Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
Volume
693.00
Value Traded
1.93 K
Short % Float
0.03%
Days to Cover
1.1
+1.19%Week
-11.72%1 Month
-26.33%3 Month
-30.81%6 Month
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
258.49 M
EPS (TTM)
-
P/E Ratio
-
Ent. Value
-
Total Shares
50.49 M
Float Shares
37.77 M
Insiders
-
Institutions
0.01%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
PoA blends historical approval base rates, trial design score and FDA review track record.
CUVL Catalyst Timeline
Dated clinical, regulatory and corporate events for Clinuvel Pharmaceuticals Limited American Depositary Shares
Catalyst Timeline
Dated clinical, regulatory & corporate events for Clinuvel Pharmaceuticals Limited American Depositary Shares
4Total events
1Upcoming
0Tier-1 (high impact)
2026 to 2026Coverage
Upcoming catalysts 1
TBD
T2Management Change
Subscribe to view catalyst details
Event history 1
Past FDA Catalysts and PDUFA Decisions
How CUVL actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| - | Example Drug | Phase 3 data readout | Phase 3 |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
Pipeline Score
Pipeline Value
Valuation Signal
1
Drugs Scored
rNPV / MCap
Top Drug
Top 89%
Micro Cap(rank 586 of 658)
Percentile Rank
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Afamelanotide Small moleculeNCT06109649 | Vitiligo | Phase 3 | ACTIVE NOT_RECRUITING | 200 | Jun 1, 2026 | ||||||
| Afamelanotide Small moleculeCompletedNCT06388642 | Erythropoietic Protoporphyria | Phase 1 | COMPLETED | 28 | Jan 20, 2025 |
Clinical Trial Results
Readouts, endpoints and source filings for every CUVL program
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| John SmithCEO | Buy | 50,000 150,000 held | $45.50 | 01/10/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in CUVL
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in CUVL for Q2 2026. | ||||
CUVL Institutional Ownership Trends
CUVL Short Interest
Shares sold short, counted twice a month.
0.03%
Short % of Float
of tradable shares sold short
12.1K
Shares Sold Short
-54.4% vs prior count
1.1 Low
Days to Cover
trading days of normal volume to buy every short share back
11.2K
Avg Daily Volume
the average used for days to cover
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How CUVL ranks across every disease it competes in
Competitive 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.
Start free trialCUVL 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
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 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 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 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 →-CUVL
Apr 24, 2026CLINUVEL receives final EMA scientific advice for pivotal Phase III vitiligo study
CLINUVEL PHARMACEUTICALS has received final scientific advice from the EMA for its pivotal Phase III study, CUV107, evaluating SCENESSE® as a treatment for vitiligo. The EMA emphasized a 'totality of evidence' approach, with a focus on patient-reported outcomes and photographic assessments. The study is set to begin in the second half of 2026.
Read more →-CUVL
Apr 15, 2026CLINUVEL: advancing peptides for photomedicine and vitiligo care at AAD 2026
CLINUVEL presented its advancements in photomedicine and vitiligo care at the AAD 2026 Annual Meeting, engaging over 20,000 dermatology professionals. The company highlighted its Phase III study on afamelanotide, which showed promising results in repigmentation for vitiligo patients. The event emphasized a holistic approach to patient care and fostered discussions on improving clinical trial diversity.
Read more →-CUVL
Dec 8, 2025CLINUVEL expands Singapore RD&I Centre to pioneer next-generation peptide therapies
CLINUVEL Pharmaceuticals has announced a significant expansion of its VALLAURIX Research, Development and Innovation Centre in Singapore, supported by a five-year investment from the Singapore Economic Development Board. This expansion aims to enhance the development of liquid long-acting peptide formulations and strengthen the company's global capabilities in peptide-based medicine. The facility is expected to be fully operational by FY2028.
Read more →-CUVL
Sep 29, 2025CLINUVEL to advance novel pharmaceutical formulations in preclinical program
CLINUVEL is advancing new sustained-release liquid drug formulations in a preclinical program, focusing on optimizing drug release kinetics for peptides. The formulations aim to enhance patient exposure while minimizing dosing. The preclinical program is expected to conclude in the second half of 2026, following promising results from extensive research.
Read more →-CUVL
Aug 22, 2025CLINUVEL preparing upgrade of ADR program to Level II, Nasdaq uplist
CLINUVEL is planning to upgrade its Level I ADR program to a Level II listing on Nasdaq by the end of 2025. This move aims to enhance visibility and trading access for U.S. investors, with approximately 28% of its shares currently held by U.S.-based investors. The primary listing on the ASX will remain unchanged, and no capital raising is proposed in connection with this upgrade.
Read more →-CUVL
May 7, 2025CLINUVEL recruits 200 patients in Phase III vitiligo trial CUV105
CLINUVEL has successfully recruited over 200 patients for its Phase III trial (CUV105) of SCENESSE® in vitiligo. The trial aims to evaluate the efficacy of afamelanotide in repigmenting skin in patients with darker skin types. Initial clinical observations have been positive, with results expected in late 2026.
Read more →-CUVL
Mar 4, 2025Clinuvel Introduces Groundbreaking Vitiligo Program at the World’s Biggest Dermatology Meeting, AAD 2025
Clinuvel Pharmaceuticals is set to debut its innovative vitiligo program at the AAD Annual Meeting 2025. The Pavilion of Photomedicine will provide an immersive experience showcasing the history and future of photomedicine, including the development of SCENESSE® for vitiligo. The event will feature discussions with advocates and experts, highlighting the psychological impact of vitiligo and the promise of new treatments.
Read more →-CUVL
Sep 30, 2024CLINUVEL files Canadian New Drug Submission for SCENESSE® in EPP
CLINUVEL has submitted a New Drug Submission to Health Canada for SCENESSE® (afamelanotide), aimed at preventing phototoxicity in adult patients with erythropoietic protoporphyria (EPP). This submission, if approved, would mark the first available treatment for EPP patients in Canada. Currently, patients have been receiving treatment under the Special Access Program, which has facilitated access to this therapy.
Read more →-CUVL
Jun 18, 2024Afamelanotide in fair-skinned Parkinson’s patients
CLINUVEL has launched a clinical program to evaluate afamelanotide for treating early-stage Parkinson's Disease in fair-skinned patients. The Phase IIa CUV901 study aims to assess the drug's safety and its effects on alpha-synuclein levels and cognitive functions. The study is set to enroll patients by the end of 2024, marking a significant step in Parkinson's research.
Read more →About Clinuvel Pharmaceuticals Limited American Depositary Shares
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