Celcuity Inc. 8-K

What Happened
On June 2, 2026 Celcuity Inc. filed an 8-K and issued a press release reporting detailed efficacy and safety results from the PIK3CA mutant-type (MT) cohort of its Phase 3 VIKTORIA-1 trial of gedatolisib. The gedatolisib-triplet showed a statistically significant improvement in progression‑free survival (PFS) versus alpelisib plus fulvestrant (HR = 0.50; 95% CI 0.37–0.68; p < 0.0001). Median PFS by blinded central review was 11.1 months for the gedatolisib‑triplet vs. 5.6 months for alpelisib plus fulvestrant. Objective response rate (ORR) for the triplet was 48.9% vs. 26.0% for alpelisib plus fulvestrant; median duration of response (DOR) was 15.7 vs. 7.5 months. The gedatolisib‑doublet also showed improved PFS (median 11.3 vs. 5.6 months; HR = 0.51; 95% CI 0.33–0.79; descriptive p = 0.0013) with ORR 35.7% and DOR 24.2 months. Safety was generally manageable with mostly low‑grade treatment‑related adverse events; noted Grade 3+ events and discontinuation rates are summarized below. Celcuity plans to submit an sNDA to the FDA for these data and says it is on track to launch gedatolisib commercially in anticipation of potential FDA approval in Q3 2026. Separately, the FDA has granted Priority Review of Celcuity’s NDA for gedatolisib in PIK3CA wild‑type disease with a PDUFA date of July 17, 2026.

Key Details

• Filing date: 8‑K filed June 2, 2026; press release furnished as Exhibit 99.1.
• Primary efficacy: Gedatolisib‑triplet median PFS 11.1 vs. 5.6 months (HR 0.50; 95% CI 0.37–0.68; p < 0.0001).
• Response and durability: Triplet ORR 48.9% vs. 26.0%; triplet median DOR 15.7 vs. 7.5 months. Doublet median PFS 11.3 months (HR 0.51; 95% CI 0.33–0.79).
• Safety highlights: Grade 3+ neutropenia 58.8% (triplet) vs. 0% (doublet) vs. 0.7% (alpelisib); hyperglycemia 2.6% (triplet) vs. 14.5% (alpelisib). Treatment discontinuations due to TRAEs: 2.6% (triplet), 3.8% (doublet), 7.1% (alpelisib). One Grade 5 TRAE in triplet (related to palbociclib); two Grade 5 TRAEs in alpelisib arm.
• Regulatory path: Company intends to submit these PIK3CA MT data as an sNDA to the FDA; NDA for PIK3CA WT received Priority Review with PDUFA date July 17, 2026.

Why It Matters
These Phase 3 results are material because they show statistically significant and clinically meaningful improvement in PFS and higher response rates for gedatolisib combinations versus an approved comparator in a defined patient population (HR+/HER2‑, PIK3CA MT, after CDK4/6 inhibitor therapy). Celcuity’s planned sNDA submission and stated commercial readiness — together with an active Priority Review for a related NDA — are direct regulatory and business actions investors can track. Key near‑term dates and outcomes to watch are the sNDA submission timing, the PDUFA date (July 17, 2026 for the WT NDA), and any FDA feedback or labeling decisions.