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Form 8-K Cyclerion Therapeutics, For: Feb 17

Tue, 17 Feb 2026 07:22:00 -0500

si-local-file:///var/storage/secattach/20260217/26006043.html

Form 8-K Cyclerion Therapeutics, For: Feb 17

Tue, 17 Feb 2026 07:22:00 -0500

si-local-file:///var/storage/secattach/20260217/26006043.html

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

Cyclerion Therapeutics (NASDAQ: CYCN) received positive written feedback from the U.S. Food and Drug Administration regarding its planned Phase 2 proof-of-concept study for CYC-126, an investigational therapy for treatment-resistant depression.

The FDA provided guidance on CYC-126's regulatory pathway and supported the company's proposed study design. CYC-126 combines anesthetic agents with real-time electroencephalogram monitoring and algorithm-guided dosing. The treatment will be regulated under the FDA's Center for Drug Evaluation and Research, with input from the Center for Devices and Radiologic Health.

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.

Cyclerion receives FDA feedback on depression treatment study

Tue, 17 Feb 2026 07:00:35 -0500

The planned study is a randomized, double-blind clinical trial evaluating CYC-126 in adults with treatment-resistant depression who are candidates for monitored anesthesia.