In a Feb. 24 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that Axsome Therapeutics Inc. (AXSM:NASDAQ) finished patient enrollment for its INTERCEPT early-stage migraine study and two possible value inflection points are expected in March 2020.
Selvaraju described the design of INTERCEPT, a pivotal, Phase 3, randomized, double-blind, multicenter, placebo-controlled trial. About 300 patients are being randomized in a 1:1 ratio for treatment with AXS-07 (rizatriptan and meloxicam) or placebo, which will be given at the earliest sign of migraine pain.
INTERCEPT has two primary endpoints. Both measured at two hours post dosing, they are the proportion of patients who no longer have migraine pain and who no longer suffer from their most bothersome migraine symptom, such as nausea, phonophobia or photophobia.
The analyst commented that positive INTERCEPT data "should position AXS-07 extremely favorably within the migraine market, in light of the prior positive top-line data generated from the MOMENTUM study." MOMENTUM evaluated the effect of AXS-07 on migraine patients who previously achieved no response to available therapies. The combination of data from the two trials should "permit Axsome to position AXS-07 as a potentially best-in-class, rapid-onset migraine therapy," he added.
Selvaraju highlighted that two potentially stock-moving catalysts are expected in March. They are the release of topline data from two studies: INTERCEPT with AXS-07 and STRIDE-1 evaluating AXS-05, or bupropion and dextromethorphan, in patients with treatment-resistant depression. "Positive data in treatment-resistant depression would conclusively position AXS-05 as a best-in-class antidepressant therapy and constitute a key value inflection point for Axsome shares," he indicated.
Another possible inflection point, potentially even greater than with STRIDE, according to Selvaraju, is expected later, sometime in H1/20, with the release of topline data from Axsome's Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer's disease-related agitation.
Finally, the analyst noted that "Axsome's shares continue to look undervalued" and the biopharma's "current market cap still only reflects substantial credit for AXS-05 in major depressive disorder and treatment-resistant depression and possibly AXS-07 in migraine, while the other pipeline programs remain comparatively ignored."
H.C. Wainwright has a Buy rating and a $200 per share target price on Axsome, whose stock is trading at around $84.76 per share.
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Disclosures from H.C. Wainwright & Co., Axsome Therapeutics Inc., Company Update, February 24, 2020
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Axsome Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of January 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Axsome Therapeutics, Inc..
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from Axsome Therapeutics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did receive compensation from Axsome Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Axsome Therapeutics, Inc. during the past 12 months.
The Firm does not make a market in Axsome Therapeutics, Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.
