Axsome Therapeutics, Inc. (AXSM) Q1 2026 Earnings Call

Investor webinar replay

Replay transcript excerpt

That design was chosen. And I guess if it's positive, would you expect to have to do a parallel study after that? Thanks for the question. So we do anticipate that we would need two positive trials. That's the standard for any approval for any indication at the FDA. And in terms of the reason for the randomized withdrawal design, one of the challenges with neuropsychiatric indications and depression in particular is the high placebo response. So how do you deal with that? So in the prior studies, in the prior study, which we conducted with solriamfetol in this indication, what we saw in the active arm was clearly, a very pronounced antidepressant effect. So we wanted to make sure is that we're able to tease out and really demonstrate that this is a drug effect, and while minimizing the impact of the placebo response. So that's the rationale behind the selection of that study design. Okay. Thank you very much. And can I also ask just like long term, how are you thinking about profitability? And does the increased conviction in OVELITY and what that could do from a sales perspective? Does I guess does profitability start to become a goal for the company or is the focus kind of more on sort of revenue growth? Right now, our focus continues to be on revenue growth. So I think if you have to put things in priority order, revenue growth is number one, then getting the cash flow positivity is two and then profitability shortly thereafter. Great. Thank you. Thank you. Next question is coming from Greg Sublimez from Mizuho. Your line is now live. Good morning, guys. Congrats on all of the progress and especially the AD agitation approval. And thanks for taking my questions. I've got questions on OVELODI. And I'm curious if you could provide some color around how we should thi...