CYCN (Cyclerion Therapeutics, Inc.) PDUFA Date | FDA Catalyst & Approval Status

Apr 1, 2026

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Cyclerion Therapeutics and Korsana Biosciences Announce Merger Agreement

Cyclerion Therapeutics and Korsana Biosciences have announced a merger agreement, with the combined entity to operate as Korsana Biosciences, Inc. The merger is supported by a significant private investment, expected to fund operations through 2029. The lead program, KRSA-028, targets Alzheimer's disease and aims to advance through clinical trials. The transaction is anticipated to close in Q3 2026, pending shareholder approvals.

Feb 17, 2026

Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board

Cyclerion Therapeutics announced positive feedback from the FDA regarding its CYC-126 Phase 2 proof-of-concept study for treatment-resistant depression. The company is set to initiate the study in the second half of 2026, supported by a newly formed Clinical Advisory Board. This development aims to address significant unmet needs in treating this condition.

Cyclerion Therapeutics Announces Strategic Agreement with Medsteer and Progress Toward Initiating Phase 2 Proof-of-Concept Study for CYC-126 in Treatment-Resistant Depression

Cyclerion Therapeutics has announced a strategic collaboration with Medsteer to advance the development of CYC-126, a novel therapy for treatment-resistant depression. The partnership aims to integrate Medsteer's anesthetic delivery technology into CYC-126, enhancing its precision and effectiveness. The Phase 2 proof-of-concept study is expected to begin in the second half of 2026, with further updates to be shared in an upcoming investor webcast.

Sep 24, 2025

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Cyclerion Announces Transformational Relaunch as a Neuropsychiatric Company - Cyclerion Relaunches, Advancing a Phase 2-Ready Program for Millions Living with Treatment-Resistant Depression Through MIT License Agreement

Cyclerion Therapeutics has announced a transformative relaunch as a neuropsychiatric company, focusing on developing treatments for conditions with significant unmet needs, particularly treatment-resistant depression. This strategic shift is supported by a licensing agreement with the Massachusetts Institute of Technology. The company's lead program, expected to enter Phase 2 trials in 2026, aims to utilize anesthetic agents to improve brain connectivity. Cyclerion's leadership emphasizes its commitment to offering innovative therapies and maximizing value for stakeholders.

Dec 17, 2024

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Cyclerion s sGC Stimulator Portfolio Generates Revenues to Enable Company Growth Cyclerion Has Renegotiated Praliciguat License Agreement to Obtain Upfront and Near-Term Payments as well as Entered into a License Option

Cyclerion Therapeutics, Inc. has renegotiated its license agreement for praliciguat, securing $1.75 million in upfront payments and future milestone cash potential. The agreements enable the company to leverage its legacy soluble guanylate cyclase stimulator assets to support growth without immediate dilution. Additionally, Cyclerion has entered a license option for olinciguat, facilitating the evaluation of the asset by a clinical-stage partner. These strategies aim to expand the company's position in the central nervous system space and enhance shareholder value.

Aug 7, 2024

Regina Graul, Ph.D., Promoted to Chief Executive Officer

Cyclerion Therapeutics, Inc. has announced the promotion of Regina Graul, Ph.D., to Chief Executive Officer. Dr. Graul, who has held the position of President since December 2023, has been credited with strengthening the company's operations and spearheading evaluations for new therapies. Her leadership is expected to drive shareholder value, with a focus on reducing costs and exploring potential business opportunities. The company expresses confidence in her ability to lead Cyclerion towards growth and success.

Cyclerion Appoints Regina Graul, Ph.D., as President Dr. Graul will lead the rebuild of Cyclerion, bringing more than two decades of drug making experience, R&D portfolio leadership, and a deep expertise in company strat

Cyclerion Therapeutics has appointed Dr. Regina Graul as its new president, as the company seeks to rebuild and innovate following leadership changes. Dr. Graul brings over two decades of experience in drug development and will work closely with the board of directors to enhance the organization's strategic direction. Former CEO Peter Hecht will remain involved as a strategic consultant. The company aims to leverage its existing assets and explore new opportunities for growth and patient treatment solutions.

Nov 30, 2023

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Cyclerion Strengthens Board of Directors with Experienced Company Builder and Cutting-edge Innovator - Dina Katabi, Ph.D.: World leader in healthcare AI applications at MIT; inventor of groundbreaking wireless devices fo

Cyclerion Therapeutics has announced the strengthening of its Board of Directors with the appointments of Dina Katabi, Ph.D., a renowned expert in healthcare AI, and Michael Higgins. The addition of these leaders is expected to facilitate the company's strategic transformation as it explores opportunities for licenses, mergers, and acquisitions. Cyclerion, which focuses on developing treatments for serious diseases, aims to leverage their combined expertise to enhance shareholder value.

Jun 1, 2023

Cyclerion Regains Compliance with Nasdaq Minimum Bid Price Requirement

Cyclerion Therapeutics, Inc. has announced that it has regained compliance with Nasdaq's minimum bid price requirement. The company received a formal notice confirming that it met the $1.00 per share threshold for ten consecutive trading days, resolving its previous non-compliance issue. As a result, Cyclerion's stock will continue to be listed and traded on the Nasdaq Capital Market.

May 15, 2023

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Cyclerion Announces Reverse Stock Split

Cyclerion Therapeutics has executed a reverse stock split at a ratio of 1-for-20, effective on May 15, 2023. This decision, approved by the company's stockholders during their annual meeting, aims to consolidate its outstanding shares. The split-adjusted shares will commence trading under a new CUSIP number on May 16, 2023. Additionally, Cyclerion has secured an agreement to sell its assets to a private company for $81M, pending shareholder approval.

May 11, 2023

Cyclerion Announces Definitive Agreement for Zagociguat and CY3018 Certain Cyclerion shareholders and new investors have agreed to invest $81M to launch a new company targeting diseases of mitochondrial dysfunction Cycle

Cyclerion Therapeutics has signed a definitive agreement to sell its assets zagociguat and CY3018 to a newly established company, NewCo, for $81 million. Cyclerion will receive $8 million in cash, reimbursement of development costs, and a 10% equity stake in NewCo, which aims to develop treatments for diseases associated with mitochondrial dysfunction. This agreement activates a previously announced $5 million investment by Cyclerion’s CEO, subject to shareholder approval. The transaction aims to enhance the focus and resources dedicated to these promising drug candidates.

Cyclerion Therapeutics Enters into Exclusive Negotiation Period and Binding Equity Investment Agreement

Cyclerion Therapeutics has announced an exclusive negotiation period regarding a proposal from an investor group, including its CEO, to purchase assets related to zagociguat and CY3018. The CEO is also set to invest $5 million in equity as part of a binding agreement. However, the negotiations are still subject to Board and shareholder approval, and there are no assurances that a successful agreement will be reached.

Mar 22, 2023

Cyclerion Reports Corporate Update and Full Year 2022 Financial Results

Cyclerion Therapeutics provided a corporate update and financial results for 2022, highlighting progress in their zagociguat program for MELAS. They reported a potential first-ever therapy for this rare disease and ongoing collaboration with the FDA for further studies. Despite a net loss of approximately $44.1 million and challenges posed by the capital market, Cyclerion is focused on maximizing shareholder value and advancing its clinical candidates, including CY3018 and olinciguat.

Cyclerion Concludes Unsolicited Proposal Is Not in The Best Interest of The Company

Cyclerion Concludes Unsolicited Proposal Is Not in The Best Interest of The Company CAMBRIDGE, Mass., Nov. 22, 2022 Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced that the Board of Directors of the Company acting solely by all of its independent and disinterested me

Oct 6, 2022

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Cyclerion Announces Mitochondrial Disease-Focused Corporate Strategy Recent positive MELAS clinical study data drive urgency to deliver potential first-ever therapy for patients with rare, genetic mitochondrial diseases

Cyclerion Announces Mitochondrial Disease-Focused Corporate Strategy Recent positive MELAS clinical study data drive urgency to deliver potential first-ever therapy for patients with rare, genetic mitochondrial diseases Development programs prioritized and organization structur

Cyclerion Announces CY6463 Clinical Pipeline Progress and Second Quarter 2022 Financial Results Positive topline results for CY6463 announced in two clinical studies in patients with Mitochondrial Encephalomyopathy, Lact

Cyclerion Announces CY6463 Clinical Pipeline Progress and Second Quarter 2022 Financial Results Positive topline results for CY6463 announced in two clinical studies in patients with Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Cognitive

Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS) Study data demonstrate positive effects of CY6463 on cognition and inf

Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS) Study data demonstrate positive effects of CY6463 on cognition and inflammation after two weeks of dosing in patients with stabl

Jul 26, 2022

Steven E. Hyman, M.D., Appointed to Cyclerion Therapeutics' Board of Directors Renowned neuroscience leader to further long-term clinical research strategy and external collaborations

Steven E. Hyman, M.D., Appointed to Cyclerion Therapeutics' Board of Directors Renowned neuroscience leader to further long-term clinical research strategy and external collaborations CAMBRIDGE, Mass., July 26, 2022 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN

Jun 10, 2022

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Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in MELAS Patients at UMDF Mitochondrial Medicine 2022 Symposium Data from an eight-patient, open-label study demonstrate improvements across mult

Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in MELAS Patients at UMDF Mitochondrial Medicine 2022 Symposium Data from an eight-patient, open-label study demonstrate improvements across multiple biomarkers of mitochondrial function, inflammation, ce

Cyclerion Announces CY6463 Clinical Pipeline Progress and First Quarter 2022 Financial Results Characterizing the novel neuropharmacology of CY6463's NO-sGC-cGMP signal modulation in an integrated clinical strategy curre

Cyclerion Announces CY6463 Clinical Pipeline Progress and First Quarter 2022 Financial Results Characterizing the novel neuropharmacology of CY6463's NO-sGC-cGMP signal modulation in an integrated clinical strategy currently involving three ongoing, exploratory, biomarker-rich,

Feb 24, 2022

Cyclerion Announces CY6463 Clinical Pipeline and Corporate Updates Phase 2a study in Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) enrollment closed; topline data expected in Q2 2022

Cyclerion Announces CY6463 Clinical Pipeline and Corporate Updates Phase 2a study in Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) enrollment closed; topline data expected in Q2 2022 Phase 1b study in Cognitive Impairment Associated with Sch

Nov 9, 2021

Cyclerion Therapeutics Reports Third Quarter 2021 Financial Results and Corporate Update First patients enrolled in study in Cognitive Impairment Associated with Schizophrenia (CIAS) Patient screening underway in study i

Cyclerion Therapeutics Reports Third Quarter 2021 Financial Results and Corporate Update First patients enrolled in study in Cognitive Impairment Associated with Schizophrenia (CIAS) Patient screening underway in study in Alzheimer's disease with vascular pathology (ADv) Enrol

Sep 30, 2021

On a mission to develop treatments that restore cognitive function CORPORATE PRESENTATION Safe harbor statement This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of

On a mission to develop treatments that restore cognitive function CORPORATE PRESENTATION Safe harbor statement This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Excha

Cyclerion Therapeutics Reports Second Quarter 2021 Financial Results and Corporate Update Continuing to progress clinical development of CY6463, a first-in-class, CNS-penetrant soluble guanylate cyclase (sGC) stimulator

Cyclerion Therapeutics Reports Second Quarter 2021 Financial Results and Corporate Update Continuing to progress clinical development of CY6463, a first-in-class, CNS-penetrant soluble guanylate cyclase (sGC) stimulator for the treatment of neurological diseases associated with

Jun 4, 2021

Cyclerion Therapeutics Announces Global Licensing Agreement with Akebia Therapeutics for Praliciguat Cyclerion eligible to receive up to $585 million in potential future development and commercial milestone payments, and

Cyclerion Therapeutics Announces Global Licensing Agreement with Akebia Therapeutics for Praliciguat Cyclerion eligible to receive up to $585 million in potential future development and commercial milestone payments, and tiered sales-based royalties Praliciguat out-licensing f

Apr 27, 2021

CYCNFDA Updates

Cyclerion Therapeutics Hosted Webinar to Discuss Pipeline Progress Provided updates on development strategy and execution for CY6463, a first-in-class, CNS-penetrant sGC stimulator, including IND clearance from FDA in AD

Cyclerion Therapeutics Hosted Webinar to Discuss Pipeline Progress Provided updates on development strategy and execution for CY6463, a first-in-class, CNS-penetrant sGC stimulator, including IND clearance from FDA in ADv and ongoing MELAS Introduced new CY6463 clinical program

Apr 26, 2021

Cyclerion Therapeutics Appoints Errol De Souza, Ph.D., to Board of Directors S enior CNS expert and biotech business leader to inform strategy and future clinical development

Cyclerion Therapeutics Appoints Errol De Souza, Ph.D., to Board of Directors Senior CNS expert and biotech business leader to inform strategy and future clinical development CAMBRIDGE, Mass., April 26, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clin

Mar 18, 2021

Cyclerion Therapeutics Announces Departure of Chief Medical Officer

Cyclerion Therapeutics Announces Departure of Chief Medical Officer CAMBRIDGE, Mass., March. 18, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, t

Jan 13, 2021

This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking state

January 2021 On a mission to develop treatments that restore cognitive function Exhibit 99.1 This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, a

Oct 14, 2020

Cyclerion Announces Positive Data from IW-6463 CNS Translational Pharmacology Study in Healthy Elderly Subjects Showed significant improvements in neurophysiological and objective performance measur

Cyclerion Announces Positive Data from IW-6463 CNS Translational Pharmacology Study in Healthy Elderly Subjects Showed significant improvements in neurophysiological and objective performance measures associated with age-related cognitive decline and neurodegenerative diseases

Aug 3, 2020

Cyclerion Therapeutics Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights

Therapeutics Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights Mass., August 3, 2020 - Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing treatments for serious and orphan diseases, reported financial r

Jul 9, 2020

Delivering impact in CNS diseases Investor webinar

Delivering impact in CNS diseases Investor webinar July 9, 2020 Safe Harbor Statement This presentation contains forward - looking statements. Any statements contained in this presentation that are not historical fac ts may be deemed to be forward looking statements. Words such

Jun 18, 2020

Cyclerion to Host Webcast Investor Event on

to Host Webcast Investor Event on July 9, 2020 - CNS therapies investor event to precede clinical study results - translational pharmacology study subject dosing complete; topline data expected late summer 2020 - CAMBRIDGE, Mass., JUNE 18, 2020 - Cyclerion Therapeutics, Inc.

Apr 14, 2020

Safe Harbor Statement 2 This presentation contains forward - looking statements. Any statements contained in this presentation that are not historical fac ts may be deemed to be forward looking statements. Words such as

Creating breakthrough treatments for patients with serious and orphan diseases by harnessing the power of soluble guanylate cyclase ( sGC ) April 10, 2020 Exhibit 99.1 Safe Harbor Statement 2 This presentation contains forward - looking statements. Any statements contained in th

Jan 15, 2020

Cyclerion announces IW-6463 phase 1 healthy volunteer study results that support further development for neurodegenerative diseases - Results in 110 subjects demonstrate favorable safety, CNS pharmacokinetics, and eviden

IW-6463 phase 1 healthy volunteer study results that support further development for neurodegenerative diseases CAMBRIDGE, Mass., Jan. 13, 2020 - Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), today announces positive Phase 1 study results that provide the foundation for continu

Oct 30, 2019

Cyclerion Therapeutics Announces Praliciguat Topline Phase 2 Results in Diabetic Nephropathy Study did not reach statistical significance on primary endpoint Positive trends on primary and secondary

Cyclerion Therapeutics Announces Praliciguat Topline Phase 2 Results in Diabetic Nephropathy Study did not reach statistical significance on primary endpoint Positive trends on primary and secondary endpoints indicate profile that merits further investigation Company intends t

Aug 12, 2019

Cyclerion Therapeutics Reports Second Quarter 2019 Financial Results and Progress on Four Clinical Studies with Data Readouts Anticipated in the Next 12 Months Two praliciguat Phase 2 studies for di

Cyclerion Therapeutics Reports Second Quarter 2019 Financial Results and Progress on Four Clinical Studies with Data Readouts Anticipated in the Next 12 Months Two praliciguat Phase 2 studies for diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF) on

May 13, 2019

Cyclerion Therapeutics Provides a Corporate and Pipeline Overview as a Newly Launched Public Biopharmaceutical Company Completed enrollment in Phase 2 studies of praliciguat in diabetic nephropathy

Cyclerion Therapeutics Provides a Corporate and Pipeline Overview as a Newly Launched Public Biopharmaceutical Company Completed enrollment in Phase 2 studies of praliciguat in diabetic nephropathy and heart failure with preserved ejection fraction (HFpEF) Based on encouraging

Apr 9, 2019

Cyclerion Announces the Appointment of Andreas Busch, Ph.D., as Chief Innovation Officer Dr. Busch will lead Cyclerion s Innovation Center and provide strategic oversight of the company s soluble guanylate cyclase (sGC)

Cyclerion Announces the Appointment of Andreas Busch, Ph.D., as Chief Innovation Officer Dr. Busch will lead Cyclerion s Innovation Center and provide strategic oversight of the company s soluble guanylate cyclase (sGC) portfolio CAMBRIDGE, Mass., April 9, 2019 Cyclerion Therap

Mar 19, 2019