Piper Sandler Reiterates Overweight Rating on Axsome Therapeutics (AXSM)

Piper Sandler analyst David Amsellem reiterated an Overweight rating and $148.00 price target on Axsome Therapeutics (NASDAQ: AXSM).

The analyst commented: "Esreboxetine RTF Less Than Ideal, But Not A Consequential Driver Of The Shares; Axsome announced that it received a Refuse to File (RTF) letter from the FDA regarding its NDA for oral norepinephrine reuptake inhibitor AXS-14 (esreboxetine) for the treatment of fibromyalgia (FM). Though both studies included in the filing met their primary endpoints, the agency did not consider one of these studies, a shorter, smaller Phase II trial that incorporated a flexible dosing paradigm, as sufficient to support the filing. In other words, the FDA wants AXSM to run a confirmatory Phase III trial. We believe the additional study is worth the trouble, in the context of a space that has not seen the approval of a new agent in over a decade, and in the context of a product where AXSM can readily leverage its existing commercial infrastructure. We reiterate our Overweight rating and $148 PT."

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 $109.87 yesterday.

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