Zealand Pharma A/S (ZLDPF) FDA Approvals $35.50 0.00 (0.00%) As of 11/12/2026 09:55 AM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartEarningsFDA EventsNews and TrendsSEC FilingsShort Interest Zealand Pharma A/S's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Zealand Pharma A/S (ZLDPF). Over the past two years, Zealand Pharma A/S has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ZP9830. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ZP9830 FDA Regulatory Events ZP9830 is a drug developed by Zealand Pharma A/S for the following indication: in people with plaque psoriasis. 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. Top-line results - October 19,2026Top-Line Results Phase 1Drug: ZP9830Announced Date: October 19, 2026Indication: in people with plaque psoriasis.AnnouncementZealand Pharma A/S announced positive Phase 1 multiple ascending dose (MAD) topline results for the company’s novel Kv1.3 ion channel blocker, ZP9830.Read Announcement Zealand Pharma A/S FDA Events - Frequently Asked Questions Has Zealand Pharma A/S received FDA approval? As of now, Zealand Pharma A/S (ZLDPF) has not received any FDA approvals for its therapy in the last two years. What drugs has Zealand Pharma A/S submitted to the FDA? In the past two years, Zealand Pharma A/S (ZLDPF) has reported FDA regulatory activity for ZP9830. What is the most recent FDA event for Zealand Pharma A/S? The most recent FDA-related event for Zealand Pharma A/S occurred on October 19, 2026, involving ZP9830. The update was categorized as "Top-line results," with the company reporting: "Zealand Pharma A/S announced positive Phase 1 multiple ascending dose (MAD) topline results for the company’s novel Kv1.3 ion channel blocker, ZP9830." What conditions do Zealand Pharma A/S's current drugs treat? Currently, Zealand Pharma A/S has one therapy (ZP9830) targeting the following condition: in people with plaque psoriasis.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events BioCryst Pharmaceuticals FDA EventsRezolute FDA EventsWAVE Life Sciences FDA EventsZai Lab FDA EventsMerck & Co., Inc. FDA EventsAltimmune FDA EventsPlus Therapeutics FDA EventsAlpha Tau Medical FDA EventsImmuneering FDA EventsMetaVia FDA EventsNeonc Technologies FDA EventsTraws Pharma FDA EventsTakeda Pharmaceutical FDA EventsBridgeBio Pharma FDA EventsCoherus Oncology 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 Vaxcyte FDA Events Madrigal Pharmaceuticals FDA Events TG Therapeutics FDA Events Krystal Biotech FDA Events Protagonist Therapeutics FDA Events Arrowhead Pharmaceuticals FDA Events Rhythm Pharmaceuticals FDA Events Praxis Precision Medicines FDA Events Alkermes FDA Events Kiniksa Pharmaceuticals International FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for OTCMKTS:ZLDPF last updated on 10/19/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Top-line results - October 19,2026Top-Line Results Phase 1Drug: ZP9830Announced Date: October 19, 2026Indication: in people with plaque psoriasis.AnnouncementZealand Pharma A/S announced positive Phase 1 multiple ascending dose (MAD) topline results for the company’s novel Kv1.3 ion channel blocker, ZP9830.Read Announcement
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