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Incyte (INCY) Announces Positive Data on Jakafi for GVHD
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Incyte Corporation (INCY - Free Report) announced updated results from a pivotal phase II REACH1 study on lead drug Jakafi at the American Society of Hematology (ASH) Annual Meeting 2018 in San Diego, California.
The study evaluated Jakafi in combination with corticosteroids as a treatment for patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids.
In the trial, 68% of patients had Grade III or Grade IV disease at baseline, illustrative of an at-risk patient population. The updated data show that responses were observed irrespective of grade or steroid refractory (SR) criteria. Responses to Jakafi were rapid and durable. The median time to response was seven days and the median duration of response (DOR) for patients who had a minimum of six months of follow-up was 345 days.
The study had earlier met its primary endpoint, demonstrating an overall response rate (ORR) of 55% (n=39/71) at Day 28 along with a best overall response rate (BORR) — patients achieving a response at any time point during the study — of 73% (n=52/71).
The updated results further reinforce the potential of Jakafi as a therapeutic option in GVHD and specifically reinforce the durability of responses seen in acute GVHD patients treated with Jakafi.
Incyte had already submitted a supplemental New Drug Application (sNDA) to the FDA on the basis of data from the REACH1 study. The FDA assigned priority review to the sNDA and set a target action date of Feb 24, 2019.
Jakafi became the first FDA-approved JAK inhibitor for any indication. It is also the first and the only product approved by the FDA for the treatment of rare blood cancers like myelofibrosis (November 2011) and polycythemia vera (December 2014).
Its label has been updated several times since approval. It was updated in June 2013 to include information on a new recommended dosing guidance for patients with low platelet count.
Incyte expects Jakafi revenues of $1,370-$1,400 million in 2018, which is more than 20% growth in 2017.
The company is working to further expand Jakafi’s label. Meanwhile, REACH2 and REACH3 studies, evaluating steroid-refractory acute and steroid-refractory chronic graft-versus-host disease, respectively, are ongoing in collaboration with Novartis (NVS - Free Report) . Incyte plans to enroll more than 300 patients in each of these studies. Data from these studies are expected in 2019.
Data from the phase II trial on the cream formulation of Jakafi in adult patients with atopic dermatitis were encouraging. Hence, Incyte is planning to initiate a global, pivotal phase III trial for this indication. Data from the randomized phase II trial on Jakafi cream in patients with vitiligo are expected in 2019.
Approval of new drugs and label expansion of existing drugs bode well for Incyte. In June 2018, Incyte and partner Eli Lilly and Company (LLY - Free Report) announced that the FDA has approved the 2 mg dose of Olumiant (baricitinib), a once-daily oral medication, for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.
Incyte’s stock has lost 29% in the year so far compared with the industry’s 13.8% decline.
The company suffered a huge setback with the failure of the phase III study, ECHO-301, as it was one of the most promising candidates for Incyte, evaluating epacadostat in combination with Merck’s (MRK - Free Report) Keytruda. Further, the approval of the 4mg dose of baricitinib is also doubtful.
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Incyte (INCY) Announces Positive Data on Jakafi for GVHD
Incyte Corporation (INCY - Free Report) announced updated results from a pivotal phase II REACH1 study on lead drug Jakafi at the American Society of Hematology (ASH) Annual Meeting 2018 in San Diego, California.
The study evaluated Jakafi in combination with corticosteroids as a treatment for patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids.
In the trial, 68% of patients had Grade III or Grade IV disease at baseline, illustrative of an at-risk patient population. The updated data show that responses were observed irrespective of grade or steroid refractory (SR) criteria. Responses to Jakafi were rapid and durable. The median time to response was seven days and the median duration of response (DOR) for patients who had a minimum of six months of follow-up was 345 days.
The study had earlier met its primary endpoint, demonstrating an overall response rate (ORR) of 55% (n=39/71) at Day 28 along with a best overall response rate (BORR) — patients achieving a response at any time point during the study — of 73% (n=52/71).
The updated results further reinforce the potential of Jakafi as a therapeutic option in GVHD and specifically reinforce the durability of responses seen in acute GVHD patients treated with Jakafi.
Incyte had already submitted a supplemental New Drug Application (sNDA) to the FDA on the basis of data from the REACH1 study. The FDA assigned priority review to the sNDA and set a target action date of Feb 24, 2019.
Jakafi became the first FDA-approved JAK inhibitor for any indication. It is also the first and the only product approved by the FDA for the treatment of rare blood cancers like myelofibrosis (November 2011) and polycythemia vera (December 2014).
Its label has been updated several times since approval. It was updated in June 2013 to include information on a new recommended dosing guidance for patients with low platelet count.
Incyte expects Jakafi revenues of $1,370-$1,400 million in 2018, which is more than 20% growth in 2017.
The company is working to further expand Jakafi’s label. Meanwhile, REACH2 and REACH3 studies, evaluating steroid-refractory acute and steroid-refractory chronic graft-versus-host disease, respectively, are ongoing in collaboration with Novartis (NVS - Free Report) . Incyte plans to enroll more than 300 patients in each of these studies. Data from these studies are expected in 2019.
Data from the phase II trial on the cream formulation of Jakafi in adult patients with atopic dermatitis were encouraging. Hence, Incyte is planning to initiate a global, pivotal phase III trial for this indication. Data from the randomized phase II trial on Jakafi cream in patients with vitiligo are expected in 2019.
Approval of new drugs and label expansion of existing drugs bode well for Incyte. In June 2018, Incyte and partner Eli Lilly and Company (LLY - Free Report) announced that the FDA has approved the 2 mg dose of Olumiant (baricitinib), a once-daily oral medication, for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.
Incyte’s stock has lost 29% in the year so far compared with the industry’s 13.8% decline.
The company suffered a huge setback with the failure of the phase III study, ECHO-301, as it was one of the most promising candidates for Incyte, evaluating epacadostat in combination with Merck’s (MRK - Free Report) Keytruda. Further, the approval of the 4mg dose of baricitinib is also doubtful.
Zacks Rank & Key Pick
Incyte carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6% and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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