Axsome Therapeutics, Inc. (AXSM - Free Report) announced that its novel, oral, multi-mechanistic investigational candidate, AXS-07, met two regulatory co-primary endpoints in the phase III INTERCEPT study. The co-primary goals are freedom from migraine pain and freedom from most bothersome symptoms compared to placebo in the study.
AXS-07 substantially and significantly eliminated migraine pain and also substantially and significantly prevented progression of migraine pain intensity in the late-stage study that evaluated the candidate for early treatment of migraine.
Per the press release, when treated with AXS-07, 33% patients achieved freedom from migraine pain compared to 16% subjects who received placebo after two hours of dosing. Prevented progression of migraine pain beyond mild intensity was experienced by 74% of AXS-07 patients compared to 47% of placebo within two to 24 hours of treatment.
Per the company, this randomized, double-blind, placebo-controlled INTERCEPT study enrolled 302 patients who were randomized in a 1:1 ratio to treat a single migraine attack with a single dose of AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan) or placebo at the earliest sign of migraine pain when the pain intensity was mild.
AXS-07 substantially and significantly lowered functional disability while also demonstrating overall disease improvement. Treatment with AXS-07 led to 73.5% of patients performing normal activities at 24 hours compared to 47.4% of patients who received placebo.
Shares of Axsome have plunged 48.2% so far this year compared with the industry’s decrease of 11.61%.
We remind investors that in December 2019, AXS-07 met the two regulatory co-primary endpoints in the phase III MOMENTUM study evaluating the same for acute treatment of migraine.
Notably, the MOMENTUM study enrolled patients only with a history of inadequate response to prior acute treatments, while the INTERCEPT study, recruited all comers in which patients received AXS-07 at the initial stage of migraine pain when the pain was mild, before it got moderate or severe.
Axsome plans to file a new drug application for AXS-07 to the FDA in the fourth quarter of 2020 to treat acute migraine. The successful development and commercialization of the candidate will lend a significant boost to Axsome.
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. , Abeona Therapeutics Inc. and Celldex Therapeutics, Inc. (CLDX - Free Report) , all sporting a Zacks Rank #1 (Strong Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.
Abeona’s loss per share estimates have been narrowed 21.5% for 2020 and 16.8% for 2021 over the past 60 days.
Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.8% for 2021 over the past 60 days.
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Axsome Therapeutics, Inc. (AXSM - Free Report) announced that its novel, oral, multi-mechanistic investigational candidate, AXS-07, met two regulatory co-primary endpoints in the phase III INTERCEPT study. The co-primary goals are freedom from migraine pain and freedom from most bothersome symptoms compared to placebo in the study.
AXS-07 substantially and significantly eliminated migraine pain and also substantially and significantly prevented progression of migraine pain intensity in the late-stage study that evaluated the candidate for early treatment of migraine.
Per the press release, when treated with AXS-07, 33% patients achieved freedom from migraine pain compared to 16% subjects who received placebo after two hours of dosing. Prevented progression of migraine pain beyond mild intensity was experienced by 74% of AXS-07 patients compared to 47% of placebo within two to 24 hours of treatment.
Per the company, this randomized, double-blind, placebo-controlled INTERCEPT study enrolled 302 patients who were randomized in a 1:1 ratio to treat a single migraine attack with a single dose of AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan) or placebo at the earliest sign of migraine pain when the pain intensity was mild.
AXS-07 substantially and significantly lowered functional disability while also demonstrating overall disease improvement. Treatment with AXS-07 led to 73.5% of patients performing normal activities at 24 hours compared to 47.4% of patients who received placebo.
Shares of Axsome have plunged 48.2% so far this year compared with the industry’s decrease of 11.61%.
We remind investors that in December 2019, AXS-07 met the two regulatory co-primary endpoints in the phase III MOMENTUM study evaluating the same for acute treatment of migraine.
Notably, the MOMENTUM study enrolled patients only with a history of inadequate response to prior acute treatments, while the INTERCEPT study, recruited all comers in which patients received AXS-07 at the initial stage of migraine pain when the pain was mild, before it got moderate or severe.
Axsome plans to file a new drug application for AXS-07 to the FDA in the fourth quarter of 2020 to treat acute migraine. The successful development and commercialization of the candidate will lend a significant boost to Axsome.
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. , Abeona Therapeutics Inc. and Celldex Therapeutics, Inc. (CLDX - Free Report) , all sporting a Zacks Rank #1 (Strong Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.
Abeona’s loss per share estimates have been narrowed 21.5% for 2020 and 16.8% for 2021 over the past 60 days.
Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.8% for 2021 over the past 60 days.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2019, while the S&P 500 gained and impressive +53.6%, five of our strategies returned +65.8%, +97.1%, +118.0%, +175.7% and even +186.7%.
This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
See their latest picks free >>
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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