85% — What will the FDA's decision be on Roflumilast (ARQ-151) by Arcutis Biotherapeutics in June 2026 Leader: Full Approval at 85% · Kalshi 85% · 3 contracts · $157 volume · medium confidence Updated 2026-06-26 14:02:16 UTC Tracks the leading outcome in a winner-take-all prediction market set with 3 outcomes. Why this matters: Markets are pricing an 82% likelihood that the FDA approves Roflumilast (ARQ-151), Arcutis Biotherapeutics' topical treatment, by end of June 2026. This high confidence reflects either recent positive clinical data or an advanced stage in the review process, with relatively low odds assigned to outright denial (4%) or no decision within the timeframe (9%). The approval probability would shift materially based on whether the FDA issues a Complete Response Letter citing additional data needs, or if Arcutis withdraws the application. The key resolution event is the FDA's action letter, which typically arrives by the Prescription Drug User Fee Act (PDUFA) deadline. Movement in these prices would signal new information about manufacturing compliance, efficacy data interpretation, or regulatory feedback. Key factors: - FDA PDUFA action letter deadline in June 2026 is the hard resolution date; any decision after month-end resolves as 'No Decision' - Recent regulatory communications or clinical trial results that would indicate FDA satisfaction with efficacy and safety profile relative to dermatology standards - Manufacturing or chemistry/manufacturing/controls (CMC) issues that could trigger a Complete Response Letter rather than approval - Competitive landscape and unmet need in the indication (atopic dermatitis, plaque psoriasis, or other inflammatory skin condition) may influence expedited review pathway status - Historical approval rates for similar topical immunomodulatory agents and whether ARQ-151 follows typical approval timelines or faces unusual scrutiny Contracts: - What will the FDA's decision be on Roflumilast (ARQ-151) by Arcutis Biotherapeutics in June 2026?: Full Approval — 85¢ Kalshi $140 (weight 89%) - What will the FDA's decision be on Roflumilast (ARQ-151) by Arcutis Biotherapeutics in June 2026?: Conditional / Accelerated Approval — 8¢ Kalshi $0 (weight 0%) - What will the FDA's decision be on Roflumilast (ARQ-151) by Arcutis Biotherapeutics in June 2026?: No Decision — 3¢ Kalshi $17 (weight 11%) --- ## 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. --- *Last verified: 2026-06-26T13:20:51.415Z* By SimpleFunctions — https://simplefunctions.dev/ Cite as: "85% per prediction markets (SimpleFunctions, June 2026)" Canonical: https://simplefunctions.dev/answer/roflumilast Full data: https://simplefunctions.dev/api/public/query?q=What%20will%20the%20FDA's%20decision%20be%20on%20Roflumilast%20(ARQ-151)%20by%20Arcutis%20Biotherapeutics%20in%20June%202026 Provider: SimpleFunctions — https://simplefunctions.dev