FDA Refuses Axsome’s NDA for Fibromyalgia Drug

Axsome Therapeutics ( (AXSM) ) just unveiled an update.

On June 9, 2025, Axsome Therapeutics announced that the FDA issued a Refusal to File letter for its NDA for AXS-14, a drug intended for fibromyalgia management. The FDA found one of the trials inadequate due to its design, prompting Axsome to plan an additional trial in late 2025 to meet FDA requirements, reflecting the company’s commitment to addressing unmet needs in fibromyalgia treatment.

The most recent analyst rating on (AXSM) stock is a Buy with a $175.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.

Spark’s Take on AXSM Stock

According to Spark, TipRanks’ AI Analyst, AXSM is a Neutral.

Axsome Therapeutics’ overall stock score reflects its strong revenue growth and strategic financial maneuvers, like the loan agreement with Blackstone. However, ongoing challenges with profitability, cash flow, and regulatory hurdles limit the score, highlighting the risks typical in the biotech sector.

To see Spark’s full report on AXSM stock, click here.

More about Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system disorders. It develops products with novel mechanisms of action to improve patient outcomes and has a neuroscience portfolio that includes FDA-approved treatments for various neurological and psychiatric conditions.

Average Trading Volume: 707,796

Technical Sentiment Signal: Buy

Current Market Cap: $5.51B

For detailed information about AXSM stock, go to TipRanks’ Stock Analysis page.