Scinai Immunotherapeutics (SCNI) FDA Approvals $0.23 -0.02 (-6.92%) Closing price 07/24/2026 03:59 PM EasternExtended Trading$0.24 +0.00 (+2.17%) As of 07/24/2026 05:30 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 FilingsTrendsBuy This Stock Scinai Immunotherapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Scinai Immunotherapeutics (SCNI). Over the past two years, Scinai Immunotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PC111. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. PC111 FDA Regulatory Events PC111 is a drug developed by Scinai Immunotherapeutics for the following indication: For Pemphigus and SJS/TEN. 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. Publication - July 29,2025Publication Drug: PC111Announced Date: July 29, 2025Indication: For Pemphigus and SJS/TENAnnouncementScinai Immunotherapeutics Ltd. announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody.AI SummaryScinai Immunotherapeutics announced that a new peer-reviewed article in the Journal of Dermatological Treatment validates the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody. Authored by Dr. Roberta Lotti and colleagues, the study confirms that PC111 prevents blister formation in in vitro, ex vivo, and in vivo humanized models of pemphigus by targeting soluble Fas Ligand, a key factor in keratinocyte apoptosis and acantholysis. Building on award-winning research, the paper shows PC111’s non-immunosuppressive action at the skin cell level. Data from a proprietary humanized FasL mouse model demonstrated a significant reduction in disease activity. The authors also highlight PC111’s promise in treating Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis by preventing FasL-mediated keratinocyte apoptosis and ocular damage. With orphan drug designation in the EU and planned studies in the U.S., PC111 offers a safer, fast-acting alternative to chronic immunosuppression.Read Announcement Scinai Immunotherapeutics FDA Events - Frequently Asked Questions Has Scinai Immunotherapeutics received FDA approval? As of now, Scinai Immunotherapeutics (SCNI) has not received any FDA approvals for its therapy in the last two years. What drugs has Scinai Immunotherapeutics submitted to the FDA? In the past two years, Scinai Immunotherapeutics (SCNI) has reported FDA regulatory activity for PC111. What is the most recent FDA event for Scinai Immunotherapeutics? The most recent FDA-related event for Scinai Immunotherapeutics occurred on July 29, 2025, involving PC111. The update was categorized as "Publication," with the company reporting: "Scinai Immunotherapeutics Ltd. announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody." What conditions do Scinai Immunotherapeutics' current drugs treat? Currently, Scinai Immunotherapeutics has one therapy (PC111) targeting the following condition: For Pemphigus and SJS/TEN. 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FDA EventsBeam Therapeutics FDA EventsGenmab A/S FDA EventsHCW Biologics FDA EventsInhibikase Therapeutics FDA EventsIncannex Healthcare FDA EventsLantern Pharma FDA EventsJohnson & Johnson FDA EventsEli Lilly and Company FDA EventsArrowhead Pharmaceuticals 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 Vaccinex FDA Events Virax Biolabs Group FDA Events Galmed Pharmaceuticals FDA Events SciSparc FDA Events CASI Pharmaceuticals FDA Events Artelo Biosciences FDA Events Abpro FDA Events Purple Biotech FDA Events PMGC FDA Events Silexion Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:SCNI last updated on 7/29/2025 by MarketBeat.com Staff. 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Publication - July 29,2025Publication Drug: PC111Announced Date: July 29, 2025Indication: For Pemphigus and SJS/TENAnnouncementScinai Immunotherapeutics Ltd. announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody.AI SummaryScinai Immunotherapeutics announced that a new peer-reviewed article in the Journal of Dermatological Treatment validates the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody. Authored by Dr. Roberta Lotti and colleagues, the study confirms that PC111 prevents blister formation in in vitro, ex vivo, and in vivo humanized models of pemphigus by targeting soluble Fas Ligand, a key factor in keratinocyte apoptosis and acantholysis. Building on award-winning research, the paper shows PC111’s non-immunosuppressive action at the skin cell level. Data from a proprietary humanized FasL mouse model demonstrated a significant reduction in disease activity. The authors also highlight PC111’s promise in treating Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis by preventing FasL-mediated keratinocyte apoptosis and ocular damage. With orphan drug designation in the EU and planned studies in the U.S., PC111 offers a safer, fast-acting alternative to chronic immunosuppression.Read Announcement
