zolucatetide — FDA meeting
Q4 2026
Expect to engage with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2026 to discuss and align on the planned registrational Phase 3 trialSource filing
catalyst calendar
PARABILIS MEDICINES INC · Data as of 2026-10-25
Q4 2026
Expect to engage with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2026 to discuss and align on the planned registrational Phase 3 trialSource filing
Q1 2027
Parabilis anticipates disclosing additional data in the first quarter of 2027 from patients with FAP and concomitant desmoid tumors currently enrolled in the ongoing Phase 1/2 trial.Source filing
H1 2027
Expect to share clinical data from additional patients in the first half of 2027 for ACP, a locally aggressive tumor arising near the pituitary gland associated with significant lifelong morbidity and no approved drug therapies, with a conservatively estimated 15-year prevalence of approximately 5,000 to 9,000 patients in the U.S.Source filing
in 2029
Parabilis plans to initiate the randomized, double-blind PEDESTAL Phase 3 trial ( P hase 3 E valuation of DES moid T umor A ctivity with zo L ucatetide) in the first half of 2027, with topline results anticipated in 2029.Source filing