Incyte (INCY) recently announced that the FDA has accepted for Priority Review the company’s new drug application (NDA) for pemigatinib, notes biotech expert John McCamant, editor of The Medical Technology Stock Letter.
Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
The drug development candidate is currently in multiple Phase II/III trials in various FGFR tumor types. Because FGFR is a growth factor which plays a key role in both tumor cell proliferation and survival, in our view, there is clearly potential for pemugatinib to become a cancer drug for multiple indications.
Importantly, Priority Review shortens the review period to 8 months compared to 12 months for Standard Review. The PDUFA target action date is May 30, 2020. The NDA submission is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.
The next potential catalyst for Incyte will be the Phase III GRAVITAS-301 trial for itacitinib in steroid naïve acute GVHD which is due before year end. Given Jakafi’s positive outcome in steroid refractory acute GVHD, we expect the data to be positive despite the fact that steroid naïve patients require higher efficacy than refractory patients.
With the recent M&A activity, we want to remind investors that this company remains a prime takeout candidate with strong revenues and a wholly owned pipeline of oncology development assets.
