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Incyte (INCY) Reports Phase III Follow-Up Data for Jakafi
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Incyte Corporation (INCY - Free Report) announced a new 208-week (4-year) follow-up data from the phase III RESPONSE study of Jakafi. The study compared the efficacy and safety of Jakafi with best available therapy (BAT) in patients with polycythemia vera (PV), who are resistant to or intolerant of hydroxyurea (HU).
The primary response was a composite endpoint of the proportion of patients, who achieved both hematocrit (Hct) control (defined as no phlebotomy eligibility from week 8 through week 32) and a spleen volume reduction of at least 35% from baseline at week 32. The study met the primary endpoint showing that Jakafi was superior to BAT at controlling hematocrit (Hct) and reducing spleen volume at week 32.
The data from this study showed that durable primary response to Jakafi in patients with PV who are resistant to or intolerant of HU and overall safety profile for Jafaki remained consistent with the 80-week RESPONSE data published earlier. In fact, the 80 week follow up from the RESPONSE study confirmed that among patients who initially responded to Jakafi treatment have probability of maintaining primary and hematocrit (Hct) responses for greater than 80 weeks was 92% and 89%, respectively. Thus confirming that Jakafi could be an effective long-term treatment option for patients with PV who are HU-resistant or intolerant.
So far this year, Incyte’s shares have declined 3.7%, as against the industry’s growth of 2.6%.
Jakafi is Incyte’s sole marketed product and is a first-in-class JAK1/JAK2 inhibitor. It 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. Also, Jakafi is approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF) including primary MF, post-PV MF, and post-essential thrombocythemia MF.
While Incyte markets the drug in the United States, it is marketed by Novartis (NVS - Free Report) as Jakavi outside the country. Its label has been updated several times since approval. In March 2016, the FDA approved supplemental labeling for Jakafi to include additional safety data as well as efficacy analyses from the RESPONSE study that assessed the durability of response in Jakafi-treated patients after 80 weeks.
Sucampo’s earnings per share estimates have moved up from 3 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 18%, year to date.
Johnson and Johnson’s earnings per share estimates have moved up from $7.19 to $7.28 for 2017 and from $7.75 to $7.85 for 2018, over the last 60 days. The company pulled off a positive earnings surprise in all of the trailing four quarters, with an average beat of 3.12%. The share price of the company has increased 22%, year to date.
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Incyte (INCY) Reports Phase III Follow-Up Data for Jakafi
Incyte Corporation (INCY - Free Report) announced a new 208-week (4-year) follow-up data from the phase III RESPONSE study of Jakafi. The study compared the efficacy and safety of Jakafi with best available therapy (BAT) in patients with polycythemia vera (PV), who are resistant to or intolerant of hydroxyurea (HU).
The primary response was a composite endpoint of the proportion of patients, who achieved both hematocrit (Hct) control (defined as no phlebotomy eligibility from week 8 through week 32) and a spleen volume reduction of at least 35% from baseline at week 32. The study met the primary endpoint showing that Jakafi was superior to BAT at controlling hematocrit (Hct) and reducing spleen volume at week 32.
The data from this study showed that durable primary response to Jakafi in patients with PV who are resistant to or intolerant of HU and overall safety profile for Jafaki remained consistent with the 80-week RESPONSE data published earlier. In fact, the 80 week follow up from the RESPONSE study confirmed that among patients who initially responded to Jakafi treatment have probability of maintaining primary and hematocrit (Hct) responses for greater than 80 weeks was 92% and 89%, respectively. Thus confirming that Jakafi could be an effective long-term treatment option for patients with PV who are HU-resistant or intolerant.
So far this year, Incyte’s shares have declined 3.7%, as against the industry’s growth of 2.6%.
Jakafi is Incyte’s sole marketed product and is a first-in-class JAK1/JAK2 inhibitor. It 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. Also, Jakafi is approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF) including primary MF, post-PV MF, and post-essential thrombocythemia MF.
While Incyte markets the drug in the United States, it is marketed by Novartis (NVS - Free Report) as Jakavi outside the country. Its label has been updated several times since approval. In March 2016, the FDA approved supplemental labeling for Jakafi to include additional safety data as well as efficacy analyses from the RESPONSE study that assessed the durability of response in Jakafi-treated patients after 80 weeks.
Incyte Corporation Price
Incyte Corporation Price | Incyte Corporation Quote
Zacks Rank & Stocks to Consider
Incyte has a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space are Sucampo Pharmaceuticals and Johnson and Johnson (JNJ - Free Report) . Both the companies hold a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 3 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 18%, year to date.
Johnson and Johnson’s earnings per share estimates have moved up from $7.19 to $7.28 for 2017 and from $7.75 to $7.85 for 2018, over the last 60 days. The company pulled off a positive earnings surprise in all of the trailing four quarters, with an average beat of 3.12%. The share price of the company has increased 22%, year to date.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>