| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Clinuvel Pharmaceuticals Limited American Depositary Shares
$6.52
+0.24 (+3.82%)
D 23Pipeline Score Richly Valued Biotech · Clinical
Market Cap
328.79 M
EPS
-
P/E Ratio
-
Value Trade
1.93 K
9.58 %
Week
-3.26 %
1 Month
-11.89 %
3 Month
-11.89 %
6 Month
%
5 Year
%
All Time
Cash Data
Cash Position
-
Monthly Burn
-
Runway
-
Overview
Volume
79.28 K
52 Week Range
-
% held by Insiders
-
% held by Institutions
0.01 %
Enterprise Value
-
Total Shares
50.43 M
Short %
0 %
Float Shares
-
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Clinuvel Pharmaceuticals Limited American Depositary Shares
4Total events
1Upcoming
0Tier-1 (high impact)
2026 – 2026Coverage
Upcoming catalysts 1
TBD
T2Management Change
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Event history 2
TBD
●Quarterly UpdateCorporate
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TBD
◆IpoCorporate
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Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
— | Example Drug | Phase 3 data readout | Phase 3 | — | – | 0% | 0% |
— | Example Drug | Phase 3 data readout | Phase 3 | — | – | 0% | 0% |
— | Example Drug | Phase 3 data readout | Phase 3 | — | – | 0% | 0% |
Drug Pipeline Intelligence
D23
Pipeline Score $6M
Pipeline ValueRichly Valued
Valuation Signal1
Drugs Scored0.0x
rNPV / MCap Top 22%
Micro Cap (rank 733 of 938)
Percentile RankClinuvel Pharmaceuticals Limited American Depositary Shares faces pipeline headwinds (23/100), with $32M risk-adjusted pipeline value, led by Afamelanotide in Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers (Phase 1).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Afamelanotide and NB-UVB Light Small molecule | Vitiligo | Phase 3 | NCT06109649 | 58% | $32M | ACTIVE NOT_RECRUITING | 200 | SLOW | C (42) | Jun 1, 2026 | - | Aug 1, 2026 |
CUVL Clinical Trial Results & History
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
Example Drug | Example indication for clinical evaluation | Phase 3 | 2025-12-01 | The study met its primary endpoint demonstrating statistically significant improvement. Read More | Phase 3 Study Results Announcement | |
Example Drug | Example indication for clinical evaluation | Phase 3 | 2025-12-01 | The study met its primary endpoint demonstrating statistically significant improvement. Read More | Phase 3 Study Results Announcement | |
Example Drug | Example indication for clinical evaluation | Phase 3 | 2025-12-01 | The study met its primary endpoint demonstrating statistically significant improvement. Read More | Phase 3 Study Results Announcement |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in CUVL
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
CUVL Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
-CUVL
Aug 26, 2026▼ -11.4%on this news
CLINUVEL considers Nasdaq listing, ASX delisting
CLINUVEL is contemplating a move to list on the Nasdaq while potentially delisting from the ASX. The company's headquarters will be relocated to the United States, which may provide better opportunities for growth and market engagement. This strategic shift reflects CLINUVEL's ambitions in the biopharma sector.
Read more →-CUVL
Aug 26, 2026▼ -11.4%on this newsshared move
A decade of profitability provides foundation for CLINUVEL’s U.S. expansion
CLINUVEL has reported a decade of profitability, which serves as a strong foundation for its expansion into the U.S. market. This financial success positions the company favorably for future growth opportunities. The announcement highlights the company's strategic focus on enhancing its presence in the U.S.
Read more →-CUVL
Aug 26, 2026▼ -11.4%on this newsshared move
Appendix 4E & Annual Report
CLINUVEL has released its Appendix 4E and Annual Report, providing insights into its corporate governance, pharmaceutical development, and financial summary. The report includes information on its products, photomedicine foundation, and investor relations. It serves as a comprehensive overview of the company's activities and performance over the past year.
Read more →-CUVL
Aug 26, 2026▼ -11.4%on this newsshared move
CLINUVEL Investor Presentation
CLINUVEL has announced an investor presentation detailing its U.S. expansion plans. The company emphasizes a strong foundation supporting this growth initiative. The presentation is set to provide insights into the financial and regulatory aspects of the expansion, highlighting the company's strategic direction.
Read more →-CUVL
Aug 26, 2026▼ -11.4%on this newsshared move
Appendix 4G and Corporate Governance Statement
The article provides an overview of Clinuvel's corporate governance and various aspects of its operations, including pharmaceuticals, photomedicine, and investor relations. It outlines the company's commitment to transparency and governance standards. However, specific details regarding governance changes or updates are not provided.
Read more →-CUVL
Aug 26, 2026▼ -11.4%on this newsshared move
Dividend/Distribution – CUV
The article provides an overview of CLINUVEL's corporate structure and various aspects of its operations, including pharmaceuticals, photomedicine, and investor relations. It lists resources available for investors, such as annual reports and financial summaries. However, it lacks specific details regarding dividends or distributions.
Read more →-CUVL
Aug 19, 2026▲ +9.1%on this news
CLINUVEL Annual Results — Investor Webinar
CLINUVEL held an investor webinar to discuss its annual results. The event covered various aspects of the company, including its pharmaceutical development, photomedicine foundation, and financial summary. Investors were provided with insights into the company's performance and future directions.
Read more →-CUVL
Aug 14, 2026Notice of initial substantial holder
The article provides a notice regarding the initial substantial holder for CLINUVEL Pharmaceuticals. It outlines various aspects of the company, including its governance, product offerings, and investor information. However, specific details about the substantial holder are not included in the text provided.
Read more →-CUVL
Aug 12, 2026CLINUVEL’s injectable peptide platform
CLINUVEL is refining its injectable peptide platform, specifically the VLRX-L candidate, following encouraging pre-clinical data. This development suggests a positive trajectory for the platform's future. The announcement highlights the company's ongoing commitment to advancing its innovative therapies.
Read more →-CUVL
Jul 30, 2026Commercial update on vitiligo
CLINUVEL has provided a commercial update regarding its developments in vitiligo treatments. The company continues to focus on its pharmaceutical and photomedicine initiatives. However, specific details about product advancements or market strategies were not disclosed in the article.
Read more →-CUVL
Jul 28, 2026Update: SCENESSE® in vitiligo
The article announces an evaluation of SCENESSE® in combination with adjuvant narrowband UVB for the treatment of vitiligo. This evaluation is part of ongoing clinical developments in Melbourne, Australia. The news highlights a positive step forward in exploring new treatment options for this condition.
Read more →-CUVL
Jul 27, 2026Appendix 3H — Notification of cessation of securities
CLINUVEL has issued a notification regarding the cessation of certain securities. The announcement is part of their ongoing corporate governance and investor relations activities. Further details about the implications of this cessation were not provided in the article.
Read more →-CUVL
Jul 23, 2026CLINUVEL implements strategic reorganisation to refocus on U.S. markets
CLINUVEL Pharmaceuticals is implementing a strategic reorganization to focus on the U.S. market, effective January 1, 2027. This includes relocating its headquarters to the U.S. and reducing its workforce by 10%-20%. The company aims to enhance regulatory engagement and capitalize on the larger U.S. pharmaceutical market, which represents over 40% of global value.
Read more →-CUVL
Jul 21, 2026▼ -5.1%on this newsshared move
CLINUVEL’s ADS commences trading on Nasdaq
CLINUVEL has announced that its American Depositary Shares (ADS) have commenced trading on the Nasdaq. This strategic move is expected to enhance the company's visibility in the U.S. market and attract a broader range of investors. The listing on Nasdaq marks a significant milestone for CLINUVEL as it seeks to expand its presence in the pharmaceutical industry.
Read more →-CUVL
Jul 20, 2026CLINUVEL’s ADS to commence trading on Nasdaq
CLINUVEL's American Depositary Shares (ADS) are set to begin trading on Nasdaq, specifically on the Global Select Market. This transition is expected to elevate the company's profile and potentially attract a broader investor base. The announcement highlights CLINUVEL's commitment to maintaining high standards in its market presence.
Read more →-CUVL
Jul 13, 2026SCENESSE® approved for EPP in Canada
CLINUVEL's SCENESSE® has been approved for the treatment of Erythropoietic Protoporphyria (EPP) in Canada. This approval signifies an important milestone for the company and enhances the therapeutic options available to patients suffering from this rare condition. The move reflects CLINUVEL's commitment to expanding its reach in the pharmaceutical market.
Read more →Competitive Position
How CUVL ranks across every disease it competes inCompetitive Position is a premium feature
See how CUVL ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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