Celcuity Shares Drop 25% After Trial Shows 11.1-Month PFS
CELC•Celcuity shares dropped 25% after mixed Phase 3 VIKTORIA-1 trial data showed gedatolisib achieved median progression-free survival of 11.1 months versus 5.6 months standard care. Analyst maintained a $171 price target and expects FDA approval by July 2026 based on long-term efficacy outlook.
1. Mixed Phase 3 VIKTORIA-1 Trial Data
Celcuity’s pivotal Phase 3 VIKTORIA-1 trial showed gedatolisib achieved a median progression-free survival of 11.1 months compared to 5.6 months under standard care, marking a significant improvement for some patients. The results underperformed prior expectations on overall trial endpoints, setting the stage for key regulatory discussions ahead of a planned FDA filing in July 2026.
2. Analyst Price Target and Approval Timeline
Craig-Hallum maintained a $171 price target on Celcuity, implying roughly 92% upside based on projected gedatolisib sales and long-term market penetration. The firm cited durable efficacy signals despite mixed data and anticipates an FDA decision by July 2026 as the next major catalyst.
3. Share Volatility and Outlook
Shares plunged over 25% on the clinical data release, underscoring biotech valuation sensitivity to trial outcomes. Investors will monitor upcoming regulatory milestones and additional efficacy readouts for signs of sustained momentum or further downside risk.
