Operator

Welcome to Egetis Therapeutics Q1 Report 2026. [Operator Instructions] Now, I will hand the conference over to CEO, Nicklas Westerholm. Please go ahead.

Nicklas Westerholm
Chief Executive Officer

Good morning, and a warm welcome to our quarter 1 results plan for the coming 30 minutes. For those who haven't had the privilege to meet before, my name is Nicklas Westerholm, I'm the CEO of the company. With me today, we also have Yilmaz Mahshid, Chief Financial Officer; Henrik Krook, Vice President, Commercial Operations; Anny Bedard, President of our U.S. Business; and Karl Hard, Vice President and Head of Investor Relations.

Let's turn to our attention to the topics covered today depicted on the slide in front of you. To summarize, quarter 1 has been historical for Egetis with several key milestones delivered. Amongst others and most importantly, the FDA acceptance of our new drug application for Emcitate for the treatment of MCT8 deficiency, where the agency also granted us a priority review with a so-called PDUFA target action date, i.e., decision date set to September 28, 2026.

We will also provide an update on the launch preparations in the U.S. as well as the commercialization in the European Union. And furthermore, financial update will be covered by our CFO. And we aim to leave ample time for Q&A at the end of the session. So let's turn our attention to the