Axsome Therapeutics Receives FDA Priority Review for AXS-05, Shares Surge Nearly 20%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: Fool
- Significant Stock Surge: Axsome Therapeutics' shares soared over 20% at year-end, with a 19.4% increase as of 12:10 p.m. ET, reflecting strong investor optimism regarding the company's drug developments.
- FDA Priority Review: The FDA granted priority review for AXS-05 for treating Alzheimer's disease agitation, with a target action date set for April 30, 2026, providing Axsome with a shortened timeline for a potential major catalyst.
- Notable Sales Growth: Sales of AXS-05, branded as Auvelity, grew 69% year-over-year in Q3, accounting for 80% of Axsome's quarterly revenue, indicating robust performance in the depression treatment market.
- New Drug Application Progress: Axsome's other drug, AXS-12, is expected to have its new drug application (NDA) submitted next month, further boosting investor confidence in the company's growth prospects and potentially driving stock price increases.
Analyst Views on AXSM
Wall Street analysts forecast AXSM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AXSM is 175.25 USD with a low forecast of 148.00 USD and a high forecast of 202.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
15 Analyst Rating
15 Buy
0 Hold
0 Sell
Strong Buy
Current: 148.790
Low
148.00
Averages
175.25
High
202.00
Current: 148.790
Low
148.00
Averages
175.25
High
202.00
About AXSM
Axsome Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of medicines for people living with central nervous system (CNS) conditions. The Company's commercial products include Auvelity, Sunosi and Symbravo. It is also advancing a diversified, late-stage pipeline of product candidates for serious neurological and psychiatric conditions, which include AXS-05, AXS-12, AXS-14 and AXS-17. Auvelity (dextromethorphan-bupropion) is an oral, N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity indicated for the treatment of major depressive disorder (MDD). Sunosi (solriamfetol) is an oral medication indicated for the treatment of excessive daytime sleepiness (EDS), in patients with narcolepsy or obstructive sleep apnea. Symbravo (meloxicam and rizatriptan, 20 mg/10mg tablets) is an oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
