The main short term catalyst for Incyte Pharmaceuticals (Nasdaq: INCY) is a PDUFA date of Dec 3 for its JAK1/JAK2 inhibitor ruxolinitib -ruxo for short. This drug met its primary and secondary endpoints in two pivotal Phase III trials named COMFORT I and COMFORT II. In both trials patients treated in the ruxo arm experienced significant spleen reduction as well as clinically meaningful improvements of symptoms and quality of life. These trials were conducted under a Special Protocol Assessment with the FDA.
(As published on Seeking Alpha on Nov 3 2011, click here to read the post and additional comments)
Ariad Pharmaceuticals’ $1.5bn market cap is mainly driven by two drugs in advanced clinical stages: ridaforolimus for soft tissue and bone sarcoma and ponatinib for chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The former is partnered with Merck and presented top-line results of the phase III SUCCEED trial early this year. Merck is now on track to file an NDA later this year. Ariad also announced on August 18 that the EMA had accepted the MAA of the drug.