Celcuity Inc. 8-K

What Happened

• On May 1, 2026, Celcuity Inc. announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant, with or without palbociclib, in patients with HR+/HER2‑ locally advanced or metastatic breast cancer who progressed on or after a CDK4/6 inhibitor and an aromatase inhibitor.
• The trial’s primary efficacy analysis showed that gedatolisib + fulvestrant + palbociclib produced a statistically significant and clinically meaningful improvement in progression‑free survival (PFS) versus alpelisib (a PI3Kα inhibitor) + fulvestrant. A secondary comparison of gedatolisib + fulvestrant versus alpelisib + fulvestrant (not part of the primary hierarchical analysis) also showed a statistically significant and clinically meaningful PFS benefit.
• Both gedatolisib regimens were reported as generally well tolerated with manageable safety profiles and no new safety signals. Celcuity plans to submit these data to the FDA as a supplemental NDA (sNDA) and to present the data at the 2026 ASCO Annual Meeting.

Key Details

• Date filed: May 1, 2026 (press release furnished as Exhibit 99.1).
• Trial: Phase 3 VIKTORIA-1, PIK3CA mutant cohort, HR+/HER2‑ advanced/metastatic breast cancer after CDK4/6 inhibitor + aromatase inhibitor.
• Efficacy: Statistically significant, clinically meaningful improvement in PFS for gedatolisib + fulvestrant + palbociclib vs alpelisib + fulvestrant; secondary gedatolisib + fulvestrant vs alpelisib + fulvestrant also positive.
• Regulatory plans: Company intends to submit an sNDA to the FDA and share results at ASCO 2026; plans to pursue submissions with other regulatory authorities thereafter.

Why It Matters

• Positive Phase 3 topline results targeting a defined genetic subset (PIK3CA mutant) support Celcuity’s regulatory pathway (sNDA) and could meaningfully affect the company’s clinical and commercial outlook if validated through full data review and regulatory review.
• For investors, the announcement is a material clinical development: it may influence near‑term regulatory milestones (sNDA submission) and future valuation, but the company notes the topline results are based on ongoing analyses and could change upon full review; forward‑looking statements and standard regulatory risks apply.