SciSparc (SPRC) FDA Approvals $4.64 +0.31 (+7.16%) Closing price 04:00 PM EasternExtended Trading$4.62 -0.02 (-0.41%) As of 07:55 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 EventsInsider TradesNews and TrendsSEC Filings SciSparc's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by SciSparc (SPRC). Over the past two years, SciSparc has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SCI-110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. SCI-110 FDA Regulatory Timeline and Events SCI-110 is a drug developed by SciSparc for the following indication: For the treatment of Tourette Syndrome ("TS"). 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 - September 2,2026Provided Update Orphan DrugDrug: SCI-110Announced Date: September 2, 2026Indication: For the treatment of Tourette Syndrome ("TS").AnnouncementSciSparc Ltd. announced that its subsidiary, NeuroThera Labs Inc announced that it is pursuing U.S. Food and Drug Administration ("FDA") Orphan Drug Designation covering SCI-110, its drug candidate for the treatment adults with Tourette Syndrome ("TS"), a rare condition that may qualify for Orphan Drug Designation.Read AnnouncementProvided Update - August 5,2026Provided Update Phase 2bDrug: SCI-110Announced Date: August 5, 2026Indication: For the treatment of Tourette Syndrome ("TS").AnnouncementSciSparc Ltd. announced the initiation of NeuroThera’s Phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, New Haven, Connecticut, USA.AI SummarySciSparc Ltd. announced that NeuroThera’s Phase IIb clinical trial has begun at the Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut. The center is one of the study’s key clinical sites and will evaluate SCI-110 in adults with Tourette syndrome (TS). SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single dosage form. The treatment is being developed to reduce tics and related symptoms in adults with TS, while also aiming to limit side effects. The trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. NeuroThera Labs, a clinical-stage pharmaceutical company, is developing therapies for central nervous system disorders and other underserved conditions. The Phase IIb study represents continued progress in evaluating SCI-110 across multiple international research centers.Read AnnouncementInitiation - July 15,2026Initiation Phase 2bDrug: SCI-110Announced Date: July 15, 2026Indication: For the treatment of Tourette Syndrome ("TS").AnnouncementSciSparc Ltd announced the initiation of its Phase IIb clinical trial site at Hannover Medical School, Hanover, Germany ("MHH"), for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults.AI SummarySciSparc Ltd. announced that it has opened a Phase IIb clinical trial site at Hannover Medical School in Hanover, Germany, for SCI-110, its cannabinoid-based treatment candidate for adults with Tourette Syndrome. The trial is also being conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. The company says this step moves the study forward as it works to test SCI-110 in multiple medical centers. SCI-110 is designed to address the needs of adults living with Tourette Syndrome, a condition that can cause repeated movements and vocal tics. SciSparc said the new site expands its clinical reach and supports its effort to gather data from an international patient group.Read Announcement SciSparc FDA Events - Frequently Asked Questions Has SciSparc received FDA approval? As of now, SciSparc (SPRC) has not received any FDA approvals for its therapy in the last two years. What drugs has SciSparc submitted to the FDA? In the past two years, SciSparc (SPRC) has reported FDA regulatory activity for SCI-110. What is the most recent FDA event for SciSparc? The most recent FDA-related event for SciSparc occurred on September 2, 2026, involving SCI-110. The update was categorized as "Provided Update," with the company reporting: "SciSparc Ltd. announced that its subsidiary, NeuroThera Labs Inc announced that it is pursuing U.S. Food and Drug Administration ("FDA") Orphan Drug Designation covering SCI-110, its drug candidate for the treatment adults with Tourette Syndrome ("TS"), a rare condition that may qualify for Orphan Drug Designation." What conditions do SciSparc's current drugs treat? Currently, SciSparc has one therapy (SCI-110) targeting the following condition: For the treatment of Tourette Syndrome ("TS").. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arvinas FDA EventsArrowhead Pharmaceuticals FDA EventsBioCardia FDA EventsImmunic FDA EventsKura Oncology FDA EventsLakewood-Amedex Biotherapeutics FDA EventsLipocine FDA EventsLantern Pharma FDA EventsNurix Therapeutics FDA EventsPulse Biosciences FDA EventsPureTech Health FDA EventsZenas BioPharma FDA EventsAbbVie FDA EventsArcutis Biotherapeutics FDA EventsBridgeBio Pharma 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 Moleculin Biotech FDA Events Medicus Pharma FDA Events Quoin Pharmaceuticals FDA Events Traws Pharma FDA Events Ensysce Biosciences FDA Events Acurx Pharmaceuticals FDA Events Reviva Pharmaceuticals FDA Events Lexaria Bioscience FDA Events NuCana FDA Events Heatwurx FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:SPRC last updated on 9/2/2026 by MarketBeat.com Staff. 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Provided Update - September 2,2026Provided Update Orphan DrugDrug: SCI-110Announced Date: September 2, 2026Indication: For the treatment of Tourette Syndrome ("TS").AnnouncementSciSparc Ltd. announced that its subsidiary, NeuroThera Labs Inc announced that it is pursuing U.S. Food and Drug Administration ("FDA") Orphan Drug Designation covering SCI-110, its drug candidate for the treatment adults with Tourette Syndrome ("TS"), a rare condition that may qualify for Orphan Drug Designation.Read Announcement
Provided Update - August 5,2026Provided Update Phase 2bDrug: SCI-110Announced Date: August 5, 2026Indication: For the treatment of Tourette Syndrome ("TS").AnnouncementSciSparc Ltd. announced the initiation of NeuroThera’s Phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, New Haven, Connecticut, USA.AI SummarySciSparc Ltd. announced that NeuroThera’s Phase IIb clinical trial has begun at the Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut. The center is one of the study’s key clinical sites and will evaluate SCI-110 in adults with Tourette syndrome (TS). SCI-110 combines dronabinol with palmitoylethanolamide, an endocannabinoid-like compound, in a single dosage form. The treatment is being developed to reduce tics and related symptoms in adults with TS, while also aiming to limit side effects. The trial is also underway at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel. NeuroThera Labs, a clinical-stage pharmaceutical company, is developing therapies for central nervous system disorders and other underserved conditions. The Phase IIb study represents continued progress in evaluating SCI-110 across multiple international research centers.Read Announcement
Initiation - July 15,2026Initiation Phase 2bDrug: SCI-110Announced Date: July 15, 2026Indication: For the treatment of Tourette Syndrome ("TS").AnnouncementSciSparc Ltd announced the initiation of its Phase IIb clinical trial site at Hannover Medical School, Hanover, Germany ("MHH"), for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults.AI SummarySciSparc Ltd. announced that it has opened a Phase IIb clinical trial site at Hannover Medical School in Hanover, Germany, for SCI-110, its cannabinoid-based treatment candidate for adults with Tourette Syndrome. The trial is also being conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. The company says this step moves the study forward as it works to test SCI-110 in multiple medical centers. SCI-110 is designed to address the needs of adults living with Tourette Syndrome, a condition that can cause repeated movements and vocal tics. SciSparc said the new site expands its clinical reach and supports its effort to gather data from an international patient group.Read Announcement
