AXSM Stock Down on Top-Line Data From Depression Study on Solriamfetol

Axsome Therapeutics AXSM announced top-line data from the phase III PARADIGM study, which evaluated solriamfetol for the treatment of major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).

Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.

Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.

Jazz had received approval for Sunosi as a treatment for narcolepsy in 2019.

Year to date, shares of Axsome have rallied 32% compared with the industry’s increase of 2.4%.

Data From AXSM's PARADIGM Study on Solriamfetol

The phase III, proof-of-concept study evaluated solriamfetol versus placebo in MDD patients with severe EDS and without severe EDS. Patients were randomized to receive solriamfetol (300 mg) or a placebo for six weeks.

In the overall patient population, treatment with solriamfetol failed to demonstrate a statistically significant change on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo — the study’s primary endpoint.

Axsome’s stock was down 4.3% on April 1 following the announcement of the news.

However, in the prespecified subgroup of patients with severe EDS, treatment with solriamfetol led to greater improvements in depressive symptoms versus placebo. In patients without severe EDS, there was no meaningful difference versus placebo on the study endpoints.

Based on this outcome, Axsome plans to initiate a phase III study on solriamfetol in MDD patients with EDS later in 2025.

Treatment with solriamfetol was generally safe and well-tolerated in the PARADIGM study.

AXSM's Other Ongoing Studies on Solriamfetol

Besides MDD, Axsome is evaluating solriamfetol in separate phase III studies for treating attention deficit hyperactivity disorder (ADHD), binge eating disorder (BED) and excessive sleepiness associated with shift work disorder (SWD).

Last month, the company announced data from the phase III FOCUS study, which evaluated solriamfetol (150 mg, 300 mg) for the treatment of ADHD. The study met its primary and key secondary endpoints.

However, the higher dose of solriamfetol (300 mg) could not achieve the primary and secondary endpoints with statistical significance versus placebo. AXSM shares tanked on this news.

Top-line data from the ENGAGE study and the SUSTAIN study, evaluating solriamfetol for treating BED and SWD in adults, respectively, are expected in 2026.

Sunosi — A Key Top-Line Driver for AXSM

Sunosi has become an important revenue driver for Axsome since its acquisition from Jazz. The drug generated sales worth $94.3 million in 2024, reflecting an increase of 26% on a year-over-year basis.

Successful development and potential approval for additional indications could further boost sales of the drug.

AXSM's Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Dynavax Technologies Corporation DVAX and Krystal Biotech, Inc. KRYS, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share estimates have increased from 49 cents to 57 cents for 2026. Year to date, shares of DVAX have decreased 0.5%.

DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.

In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.40 to $7.06 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $11. Year to date, shares of KRYS have risen 11.5%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.

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This article originally published on Zacks Investment Research (zacks.com).

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