Monitor dossier validation and first formal feedback expected in approximately four months. Approval in even one EU market would open a new revenue stream for Clinuvel, but the 300-day review timeline means no near-term commercial impact.
Price Chart
Executive Summary
Clinuvel filed a marketing authorization dossier for its second product, NEURACTHEL Instant (tetracosactide), with European regulators under the decentralized procedure. The filing targets three initial EU markets and addresses a global ACTH market estimated at US$1.3 billion annually. The product is not yet approved anywhere, and the review process is expected to take 300 days plus clock stops.
Key Facts
- NEURACTHEL Instant (tetracosactide) dossier filed via European decentralized procedure (DCP) in three initial EU member states.
- Global ACTH market estimated at US$1.3 billion annually.
- DCP review process intended to take 300 days excluding clock stops, with final position at day 270.
- NEURACTHEL Instant is not currently approved in any country.
- Timeline for US FDA filing is under review.
- Further submissions to UK MHRA and other EU states are being evaluated.
Financial Impact
No financial figures provided; global ACTH market estimated at US$1.3B annually.
Risk Factors
- Regulatory approval is not guaranteed; DCP review may result in rejection or require additional data.
- NEURACTHEL Instant is not approved in any country, adding execution risk.
- Clock stops during DCP review could extend the timeline beyond 300 days.
- Competition from existing ACTH products and other branded generics.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001493152-26-049334 |
| Document: form6-k.htm | 0001493152-26-049334 |
| Document: 0001493152-26-049334-index-headers.html | 0001493152-26-049334 |
| Document: 0001493152-26-049334-index.html | 0001493152-26-049334 |
| Document: 0001493152-26-049334.txt | 0001493152-26-049334 |
| Earnings Context (Synthetic; results releases only) | 0001493152-26-049334 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 30, 2026 2d ago | 20-F | $4.94 | awaiting T+20 | awaiting T+20 | $5.07 (+2.63%) |
Oct 30, 2026 2d ago | 6-K | $4.94 | awaiting T+20 | awaiting T+20 | $5.07 (+2.63%) |
Oct 15, 2026 17d ago | 6-K | $5.06 | awaiting T+20 | awaiting T+20 | $5.07 (+0.20%) |
Oct 7, 2026 25d ago | 6-K | $5.80 | awaiting T+20 | awaiting T+20 | $5.07 (−12.59%) |
Oct 2, 2026 4w ago | 6-K | $6.03 $5.07 | ▼ −15.92% | ▼ −14.11% | $5.07 (−15.92%) |
Oct 1, 2026 4w ago | 6-K | $5.66 $5.15 | ▼ −9.01% | ▼ −9.71% | $5.07 (−10.42%) |
Aug 27, 2026 9w ago | 6-K | $6.77 $5.78 | ▼ −14.62% | ▼ −14.12% | $5.07 (−25.11%) |
Aug 27, 2026 9w ago | Press Release | $6.77 $5.78 | ▼ −14.62% | ▼ −14.12% | $5.07 (−25.11%) |
Aug 20, 2026 10w ago | 6-K | $7.80 $5.90 | ▼ −24.36% | ▼ −24.36% | $5.07 (−35.00%) |
Jul 23, 2026 14w ago | 6-K | $6.95 $7.80 | ▲ +12.23% | ▲ +8.92% | $5.07 (−27.05%) |
US Market Status
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