treatment of migraine.”
“The bottom line is we remain buyers of (Biohaven’s stock),” the analyst’s note said in part. Biohaven is scheduled to submit migraine prevention data to the FDA sometime before the end of the year, according to Kulkarni.
The price of the company’s stock, which trades on the Nasdaq exchange under the symbol BHVN, has fluctuated wildly in 2019.
It was trading at around $35 per share at the start of January and closed at a high of $67.01 on June 7. Since then, the price has plunged dramatically, hitting low of $37.38 on Aug. 20.
The company’s stock closed at $41.90 per share Monday, down $1.34 from Friday’s close of U.S financial markets.