Celcuity Announces NDA Plan for Gedatolisib WT Cohort Following Strong Phase 3 Results and Q3 Earnings Call

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Celcuity Inc. (NASDAQ: CELC) announced that its pivotal Phase 3 VIKTORIA-1 study met primary endpoints in the wild-type PIK3CA cohort, marking a major step forward for gedatolisib, its dual PI3K/mTOR inhibitor program.
The company plans to submit an NDA for this cohort in Q4 2025, following strong efficacy and safety outcomes presented at ESMO 2025.

✨ Why it matters: This milestone underscores gedatolisib’s potential to become a new standard of care for HR+/HER2− breast cancer — significantly expanding Celcuity’s reach in the targeted oncology market.

🧩 Context

Celcuity is a clinical-stage oncology biotech focused on precision therapies targeting the PI3K/AKT/mTOR signaling pathway.

Until now, the company’s efforts centered on developing gedatolisib for both PIK3CA-mutant and wild-type HR+/HER2− breast cancer, but this latest success represents a meaningful expansion into the broader wild-type population.

This aligns with a growing trend in oncology toward biomarker-driven therapies that can benefit larger patient subsets.

💡 In essence, the update shows how Celcuity is leveraging its precision oncology expertise to capture a broader commercial opportunity beyond mutation-specific indications.

⚗️ Clinical

From a clinical standpoint, gedatolisib is being developed for HR+/HER2− advanced breast cancer, currently in the registrational Phase 3 stage.
The drug is a dual PI3K/mTOR inhibitor, designed to inhibit tumor growth by blocking key survival signaling pathways.

Early VIKTORIA-1 data showed significant progression-free survival (PFS) improvement and a favorable safety profile compared to standard therapy.

In terms of competition, Novartis (alpelisib) and Gilead (idelalisib) target related pathways, though Celcuity aims to differentiate through superior tolerability and broader genetic applicability.