21:13:23 EDT Wed 02 Sep 2026
Enter Symbol
or Name
USA
CA



Neurothera Labs Inc (2)
Symbol NTLX
Shares Issued 192,142,499
Close 2026-09-01 C$ 0.24
Market Cap C$ 46,114,200
Recent Sedar+ Documents

Neurothera seeks orphan drug designation for SCI-110

2026-09-02 17:33 ET - News Release

An anonymous director of SciSparc reports

SCISPARC: SUBSIDIARY NEUROTHERA LABS PURSUES FDA ORPHAN DRUG DESIGNATION FOR ADULT TOURETTE SYNDROME DRUG; ENGAGES GOVERNMENT AND PUBLIC AFFAIRS FIRM RK STRATEGIES

SciSparc Ltd.'s subsidiary, Neurothera Labs Inc., a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous system disorders, is pursuing U.S. Food and Drug Administration orphan drug designation covering SCI-110, its drug candidate for the treatment in adults with Tourette's syndrome, a rare condition that may qualify for orphan drug designation.

To support and accelerate this regulatory pathway, Neurothera has engaged RK Strategies Inc., a U.S. government and public affairs consulting and lobbying firm focused primarily on health care 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 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 co-morbid 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 2b program, now under way at three leading academic centres: the Yale Child Study Center in New Haven, Connecticut, United States; 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 2b program builds on phase 2a results in which SCI-110 achieved an average tic reduction of 21 per cent 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 health care, pharmaceuticals, preparedness, biodefence, defence and technology, with a focus on engagement before U.S. policy-makers and other stakeholders. RK Strategies' work has included advising elected officials and supporting policy outcomes across health care preparedness and related areas.

About SciSparc Ltd.

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 tetrahydrocannabinol and/or non-psychoactive cannabidiol: SCI-110 for the treatment of Tourette's 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 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.

We seek Safe Harbor.

© 2026 Canjex Publishing Ltd. All rights reserved.