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Alder Biopharmaceuticals, Inc.’s shares plummeted almost 28% despite the announcement of positive top line results from phase III PROMISE I study, evaluating its lead pipeline candidate eptinezumab (ALD403) for prevention of frequent episodic migraine.
Though the study has met both is primary and secondary endpoints, the safety profile of eptinezumab was almost in line with placebo and consistent with the previously reported eptinezumab trials.
The PROMISE 1 study evaluated the efficacy and safety of eptinezumab across three doses (300mg, 100mg or 30mg), administered by intravenous infusion once every 12 weeks through week 24. The study has met its primary endpoint, inducing a mean change in monthly migraine days from baseline for weeks 1 through 12.
Patients who were applied with eptinezumab had experienced a 4.3 monthly migraine days reduction for 300mg and 3.9 days for 100mg compared with an average 3.2 days under the effect of placebo.
Good news is that a significant decrease in proportion of patients suffering from migraine was observed from day one, after the first dose was administered. In the opening month under trial, 31.5% and 30.8% of patients administered with eptinezumab dosages of 300mg and 100mg respectively, had experienced an above 75% drop in monthly migraine days from baseline versus 20.3% with placebo. As it is evident, the results were not substantially better than placebo, causing the shares to inevitably downslide.
Shares of Alder have underperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has lost 35.2% compared with the broader industry’s progress of 8.9%.
Notably in Nov 2016, the company had initiated another pivotal phase III study (PROMISE 2) on eptinezumab for treatment of chronic migraine. Enrollment for the study is underway and the top line data is expected to be issued in the first half of 2018.
Based on the outcomes from two pivotal phase III studies and a single open-label phase III study, the company plans to file a Biologics License Application (BLA) in the second half of 2018.
It is important to remind investors that eptinezumab uses calcitonin gene-related peptide (CGRP) antibody for prevention of migraine. Amgen Inc.’s (AMGN - Free Report) erenumab, Eli Lilly and Company’s (LLY - Free Report) galcanezumab and Teva Pharmaceutical Industries Limited’s (TEVA - Free Report) fremanezumab/TEV-48125 are also being evaluated for treating the same disease using anti-CGRP.
Per the company’s release, migraine is a serious neurological disease affecting about 36 million people in the U.S. Among them, around 13 million adults live with migraines, occurring four or more days a month. Approximately 90% of them doesn’t resort to any preventive therapy. Hence, approval of the drug would provide the company with an access to a market having immense commercial potential.
We expect investors’ focus to remain on the updates related to further development of eptinezumab.
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Alder's Shares Dip Despite Positive Migraine Trial Results
Alder Biopharmaceuticals, Inc.’s shares plummeted almost 28% despite the announcement of positive top line results from phase III PROMISE I study, evaluating its lead pipeline candidate eptinezumab (ALD403) for prevention of frequent episodic migraine.
Though the study has met both is primary and secondary endpoints, the safety profile of eptinezumab was almost in line with placebo and consistent with the previously reported eptinezumab trials.
The PROMISE 1 study evaluated the efficacy and safety of eptinezumab across three doses (300mg, 100mg or 30mg), administered by intravenous infusion once every 12 weeks through week 24. The study has met its primary endpoint, inducing a mean change in monthly migraine days from baseline for weeks 1 through 12.
Patients who were applied with eptinezumab had experienced a 4.3 monthly migraine days reduction for 300mg and 3.9 days for 100mg compared with an average 3.2 days under the effect of placebo.
Good news is that a significant decrease in proportion of patients suffering from migraine was observed from day one, after the first dose was administered. In the opening month under trial, 31.5% and 30.8% of patients administered with eptinezumab dosages of 300mg and 100mg respectively, had experienced an above 75% drop in monthly migraine days from baseline versus 20.3% with placebo. As it is evident, the results were not substantially better than placebo, causing the shares to inevitably downslide.
Shares of Alder have underperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has lost 35.2% compared with the broader industry’s progress of 8.9%.
Notably in Nov 2016, the company had initiated another pivotal phase III study (PROMISE 2) on eptinezumab for treatment of chronic migraine. Enrollment for the study is underway and the top line data is expected to be issued in the first half of 2018.
Based on the outcomes from two pivotal phase III studies and a single open-label phase III study, the company plans to file a Biologics License Application (BLA) in the second half of 2018.
It is important to remind investors that eptinezumab uses calcitonin gene-related peptide (CGRP) antibody for prevention of migraine. Amgen Inc.’s (AMGN - Free Report) erenumab, Eli Lilly and Company’s (LLY - Free Report) galcanezumab and Teva Pharmaceutical Industries Limited’s (TEVA - Free Report) fremanezumab/TEV-48125 are also being evaluated for treating the same disease using anti-CGRP.
Per the company’s release, migraine is a serious neurological disease affecting about 36 million people in the U.S. Among them, around 13 million adults live with migraines, occurring four or more days a month. Approximately 90% of them doesn’t resort to any preventive therapy. Hence, approval of the drug would provide the company with an access to a market having immense commercial potential.
We expect investors’ focus to remain on the updates related to further development of eptinezumab.
Alder BioPharmaceuticals, Inc. Price
Alder BioPharmaceuticals, Inc. Price | Alder BioPharmaceuticals, Inc. Quote
Zacks Rank
Alder currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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>>