# What will the FDA's decision be on Roflumilast (ARQ-151) by Arcutis Biotherapeutics in June 2026

> Full Approval leads at 85%, runner-up 8% across 3 winner-take-all outcomes — refreshed 45 min ago.

URL: https://simplefunctions.dev/odds/roflumilast
Updated: 2026-06-26T13:20:51.415Z
Category: general
Status: active
Closes: 2026-07-01

## Headline

- Leader: Full Approval at 85%
- Runner-up: Conditional / Accelerated Approval at 8%
- Outcomes: 3 (winner-take-all)
- Venue: Kalshi (3 contracts)
- 24h volume: $157

## Bound contracts (3)

| Outcome | Price | 24h | Volume | Venue | Slug |
|---|---|---|---|---|---|
| Full Approval | 85¢ | ±0 | $140 | kalshi | /markets/what-will-the-fdas-decision-be-on-roflumilast-arq-kalshi-kxroflumilast-26-fa |
| Conditional / Accelerated Approval | 8¢ | ±0 | $0 | kalshi | /markets/what-will-the-fdas-decision-be-on-roflumilast-arq-kalshi-kxroflumilast-26-ca |
| No Decision | 3¢ | −2pp | $17 | kalshi | /markets/what-will-the-fdas-decision-be-on-roflumilast-arq-kalshi-kxroflumilast-26-nd |

## 30-day trajectory

| Day | Full Approval | Conditional / Accelerated Approval | No Decision |
|---|---|---|---|
| 2026-06-09 | 79 | 2 | 7 |
| 2026-06-10 | 81 | — | 9 |
| 2026-06-18 | 77 | 4 | 11 |
| 2026-06-19 | 77 | — | — |
| 2026-06-25 | 81 | 5 | 5 |
| 2026-06-26 | 81 | — | — |

_14 days of price history captured. Each row is the daily mean of intraday 5-min captures._

## What moved the line

- 2026-06-20 · Conditional / Accelerated Approval +5pp 4→9¢ · kalshi
- 2026-06-22 · Full Approval −4pp 80→76¢ · kalshi
- 2026-06-25 · Full Approval +3pp 78→81¢ · kalshi
- 2026-06-20 · No Decision −3pp 11→8¢ · kalshi
- 2026-06-22 · Conditional / Accelerated Approval −3pp 9→6¢ · kalshi

## Analysis

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

## Methodology

Headline is the **leader's price**, not an arithmetic mean — averaging disjoint winner-take-all outcomes is meaningless. Per-outcome prices come from the venue's last-traded mid; cross-venue values are simple means across contracts on each venue.

## How to use this data

- HTML: https://simplefunctions.dev/odds/roflumilast
- JSON: https://simplefunctions.dev/api/public/odds?slug=roflumilast

## License

CC-BY-4.0. Attribute "SimpleFunctions" with a link to https://simplefunctions.dev. See https://simplefunctions.dev/legal for terms.