SciSparc: Subsidiary NeuroThera Labs Pursues FDA Orphan Drug Designation For Adult Tourette Syndrome Drug; Engages Government and Public Affairs Firm RK Strategies

Rhea-AI Summary

SciSparc (SPRC) reported that majority-owned subsidiary NeuroThera Labs is pursuing U.S. FDA Orphan Drug Designation for SCI-110, its cannabinoid-based candidate for adults with Tourette Syndrome, and has engaged U.S. government and public affairs firm RK Strategies to support this regulatory and policy effort.

Orphan status in the United States is reserved for investigational therapies targeting diseases affecting fewer than 200,000 people and, if granted, can offer regulatory and commercial advantages. SCI-110 combines dronabinol with palmitoylethanolamide in a single oral dosage form, targeting tic reduction and associated comorbid symptoms while aiming to limit side effects. NeuroThera has advanced SCI-110 into a Phase IIb program at three academic centers in the United States, Germany and Israel, following Phase IIa data showing an average tic reduction of 21% on the Yale Global Tic Severity Scale Total Tic Score.

Positive

• NeuroThera pursuing FDA Orphan Drug Designation for SCI-110 in adult Tourette Syndrome
• Phase IIb clinical program for SCI-110 initiated at three academic centers in the U.S., Germany and Israel
• Prior Phase IIa trial showed an average tic reduction of 21% on a standard severity scale
• Engagement of RK Strategies to support U.S. regulatory, policy and market-access positioning

Negative

• None.

Market Reaction – SPRC

-2.82% $5.51 15.7x vol

15m delay

-2.82% Vs previous close

+10.4% Peak in 1 min

$5.51 Last Price

$5.46 $6.97 Day Range

$3.20M Market Cap

15.7x Rel. Volume

Following this news, SPRC has declined 2.82%, reflecting a moderate negative market reaction. Argus tracked a peak move of +10.4% during the session. Our momentum scanner has triggered 8 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $5.51. Trading volume is exceptionally heavy at 15.7x the average, suggesting significant selling pressure.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

The tag-specific clinical-trial record showed an average move of 10.98% across five events. Recent o...

Analysis

The tag-specific clinical-trial record showed an average move of 10.98% across five events. Recent outcomes included 14.75% and -14.48% reactions. The active F-3/A resale registration remains a structural risk to monitor.

Key Figures

Orphan designation threshold: Fewer than 200,000 individuals Clinical development stage: Phase IIb Trial centers: 3 academic centers +2 more

5 metrics

Orphan designation threshold Fewer than 200,000 individuals U.S. rare-disease designation criterion

Clinical development stage Phase IIb SCI-110 Tourette Syndrome program

Trial centers 3 academic centers Yale, Hannover Medical School, and Tel Aviv Sourasky Medical Center

Average tic reduction 21% Phase IIa results measured by Yale Global Tic Severity Scale Total Tic Score

RK Strategies founded 2017 Government and public affairs firm

Previous Clinical trial Reports

5 past events · Latest: Aug 31 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Aug 31	Autism trial enrollment	Positive	-14.5%	Enrollment reached 26 children in the ongoing SCI-210 autism trial.
Aug 05	Tourette Phase IIb launch	Positive	+2.2%	SCI-110 Phase IIb trial opened at Yale for adult Tourette Syndrome.
Jul 31	Quantum workflow milestone	Positive	-18.2%	Clinical-data platform demonstrated an end-to-end hybrid quantum-classical workflow.
Jul 29	Quantum platform validation	Positive	+70.5%	Internal validation advanced quantum sampling for clinical-trial data analysis.
Jul 15	Tourette Phase IIb initiation	Positive	+14.8%	Hannover Medical School initiated a Phase IIb SCI-110 trial site.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific clinical-trial announcements produced three aligned positive reactions and two divergences, including a negative reaction to recent enrollment news.

Key Terms

orphan drug designation, phase iib, yale global tic severity scale total tic score, dronabinol, +1 more

5 terms

orphan drug designation regulatory

"it is pursuing U.S. Food and Drug Administration (“FDA”) Orphan Drug Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

phase iib medical

"NeuroThera recently advanced SCI-110 into the next stage of clinical development"

Phase IIb is a mid-stage clinical trial that tests whether an experimental treatment works and what dose is best by studying it in a larger group of patients than early tests. For investors, Phase IIb results are important because they substantially reduce uncertainty about a drug’s effectiveness and safety, and positive or negative outcomes often drive company valuation, partnership interest, and the likelihood of advancing to the large, costly Phase III trials.

yale global tic severity scale total tic score medical

"as measured by the Yale Global Tic Severity Scale Total Tic Score"

A clinician-rated measure that sums severity of motor and vocal tics to produce a single score (motor tic score 0–25 plus vocal tic score 0–25, total range 0–50). It quantifies how frequent, intense, and disruptive tics have been over a recent period; think of it like a single thermometer reading that combines two related symptoms. Investors use it to compare treatment effects across trials and judge how much a therapy reduces core tic symptoms.

dronabinol medical

"combine dronabinol with palmitoylethanolamide (PEA)"

A prescription medication that is a lab-made version of the main psychoactive component of cannabis (Δ9‑tetrahydrocannabinol), used to treat nausea, vomiting, and appetite loss in specific medical settings. Investors care because its sales, regulatory approvals, patent life, and competition from generics or alternative therapies directly affect revenue and risk for pharmaceutical companies—think of it as a branded ingredient whose market value depends on approval, demand, and exclusivity.

palmitoylethanolamide medical

"combine dronabinol with palmitoylethanolamide (PEA)"

Palmitoylethanolamide (PEA) is a naturally occurring fatty molecule produced in the body and sold as a supplement or experimental therapy for reducing pain and inflammation; think of it as a built‑in calming signal that helps quiet irritated tissues. Investors watch PEA because its potential medical benefits, regulatory path (supplement vs. drug), and clinical evidence drive market demand, pricing and the risk/reward of companies developing or selling PEA-based products — similar to how a promising ingredient can change the fortunes of a consumer brand.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

This strategic engagement is designed to strengthen NeuroThera’s U.S. market position, visibility among key U.S. federal stakeholders, reinforce the clinical and public‑health importance of advancing new treatment options for adult Tourette Syndrome

TEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), today announced that its subsidiary, NeuroThera Labs Inc. (TSXV: NTLX) ("NeuroThera"), a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous system disorders, today 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.

To support and accelerate this regulatory pathway, NeuroThera has engaged RK Strategies, Inc. (“RK Strategies”), a U.S. government and public affairs consulting and lobbying firm focused primarily on healthcare issues.

This strategic engagement is designed to strengthen NeuroThera’s visibility among key federal stakeholders, reinforce the clinical and public‑health importance of advancing new treatment options for adult TS, and help shape a policy environment that supports long‑term market access and commercial success.  FDA Orphan Drug Designation is a meaningful regulatory and commercial opportunity for NeuroThera. This status is reserved for investigational therapies targeting rare diseases or conditions affecting fewer than 200,000 individuals in the United States. For a company advancing a first‑in‑class treatment for adult TS, the designation, if granted, can potentially materially strengthen the product’s market profile.

SCI-110 is NeuroThera’s proprietary cannabinoid-based therapeutic candidate uniquely formulated to combine dronabinol with palmitoylethanolamide (PEA) in a single oral dosage form. SCI-110 is designed to address a significant unmet need in adult TS by targeting both tic reduction and associated comorbid symptoms, while aiming to minimize side effects. NeuroThera recently advanced SCI-110 into the next stage of clinical development with the initiation of its Phase IIb program, now underway at three leading academic centers: the Yale Child Study Center in New Haven, Connecticut, USA; Hannover Medical School, Hannover, Germany; and Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. This global footprint underscores the continuous growing clinical interest in cannabinoid‑based approaches for neuropsychiatric disorders and reflects NeuroThera’s commitment to rigorous, multinational evaluation.

The Phase IIb program builds on Phase IIa results in which SCI-110 achieved an average tic reduction of 21% across the study population, as measured by the Yale Global Tic Severity Scale Total Tic Score. These findings provide early clinical validation of the drug’s mechanism and support its potential to become a differentiated therapeutic option in a market with limited effective treatments.

Together, the advancing clinical program, multinational trial execution, and potential efficacy signals position SCI‑110 as a compelling late‑stage asset with meaningful value‑creation potential as NeuroThera progresses toward regulatory milestones and future commercialization.

RK Strategies is a government and public affairs consulting and lobbying firm founded in 2017 by Ryan Kane. The firm advises private and publicly traded companies in healthcare, pharmaceuticals, preparedness, biodefense, defense and technology, with a focus on engagement before U.S. policymakers and other stakeholders. RK Strategies’ work has included advising elected officials and supporting policy outcomes across healthcare preparedness and related areas.

About SciSparc Ltd. (Nasdaq: SPRC):

The Company, through its majority-owned subsidiary NeuroThera, engages in clinical-stage pharmaceutical developments. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company, together with its majority-owned subsidiary NeuroThera, is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus. The Company, through NeuroThera, also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seed oil-based products on the Amazon.com Marketplace.

About NeuroThera Labs Inc.

NeuroThera is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc uses forward-looking statements when it discusses NeuroThera’s pursuit of Orphan Drug Designation for NeuroThera’s SCI-110; that the strategic engagement with RK Strategies is designed to strengthen NeuroThera’s visibility among key federal stakeholders, reinforce the clinical and public‑health importance of advancing new treatment options for adult TS, and help shape a policy environment that supports long‑term market access and commercial success; that Orphan Drug Designation can potentially materially strengthen the product’s market profile; the potential benefits, advantages and capabilities of SCI-110; significant unmet need in adult TS; that global footprint underscores the continuous growing clinical interest in cannabinoid‑based approaches for neuropsychiatric disorders; SCI-110’s potential to become a differentiated therapeutic option in a market with limited effective treatments; and that the advancing clinical program, multinational trial execution, and potential efficacy signals position SCI‑110 as a compelling late‑stage asset with meaningful value‑creation potential as NeuroThera progresses toward regulatory milestones and future commercialization. Because such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc’s Annual Report on Form 20-F, filed with the SEC on April 29, 2026, as amended on August 19, 2026, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact:
IR@scisparc.com
Tel: +972-3-6167055

FAQ

What did SciSparc (SPRC) announce about NeuroThera Labs and Tourette Syndrome treatment?

SciSparc reported that subsidiary NeuroThera Labs is pursuing U.S. FDA Orphan Drug Designation for SCI-110, a cannabinoid-based candidate for adults with Tourette Syndrome, and has retained RK Strategies to support regulatory and policy engagement in the United States.

What is SCI-110, the Tourette Syndrome drug candidate mentioned by SciSparc (SPRC)?

SCI-110 is NeuroThera’s proprietary cannabinoid-based therapeutic that combines dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. It is designed to reduce tics and address associated comorbid symptoms in adults with Tourette Syndrome while aiming to minimize side effects.

What clinical trial results has SCI-110 shown so far for Tourette Syndrome?

In a Phase IIa study, SCI-110 achieved an average tic reduction of 21% across the study population, measured by the Yale Global Tic Severity Scale Total Tic Score. These findings provide early clinical support for further development in adult Tourette Syndrome.

What stage of clinical development is SCI-110 in according to SciSparc (SPRC)?

SCI-110 has advanced into a Phase IIb clinical program. The trial is underway at three academic centers: the Yale Child Study Center in New Haven, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center in Israel, reflecting multinational clinical evaluation.

Why is FDA Orphan Drug Designation important for NeuroThera Labs and SCI-110?

FDA Orphan Drug Designation applies to therapies for rare diseases affecting fewer than 200,000 people in the U.S. The company states that, if granted for SCI-110 in adult Tourette Syndrome, it could materially strengthen the product’s market profile and commercial prospects.

Who is RK Strategies and what role will it play for NeuroThera Labs and SCI-110?

RK Strategies is a U.S. government and public affairs consulting and lobbying firm focused mainly on healthcare. NeuroThera engaged the firm to enhance its visibility with federal stakeholders, highlight the public-health need in adult Tourette Syndrome, and support a policy environment for market access.

What other drug development programs does SciSparc (SPRC) mention alongside SCI-110?

SciSparc highlights a cannabinoid-focused pipeline that includes SCI-110 for Tourette syndrome and for Alzheimer’s disease and agitation, and SCI-210 for autism spectrum disorder and status epilepticus. The company, through NeuroThera, also has a business selling hemp seed oil-based products on Amazon.