Axsome Therapeutics' (AXSM) data package for its AXS-05 candidate drug for Alzheimer's disease agitation is likely approvable, RBC Capital Markets said in a note Friday after a meeting with the company's management.
Axsome seems to have kept alignment with the US Food and Drug Administration during AXS-05's regulatory process, with "no changes to the package in the run-up to filing, and no major data submissions since -- which gives us confidence that the filing acceptance is simply a matter of time," RBC said.
Axsome is well placed to "take advantage of payer contracts, brand awareness, and prescriber overlap to execute on what could be a rapid launch with significant peak sales," the note said.
RBC said that it likes Axsome's shares heading into next year, because in addition to the "near-term optionality" offered by AXS-05 in Alzheimer's agitation, the company's Auvelity treatment for major depressive disorder "sets a floor value" for the stock.
Meanwhile, any upside on the company's other products, like Sunosi, Symbravo, and others, may support further upside, the note said.
RBC has an outperform rating on Axsome with a $198 price target.
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