Specifically, the Food and Drug Administration extended the review period for Incyte’s new-drug application. The action date has been extended by three months to Sept. 21.
Incyte recently traded at $82.52, down 5.7%. It has firmed 0.7% over the past six months.
“The FDA extended the … action date to allow time to review additional analyses of previously submitted data provided by Incyte in response to the FDA’s information request.” the company said.
“The submission of the additional information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension.”
Incyte is unbowed.
“We are confident in the potential of ruxolitinib cream to offer a safe and effective treatment option for atopic dermatitis and will continue to work with the FDA to bring this targeted topical therapy to patients in the U.S. as soon as possible,” said Steven Stein, Incyte’s chief medical officer.
Ruxolitinib cream is in Phase 3 development to treat adolescents and adults with atopic dermatitis and vitiligo, another skin condition.
In other drug news, Vertex Pharmaceuticals VRTX shares fell Friday, after the company halted an effort to develop a therapy for a rare genetic disorder that affects the lungs and liver.
Meanwhile, Curis CRIS shares lost a third of their market value Friday, after the drugmaker said it would take a 300mg dose of its CA-4948 leukemia treatment into Phase 2 trials.