Welcome to our dedicated page for Cyclerion Therapeutics news (Ticker: CYCN), a resource for investors and traders seeking the latest updates and insights on Cyclerion Therapeutics stock.
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing treatments for serious and orphan diseases. Established in 2018 and headquartered in Cambridge, Massachusetts, Cyclerion harnesses the potential of soluble guanylate cyclase (sGC) pharmacology to create groundbreaking therapies for conditions with significant unmet medical needs.
The company's portfolio includes several promising product candidates:
- Olinciguat: An orally administered vascular sGC stimulator currently in Phase II studies aimed at treating sickle cell disease (SCD).
- Praliciguat: An orally administered systemic sGC stimulator in Phase II trials targeting diabetic nephropathy and heart failure with preserved ejection fraction.
- IW-6463: An orally administered, CNS-penetrant sGC stimulator in Phase I trials for neurodegenerative diseases.
In addition to these advanced candidates, Cyclerion is also working on discovering liver-targeted and lung-targeted sGC stimulators.
One of the latest developments for Cyclerion is its strategic partnership with Tisento Therapeutics, Inc. In July 2023, Cyclerion announced the closing of an asset purchase agreement with Tisento, which includes an $81 million Series A financing to support the development of Phase 2 soluble guanylate cyclase (sGC) stimulator zagociguat and other assets. Cyclerion received 10 percent equity ownership in Tisento, providing its shareholders with future value creation opportunities.
Cyclerion’s collaboration with Tisento marks a significant advancement, particularly for the brain-penetrant sGC stimulators zagociguat and CY3018. Phase 2a data from Cyclerion's studies demonstrated that zagociguat could significantly improve disease-associated biomarkers in patients with MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes), offering hope for better treatment options where none previously existed.
With a focus on delivering new therapeutic solutions, Cyclerion continues to explore collaborations, licenses, and other strategic options to enhance shareholder value while advancing its portfolio of innovative treatments.
Cyclerion Therapeutics announced positive topline data from a Phase 2a study of CY6463, an oral treatment for Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). In the open-label study involving eight patients, CY6463 showed improvements in biomarkers related to mitochondrial function, inflammation, and cerebral blood flow after 29 days of treatment. The drug was well tolerated with no serious adverse events. These results support further development of CY6463 as a potential treatment option for MELAS and other CNS diseases associated with mitochondrial dysfunction.
Cyclerion Therapeutics (Nasdaq: CYCN) announced significant updates ahead of the UMDF Mitochondrial Medicine 2022 Symposium from June 8-11, 2022. Chad Glasser, Director of Clinical Research, will present topline data from the MELAS clinical study on June 10, 2022. Additionally, Dr. Leonard Burg will showcase preclinical data demonstrating that CY6463 improves function in zebrafish disease models on June 9, 2022. CY6463 is being developed as a first-in-class treatment for various CNS diseases, specifically targeting cognitive function restoration.
Cyclerion Therapeutics (Nasdaq: CYCN) recently announced progress in clinical development for its lead program, CY6463, focused on cognitive function restoration. Enrollment closed for two studies: MELAS, with topline data expected in Q2 2022, and CIAS, with results anticipated in Q3 2022. The Alzheimer's Disease with vascular pathology (ADv) trial is still recruiting. Financially, CYCN reported a Q1 2022 net loss of approximately $13 million, slightly lower than Q1 2021. Cash reserves stood at about $41 million, down from $54 million at the end of 2021.
Cyclerion Therapeutics has provided updates on its clinical development pipeline for CY6463, focusing on cognitive impairment linked to CNS diseases. Enrollment for the Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) Phase 2a study has closed, with topline data expected in Q2 2022. The Cognitive Impairment Associated with Schizophrenia (CIAS) study is ongoing, with topline data anticipated in H2 2022. The Alzheimer’s Disease with vascular pathology (ADv) study is also active. Financially, Cyclerion reported a net loss of $51.6 million for 2021, a decrease from $77.8 million in 2020.
Cyclerion Therapeutics and Ariana Pharma announced a collaboration to leverage artificial intelligence for identifying patient-selection biomarkers. This partnership aims to enhance the clinical development of Cyclerion's investigational drug, CY6463, targeting neurological and neuropsychiatric diseases related to cognitive impairment. The AI technology used will analyze data from previous clinical studies to accelerate CY6463's development and optimize patient targeting, ultimately aiming for effective treatments.
Cyclerion Therapeutics has commenced patient dosing in its Phase 2a study for Alzheimer’s Disease with Vascular Pathology (ADv), assessing CY6463. This randomized, placebo-controlled trial aims to evaluate the tolerability, safety, and pharmacokinetics of CY6463 over 12 weeks. The study targets around 30 participants with confirmed Alzheimer’s pathology and cardiovascular risk factors. Preliminary studies indicate the potential of CY6463 to improve cognitive function by leveraging the NO-sGC-cGMP signaling pathway.
Cyclerion Therapeutics (Nasdaq: CYCN) announced its management will attend the Jefferies London Healthcare Conference from Nov. 16-18, 2021. A pre-recorded presentation will be available on-demand starting Nov. 18 for 30 days on their investor website. Cyclerion focuses on developing treatments for cognitive function, with their leading compound, CY6463, showing promise in clinical trials for various CNS diseases, including Alzheimer's Disease with vascular pathology. They are also advancing another compound, CY3018.
Cyclerion Therapeutics reported advancements in its lead investigational candidate, CY6463, designed for cognitive disorders, in its Q3 2021 results. Enrollment has begun in clinical studies for Cognitive Impairment Associated with Schizophrenia (CIAS), Alzheimer's with vascular issues (ADv), and MELAS, with clinical data anticipated in H1 2022. As of September 30, 2021, the company held approximately $63 million in cash, down from $70 million in June. R&D and G&A expenses decreased significantly, contributing to an improved net loss of $11.3 million compared to $18.8 million in Q3 2020.
Cyclerion Therapeutics announces progress in developing CY6463, a soluble guanylate cyclase (sGC) stimulator aimed at treating CNS diseases linked to cognitive impairment. Recent preclinical studies showed that CY6463 effectively reduces neuroinflammation markers and crosses the blood-brain barrier. The results, published in the Journal of Neuroinflammation, support CY6463's potential as a therapeutic solution for conditions like Alzheimer's. Cyclerion is advancing its clinical studies, focusing on gauging significant clinical benefits for patients suffering from these serious conditions.
Cyclerion Therapeutics (NASDAQ: CYCN) has announced participation in two upcoming investor conferences. The H.C. Wainwright 23rd Annual Global Investment Conference will be held from September 13-15, 2021, featuring an on-demand session starting September 13 at 7:00 a.m. EDT. Additionally, the Cantor Fitzgerald Virtual Global Healthcare Conference is scheduled for September 30, 2021, at 2:40 p.m. EDT. Live webcasts can be accessed through the Investors & Media section of Cyclerion's website, with archived versions available for 90 days.
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