Must Watch Milestones for Apnimed in 2026

Pharmaceutical Executive: Looking beyond this year’s conference, what milestones should the market be watching for from Apnimed in 2026?

Graham Goodrich:

We have stated publicly that we intend to file our NDA with the FDA in the first half of 2026 it's a really exciting time, with that is the development of our commercial model. We're focused on insights, access and infrastructure. It's getting the insights that we need so that we can understand the customers, people with OSA, and that we can deliver an experience for them that's going to be world class.

So, we're investing a lot of time in the commercialization process as we, in parallel, prepare our submission to the FDA. You'll see us begin to build out the next level of our commercial commercialization model and the infrastructure that we need to support that and then, accordingly, if you assume a submission in the first half of 2026 we're expecting a 10 month review process. So, we would expect a decision by the FDA in the first half of 2027 so it's a really exciting time.

We know that organic demand for a pill that could treat sleep apnea is massive, and we're doing everything we can to bring that to market to as many people as possible, as soon as possible.