Lōkahi Therapeutics Moves LT-100 Toward Single-Injection Dosing Following FDA Meeting
GCTK has more than doubled off its 52-week low of $0.25 on elevated volume (32× avg).
Summary
Lōkahi Therapeutics, a Glucotrack subsidiary, reported FDA meeting and nonclinical study results supporting a shift to single-injection LT-100 dosing, with clinical evaluation expected to start by Q4 2026.
Key Events · Product Development and Regulatory · GCTK
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FDA Type C Meeting Completed
In May 2026, Lōkahi discussed its clinical strategy for LT-100 with the FDA, defining a path toward evaluating a single subcutaneous injection approach.
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Nonclinical Study Supports New Dosing
A minipig study comparing subcutaneous and intradermal administration showed systemic exposure consistent with prior clinical experience, supporting the simplified regimen.
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Clinical Evaluation Timeline
Lōkahi anticipates initiating clinical evaluation of single-injection LT-100 as early as Q4 2026, with an initial readout potentially in H1 2027.
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Strategic Context
This progress comes as Glucotrack faces going-concern risk and a pending reverse stock split vote; positive pipeline news may bolster shareholder confidence and financing efforts.
Analysis · GCTK · Industrial Applications And Services
Glucotrack's subsidiary Lōkahi Therapeutics disclosed progress in simplifying LT-100 administration from 15 intradermal injections to a single subcutaneous injection. An FDA Type C meeting in May 2026 and a completed nonclinical minipig study support the planned clinical evaluation. The company expects to start clinical evaluation as early as Q4 2026, with initial data in H1 2027. This is a meaningful regulatory and clinical milestone for a company facing going-concern risk and Nasdaq delisting — positive development news that could influence the upcoming reverse stock split vote and near-term financing efforts.
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At the time of this filing, GCTK was trading at $0.74 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $2.2M. The 52-week trading range was $0.25 to $14.14. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.