In a Dec. 31 research note, Ladenburg Thalmann analyst Matthew Kaplan reported that the topline efficacy and safety results of Axsome Therapeutics Inc.'s (AXSM:NASDAQ) MOVEMENT Phase 3 clinical trial are positive.
The MOVEMENT, or Multi-mechanistic Treatment Overtime of Migraine Symptoms, study evaluated Axsome's AXS-07 as a long-term acute migraine treatment, over both 6 and 12 months.
To date, the available data showed "rapid and durable migraine pain relief with a long-term safety profile consistent with prior controlled studies," Kaplan added.
The analyst reviewed the specific findings.
By one and two hours post dosing with AXS-07, an average of 39% and 68% of patients, respectively, experienced rapid relief of migraine pain. Also at two hours, an average of 38% were free of pain, and an average of 47% were also free of the most bothersome symptoms associated with migraine: photophobia, phonophobia and nausea.
Regarding safety, Kaplan relayed, study participants generally tolerated long-term dosing of AXS-07 well. The most common reported adverse events, occurring in 3% or fewer patients, were dizziness, nausea and vomiting. Of the total several hundred study participants, 1.6% quit the 12-month study because of adverse events they experienced.
"Overall, we are impressed with the MOVEMENT Phase 3 results, which we view as being consistent with and reinforcing the results observed in the two pivotal studies of AXS-07 which showed rapid, durable, and statistically significant improvement in migraine symptoms with clear superiority over rizatriptan," wrote Kaplan. MOMENTUM and INTERCEPT were the prior pivotal Phase 3 studies.
Now that the MOVEMENT trial is finished, the next step for Axsome's AXS-07 is filing of a new drug application to the U.S. Food and Drug Administration. The biopharma is expected to do that in Q1/21.
Ladenburg Thalmann has a Buy rating and a $186 per share price target on Axsome Therapeutics; the stock is now trading at about $75.89 per share.
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Disclosures from Ladenburg Thalmann, Axsome Therapeutics Inc., December 31, 2020
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 firm’s 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. 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.
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.
