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, Inc. (NASDAQ: CYCN) announced on March 27, 2023, that the FDA has granted orphan drug designation to zagociguat for treating mitochondrial diseases. This designation recognizes zagociguat’s potential as a first-ever therapy for MELAS, a rare genetic mitochondrial disease lacking approved treatments. In a recent study, zagociguat showed improvements in multiple disease-relevant biomarkers, indicating promise as a symptomatic and potentially disease-modifying therapy. The orphan drug designation provides development incentives, including tax credits and seven-year marketing exclusivity upon FDA approval.
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) provided updates on its zagociguat program for treating MELAS, a rare mitochondrial disease. Following discussions with the FDA, they refined the Phase 2b study design and requested Orphan Drug Designation. The company is assessing capital options due to challenging market conditions to support study execution. Additionally, Cyclerion is advancing other candidates like CY3018 and olinciguat with promising profiles. Financially, as of December 31, 2022, cash and equivalents were $13.4 million, with 2022 net loss reduced to $44.1 million from $51.6 million in 2021.
Cyclerion Therapeutics (Nasdaq: CYCN) announced on November 22, 2022, that its Independent Board reviewed a non-binding asset purchase proposal from a group that includes the CEO. The Board concluded the proposal is not in the Company's best interest after consulting with legal and financial advisors. Cyclerion focuses on developing treatments for mitochondrial diseases, specifically MELAS, with its lead molecule, CY6463, demonstrating rapid improvement in disease-relevant biomarkers during clinical trials.
Cyclerion Therapeutics announced a strategic focus on developing CY6463 for patients with Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). Following positive clinical study data, the company aims to deliver the first approved therapy for rare mitochondrial diseases. Cyclerion plans a meeting with the FDA in Q4 2022 to discuss development pathways. The workforce will be reduced by about 45%, leading to annual savings of approximately $4.1 million. The company intends to out-license other assets for funding while focusing on MELAS.
Cyclerion Therapeutics (Nasdaq: CYCN) announced positive topline results for CY6463 in two clinical studies targeting Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) and Cognitive Impairment Associated with Schizophrenia (CIAS). The studies demonstrated favorable safety, tolerability, and therapeutic activity, reinforcing previous preclinical findings.
Financially, the company's cash balance was approximately $30.3 million as of June 30, 2022, down from $41.1 million in March 2022, with a net loss of $13.4 million for Q2 2022.
Cyclerion Therapeutics announced positive topline results from a clinical study of CY6463, aimed at treating cognitive impairment associated with schizophrenia. The 14-day study showed that CY6463, administered in 15 mg doses, was safe and effective, with no serious adverse events reported. Cognitive performance improved significantly compared to placebo, with an effect size of 0.60. There were also positive changes in inflammatory biomarkers. These findings suggest the potential of CY6463 as a therapeutic option for cognitive deficits in schizophrenia and warrant further development.
Cyclerion Therapeutics (Nasdaq: CYCN) has appointed Dr. Steven E. Hyman to its Board of Directors, effective July 25, 2022. Dr. Hyman, a notable figure in neuroscience, will assist in shaping the company’s research and clinical strategies while enhancing external collaborations. His expertise in developing treatments for neuropsychiatric diseases will be vital as Cyclerion advances its lead molecule, CY6463, targeting cognitive dysfunction. Cyclerion focuses on therapies for conditions such as Alzheimer's and Mitochondrial Encephalomyopathy.
Cyclerion Therapeutics (CYCN) announced positive results from a signal-seeking Phase 2a study of CY6463, a CNS-penetrant sGC stimulator for MELAS patients. Conducted with eight participants, the study showed CY6463 was well-tolerated, with no serious adverse events reported. Improvements were noted across various mitochondrial disease biomarkers and cerebral blood flow metrics after 29 days of treatment. The findings support further investigation of CY6463 as a potential therapy for MELAS, addressing the significant unmet need for effective treatment options.
Cyclerion Therapeutics (NASDAQ: CYCN) will present positive topline data from its Phase 2a study of CY6463 in MELAS patients during a webinar on June 28, 2022. The study aims to evaluate the safety and effectiveness of CY6463, a CNS-penetrant sGC stimulator. Amel Karaa, M.D., will discuss the implications of the findings for MELAS patients, who currently have no approved therapies. The study involved eight adults and could signal a new therapeutic option for this debilitating condition.
Cyclerion Therapeutics (Nasdaq: CYCN) reported promising preclinical results for its sGC stimulator, CY6463, showing improved cellular energetics and reduced inflammation in mitochondrial disease models. Notably, CY6463 increased ATP levels and restored mitochondrial gene expression in patients with mitochondrial complex 1 deficiency. These findings support ongoing clinical studies for treating CNS diseases associated with mitochondrial dysfunction. The data was presented at the 10th International Conference on cGMP in Germany on June 17, 2022.
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