Us2.ai receives FDA clearance for Us2.v2,transforming…

RESEARCH TRIANGLE PARK, N.C. — Chimerix, the antiviral drug company that last week filed for an initial public offering of stock, is now on a faster regulatory path for its lead drug candidate.

The Food and Drug Administration’s “fast track” designation for CMX001 gives the Research Triangle Park company’s compound priority review. That faster review is reserved for new drugs addressing serious or life threatening conditions that have few if any alternative treatments. CMX001 is a compound that Chimerix is developing to prevent cytomegalovirus (CMV) infection, an infection that can severely sicken patients with already compromised immune systems. The antiviral works by blocking replication of double-stranded DNA (dsDNA) viruses.

Chimerix has completed phase II clinical trials studying CMX001 as a way of preventing CMV in patients undergoing hematopoietic stem cell transplant procedures. The company expects to start a phase III study later this year in patients undergoing these transplants.