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Gilead Reports Phase III Myelofibrosis Data on Momelotinib

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Gilead Sciences Inc. (GILD - Free Report) announced top-line data from two randomized phase III studies – SIMPLIFY 1 and SIMPLIFY 2 – on JAK inhibitor momelotinib, in comparison to Incyte Corporation’s (INCY - Free Report) Jakafi (ruxolitinib) or the best alternative therapy (BAT), in patients suffering from myelofibrosis.

In the double-blinded, active-controlled study, SIMPLIFY-1, patients who had not previously been treated with a JAK inhibitor were randomized to receive momelotinib or Jakafi for 24 weeks. In the SIMPLIFY-2 study, patients previously treated with, but not refractory to, Jakafi were randomized to receive momelotinib or BAT for 24 weeks.

Results demonstrated that the SIMPLIFY-1 study met the pre-specified primary endpoint of non-inferiority to Jakafi for splenic response rate at week 24 (SRR24), defined as the percentage of patients experiencing a ≥35% reduction in spleen volume. However, non-inferiority was not reached for the key secondary endpoint of response rate in total symptom score (TSS). Nevertheless, larger improvements in all three pre-specified anemia-related secondary endpoints (proportion of patients who are transfusion independent, or transfusion dependent and transfusion rate) were observed in patients treated with momelotinib compared to Jakafi.

SIMPLIFY-2, on the other hand, failed to meet the primary endpoint of superiority of momelotinib, in comparison to BAT, in patients previously treated with Jakafi in SRR24 (momelotinib: 6.7%; BAT: 5.8%). However, differences in favor of momelotinib were observed for the pre-specified secondary endpoints of TSS and one of the three anemia-related endpoints (transfusion independence).

Results of the two studies are apparently far from impressive. Given that both these data show some treatment benefit with momelotinib, including the anemia-related endpoints, Gilead plans to discuss the same with regulatory authorities to determine the next step ahead.

The company intends to submit detailed results from the studies for presentation at forthcoming scientific conferences.



We note that Gilead’s efforts to develop its pipeline have not been very successful of late. The company has faced quite a few pipeline-related setbacks this year itself. It has had to terminate phase II and IIb studies on simtuzumab for the treatment of idiopathic pulmonary fibrosis, nonalcoholic steatohepatitis and primary sclerosing cholangitis; phase II and II/II studies on GS-5745 for the treatment of Crohn's Disease and ulcerative colitis.

With Gilead’s HCV franchise currently under intense competitive and pricing pressure, the company needs to bring new products to market.

Zacks Rank & Stocks to Consider

Gilead is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector are Anika Therapeutics Inc. (ANIK - Free Report) , Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Incyte. While Anika and Vanda sport a Zacks Rank #1 (Strong Buy), Incyte carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 17% year to date.

Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016 while earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged 77% year to date.

Incyte’s earnings estimates increased from 20 cents to 68 cents for 2016 and from $1.42 to $1.69 for 2017 over the last 60 days. The company posted a positive average beat of 431.43% over the last four quarters.

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