Guggenheim Reiterates Buy Rating on Axsome Therapeutics (AXSM)

Guggenheim analyst Yatin Suneja reiterated a Buy rating and $135.00 price target on Axsome Therapeutics (NASDAQ: AXSM).

The analyst commented: " Today, AXSM announced much awaited results from two Phase III studies of Auvelity (approved for MDD) in Alzheimer's disease agitation (ADA). ACCORD-2 (n=167; randomized withdrawal study) met the primary and secondary endpoints, while ADVANCE-2 (n=408; randomized controlled study) failed, but all endpoints numerically favored Auvelity. Given the robust data observed in previously completed ADVANCE-1 study (n=366; see HERE) and across the other two RW studies (ACCORD-1 n=108 and ACCORD-2), the failure in ADVANCE-2 is a surprise. Auvelity has now demonstrated stat-sig efficacy in three completed Phase III studies (ADVANCE-1, ACCORD-1 and ACCORD-2), with supportive efficacy and controlled safety results in a fourth trial
(ADVANCE-2). These studies will form the basis of an NDA filing in 2H25. While we believe that the overall NDA package is comprehensive and supports approval of Auvelity for ADA, the failure of ADVANCE-2 creates a regulatory uncertainty for investors. We also note that Rexulti (OTSKY) approval in ADA was based on successful results in 2 of 3 studies, but the key difference is that Rexulti studies were all randomized placebo-controlled, which is not the case with Auvelity. Hence, it comes down to FDA's view/acceptability of randomized withdrawal studies as evidence of primary efficacy. Given these dynamics, we now believe that FDA decision (to come in 2026) will become a bigger catalyst for the stock. In the meantime, we expect the stock to trade in the $80 range, with potential upside in the $130 range on approval."

For an analyst ratings summary and ratings history on Axsome Therapeutics click here. For more ratings news on Axsome Therapeutics click here.

Shares of Axsome Therapeutics closed at $86.70 yesterday.

You May Also Be Interested In

• Correction: Kepler Cheuvreux Upgrades Siemens AG (SIE:GR) (SIEGY) to Hold
• National Bank Financial Upgrades Wesdome Gold Mines Ltd. (WDO:CN) (WDOFF) to Outperform
• Berenberg Starts Brooks Macdonald Group PLC (BRK:LN) at Buy