In a Dec. 30 research note, analyst Matthew Kaplan reported that Ladenburg Thalmann increased its price target on Buy-rated Axsome Therapeutics Inc. (AXSM:NASDAQ) to $165 per share from $135 following "robust" results from the biopharma's Phase 3 AXS-07 MOMENTUM trial in migraines in difficult to treat patients. Axsome's current share price, in comparison, is about $101.31.
These Phase 3 data increase the likelihood that the U.S. Food and Drug Administration (FDA) approves AXS-07, Kaplan commented. Axsome intends to file a new drug application with the FDA for AXS-07 in H2/20. Before that date, in Q1/20, topline results will be available from the AXS-07 INTERCEPT Phase 3 trial in migraines.
The analyst reviewed the study's outcome. The topline efficacy results were "impressive," he added, demonstrating "rapid, durable and highly statistically significant improvements in primary and secondary endpoints evaluated." The fact that Axsome achieved these results in patients with a history of inadequate response to prior acute treatments is "even more remarkable."
The two primary endpoints were freedom from pain and freedom from the most bothersome symptom, either photophobia, phonophobia or nausea, both at two hours post treatment. AXS-07 resulted in a 19.9% rate of pain relief at two hours versus 6.7% for placebo and a 36.9% rate of relief from the most bothersome symptom compared to 24.4% with placebo.
The secondary endpoints were superiority of AXS-07 over the individual components, rizatriptan and MoSEIC meloxicam, based on sustained pain relief two to 24 hours after dosing. "Overall, AXS-07 showed clear superiority over rizatriptan as it demonstrated statistically significant results for one-hour pain relief, two- to 24-hour sustained pain relief, two- to 48-hour pain relief, two- to 24-hour sustained pain freedom, two- to 48-hour sustained pain freedom, patient global impression of change, functional improvement at 24 hours and use of rescue medications," explained Kaplan.
He noted further that AXS-07 proved to be safe and was well tolerated. The most frequently experienced adverse events were nausea, dizziness and somnolence, which occurred as often or less often as that with a placebo.
Kaplan concluded that "AXS-07's multimechanistic modes of action represent an attractive novel treatment option in both the frontline and refractory migraine treatment settings."[NLINSERT]
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Disclosures from Ladenburg Thalmann, Axsome Therapeutics Inc., December 30, 2019
ANALYST CERTIFICATION: I, Matthew L. Kaplan, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, 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, provided, however, that:
The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firmís total revenues, a portion of which is generated by investment banking activities.
COMPANY SPECIFIC DISCLOSURES:
Ladenburg Thalmann & Co. Inc. makes a market in Axsome Therapeutics, Inc.
Ladenburg Thalmann & Co. Inc. has managed or co-managed a public offering for Axsome Therapeutics, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc. expects to receive compensation for investment banking and/or advisory services from Axsome Therapeutics, Inc. within the next 3 months.
Ladenburg Thalmann & Co. Inc. intends to seek compensation for investment banking and/or advisory services from Axsome Therapeutics, Inc. within the next 3 months.
Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Axsome Therapeutics, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc had an investment banking relationship with Axsome Therapeutics, Inc. within the last 12 months.
Ladenburg Thalmann & Co Inc. acted in an advisory capacity for Axsome Therapeutics, Inc. in the last 12 months.
Matthew L. Kaplan, or a member of their household, has a financial interest in the securities of Axsome Therapeutics, Inc. (AXSM) in the form of (long position in common).
The research analyst principally responsible for the preparation of this research report, or a member of their household, has a financial interest in the securities of Axsome Therapeutics, Inc. in the form of a long position in common stock.