The performance of Axsome Therapeutics’ AXS-05 in the Phase 3 GEMINI study was “remarkably consistent” with the positive and pivotal Phase II ASCEND trial from both a Montgomery-Asberg Depression Rating Scale improvement and remission perspective, William Blair analyst Myles Minter tells investors in a research note. Today’s data is “transformational” for the company, enabling a New Drug Application submission in the second half of 2020 for AXS-05 in major depressive disorder pending positive long-term open label safety data, says the analyst. He estimates peak sales of beyond $900M in the U.S. alone with market entry early 2022. Minter, who increased his probability of success for the drug to 90%, believes Axsome is a “strong takeout candidate.” He sees a takeout value in the range of $120 to beyond $140 per share and calls Axsome his top pick for 2020. The stock in morning trading is up 64%, or $29.85, to $76.64.
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