NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage pharmaceutical company and subsidiary of SciSparc Ltd., announced on October 22, 2026 that it has completed manufacturing of its investigational product SCI-110 and received a European Qualified Person batch release certification, a critical regulatory step authorising shipment of clinical trial material to study sites. The milestone clears the path toward patient enrolment in the company's FDA-approved Phase IIb clinical trial evaluating SCI-110 for Tourette Syndrome in adults. Investors may be watching this development closely given the substantial unmet treatment needs in the Tourette Syndrome space.

Key Points

  • NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage pharmaceutical company and subsidiary of SciSparc Ltd.
  • European Qualified Person batch release certification obtained, enabling shipment of SCI-110 clinical trial material to participating study sites
  • All three clinical sites — Yale School of Medicine, Hannover Medical School, and Tel Aviv Sourasky Medical Center — have completed site initiation activities
  • Investors should watch for confirmation of investigational product shipments and the commencement of patient enrolment

European QP Batch Release Unlocks SCI-110 Shipments to Trial Sites

NeuroThera Labs has successfully completed the manufacturing of SCI-110 and secured a batch release certification from a European Qualified Person, a formal regulatory authorisation required before clinical trial materials can be shipped to study sites. The company states this milestone enables site activation activities and directly supports the initiation of patient enrolment in its FDA-approved Phase IIb clinical trial. The release describes investigational product shipments to study sites as expected in the near term, though specific shipment dates were not disclosed in the announcement.

Three International Clinical Sites Ready to Receive SCI-110 Supplies

The Phase IIb trial is being conducted across three internationally recognised institutions: the Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut; Hannover Medical School in Hanover, Germany; and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. The announcement states that all three sites have successfully completed their site initiation activities and are prepared to receive clinical trial drug supplies following the QP batch release, representing a coordinated operational readiness across multiple jurisdictions.

SCI-110's Cannabinoid Combination Targets Adults With Tourette Syndrome

SCI-110 is described by the company as a proprietary, patent-protected cannabinoid-based drug candidate that combines dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. The Phase IIb study is designed to evaluate SCI-110's efficacy, safety, and tolerability in adults with Tourette Syndrome, a neurological condition the company characterises as having substantial unmet treatment needs. The immediate share price impact of this announcement was not clear from available public information.