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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.

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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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