Recently, Incyte Corporation (INCY) presented additional data from a late-stage study (n=309) of its lead pipeline candidate INC424 (ruxolitinib) for treating patients suffering from myelofibrosis (MF), a rare bone marrow disorder. Data from the study, COMFORT- I, were presented at a conference of the European Hematology Association.
Data from the randomized, double-blind, placebo-controlled study revealed that there was a significant reduction in spleen volume in addition to improvements in total symptom score (TSS) in patients treated in the INC424 arm. Patients in the placebo arm experienced enlargement of the spleen coupled with worsening of symptoms of the disease.
We note that COMFORT- I, conducted by Incyte across multiple sites in the US, Canada and Australia, evaluated the safety and efficacy of INC424 versus placebo in patients suffering from primary MF, post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF).
The European portion of the study (COMFORT – II: n=219) was conducted by partner Novartis (NVS). Incyte is currently seeking US approval of INC424 for the MF indication. Towards fulfilling this objective, Incyte submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for INCB424 earlier in the month.
European approval of the drug for the same indication is also expected to be sought shortly. Detailed results from both studies were recently announced at the 2011 American Society of Clinical Oncology.
We believe that if INC424 is approved and subsequently marketed successfully for MF then it will be a path-breaking achievement for Incyte.
Our Recommendation
Currently, we have a Neutral stance on Incyte in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.
INCYTE CORP (INCY): Free Stock Analysis Report
Be the first to comment