Weekly Catalyst Report
Incyte Corporation (September 21st and 22nd)
Incyte Corporation (ticker: INCY) has a confirmed PDUFA date of September 21, 2021 for its drug candidate ruxolitinib cream. Incyte is developing this cream for the treatment of atopic dermatitis. This PDUFA date was extended previously as announced on June 11, 2021 following the FDA’s request for additional information. The ruxolitinib cream is also being developed for the treatment of patients with vitiligo. Of note, the data from Incyte’s two phase 3 trials for vitiligo has been accepted for presentation on October 2nd, 2021. This conference (European Academy of Dermatology and Venereology) will also highlight additional data from the atopic dermatitis investigations. Incyte also has a second PDUFA date of September 22, 2021 for the oral version of ruxolitinib. The indication for oral ruxolitinib is the treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. This PDUFA date was also extended by the FDA following requests for additional information as announced on June 8, 2021. In the interim, the FDA has issued additional warnings for drugs in the same class of ruxolitinib, thus it is certainly possible that the additional information pertained to this. However, at this time ruxolitinib is not approved for the same indications as other members of the medication class which are required to include this new warning, so it is unclear if then applications will be impacted.
Incyte Corporation is a large-cap company with a current market capitalization of $16,764 million. Incyte Corporation’s 52 week low is $70.97 and 52 week high is $101.47. Incyte Corporation closed trading on 9-20-21 at $75.91, which is 7.0% above the 52 week low and 25.2% below the 52 week high.