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. 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, BioMarin Pharmaceutical Inc. BMRN and Unum Therapeutics Inc. UMRX, 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.
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