Incyte Corporation (INCY - Free Report) inked a deal with molecular information company, Foundation Medicine, Inc., for the development, regulatory support and commercialization of companion diagnostics (CDx). The companies will initially focus on the CDx development for Incyte’s fibroblast growth factor receptor (FGFR) 1/2/3 inhibitor, pemigatinib (INCB54828), in patients with cholangiocarcinoma. CDx is a potential new precision oncology treatment option for cholangiocarcinoma.
The aim of the collaboration is to develop a companion diagnostic to enable testing at diagnosis of the stage IV disease, with the aim of reducing morbidity and mortality.
The initial CDx will include detection of activating FGFR2 translocations. It is expected to be incorporated into FoundationOne CDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay and broad CDx platform. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from the treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.
We note that pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3, which has shown selective pharmacologic activity against cancer cells with FGFR alterations in preclinical studies. The candidate is currently in phase II study, FIGHT, and is being evaluated across several FGFR-driven malignancies.
Year to date, shares of the company have declined 29.5% compared with the industry’s decline of 5.1%.
Meanwhile, the lead drug for Incyte is Jakafi which is approved in the United States for the treatment of patients with polycythemia vera (PV), who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF. The company has an agreement with Novartis (NVS - Free Report) for Jakafi (excluding topical formulations). Per the agreement, Incyte is marketing Jakafi in the United States while Novartis is responsible for the same outside the country.
The company also has an agreement with Lilly (LLY - Free Report) for Olumiant. Per the agreement, Lilly has exclusive worldwide development and commercialization rights to Olumiant. The recent FDA approval of Olumiant has triggered a $100-million milestone payment from Lilly.
Zacks Rank & Stocks to Consider
Incyte is a Zacks Rank #3 (Hold) stock.
Another better-ranked stock in the biotech sector is Gilead Sciences Inc (GILD - Free Report) , sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.12 to $6.58 for 2018 and from $6.36 to $6.48 for 2019 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has inched up 0.8% so far this year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>