Cosmo Announces Breakthrough Phase III Topline Results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in Male Hair Loss, Showing up to 539% Relative Improvement in Target-Area Hair Count vs Placebo; US and EU Submissions are Underway

Rhea-AI Summary

Cosmo (OTC:CMOPF) reported topline Phase III results for clascoterone 5% topical solution in male androgenetic alopecia from two identically designed studies (total 1,465 patients) with statistically significant Target-Area Hair Count (TAHC) improvements of 5.39x (539%) and 1.68x (168%) versus vehicle.

Patient-reported outcomes were significant combined, safety and tolerability were comparable to vehicle, and Cosmo plans parallel US and EU regulatory submissions after completing a 12-month safety follow-up expected in spring 2026. Patent protection is stated through 2036 and the U.S. market opportunity was estimated above $20B.

Positive

• Largest topical AGA Phase III program: 1,465 patients
• Efficacy: TAHC +539% and +168% versus vehicle
• Combined PROs reached statistical significance
• Safety profile comparable to vehicle (TEAEs similar)

Negative

• Efficacy variability: one study showed 539%, the other 168%
• Regulatory submissions contingent on completing 12-month safety follow-up in spring 2026

News Market Reaction

+20.53%

1 alert

+20.53% News Effect

On the day this news was published, CMOPF gained 20.53%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase III patients: 1,465 patients TAHC improvement: 5.39x (539%) vs vehicle TAHC improvement: 1.68x (168%) vs vehicle +5 more

8 metrics

Phase III patients 1,465 patients Two identically designed Phase III AGA studies (Scalp 1 and Scalp 2)

TAHC improvement 5.39x (539%) vs vehicle Target-Area Hair Count in one Phase III study

TAHC improvement 1.68x (168%) vs vehicle Target-Area Hair Count in second Phase III study

Global AGA burden 1.2–2 billion men Estimated number of men affected worldwide by androgenetic alopecia

Safety follow-up 12-month follow-up Required safety follow-up planned for completion in spring 2026

Patent term Valid through 2036 Patent protection for clascoterone 5% topical solution

U.S. market opportunity >$20B Cosmo’s U.S. market research for male AGA treatment

Pre-news share price $121.6 Price before publication, <b>-2.65%</b> over prior 24 hours

Market Reality Check

Price: $150.25 Vol: Volume 481 with relative ...

low vol

$150.25 Last Close

Volume Volume 481 with relative volume 0.31x versus 20-day average volume 1,545 ahead of this news. low

Technical Price 121.6 was trading above the 200-day MA at 77.66 before the announcement.

Peers on Argus

Peers showed mixed moves: TRULIEVE CANNABIS CORP up 4.39%, NIKA PHARMACEUTICALS ...

Peers showed mixed moves: TRULIEVE CANNABIS CORP up 4.39%, NIKA PHARMACEUTICALS INC up 3.59%, while others were roughly flat. No coordinated sector move matching CMOPF’s pre-news pullback.

Common Catalyst Select peers had unrelated news (AI/software and cannabis licensing), suggesting today’s Cosmo news was company-specific rather than sector-driven.

Historical Context

2 past events · Latest: Dec 03 (Positive)

Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Phase III results	Positive	+20.5%	Pivotal Phase III AGA data with strong efficacy and planned US/EU filings.
Nov 03	Regulatory clearance	Positive	+0.0%	CE certification for ColonPRO EU AI colonoscopy platform with strong metrics.

Pattern Detected

Limited recent history, but both major positive announcements in 2025 were followed by positive price reactions.

Recent Company History

Over recent months, Cosmo reported two notable developments. On Nov 3, 2025, it received CE certification for its ColonPRO EU AI colonoscopy platform, citing performance gains such as an 8.3 percentage‑point ADR improvement and a 9% reduction in false positives, with almost 4 million procedures supported; the stock reaction was minimal at 0.02%. On Dec 3, 2025, Cosmo released positive Phase III topline results for clascoterone 5% solution in male AGA, and the stock rose 20.53% over 24 hours.

Market Pulse Summary

The stock surged +20.5% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +20.5% in the session following this news. A strong positive reaction aligns with the clearly favorable Phase III efficacy and safety profile, as well as prior history where similar positive news saw a 20.53% gain. With price already above the 200-day MA, momentum had been constructive ahead of this announcement. Investors may still weigh execution risks around planned US/EU submissions and completion of the 12‑month safety follow-up when assessing how durable such a move might be.

Key Terms

androgenetic alopecia, dihydrotestosterone (DHT), androgen receptor inhibitor, treatment emergent adverse events, +2 more

6 terms

androgenetic alopecia medical

"for male androgenetic alopecia (AGA, also known as male-pattern hair loss)"

Androgenetic alopecia is a common form of hair loss characterized by gradual thinning and receding of hair, often following a predictable pattern. It results from a combination of genetic factors and hormone influences, similar to how certain plants are more susceptible to environmental stress. For investors, understanding trends in health and wellness, including conditions like this, can highlight shifts in consumer demand for related products and treatments.

dihydrotestosterone (DHT) medical

"In blocking dihydrotestosterone (DHT) directly at the hair-follicle receptor"

Dihydrotestosterone (DHT) is a potent male sex hormone made from testosterone that binds more strongly to the body’s hormone receptors and drives effects like facial and body hair growth, prostate tissue changes, and male-pattern hair loss. Investors care because medical treatments and drugs that block or modify DHT activity target large patient groups (for hair loss, prostate disease, and certain hormone conditions), so trial results, approvals, or safety news can materially affect company value and market demand.

androgen receptor inhibitor medical

"the first topical androgen receptor inhibitor designed to target the biological root cause"

An androgen receptor inhibitor is a drug that blocks the cellular “locks” where male hormones (androgens) normally fit, preventing those hormones from turning on growth signals in certain tissues such as prostate cancer cells. Investors watch these drugs because they can form the basis of new treatments, create recurring revenue if approved, and carry clinical and regulatory risks or milestones that can sharply change a company’s value—think of it as stopping a key from opening a keyhole to halt unwanted activity.

treatment emergent adverse events medical

"Treatment Emergent Adverse Events (TEAEs) were similar across both studies"

Treatment emergent adverse events are any new or worsened medical problems that appear after a patient starts a drug or medical intervention during a clinical trial. Investors care because the number, severity, and frequency of these events influence safety profiles, regulatory approval chances, and market acceptance; think of them like unexpected problems that crop up after installing a software update—minor ones may be manageable, but serious or common issues can stall or derail the product.

patient-reported outcomes medical

"Patient-reported outcomes (PROs) further reinforced the strength of the Topline Phase III results"

Reports provided directly by patients about their symptoms, daily functioning, and quality of life—collected through surveys, apps, or interviews—reflecting how a treatment affects real people rather than lab measures. Investors care because these firsthand accounts help regulators, doctors and payers judge a product’s real-world value and can influence approval, pricing, adoption and long-term sales; think of them as customer reviews that show whether a medical product truly improves everyday life.

topline results technical

"today announced compelling topline results from its two pivotal Phase III trials"

Topline results are the initial, high-level summary of the most important outcomes from an event such as a clinical trial or a company reporting period — for a drug study this means whether the main goals were met and basic safety info, and for a company it often means headline revenue and profit figures. Investors care because these summaries act like a headline that quickly signals whether prospects have improved or worsened, often driving immediate market reactions before the full details are released.

AI-generated analysis. Not financial advice.

Ad hoc announcement pursuant to Art. 53 LR

• 1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805)
• Both studies reached statistically significant endpoints in TAHC (Target-Area Hair Count), with one reaching 539% relative improvement to placebo and the second study reaching 168% relative improvement to placebo
• Positive safety profile demonstrated across both studies
• Positive safety profile demonstrated across both studie Largest Phase III program ever conducted for a Topical Treatment for Male Androgenetic Alopecia (AGA)
• First novel mechanism of action and first potential innovation in over 30 years in male hair loss
• Preparations are underway for parallel regulatory submissions in the United States and Europe

Dublin, Ireland--(Newsfile Corp. - December 3, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced compelling topline results from its two pivotal Phase III trials of clascoterone 5% topical solution for male androgenetic alopecia (AGA, also known as male-pattern hair loss), marking a potential  first major therapeutic breakthrough in hair-loss treatment in more than three decades.

Across 1,465 patients enrolled in two identically designed Phase III studies conducted in the United States and Europe, clascoterone 5% solution delivered robust, statistically significant (p<0.05), and clinically meaningful improvements with a safety and tolerability profile comparable to the placebo vehicle. One study demonstrated a 5.39x (539 percent) relative improvement in Target-Area Hair Count (TAHC) versus vehicle, while the second study showed a 1.68x (168 percent) relative improvement. Treatment Emergent Adverse Events (TEAEs) were similar across both studies, and similar to vehicle, with most TEAEs not related to study drug.

Patient-reported outcomes (PROs) further reinforced the strength of the Topline Phase III results. One study PRO endpoint reached statistical significance and the other study PRO showed a positive trend, while the combined analysis across both studies was statistically significant and fully consistent with the objective THAC measures, confirming that patients both experienced and perceived meaningful improvement.

These findings represent a significant advance in a condition that affects 1.2 to 2 billion men worldwide and is recognized for its emotional and social impact. Studies show that clascoterone 5% topical solution is completely new therapeutic approach to treating AGA. In blocking dihydrotestosterone (DHT) directly at the hair-follicle receptor without systemic absorption, clascoterone 5% topical solution is the first topical androgen receptor inhibitor designed to target the biological root cause of male-pattern hair loss without the risks associated with oral therapies. Unlike existing therapies, clascoterone 5% solution was developed specifically for AGA.

"These data reflect a significant milestone for patients with male pattern hair loss," said Dr. Maria Hordinsky, MD, R.W Goltz Professor of Dermatology, University of Minnesota, Department of Dermatology. “For decades, patients have had to choose between available treatment options with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all. These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure. These data have the potential to redefine how dermatologists treat androgenetic alopecia worldwide.”

Commenting on the results, Giovanni Di Napoli, CEO of Cosmo, said: “This is a pivotal moment for Cosmo and for billions of men worldwide who struggle every day with the emotional and social impact of hair loss. Androgenetic alopecia is far more than a cosmetic issue – it affects confidence, identity, and emotional well-being. For the first time in more than thirty years, we have a completely new mechanism with the potential to truly change that reality.” Di Napoli added: “With strong efficacy across the two largest Phase III studies, and a favorable safety profile, clascoterone 5% topical solution opens the door to a fundamentally better treatment paradigm for patients. At our Investor Day in July, Cosmo presented in-depth U.S. market research results showing an enormous, underserved demand. These compelling data give us full confidence in respect to the upcoming regulatory submissions. We strongly believe that clascoterone 5% topical solution will deliver meaningful benefit to patients.”

Cosmo is on track to complete the required twelve-month safety follow-up in spring 2026. Upon completion of the full dataset, Cosmo plans to promptly pursue parallel regulatory submissions in the United States and Europe. Clascoterone 5% topical solution is positioned to become the first topical androgen receptor inhibitor ever approved for AGA, subject to regulatory authorization.

Investor snapshot

• Indication: Male androgenetic alopecia
• Patients: 1,465 across two Phase III studies, largest Phase III studies conducted for topical treatment in male AGA
• Efficacy: 5.39x (539 percent) and 1.68× (168 percent) relative improvements vs Vehicle
• PRO: Statistically significant for the two Phase III studies combined
• Safety: Positive tolerability, TEAEs similar across both studies and similar to vehicle
• Mechanism: First topical androgen receptor inhibitor; first innovation in 30 years
• Patents: Valid through 2036
• Market: >$20B U.S. opportunity confirmed by Cosmo market research
• Next Milestone: Parallel FDA/EMA submissions upon completion of 12-month safety

About Clascoterone
Clascoterone 5% topical solution leverages the same active ingredient used in Winlevi®, Cosmo’s FDA and EMA approved topical acne treatment, supported by a well-established dermatologic safety profile and Cosmo’s proprietary formulation technology. Winlevi® is the #1 branded prescription topical acne product in the US with over ~1.6 million prescriptions written since launch.

About Cosmo
Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy). For more information, visit www.cosmohealthconfidence.com

Financial calendar

Berenberg European Conference, Windsor, UK ODDO BHF Forum, Lyon, France 2025 FY results, Annual report and ESG Report

December 4, 2025 January 8-9, 2026 Week of March 9, 2026

For further information, please contact:
investor.relations@cosmohc.com 

This press release contains forward-looking statements that reflect Cosmo’s current expectations regarding the clinical development, regulatory assessment, and potential future availability of the investigational product. Such statements are subject to significant known and unknown risks and uncertainties, which may cause actual results, performance or achievements to differ materially from those expressed or implied herein. These risks and uncertainties include, without limitation, the completion and outcomes of additional clinical analyses, interactions with and determinations by regulatory authorities, reliance on third-party partners, the potential impact of external scientific or medical developments, and other factors described in the Cosmo’s publicly available filings and reports. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Cosmo, and Cosmo assumes no obligation and disclaims any intent to update any such forward-looking statements, except as required by applicable law.

Attachments
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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/276765

FAQ

What were Cosmo CMOPF's Phase III topline TAHC results announced on December 3, 2025?

Two Phase III studies (total 1,465 patients) reported TAHC improvements of 5.39x (539%) and 1.68x (168%) versus vehicle.

When will Cosmo (CMOPF) submit clascoterone 5% to the FDA and EMA?

Cosmo plans parallel U.S. and EU submissions after completing the 12-month safety follow-up, expected in spring 2026.

What safety results did Cosmo report for clascoterone 5% topical solution in CMOPF trials?

Safety and tolerability were reported as positive, with TEAEs similar to vehicle and most not related to study drug.

Does Cosmo (CMOPF) claim market potential for clascoterone 5% in the U.S.?

Cosmo cited a U.S. market opportunity of more than $20B based on its market research.

How does clascoterone 5% for CMOPF differ from existing male AGA treatments?

Clascoterone 5% is described as a topical androgen receptor inhibitor targeting follicle DHT with negligible systemic absorption.

What patent protection did Cosmo (CMOPF) report for clascoterone 5%?

Cosmo reported patent coverage through 2036.