MANE

NEW HAVEN, Conn. (AP) — NEW HAVEN, Conn. (AP) — Veradermics Inc. (MANE) on Tuesday reported a loss of $30 million in its first quarter. The New Haven, Connecticut-based company said it had a loss of $1.32 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MANE at https://www.zacks.com/ap/MANE

Positive topline results from Phase 2/3 Study ‘302’ position VDPHL01 to potentially become the first FDA-approved oral treatment for pattern hair loss in nearly 30 years Upsized IPO and follow-on financing generated approximately $766.8 million in aggregate gross proceeds; pro forma cash expected to fund operations into 2030 through multiple Phase 3 readouts and potential launch NEW HAVEN, Conn., May 12, 2026--(BUSINESS WIRE)--Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate and clinical progress. "The announcement of positive Phase 2/3 topline results from Study ‘302’ in April 2026 was an inflection point for Veradermics and supports our belief that VDPHL01 can become a foundational treatment for pattern hair loss," said Reid Waldman, M.D., Chief Executive Officer of Veradermics. "We are working with urgency to deliver multiple data milestones in the second half of 2026. Following our successful IPO and subsequent financing activities, we are well capitalized to execute on these milestones and advance our mission to provide the first-ever FDA-approved non-hormonal oral treatment for pattern hair loss to both men and women." Recent Business Highlights and 2026 Anticipated Milestones VDPHL01 Registrational Program for Men and Women with Pattern Hair Loss ("PHL") Positive Topline Results from Part A in Study ‘302’ Support Potential Best-in-Indication Profile. In April 2026, Veradermics reported positive topline data from Part A of Study ‘302’, a four-arm, multicenter, randomized, double-blinded, placebo-controlled, Phase 2/3 clinical trial evaluating VDPHL01 8.5 mg in males with mild-to-moderate PHL. VDPHL01 achieved early, consistent, and robust hair growth, and demonstrated a favorable safety and tolerability profile and adverse event rates comparable to placebo. These results support the potential for VDPHL01 to become the first FDA-approved oral treatment for pattern hair loss in nearly 30 years. Twelve-month data from Study ‘302’ is anticipated in the second half of 2026. Enrollment Completed in Study ‘304’. In February 2026, Veradermics announced completion of enrollment in Study ‘304’, a confirmatory Phase 3 trial ev...

Veradermics reported positive Part A results for VDPHL01, meeting both co‑primary endpoints with significant hair‑count gains of +30.3 non‑vellus hairs (QD) and +33 (BID) at six months and strong patient‑reported improvement (nearly 50% QD and ~66% BID rated themselves “improved” or “much improved”). Safety was described as placebo‑like with no drug‑related serious adverse events or cardiac AESIs and no meaningful changes in heart rate, blood pressure, or ECGs; the only imbalanced events >5% were edema (≈1% discontinuation) and hypertrichosis (no discontinuations). Commercially, early market research showed high interest (about 73% of HCPs very/extremely likely to prescribe), and Veradermics plans additional male readouts in H2 and further Phase III/12‑month data in 2026 before finalizing a QD vs BID filing strategy. Interested in MANE? Here are five stocks we like better. Veradermics reported “positive top line results” from Part A of its Phase II/III 302 trial evaluating VDPHL01, an oral extended-release minoxidil tablet, in men with mild to moderate pattern hair loss. On a conference call, CEO Dr. Reid Waldman said the randomized, double-blind, placebo-controlled study achieved “a high degree of statistical significance in both co-primary endpoints and all key secondary endpoints in both dose groups,” while also showing a safety profile he characterized as “placebo-like overall AE rates.” According to Waldman, Study 302 enrolled 519 male subjects across 44 U.S. sites. The company presented results from Part A, the six-month placebo-controlled period, for once-daily (QD) and twice-daily (BID) dosing versus placebo. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook The co-primary endpoints were: Target Area Hair Count (TAHC), measuring non-vellus hairs (>30 microns) per square centimeter using standardized photography and digital image analysis with quality assurance review. A patient-reported outcome (PRO) responder analysis on the Androgenetic Alopecia Impact Rating Scale (AAIRS), measuring the percentage of patients rating themselves “improved” or “much improved” based on standardized photo comparisons. Waldman highlighted baseline characteristics he said made the population representative, including enrollment up to age 65, with about 60% over age 40, and an ethnically diverse group. He also said the study did not “cherry-pick” for saf...

Veradermics Incorporated (NYSE:MANE) is one of the small-cap stocks that are on fire right now. On April 27, Veradermics announced positive topline results from its Phase 2/3 “302” clinical trial evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation for male pattern hair loss. The study, which included 519 participants, met all primary and key secondary endpoints with high statistical significance. The trial also highlighted strong patient and investigator satisfaction. ~80% to 86% of patients reported improvements in hair coverage. This consistent response across the study population suggests that VDPHL01 could offer a highly reliable and differentiated clinical profile compared to existing off-label or over-the-counter options. Safety data for VDPHL01 was equally encouraging, demonstrating a favorable tolerability profile with adverse event rates similar to those of the placebo. Andrey_Popov/Shutterstock.com The extended-release gel matrix is specifically designed to maintain steady absorption while avoiding the high peak concentrations often linked to cardiac side effects. If approved, VDPHL01 would become the first non-hormonal oral treatment for pattern hair loss cleared by the FDA in nearly 30 years, potentially addressing a significant unmet need for the 80 million men and women in the U.S. currently suffering from the condition. Veradermics Incorporated (NYSE:MANE) develops therapies for dermatologic and aesthetic conditions. While we acknowledge the potential of MANE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

Conference call will take place on Monday, April 27, 2026 at 8:00 am ET NEW HAVEN, Conn., April 26, 2026--(BUSINESS WIRE)--Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced it will host an investor call and live webcast to review topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 ‘302’ clinical trial evaluating VDPHL01, a proprietary extended-release oral minoxidil tablet, in males with mild-to-moderate pattern hair loss. Webcast Details: Time: Monday, April 27, 2026 at 8:00 a.m. ET. Joining: The event and the accompanying slides will be available on the Events page in the Investors section of the company’s website. A replay will be available following the call. About VDPHL01 VDPHL01 (extended-release minoxidil tablet) is a proprietary investigational, orally available non-hormonal drug in Phase 3 development for pattern hair loss in both women and men. VDPHL01 leverages extended-release technology to deliver a minoxidil product with the potential for improved efficacy and safety. The proprietary extended-release formulation utilizes a gel matrix designed to deliver long-lasting, steady release of minoxidil for sustained absorption. VDPHL01 has been shown to avoid the high peak concentrations of immediate-release oral minoxidil, while extending time above the minimum hair growth threshold to increase time for hair to grow. If approved, VDPHL01 would be the only FDA-approved oral non-hormonal treatment for pattern hair loss in both male and female patients. VDPHL01 is protected by a broad library of patents and patent applications related to the key innovations of VDPHL01. The earliest expiring patent term is 2043. About Pattern Hair Loss Pattern hair loss, also known as androgenetic alopecia, affects an estimated 80 million people in the United States (30 million women and 50 million men). Pattern hair loss can have a significant impact on quality of life, affecting an individual’s mental health and relationships. People with pattern hair loss often experience depression, low self-esteem and social withdrawal. There have been no new FDA-approved prescription medicines for pattern hair loss in nearly 30 years. In addition to prescription medicines, current treatments include over-the-co...

Veradermics Incorporated (NYSE:MANE) saw its stock rise 17% on Monday after announcing positive topline data from a Phase 2/3 clinical study of its oral hair loss treatment, VDPHL01. The trial, known as Study ’302’, included 519 participants and successfully met all primary and key secondary endpoints with statistical significance. VDPHL01, an extended-release formulation of minoxidil, delivered a mean increase in non-vellus hair count of 30.3 hairs per cm² with once-daily dosing and 37.7 hairs per cm² with twice-daily dosing, compared with placebo. Patient-reported outcomes were also strong, with 79.3% of individuals on once-daily treatment and 86.0% on twice-daily dosing reporting improvement, versus 35.6% in the placebo group. In addition, 48.4% of once-daily patients and 58.1% of those on twice-daily treatment described their results as moderate or marked improvements. The therapy showed measurable benefits as early as Month 2, the first evaluation point in the study. Investigators reported improved hair growth in 72.0% of once-daily patients and 81.7% of twice-daily patients. VDPHL01 was generally well tolerated through six months of treatment, with adverse event rates broadly in line with placebo. The study reported no serious treatment-related adverse events and no cardiac-related safety concerns. Discontinuation rates were also lower among patients receiving the drug compared with placebo. If approved, VDPHL01 could become the first non-hormonal oral treatment for pattern hair loss cleared by the U.S. Food and Drug Administration, targeting a market of roughly 80 million men and women in the United States. The company has also completed enrollment for a second Phase 3 trial, Study ’304’, in February, with topline results expected in the second half of 2026. Veradermics stock price

Enrollment completed in two pivotal trials of VDPHL01 in male patients; topline data expected from Study 302 in 1H 2026 and Study 304 confirmatory trial in 2H 2026 Enrollment on-track in Study 306, the first-ever Phase 2/3 trial of an oral treatment specifically for female pattern hair loss Mark Neumann, seasoned biopharmaceutical commercial leader with more than 30 years of experience launching and scaling blockbuster therapies, appointed Chief Commercial and Strategy Officer Upsized IPO of $294.8 million closed in February 2026; pro forma cash, cash equivalents and marketable securities expected to fund planned operations into 2029, through multiple anticipated Phase 3 readouts and the anticipated launch of VDPHL01, if approved NEW HAVEN, Conn., March 30, 2026--(BUSINESS WIRE)--Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions, today reported financial results for the fourth quarter and full year periods ended December 31, 2025, and announced recent corporate and clinical updates. "2025 was a landmark year for Veradermics, marked by significant progress in advancing Phase 3 development of VDPHL01, and our momentum has continued into 2026 with our debut as a public company following the successful completion of our IPO," said Reid Waldman, M.D., Chief Executive Officer of Veradermics. "This year, we expect two Phase 3 readouts in men and to continue to make progress toward a planned NDA submission, while also advancing the first-ever Phase 3 trial of an oral treatment for female pattern hair loss. Backed by a strong balance sheet, we are focused on executing with urgency for the men and women who have waited far too long for new treatment options for pattern hair loss." Recent Business Highlights and 2026 Anticipated Milestones VDPHL01 Registrational Program for Men and Women with Pattern Hair Loss ("PHL") Enrollment Completed in Study 302, the First of Three Registration-directed Trials of VDPHL01 in Patients with PHL. Study 302 is a four-arm, multicenter, randomized, double-blinded, placebo-controlled, Phase 2/3 clinical trial evaluating the safety and efficacy of VDPHL01 8.5 mg in male patients with mild-to-moderate PHL. Veradermics announced completed enrollment in Study 302 in December 2025, and t...