What will the FDA's decision be on Gedatolisib by Celcuity Inc. in July 2026

30-day trend

Analysis

Markets are pricing an approximately 75% likelihood that the FDA will grant full approval for Gedatolisib (a Celcuity Inc. oncology candidate) by the end of July 2026. This probability reflects the drug's regulatory progress toward a potential approval decision within the specified timeframe. The current level is driven by the timing of the FDA review cycle and the therapeutic area's historical approval rates for similar agents. The primary catalyst would be the formal FDA decision, which typically follows completion of the agency's standard or priority review period. Approval odds would increase if recent clinical data demonstrate efficacy and safety improvements over existing treatments, while they would decline if the FDA issues a complete response letter requesting additional data, or if the decision timeline extends beyond July.

• ›FDA review timeline completion: whether the agency's decision date falls within July 2026 versus extending into later months
• ›Recent clinical trial outcomes for Gedatolisib: efficacy and safety profile relative to competitor drugs in the same indication
• ›Celcuity's regulatory communication history: any preliminary feedback or deficiency letters from the FDA before July
• ›Historical approval rates for oncology candidates in this drug class and indication
• ›Competitive landscape: whether other similar agents recently gained approval, which could influence FDA precedent and decision momentum

What moved the line

• Jun 20Full Approval↓3pp76→73¢ · Kalshi
• Jun 21No Decision↓3pp6→3¢ · Kalshi

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These markets stopped trading. Last odds and any captured outcome are shown above — full settlement detail lives at the venue.

How we compute these odds