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Axsome Focuses on Filling NDAs for Two CNS Candidates in 2020
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On Jul 14, we issued an updated research report on Axsome Therapeutics, Inc. (AXSM - Free Report) . The company is focused on developing novel therapies to manage central nervous system (CNS) disorders, for which there are limited treatment options available.
Shares of Axsome have declined 23.1% so far this year against the industry’s increase of 5.8%.
Axsome's pipeline candidates, which are being developed for multiple CNS indications, are making a good progress. The company’s portfolio includes five CNS pipeline candidates, namely AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14.
Earlier this week, Axsome completed a successful pre-new drug application (NDA) meeting with the FDA authorities on one of its lead pipeline candidates, AXS-05, for the treatment of major depressive disorder (MDD). The company remains on track to submit the planned NDA in the fourth quarter of 2020.
If successfully developed and approved, AXS-05 will be the first orally administered N-methyl-D-aspartate (NMDA) receptor antagonist to get the nod for the treatment of MDD.
AXS-05 is also being evaluated in the pivotal phase II/III ADVANCE-1 study for treating agitation associated with Alzheimer's disease (AD). It is also being investigated in the phase III STRIDE-1 study to address patients with treatment-resistant depression (TRD).
Meanwhile, Axsome is evaluating AXS-07 in the phase III MOMENTUM study as an acute treatment option of migraine and in the phase III INTERCEPT study for early treatment of migraine. The candidate met co-primary endpoints in both the above-mentioned studies.
Notably, the NDA for AXS-07 as an acute treatment of migraine is also expected to be filed in the fourth quarter of 2020.
A prospective nod to AXS-05 and AXS-07 will lend a significant boost to the company as it will be able to address an area of high unmet medical need, thereby driving growth for the future.
This apart, Axsome’s AXS-12 is being developed to treat narcolepsy. AXS-09, a novel, oral medicine consisting of esbupropion and dextromethorphan, is in early-stage development for CNS disorders. Further, AXS-14 is being developed for the treatment of fibromyalgia.
We note that with no approved products in its commercial portfolio, Axsome lacks a source of generating regular income. As a result, the company is yet to record any revenues. Thus, any developmental setback in its product pipeline will hurt the stock in the days ahead. Dearth of collaboration contracts too remains a woe.
Emergent’s earnings estimates have been revised 26.7% upward for 2020 and 29.8% for 2021 over the past 60 days. The stock has soared 79.1% year to date.
BioMarin’s earnings estimates have moved 3.3% north for 2020 and 13.4% for 2021 over the past 60 days. The stock has surged 49.5% year to date.
Unum Therapeutics’ loss per share estimates have narrowed 46% for 2020 and 82.8% for 2021 over the past 60 days. The stock has skyrocketed 294.3% year to date.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Axsome Focuses on Filling NDAs for Two CNS Candidates in 2020
On Jul 14, we issued an updated research report on Axsome Therapeutics, Inc. (AXSM - Free Report) . The company is focused on developing novel therapies to manage central nervous system (CNS) disorders, for which there are limited treatment options available.
Shares of Axsome have declined 23.1% so far this year against the industry’s increase of 5.8%.
Axsome's pipeline candidates, which are being developed for multiple CNS indications, are making a good progress. The company’s portfolio includes five CNS pipeline candidates, namely AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14.
Earlier this week, Axsome completed a successful pre-new drug application (NDA) meeting with the FDA authorities on one of its lead pipeline candidates, AXS-05, for the treatment of major depressive disorder (MDD). The company remains on track to submit the planned NDA in the fourth quarter of 2020.
If successfully developed and approved, AXS-05 will be the first orally administered N-methyl-D-aspartate (NMDA) receptor antagonist to get the nod for the treatment of MDD.
AXS-05 is also being evaluated in the pivotal phase II/III ADVANCE-1 study for treating agitation associated with Alzheimer's disease (AD). It is also being investigated in the phase III STRIDE-1 study to address patients with treatment-resistant depression (TRD).
Meanwhile, Axsome is evaluating AXS-07 in the phase III MOMENTUM study as an acute treatment option of migraine and in the phase III INTERCEPT study for early treatment of migraine. The candidate met co-primary endpoints in both the above-mentioned studies.
Notably, the NDA for AXS-07 as an acute treatment of migraine is also expected to be filed in the fourth quarter of 2020.
A prospective nod to AXS-05 and AXS-07 will lend a significant boost to the company as it will be able to address an area of high unmet medical need, thereby driving growth for the future.
This apart, Axsome’s AXS-12 is being developed to treat narcolepsy. AXS-09, a novel, oral medicine consisting of esbupropion and dextromethorphan, is in early-stage development for CNS disorders. Further, AXS-14 is being developed for the treatment of fibromyalgia.
We note that with no approved products in its commercial portfolio, Axsome lacks a source of generating regular income. As a result, the company is yet to record any revenues. Thus, any developmental setback in its product pipeline will hurt the stock in the days ahead. Dearth of collaboration contracts too remains a woe.
Axsome Therapeutics, Inc. Price and Consensus
Axsome Therapeutics, Inc. price-consensus-chart | Axsome Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Axsome currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Emergent Biosolutions Inc. (EBS - Free Report) , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Unum Therapeutics Inc. , all presently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have been revised 26.7% upward for 2020 and 29.8% for 2021 over the past 60 days. The stock has soared 79.1% year to date.
BioMarin’s earnings estimates have moved 3.3% north for 2020 and 13.4% for 2021 over the past 60 days. The stock has surged 49.5% year to date.
Unum Therapeutics’ loss per share estimates have narrowed 46% for 2020 and 82.8% for 2021 over the past 60 days. The stock has skyrocketed 294.3% year to date.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>