Pharming Group (PHGUF) FDA Approvals $1.26 0.00 (0.00%) As of 11/12/2026 Add Compare Share Share FDA Events Stock AnalysisChartEarningsFDA EventsNews and TrendsShort Interest Pharming Group's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Pharming Group (PHGUF). Over the past two years, Pharming Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Leniolisib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Leniolisib FDA Regulatory Events Leniolisib is a drug developed by Pharming Group for the following indication: Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). 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. Data Presentation - October 14,2026Data Presentation Phase 2Drug: LeniolisibAnnounced Date: October 14, 2026Indication: Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)Other Companies Involved: NASDAQ:PHAR AnnouncementPharming presented positive topline data from its Phase II trial of leniolisib in genetically identifiable primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kδ signaling.Read Announcement Pharming Group FDA Events - Frequently Asked Questions Has Pharming Group received FDA approval? As of now, Pharming Group (PHGUF) has not received any FDA approvals for its therapy in the last two years. What drugs has Pharming Group submitted to the FDA? In the past two years, Pharming Group (PHGUF) has reported FDA regulatory activity for Leniolisib. What is the most recent FDA event for Pharming Group? The most recent FDA-related event for Pharming Group occurred on October 14, 2026, involving Leniolisib. The update was categorized as "Data Presentation," with the company reporting: "Pharming presented positive topline data from its Phase II trial of leniolisib in genetically identifiable primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kδ signaling." What conditions do Pharming Group's current drugs treat? Currently, Pharming Group has one therapy (Leniolisib) targeting the following condition: Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). 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 Denali Therapeutics FDA Events Viridian Therapeutics FDA Events Amylyx Pharmaceuticals FDA Events Beam Therapeutics FDA Events IDEAYA Biosciences FDA Events Xencor FDA Events Zai Lab FDA Events NewAmsterdam Pharma FDA Events Zealand Pharma A/S FDA Events Arcus Biosciences FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for OTCMKTS:PHGUF last updated on 10/14/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Data Presentation - October 14,2026Data Presentation Phase 2Drug: LeniolisibAnnounced Date: October 14, 2026Indication: Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)Other Companies Involved: NASDAQ:PHAR AnnouncementPharming presented positive topline data from its Phase II trial of leniolisib in genetically identifiable primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kδ signaling.Read Announcement
