Guggenheim's report suggests that the FDA's decision, anticipated in 2026, will be a significant catalyst for Axsome stock. Until then, the stock is expected to trade around the $80 range, with potential to rise to the $130 range upon approval of Auvelity. The firm's price target remains unchanged despite the recent study results. InvestingPro analysis indicates that Axsome is currently undervalued, with analyst targets ranging from $105 to $180.
For deeper insights into Axsome's valuation and growth prospects, including additional ProTips and comprehensive financial analysis, check out the detailed Pro Research Report available on InvestingPro. InvestingPro analysis indicates that Axsome is currently undervalued, with analyst targets ranging from $105 to $180.
For deeper insights into Axsome's valuation and growth prospects, including additional ProTips and comprehensive financial analysis, check out the detailed Pro Research Report available on InvestingPro. The ACCORD-2 study, with 167 participants, achieved its primary and secondary objectives. However, the ADVANCE-2 study, despite having 408 participants, did not meet its endpoints, although the results numerically favored Auvelity.
The mixed outcomes have introduced some regulatory uncertainty. Auvelity has shown statistically significant efficacy in three completed Phase III studies—ADVANCE-1, ACCORD-1, and ACCORD-2. The fourth trial, ADVANCE-2, also demonstrated supportive efficacy and controlled safety results, which are expected to contribute to a New Drug Application (NDA) filing in the second half of 2025.
While the overall data package is considered comprehensive enough to support the approval of Auvelity for ADA, the ADVANCE-2 study's failure has raised questions about how the U.S. Food and Drug Administration (FDA) will view the randomized withdrawal studies as evidence of primary efficacy.
The company maintains strong fundamentals with an impressive 91.09% gross profit margin and a healthy current ratio of 2.44, indicating solid financial stability during this crucial development phase. This contrasts with the approval of Rexulti (OTSKY (OTC:OTSKY)) for ADA, which was based on successful results in two out of three studies—all of which were randomized placebo-controlled.
Guggenheim's report suggests that the FDA's decision, anticipated in 2026, will be a significant catalyst for Axsome stock. Until then, the stock is expected to trade around the $80 range, with potential to rise to the $130 range upon approval of Auvelity. The firm's price target remains unchanged despite the recent study results.
In other recent news, Axsome Therapeutics (NASDAQ:AXSM) announced positive outcomes from its Phase 3 clinical trials for AXS-05, a treatment for agitation in Alzheimer's disease patients. The company plans to submit a New Drug Application to the FDA for AXS-05 in the second half of 2025. Furthermore, Axsome reported positive results from the ENCORE Phase 3 trial for its drug candidate AXS-12, used in the treatment of narcolepsy with cataplexy.
Analyst firms such as RBC Capital Markets and H.C. Wainwright have reiterated their positive ratings on Axsome, citing robust growth drivers and strong financial performance. RBC Capital Markets increased its price target for Axsome to $132, while H.C. Wainwright maintained a $180 price target.
Mizuho (NYSE:MFG) Securities also increased its price target for Axsome shares, following a post-third quarter evaluation and the inclusion of revenue projections for solriamfetol, for two additional potential indications. The company has also reported record-breaking revenue for the third quarter, surpassing $100 million for the first time.
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