There are already lengthy patient waitlists for the medication on digital health platforms.
Sanofi and Amgen have signed collaborations with US host cities, while TV pharma commercials re-enter the spotlight.
The FDA is anticipated to make its decision on the regimen by 9 October 2026.
The approval is based on data from one pivotal Phase III study (AK111-301) and three additional supportive studies.
XtalPi stands to receive further payments based on clinical and commercial milestones, as well as future royalties.
If approved, adrabetadex would be the third addition to the I-NPC treatment paradigm.
