Axsome Begins Phase III Study on AXS-05 for Smoking Cessation

Axsome Therapeutics AXSM announced that it has dosed the first patient in the phase III SUMMIT study evaluating AXS-05 for the treatment of smoking cessation.

The randomized, double-blind, placebo-controlled phase III SUMMIT study is designed to assess the safety and efficacy of AXS-05 for treating smoking cessation in adults. In the study, active smokers will be randomized to receive AXS-05, bupropion, or placebo in a 1:1:1 ratio for approximately 12 weeks.

The primary endpoint of the SUMMIT study is to check smoking abstinence at the end of the 12-week treatment period.

Axsome currently markets AXS-05 under the trade name Auvelity in the United States for the treatment of major depressive disorder (MDD).

In April 2026, the FDA approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on data from phase III ADVANCE-1 and ACCORD-2 studies.

Year to date, shares of Axsome have increased 8.7% compared with the industry’s rise of 9.7%.

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Auvelity Drives Axsome’s Revenue Surge

Axsome’s lead drug, Auvelity, has been witnessing strong uptake. The drug has played an instrumental role in driving the company’s top line since its approval and launch in the United States in 2022. Sales of the drug have been rising consistently owing to strong demand.

Auvelity generated sales worth $333 million in the first half of 2026, increasing 54.2% year over year in the United States. The drug’s sales are being driven by prescription growth and higher volumes and the momentum is likely to continue in the rest of 2026.

The successful commercialization of Auvelity in additional indications would help the drug address a broader patient population and drive sales further in future quarters.

Besides Auvelity, Axsome’s narcolepsy drug, Sunosi (solriamfetol), is also generating incremental sales and aiding the top line. Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ.

The acquisition of Sunosi from Jazz diversified the company’s commercial portfolio.

Sunosi generated sales worth $66.5 million in the first half of 2026, reflecting an increase of 25.5% year over year. The drug has become an important revenue driver for Axsome.

Axsome’s newest product, Symbravo, was approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. The drug was launched in the United States in June 2025. Symbravo recorded sales worth $6.3 million in the first six months of 2026. The approval further diversified Axsome’s commercial portfolio.

AXSM’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are Repligen RGEN and Anika Therapeutics ANIK, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.5% year to date.

Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.

Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 117.2% year to date.

Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.

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

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