Incyte Corporation (NASDAQ:INCY) announced new 28-week data from the Phase 3 RESPONSE-2 study of Jakafi® (ruxolitinib). The data show that Jakafi was superior to best available therapy (BAT) in maintaining hematocrit control (62.2% vs. 18.7%, respectively; P<0.0001)1 without the need for phlebotomy in patients with inadequately controlled polycythemia vera (PV) resistant to or intolerant of hydroxyurea (HU) who did not have an enlarged spleen. The safety profile of Jakafi was consistent with previous studies. These findings were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.
In RESPONSE-2, patients did not have an enlarged spleen, as assessed by physical examination at each study visit (spleen palpation), and a majority (70%) were previously treated with HU only, therefore considered to have less advanced disease. The remaining patients were treated with multiple lines of therapy (30%).1
“We are pleased with the RESPONSE-2 study results presented at EHA, which reinforce the superiority of Jakafi over best available therapy in achieving hematocrit control, without phlebotomy, in patients with inadequately controlled PV without enlarged spleens,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “These results are meaningful to patients with uncontrolled PV who have few other treatment options to help manage their disease.”
Additionally, the RESPONSE-2 study demonstrated that nearly five times more patients with PV achieved complete hematologic remission with Jakafi compared to BAT at 28 weeks (23.0% vs 5.3% respectively, p=0.0019). Patients taking Jakafi also experienced improvement in their PV symptoms compared to BAT (50% vs 7.7%, respectively). Overall, Jakafi was well tolerated. Findings from this study are consistent with data from the RESPONSE pivotal trial, which evaluated patients with inadequately controlled PV with an enlarged spleen.1,2
“A key treatment goal for patients with PV is to achieve and maintain hematocrit control, and compared to best available therapy, these results from the RESPONSE-2 study demonstrate the clinical benefits of Jakafi in PV patients with less advanced disease,” said lead study investigator Francesco Passamonti, M.D., the University of Insubria, Varese, Italy. “The results from RESPONSE-2, coupled with the previously reported results, support Jakafi as a second-line treatment option for patients with PV.” (Original Source)
Shares of Incyte closed yesterday at $81.61, down $1.29 or -1.56%. INCY has a 1-year high of $133.62 and a 1-year low of $55. The stock’s 50-day moving average is $77.41 and its 200-day moving average is $82.78.
On the ratings front, Incyte has been the subject of a number of recent research reports. In a report issued on June 7, BMO analyst Ian Somaiya reiterated a Buy rating on INCY, with a price target of $97, which implies an upside of 19% from current levels. Separately, on June 6, Brean Capital’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $92.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ian Somaiya and Jonathan Aschoff have a total average return of 17.1% and -8.6% respectively. Somaiya has a success rate of 61% and is ranked #138 out of 3903 analysts, while Aschoff has a success rate of 39% and is ranked #3866.
The street is mostly Bullish on INCY stock. Out of 8 analysts who cover the stock, 8 suggest a Buy rating . The 12-month average price target assigned to the stock is $92.60, which implies an upside of 13.5% from current levels.
Incyte Corp. is a biopharmaceutical company, which focuses on the discovery, development, development, formulation, manufacturing and commercialization of proprietary therapeutics to treat serious unmet medical needs, primarily in oncology. Its product, Jakafi, a JAK1 and JAK2 inhibitor, is currently approved in the U.S. for the treatment of intermediate or high-risk myelofibrosis and is in development as a potential treatment for other cancers.