DURHAM – Biocryst, which recently failed to secure a merger and is now looking to raise $57.5 million, on Monday said it had received fast-track designation from the FDA for a drug it has under development.
The drug, known as BCX7353 is intended to prevent angioedema attacks in patients with hereditary angioedema (HAE).
According to the National Institutes of Health, hereditary angioedema “is a disorder characterized by recurrent episodes of severe swelling (angioedema). The most common areas of the body to develop swelling are the limbs, face, intestinal tract, and airway. Minor trauma or stress may trigger an attack, but swelling often occurs without a known trigger.”
“Fast Track Designation from the FDA serves as another indicator of the importance of BCX7353 to meet an unmet medical need for HAE patients in the U.S.,” said Jon Stonehouse, CEO of BioCryst, in a statement. “We remain focused on completing the Phase 3 program and preparing for an NDA filing in the second half of 2019.”
“Fast track” designation could mean more “frequent interactions” with the FDA and “priority review” for drugs under development.based upon clinical data, Biocryst noted.
The news just weeks after a merger between BioCryst and Idera Pharmaceuticals fell through.
In early July BioCryst shareholders rejected a January 2018 merger agreement with Idera Pharmaceuticals, in a special vote that left BioCryst in the Triangle rather than moving to Pennsylvania. Key shareholders said the merger undervalued BioCryst’s upside potential.
Last week, BioCryst launched the new fund-raiser, seeking to generate up to $57.5 million in stock in an underwritten public offering to kick its way into the marketplace from North Carolina.
BioCryst, founded in 1986 in Birmingham, Ala., designs and develops small-molecule drugs that block key enzymes involved in rare diseases. It moved its headquarters to Durham in 2010. That’s where it achieved its first product approval in RAPIVAB, a viral neuraminidase inhibitor for treating influenza.