Jyong Biotech (MENS) FDA Approvals $2.01 -0.07 (-3.37%) Closing price 04:00 PM EasternExtended Trading$2.00 0.00 (-0.25%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Jyong Biotech's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Jyong Biotech (MENS). Over the past two years, Jyong Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MCS‑8. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. MCS‑8 FDA Regulatory Events MCS‑8 is a drug developed by Jyong Biotech for the following indication: Prostate Cancer Prevention. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - November 20,2025Provided Update Drug: MCS‑8Announced Date: November 20, 2025Indication: Prostate Cancer PreventionAnnouncementJyong Biotech Ltd. announced that it has achieved another milestone in the development of its plant-derived new drug MCS-8 (PCP).AI SummaryJyong Biotech announced a milestone in developing its plant-derived drug candidate MCS-8 (PCP) after completing statistical analysis of primary efficacy endpoints from its ongoing Phase II trial in Taiwan. The randomized, placebo-controlled study enrolled more than 700 high‑risk men across 20 hospitals and involved over 130 urologists. Participants received two years of treatment with MCS-8 or placebo. Key results showed a 27.3% reduction in overall prostate cancer incidence and a 17.1% reduction in high‑grade prostate cancer (Gleason score ≥ 7) versus placebo. Safety data were favorable: two‑year use did not raise adverse event rates, no serious drug‑related events were reported, and key labs (liver, kidney, glucose, blood pressure) showed no harmful effects. Lipid measures trended better with MCS-8 (TG down, LDL down, HDL up), while fasting glucose rose in the placebo group. Jyong plans to prepare for a global Phase III trial with partners. MCS-8 remains investigational and is not approved for use.Read AnnouncementEnrollment Update - September 16,2025Enrollment Update Phase 2Drug: MCS‑8Announced Date: September 16, 2025Indication: Prostate Cancer PreventionAnnouncementJyong Biotech Ltd. announced that it has completed patient enrollment in its Phase II clinical trial of MCS‑8, an investigational drug candidate for prostate cancer prevention (PCP), with more than 700 high-risk subject who have enrolled into this clinical trial since its commencement.AI SummaryJyong Biotech Ltd., a science-driven biotechnology company in Taiwan, has finished enrolling patients in its Phase II clinical trial of MCS-8, a plant-derived investigational drug for prostate cancer prevention. Since the trial began, more than 700 high-risk subjects have joined the study. This randomized, placebo-controlled trial is taking place at 20 hospitals across Taiwan. Over 130 urologists are involved in testing MCS-8’s ability to prevent prostate tumors in men at high risk. The trial design follows strict protocols to measure safety and preliminary efficacy. The study aims to offer a new preventive therapy for men at risk. Fu-Feng Kuo, the company’s Chairwoman and CEO, said the team exceeded expectations by reaching this milestone despite challenges from the COVID-19 pandemic. MCS-8 remains investigational and is not yet approved. After the treatment period ends, the company will analyze data and share the results as required.Read Announcement Jyong Biotech FDA Events - Frequently Asked Questions Has Jyong Biotech received FDA approval? As of now, Jyong Biotech (MENS) has not received any FDA approvals for its therapy in the last two years. What drugs has Jyong Biotech submitted to the FDA? In the past two years, Jyong Biotech (MENS) has reported FDA regulatory activity for MCS‑8. What is the most recent FDA event for Jyong Biotech? The most recent FDA-related event for Jyong Biotech occurred on November 20, 2025, involving MCS‑8. The update was categorized as "Provided Update," with the company reporting: "Jyong Biotech Ltd. announced that it has achieved another milestone in the development of its plant-derived new drug MCS-8 (PCP)." What conditions do Jyong Biotech's current drugs treat? Currently, Jyong Biotech has one therapy (MCS‑8) targeting the following condition: Prostate Cancer Prevention. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Amylyx Pharmaceuticals FDA EventsBelite Bio FDA EventsINmune Bio FDA EventsKymera Therapeutics FDA EventsLigand Pharmaceuticals FDA EventsNatera FDA EventsProtara Therapeutics FDA EventsTenaya Therapeutics FDA EventsUrogen Pharma FDA EventsAardvark Therapeutics FDA EventsAgenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Arvinas FDA Events Candel Therapeutics FDA Events CorMedix FDA Events Allogene Therapeutics FDA Events 4D Molecular Therapeutics FDA Events Immix Biopharma FDA Events Aquestive Therapeutics FDA Events Avalo Therapeutics FDA Events Tectonic Therapeutic FDA Events REGENXBIO FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MENS last updated on 11/20/2025 by MarketBeat.com Staff. 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Provided Update - November 20,2025Provided Update Drug: MCS‑8Announced Date: November 20, 2025Indication: Prostate Cancer PreventionAnnouncementJyong Biotech Ltd. announced that it has achieved another milestone in the development of its plant-derived new drug MCS-8 (PCP).AI SummaryJyong Biotech announced a milestone in developing its plant-derived drug candidate MCS-8 (PCP) after completing statistical analysis of primary efficacy endpoints from its ongoing Phase II trial in Taiwan. The randomized, placebo-controlled study enrolled more than 700 high‑risk men across 20 hospitals and involved over 130 urologists. Participants received two years of treatment with MCS-8 or placebo. Key results showed a 27.3% reduction in overall prostate cancer incidence and a 17.1% reduction in high‑grade prostate cancer (Gleason score ≥ 7) versus placebo. Safety data were favorable: two‑year use did not raise adverse event rates, no serious drug‑related events were reported, and key labs (liver, kidney, glucose, blood pressure) showed no harmful effects. Lipid measures trended better with MCS-8 (TG down, LDL down, HDL up), while fasting glucose rose in the placebo group. Jyong plans to prepare for a global Phase III trial with partners. MCS-8 remains investigational and is not approved for use.Read Announcement
Enrollment Update - September 16,2025Enrollment Update Phase 2Drug: MCS‑8Announced Date: September 16, 2025Indication: Prostate Cancer PreventionAnnouncementJyong Biotech Ltd. announced that it has completed patient enrollment in its Phase II clinical trial of MCS‑8, an investigational drug candidate for prostate cancer prevention (PCP), with more than 700 high-risk subject who have enrolled into this clinical trial since its commencement.AI SummaryJyong Biotech Ltd., a science-driven biotechnology company in Taiwan, has finished enrolling patients in its Phase II clinical trial of MCS-8, a plant-derived investigational drug for prostate cancer prevention. Since the trial began, more than 700 high-risk subjects have joined the study. This randomized, placebo-controlled trial is taking place at 20 hospitals across Taiwan. Over 130 urologists are involved in testing MCS-8’s ability to prevent prostate tumors in men at high risk. The trial design follows strict protocols to measure safety and preliminary efficacy. The study aims to offer a new preventive therapy for men at risk. Fu-Feng Kuo, the company’s Chairwoman and CEO, said the team exceeded expectations by reaching this milestone despite challenges from the COVID-19 pandemic. MCS-8 remains investigational and is not yet approved. After the treatment period ends, the company will analyze data and share the results as required.Read Announcement
