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

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WEBVTT NOTE Transcription provided by Deepgram Request Id: 01a0425d-47d1-7b90-94b8-bbbe1e7e85aa Created: 2026-08-27T08:36:45.852Z Duration: 732.02936 Channels: 1 00:00:00.000 -- 00:00:01.599 That 00:00:01.599 -- 00:00:03.439 design was chosen. And I guess if it's 00:00:03.439 -- 00:00:04.560 positive, would you 00:00:05.120 -- 00:00:06.879 expect to have to do a parallel study 00:00:06.879 -- 00:00:07.680 after that? 00:00:10.080 -- 00:00:11.280 Thanks for the question. 00:00:12.015 -- 00:00:15.135 So we do anticipate that we would need 00:00:15.135 -- 00:00:18.255 two positive trials. That's the standard 00:00:18.495 -- 00:00:20.255 for any approval 00:00:20.575 -- 00:00:23.215 for any indication at the FDA. 00:00:23.375 -- 00:00:26.255 And in terms of the reason for the 00:00:26.255 -- 00:00:29.510 randomized withdrawal design, one of the challenges 00:00:29.590 -- 00:00:30.230 with 00:00:32.310 -- 00:00:33.190 neuropsychiatric 00:00:33.190 -- 00:00:36.070 indications and depression in particular is the high 00:00:36.070 -- 00:00:38.470 placebo response. So how do you deal with 00:00:38.470 -- 00:00:40.710 that? So in the prior studies, 00:00:40.950 -- 00:00:42.790 in the prior study, which we conducted 00:00:43.635 -- 00:00:45.074 with solriamfetol 00:00:45.074 -- 00:00:47.635 in this indication, what we saw 00:00:47.954 -- 00:00:50.835 in the active arm was clearly, 00:00:51.315 -- 00:00:53.394 a very pronounced antidepressant 00:00:53.394 -- 00:00:54.034 effect. 00:00:54.594 -- 00:00:54.995 So 00:00:55.410 -- 00:00:57.649 we wanted to make sure is that 00:00:58.450 -- 00:01:01.489 we're able to tease out and really demonstrate 00:01:01.809 -- 00:01:03.730 that this is a drug effect, 00:01:04.129 -- 00:01:05.570 and while 00:01:05.570 -- 00:01:06.370 minimizing 0...