Completion of VDPHL01 Phase 3 Enrollment for Male Pattern Hair Loss
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Should l Buy MANE?
Source: Newsfilter
- Trial Enrollment Completion: Veradermics announced the completion of enrollment for its second Phase 3 clinical trial of VDPHL01 targeting male pattern hair loss, with over 1,000 participants, marking a significant milestone that is expected to facilitate the submission of a new drug application.
- Data Release Expectations: Topline data from the initial '302' trial is anticipated in the first half of 2026, while confirmatory study '304' data is expected in the second half, providing critical efficacy and safety information that could influence FDA approval decisions.
- Innovative Drug Potential: If approved, VDPHL01 would be the first non-hormonal oral treatment option for an estimated 50 million men and 30 million women in the U.S., addressing a significant market gap that has persisted for nearly 30 years, indicating substantial market potential.
- Technological Advantage: The extended-release formulation of VDPHL01 aims to maximize minoxidil's hair growth effects while minimizing cardiac side effect risks, which is expected to enhance patient adherence to treatment and position the product favorably in the competitive hair restoration market.
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Analyst Views on MANE
Wall Street analysts forecast MANE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MANE is USD with a low forecast of USD and a high forecast of USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
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Current: 38.480
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Current: 38.480
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About MANE
Veradermics, Incorporated is a late clinical-stage biopharmaceutical company. The Company is focused on developing innovative therapeutics to address pervasive treatment challenges in highly prevalent aesthetic and dermatological conditions. Its initial focus is developing better treatments for pattern hair loss (PHL). The Company is developing VDPHL01 as an oral, non-hormonal treatment for men and women with PHL to reduce the barriers to wide adoption of chronic hair loss therapy and potentially transform PHL treatment. VDPHL01 is an oral, ER formulation of minoxidil, a proven hair growth agent, designed to maximize minoxidil’s impact on hair restoration while minimizing the risk of cardiac activity. The Company is conducting a Phase II clinical trial evaluating VDPHL01 in male and female patients with mild-to-moderate PHL.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Completion of VDPHL01 Phase 3 Enrollment for Male Pattern Hair Loss
- Trial Enrollment Completion: Veradermics announced the completion of enrollment for its second Phase 3 clinical trial of VDPHL01 targeting male pattern hair loss, with over 1,000 participants, marking a significant milestone that is expected to facilitate the submission of a new drug application.
- Data Release Expectations: Topline data from the initial '302' trial is anticipated in the first half of 2026, while confirmatory study '304' data is expected in the second half, providing critical efficacy and safety information that could influence FDA approval decisions.
- Innovative Drug Potential: If approved, VDPHL01 would be the first non-hormonal oral treatment option for an estimated 50 million men and 30 million women in the U.S., addressing a significant market gap that has persisted for nearly 30 years, indicating substantial market potential.
- Technological Advantage: The extended-release formulation of VDPHL01 aims to maximize minoxidil's hair growth effects while minimizing cardiac side effect risks, which is expected to enhance patient adherence to treatment and position the product favorably in the competitive hair restoration market.
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Veradermics Doubles in Value on First Trading Day
- Strong Debut Performance: Veradermics (ticker: MANE) opened at $34 on its first trading day, reflecting a 100% increase from its IPO price of $17, indicating strong market demand for its oral hair loss therapy.
- Continued Price Surge: Shortly after opening, the stock reached $38.98 around 2:30 PM, implying a ~129% gain from the IPO price, showcasing investor optimism regarding the company's future prospects.
- Upsized Offering: The IPO involved over 15.1 million shares priced at $17, leading to a valuation of approximately $596 million and gross proceeds of about $256.3 million, which will support further product development.
- Clinical Trial Progress: Veradermics' lead asset VDPHL01 is currently in a Phase 3 clinical trial for men with mild-to-moderate pattern hair loss, with topline data expected in H2 2026, which could enhance market acceptance and sales potential if successful.
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Veradermics Raises $256 Million for Hair Loss Therapies
- Successful Fundraising: Veradermics raised $256 million by offering 15.1 million shares at $17 each, exceeding the initial price range of $14 to $16, indicating strong market demand for its therapies.
- Increased Market Valuation: Following this financing, Veradermics commands a fully diluted market value of $606 million, which is 19% higher than previously anticipated, enhancing investor confidence and providing substantial funding for ongoing research and development.
- Clinical Trial Advancements: The company has fully enrolled a 519-patient Phase 2-3 trial in male patients and initiated two additional registration-directed Phase 3 trials targeting 498 male and 552 female patients, aimed at supporting a 505(b)(2) NDA application and accelerating product launch.
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Completion of VDPHL01 Phase 3 Enrollment for Male Pattern Hair Loss
- Trial Enrollment Completion: Veradermics announced the completion of enrollment for its second Phase 3 clinical trial of VDPHL01 targeting male pattern hair loss, with over 1,000 participants, marking a significant milestone that is expected to facilitate the submission of a new drug application.
- Data Release Expectations: Topline data from the initial '302' trial is anticipated in the first half of 2026, while confirmatory study '304' data is expected in the second half, providing critical efficacy and safety information that could influence FDA approval decisions.
- Innovative Drug Potential: If approved, VDPHL01 would be the first non-hormonal oral treatment option for an estimated 50 million men and 30 million women in the U.S., addressing a significant market gap that has persisted for nearly 30 years, indicating substantial market potential.
- Technological Advantage: The extended-release formulation of VDPHL01 aims to maximize minoxidil's hair growth effects while minimizing cardiac side effect risks, which is expected to enhance patient adherence to treatment and position the product favorably in the competitive hair restoration market.
See More
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Current Challenge: The actress is now dealing with the challenges posed by unpredictable investors in her entrepreneurial ventures.
Entrepreneurial Success: Despite the challenges, Garner appears to be successfully navigating the investment landscape.
Transition from Acting to Business: Garner's shift from acting to entrepreneurship highlights her versatility and determination in facing new challenges.
See More
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Key Players: The companies involved in these IPOs include SpaceX, OpenAI, and Anthropic.
Market Anticipation: Investors are particularly eager for these IPOs as they await significant developments later this year.
Investment Climate: The current market environment is buzzing with excitement over these high-profile companies entering the public market.
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Veradermics Doubles in Value on First Trading Day
- Strong Debut Performance: Veradermics (ticker: MANE) opened at $34 on its first trading day, reflecting a 100% increase from its IPO price of $17, indicating strong market demand for its oral hair loss therapy.
- Continued Price Surge: Shortly after opening, the stock reached $38.98 around 2:30 PM, implying a ~129% gain from the IPO price, showcasing investor optimism regarding the company's future prospects.
- Upsized Offering: The IPO involved over 15.1 million shares priced at $17, leading to a valuation of approximately $596 million and gross proceeds of about $256.3 million, which will support further product development.
- Clinical Trial Progress: Veradermics' lead asset VDPHL01 is currently in a Phase 3 clinical trial for men with mild-to-moderate pattern hair loss, with topline data expected in H2 2026, which could enhance market acceptance and sales potential if successful.
See More
Veradermics Raises $256 Million for Hair Loss Therapies
- Successful Fundraising: Veradermics raised $256 million by offering 15.1 million shares at $17 each, exceeding the initial price range of $14 to $16, indicating strong market demand for its therapies.
- Increased Market Valuation: Following this financing, Veradermics commands a fully diluted market value of $606 million, which is 19% higher than previously anticipated, enhancing investor confidence and providing substantial funding for ongoing research and development.
- Clinical Trial Advancements: The company has fully enrolled a 519-patient Phase 2-3 trial in male patients and initiated two additional registration-directed Phase 3 trials targeting 498 male and 552 female patients, aimed at supporting a 505(b)(2) NDA application and accelerating product launch.
- Strategic Listing Plans: Veradermics plans to list on the NYSE under the symbol MANE, marking a significant step in its development within the biopharmaceutical sector and laying the groundwork for future market expansion.
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