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Incyte Corporation (INCY - Free Report) recently announced that the first patient has been treated in the RESET trial on ruxolitinib.
The trial is evaluating ruxolitinib compared to anagrelide for the treatment of patients with essential thrombocythemia (ET) who are resistant to or are intolerant to hydroxyurea (HU).
The randomized, double-blind, double-dummy pivotal study (NCT03123588) evaluates the safety and efficacy of ruxolitinib versus anagrelide for the treatment of ET, a rare and chronic blood cancer.
The study is now likely to enrol approximately 120 patients, 18 years or older, with ET who are resistant to or are intolerant to HU.
The primary endpoint of this study is to find out the number of patients who achieve platelet and WBC control over 1 year of follow-up. Key secondary endpoints include safety and tolerability and the proportion of patients who achieve complete remission or partial remission.
We note that ruxolitinib is approved as Jakafi in the United States for the treatment of polycythemia vera (PV) patients who have had an inadequate response to or are intolerant to HU.
Jakafi is also approved for treatment of patients suffering from intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post-essential thrombocythemia MF.
The drug is marketed by partner Novartis AG (NVS - Free Report) outside the United States.
Incyte’s shares have moved up 4.9% year to date compared with the industry’s 1.6% gain.
In order to augment the commercial potential of the drug, the company is working on expanding the drug’s label further. Incyte has initiated a phase II study (REACH-1) on Jakafi, in combination with corticosteroids, in patients with steroid-refractory acute Graft-versus-host disease (GVHD).
Assuming REACH 1 trial will be successful, the company plans to submit an sNDA seeking accelerated approval of Jakafi for the treatment of patients with steroid-refractory acute GVHD during 2018.
Meanwhile, RESET-272, the double-blind, randomized pivotal trial of Jakafi versus anagrelide for the treatment of patients with essential thrombocythemia who are resistant to or are intolerant to HU, is now open for enrolment. Based on strong performance so far in 2017, the company upped guidance for Jakafi and now expects revenues in the range of $1,125-$1,135 million, up from the earlier projected range of $1,090-$1,120 million.
Zacks Rank & Key Picks
Incyte currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. and Corcept Therapeutics Incorporated (CORT - Free Report) . While Sucampo sports a Zacks Rank #1 (Strong Buy), Corcept carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings per share estimates have increased from $1.01 to $1.11 for 2017 and from $1.06 to $1.21 for 2018 over the last 30 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%.
Corcept’s earnings per share estimates have moved up from 45 cents to 48 cents for 2017 and from 77 cents to 80 cents for 2018 over the last 60 days. The company delivered positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%.
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Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
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Incyte (INCY) Initiates Essential Thrombocythemia Trial
Incyte Corporation (INCY - Free Report) recently announced that the first patient has been treated in the RESET trial on ruxolitinib.
The trial is evaluating ruxolitinib compared to anagrelide for the treatment of patients with essential thrombocythemia (ET) who are resistant to or are intolerant to hydroxyurea (HU).
The randomized, double-blind, double-dummy pivotal study (NCT03123588) evaluates the safety and efficacy of ruxolitinib versus anagrelide for the treatment of ET, a rare and chronic blood cancer.
The study is now likely to enrol approximately 120 patients, 18 years or older, with ET who are resistant to or are intolerant to HU.
The primary endpoint of this study is to find out the number of patients who achieve platelet and WBC control over 1 year of follow-up. Key secondary endpoints include safety and tolerability and the proportion of patients who achieve complete remission or partial remission.
We note that ruxolitinib is approved as Jakafi in the United States for the treatment of polycythemia vera (PV) patients who have had an inadequate response to or are intolerant to HU.
Jakafi is also approved for treatment of patients suffering from intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post-essential thrombocythemia MF.
The drug is marketed by partner Novartis AG (NVS - Free Report) outside the United States.
Incyte’s shares have moved up 4.9% year to date compared with the industry’s 1.6% gain.
In order to augment the commercial potential of the drug, the company is working on expanding the drug’s label further. Incyte has initiated a phase II study (REACH-1) on Jakafi, in combination with corticosteroids, in patients with steroid-refractory acute Graft-versus-host disease (GVHD).
Assuming REACH 1 trial will be successful, the company plans to submit an sNDA seeking accelerated approval of Jakafi for the treatment of patients with steroid-refractory acute GVHD during 2018.
Meanwhile, RESET-272, the double-blind, randomized pivotal trial of Jakafi versus anagrelide for the treatment of patients with essential thrombocythemia who are resistant to or are intolerant to HU, is now open for enrolment. Based on strong performance so far in 2017, the company upped guidance for Jakafi and now expects revenues in the range of $1,125-$1,135 million, up from the earlier projected range of $1,090-$1,120 million.
Zacks Rank & Key Picks
Incyte currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. and Corcept Therapeutics Incorporated (CORT - Free Report) . While Sucampo sports a Zacks Rank #1 (Strong Buy), Corcept carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings per share estimates have increased from $1.01 to $1.11 for 2017 and from $1.06 to $1.21 for 2018 over the last 30 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%.
Corcept’s earnings per share estimates have moved up from 45 cents to 48 cents for 2017 and from 77 cents to 80 cents for 2018 over the last 60 days. The company delivered positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Click here for Zacks' private trades >>