Eli Lilly and Company (LLY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for Emgality (galcanezumab) in Europe. The marketing authorization application (MAA) is seeking an approval for the calcitonin gene-related peptide (CGRP) antibody for treating migraine in adults, who encounter at least four migraine attacks per month.
The positive CHMP response will now be reviewed by the European Commission with a decision expected soon.
Shares of Eli Lilly have rallied 25.9% year to date, comparing favorably with the industry’s increase of 7.2%.
The positive opinion was based on data from two phase III clinical studies, namely EVOLVE-1 and EVOLVE-2, which evaluated Emgality for the prevention of episodic migraine and another phase III REGAIN study conducted on patients with chronic migraine. Data from all three evaluations showed that in the first month of treatment, Emgality significantly lowered the mean monthly migraine days and followed it every month during the therapy as compared to placebo.
Emgality is currently under review in the United States with a decision expected by the end of this month.
Earlier this month, the FDA granted a nod to Teva Pharmaceuticals’ (TEVA - Free Report) anti CGRP drug, Ajovy (fremanezumab) injection, as a preventive treatment of migraine.
We would like to remind investors that migraine has limited treatment options and anti-CGRP is a new treatment mechanism. Amgen (AMGN - Free Report) and Novartis’ (NVS - Free Report) anti CGRP drug Aimovig (erenumab) was also approved and launched for prevention of migraine in second-quarter 2018.
Zacks Rank
Eli Lilly currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Eli Lilly and Company (LLY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for Emgality (galcanezumab) in Europe. The marketing authorization application (MAA) is seeking an approval for the calcitonin gene-related peptide (CGRP) antibody for treating migraine in adults, who encounter at least four migraine attacks per month.
The positive CHMP response will now be reviewed by the European Commission with a decision expected soon.
Shares of Eli Lilly have rallied 25.9% year to date, comparing favorably with the industry’s increase of 7.2%.
The positive opinion was based on data from two phase III clinical studies, namely EVOLVE-1 and EVOLVE-2, which evaluated Emgality for the prevention of episodic migraine and another phase III REGAIN study conducted on patients with chronic migraine. Data from all three evaluations showed that in the first month of treatment, Emgality significantly lowered the mean monthly migraine days and followed it every month during the therapy as compared to placebo.
Emgality is currently under review in the United States with a decision expected by the end of this month.
Earlier this month, the FDA granted a nod to Teva Pharmaceuticals’ (TEVA - Free Report) anti CGRP drug, Ajovy (fremanezumab) injection, as a preventive treatment of migraine.
We would like to remind investors that migraine has limited treatment options and anti-CGRP is a new treatment mechanism. Amgen (AMGN - Free Report) and Novartis’ (NVS - Free Report) anti CGRP drug Aimovig (erenumab) was also approved and launched for prevention of migraine in second-quarter 2018.
Zacks Rank
Eli Lilly currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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