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CELCBearishCorporate Developmentsnews

High materiality8/10

Celcuity reports Phase 3 superiority for gedatolisib regimens in VIKTORIA-1

Jun 2, 2026, 1:56 PM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Despite positive trial outcomes, the immediate stock reaction was a ~25% drop, suggesting the market priced in execution risk, OS uncertainty, or valuation concerns ahead of data readouts and sNDA timelines.

AI summary

What happened, with direct paths to the underlying reporting

Celcuity reported that gedatolisib in a triplet regimen significantly improved progression-free survival (PFS) versus alpelisib plus fulvestrant in the VIKTORIA-1 Phase 3 study, with PFS of 11.1 months (vs 5.6) and a 0.50 hazard ratio. The triplet also delivered a 48.9% objective response rate. Despite the data, Celcuity stock fell about 25% on the news as the market awaits overall survival data and sNDA timing.

VIKTORIA-1 Phase 3: gedatolisib triplet outperforms comparator.
Triplet PFS 11.1 vs 5.6 months; HR 0.50.
ORR 48.9% vs 26.0%; DOR 15.7 vs 7.5 months.
Regulatory filings planned; sNDA submission to FDA planned.

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