FDA Accepts AXSM's NDA Resubmission for Migraine Drug, Stock Up

Axsome Therapeutics, Inc. AXSM announced that the FDA has accepted its resubmitted new drug application (NDA) seeking approval for AXS-07 for the acute treatment of migraine.

A final decision from the regulatory body is expected on Jan. 31, 2025. The FDA has designated the NDA resubmission as a Class 2 resubmission.

Shares of AXSM were up 6.6% on Sept. 4 following the announcement of the news.

Year to date, shares of Axsome have rallied 20.1% against the industry's decrease of 0.9%.

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The FDA issued a complete response letter to the first NDA for AXS-07 in April 2022 as it identified issues related to the chemistry, manufacturing and controls.

The NDA re-submission for AXS-07 for the acute treatment of migraine was completed during the second quarter of 2024. The FDA has not requested any additional safety or efficacy data for the NDA resubmission.

The NDA re-submission was earlier expected to be filed during the second half of 2023.

FDA Nod for AXS-07 to Diversify AXSM's Product Portfolio

Axsome currently has two marketed products in its commercial portfolio – Auvelity (AXS-05) for major depressive disorder and Sunosi (solriamfetol) for narcolepsy. A potential FDA nod for AXS-07 will diversify Axsome's commercial portfolio

Auvelity was launched in the United States in 2022 for the treatment of MDD, making it the first approved drug in the company's portfolio. The drug generated sales worth $118.4 million in the first half of 2024, up 172.8% year over year, owing to strong underlying demand.

Axsome's second marketed drug, Sunosi, is approved for treating narcolepsy. The company 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 received approval for Sunosi as a treatment for narcolepsy in 2019.

The acquisition of Sunosi from Jazz diversified Axsome's portfolio to two marketed drugs. In the first half of 2024, Sunosi's net product sales were $42.2 million, reflecting an increase of almost 35.2% year over year.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present.

In the past 60 days, estimates for Krystal Biotech's 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 50.6%.

KRYS' earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 49.9%.

In the past 60 days, estimates for Fulcrum Therapeutics' 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 22.2%.

FULC's earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.

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