76% — What will the FDA's decision be on Gedatolisib by Celcuity Inc. in July 2026
Leader: Full Approval at 76% · Kalshi 76% · 4 contracts · $23 volume · medium confidence
Updated 2026-06-26 13:13:40 UTC

Tracks the leading outcome in a winner-take-all prediction market set with 4 outcomes.

Why this matters:
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.

Key factors:
- 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

Contracts:
- What will the FDA's decision be on Gedatolisib by Celcuity Inc. in July 2026?: Full Approval — 76¢ Kalshi $23 (weight 100%)
- What will the FDA's decision be on Gedatolisib by Celcuity Inc. in July 2026?: Denied (CRL Issued) — 9¢ Kalshi $0 (weight 0%)
- What will the FDA's decision be on Gedatolisib by Celcuity Inc. in July 2026?: Conditional / Accelerated Approval — 5¢ Kalshi $0 (weight 0%)
- What will the FDA's decision be on Gedatolisib by Celcuity Inc. in July 2026?: No Decision — 4¢ Kalshi $0 (weight 0%)

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## Methodology

SimpleFunctions aggregates live YES-side prices from Kalshi and Polymarket contracts bound to this question. For binary topics the headline is the liquidity-weighted mid-price (weight = log(1 + 24h volume) × freshness, where freshness is 1.0 if updated <24h, 0.7 if <7d, 0.4 otherwise). For multi-outcome (winner-take-all) topics the headline is the current leader's price — disjoint outcomes are never arithmetically averaged. Snapshots refresh every 5 minutes during market hours.

## SF Signal

- SF Index, regime, and 30d Brier calibration are computed separately and surfaced at https://simplefunctions.dev/admin/calibration.
- No SimpleFunctions index / regime / calibration signal is bound to this topic yet — the headline above is market-derived only.

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*Last verified: 2026-06-26T12:20:49.449Z*

By SimpleFunctions — https://simplefunctions.dev/

Cite as: "76% per prediction markets (SimpleFunctions, June 2026)"
Canonical: https://simplefunctions.dev/answer/gedatolisib
Full data: https://simplefunctions.dev/api/public/query?q=What%20will%20the%20FDA's%20decision%20be%20on%20Gedatolisib%20by%20Celcuity%20Inc.%20in%20July%202026
Provider: SimpleFunctions — https://simplefunctions.dev