ARS PHARMACEUTICALS INC · Data as of 2026-09-08
H2 2026
A Phase 2b trial (NCT06927999) evaluating the company's intranasal epinephrine technology as a treatment for acute flares of chronic spontaneous urticaria is enrolling patients across the U.S. and Europe, with interim data anticipated in the second half of 2026 followed by the potential initiation of a single pivotal efficacy study in mid-2027.Source filing
Q4 2026
The interim analysis population is fully enrolled as of May 2026, and interim data from this clinical trial is anticipated in the fourth quarter of 2026, followed by the potential initiation of a single Phase 3 pivotal efficacy study in mid-2027.Source filing
Q1 2027
Interim data from Phase 2b trial in chronic spontaneous urticaria (CSU) expected in Q1 2027; no FDA-approved on-demand treatment currently exists for acute CSU flaresSource filing
early 2027
Discussions with additional states are ongoing, and we anticipate a majority of Medicaid state plans adopting neffy to their unrestricted Medicaid formularies by early 2027.Source filing