Axsome Therapeutics, Inc. (AXSM) Piper Sandler 37th Annual Healthcare Conference December 3, 2025 4:00 PM EST
Company Participants
Mark Jacobson – Chief Operating Officer
Nick Pizzie – Chief Financial Officer
Conference Call Participants
David Amsellem – Piper Sandler & Co., Research Division
Presentation
David Amsellem
Piper Sandler & Co., Research Division
Okay. Good afternoon, everyone. So continuing on day 2 of the Piper Sandler Healthcare Conference. This is David Amsellem from the Piper Biopharma Research team. So we’re delighted to have Axsome with us. We have Mark Jacobson, COO; and Nick Pizzie, CFO. So thanks, gentlemen, for joining us. So we got a lot to talk about. So let’s dive right in.
Question-and-Answer Session
David Amsellem
Piper Sandler & Co., Research Division
So — yes, a couple of things, exactly. So I want to start with the filing for Auvelity and AD agitation. It’s such a key topic. So just to start with any updates here? And just remind us for those who aren’t as well versed on this particular topic, anything we should read into the absence of a priority review here in AD agitation?
Mark Jacobson
Chief Operating Officer
Sure. So we’re — right now, we’re waiting for an important decision. And that is the next update that we’d anticipate sharing. We had confirmed on our Q3 call in early November that the sNDA was submitted. That’s good. So now we’re waiting to provide an update there. The package is such that three positive trials has breakthrough therapy designation.
And our base case expectation is if it’s accepted, it would be a standard review. And that’s simply just due to kind of our read of baseline assumptions with happenings at FDA, right, resource constraints, bandwidth considerations. It’s agnostic to our package. So that’s our base case.
And look, we’ll
