Business briefs, Feb. 26
FDA to review BioCryst’s drug application
DURHAM – BioCryst Pharmaceuticals Inc. announced Tuesday that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for its flu treatment candidate peramivir.
The announcement sent the company’s stock price up by as much as nearly 15 percent Tuesday.
“We are pleased that BioCryst's first NDA filing has been accepted by the FDA,” Jon P. Stonehouse, BioCryst’s president and CEO, said in a prepared statement. “We believe the approval of peramivir and its mode of (intravenous) administration would benefit many influenza patients, including those who cannot tolerate treatment by oral or inhaled administration.”
Stonehouse said that the company is preparing to make the drug available in the United States during the 2014-15 flu season if final approval is granted in time.
Previously, the company had suspended enrollment in a clinical trial for peramivir after an independent analysis of the results of certain tests found the drug was "trending toward futility." The company got a stop-work order for peramivir from the U.S. Department of Health and Human Services except for certain activities.
But in April 2013, BioCryst said it received a letter from the FDA outlining a way it could file for regulatory approval of the antiviral drug candidate.
The company’s stock price closed at $12.83, up about 11 percent from the previous close.
United Therapeutics stock price down on earnings results
DURHAM – The stock price of Maryland-based United Therapeutics, a drug development company with operations in the Research Triangle Park, was down as much as 5 percent Tuesday, the day of the release of the company’s fourth-quarter financial results.
The company reported a net loss in the quarter of $30.3 million. That’s down from a profit in the same quarter in the previous year of $83.3 million.
And while the company’s revenues were up about 19 percent year-over-year to $289 million in the quarter, they missed analysts’ expectations. On average, analysts expected the company to bring in about $295 million in the quarter, according to Thomson Reuters I/B/E/S.
The drug is the company’s fourth product behind a trio of pulmonary arterial hypertension treatments.
United Therapeutics makes the new drug in the Research Triangle Park and also warehouses and distributes it and two other treatments in the RTP as well.
Lincoln health center to hold Affordable Care Act event
DURHAM – The Lincoln Community Health Center, a primary care center serving the medically underserved, is holding an event from 10 a.m. to 3 p.m. March 8, to help people enroll for health insurance through the Patient Protection and Affordable Care Act.
To schedule an appointment, call 1-855-733-3711.