|Over a week ago|
Cyclerion Therapeutics, Beacon Biosignals announces strategic partnership » 19:2307/0807/08/21
Cyclerion Therapeutics, Inc. and Beacon Biosignals announced an extended and expanded strategic partnership between the two companies. This collaboration is expected to identify disease-relevant biomarkers to refine patient selection and endpoints to guide the clinical development of Cyclerion's investigational therapeutics for neurological diseases associated with cognitive impairment. "Beacon Biosignals is the leader in the identification of disease-relevant EEG neurological biomarkers. We believe that the application of this technology to our innovative pipeline may be quite powerful in guiding efficient drug development, and we look forward to a productive partnership focused on successfully advancing CY6463 for diseases associated with cognitive impairment," said Andy Busch Ph.D., Chief Scientific Officer of Cyclerion Therapeutics.
Cyclerion Therapeutics, Beacon Biosignals expand partnership » 16:3507/0807/08/21
Cyclerion Therapeutics and Beacon Biosignals announced an extended and expanded strategic partnership between the two companies. This collaboration is expected to identify disease-relevant biomarkers to refine patient selection and endpoints to guide the clinical development of Cyclerion's investigational therapeutics for neurological diseases associated with cognitive impairment. Beacon Biosignals' EEG neurobiomarker platform is engineered to discover and scale new clinical paradigms for patients with neurological and psychiatric disease. Distinct EEG profiles are associated with neurodevelopmental status and various neurological diseases, and can be affected by neurologically active therapeutics. The platform rapidly characterizes these effects and guides dose selection in humans to help overcome the challenges of translating PK/PD models from preclinical animal studies. Beacon Biosignals and Cyclerion previously collaborated on the analysis of data from a Cyclerion clinical translational pharmacology study of CY6463 which demonstrated clear effects on EEG parameters associated with aging and disease. These data were recently presented at the annual meeting of the American Academy of Neurology. Incorporation of the Beacon Biosignals approach in ongoing and planned Cyclerion patient studies is expected to support the continued clinical development of CY6463, the Company's lead clinical program, as well as CY3018, a next-generation preclinical program. CY6463 is an oral central nervous system, or CNS-penetrant sGC stimulator that is being developed for neurological diseases associated with cognitive impairment. CY6463 was designed to address multiple pathophysiological features of neurodegenerative and neuropsychiatric diseases associated with cognitive impairment. Results from initial CY6463 clinical studies have demonstrated favorable safety and tolerability and pharmacologically relevant drug exposure in the cerebral spinal fluid. In addition, CY6463 resulted in promising impacts on EEG measures, neuroinflammation, and other neurophysiological measures that support continued clinical development.
|Over a month ago|
Cyclerion Therapeutics files to sell 5.74M shares of common stock for holders 16:5006/1606/16/21
Fly Intel: After-Hours Movers » 18:3106/0706/07/21
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Cyclerion Therapeutics CEO buys 302K shares of common stock » 17:2906/0706/07/21
In a regulatory filing,…
In a regulatory filing, Cyclerion Therapeutics disclosed that its CEO Peter Hecht bought 823K shares of common stock on June 3rd in a total transaction size of $2.7M, boosting his stake by about 67%. Shares of Cyclerion Therapeutics are up over 4% at $3.28 after-hours following the disclosed transaction.
Cyclerion Therapeutics announces $18M private placement » 08:2106/0406/04/21
Cyclerion Therapeutics announced a direct private sale of approximately $18M of Cyclerion shares of common stock to EcoR1 Capital, LLC, Slate Path Capital LP, MFN Partners, LP, Invus, Peter Hecht, Ph.D., Lincoln Park Capital Fund, LLC and Polaris Partners. In the private placement, signed on June 3, 2021, the Company agreed to sell 5,735,988 shares of common stock at a price of $3.12 per share, or $3.28 per share with respect to Peter Hecht, Ph.D. in compliance with Nasdaq listing rules.
Cyclerion Therapeutics announces licensing agreement with Akebia Therapeutics » 08:1506/0406/04/21
Cyclerion Therapeutics (CYCN) announced that it has entered into an exclusive, global license agreement with Akebia Therapeutics (AKBA) for the development and commercialization of praliciguat, an oral sGC stimulator. Under the terms of the agreement, Akebia has obtained an exclusive license to research, develop and commercialize praliciguat globally and will be solely responsible for these activities going forward. Cyclerion is eligible to receive up to $225M in pre-commercial milestones, including up to $15M in the first 18 months. Total potential future development, regulatory, and commercialization milestone payments could result in up to $585M. Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages. "We are very pleased to license praliciguat to Akebia, whose demonstrated leadership in kidney disease and extensive R&D and commercialization capabilities make it an ideal partner for the future development of praliciguat. This transaction provides Cyclerion with meaningful participation in any potential near and longer-term value creation and enables us to focus on our mission to develop treatments for cognitive impairment, including our foundational assets CY6463 and CY3018, where we see enormous clinical promise," said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion.
Cyclerion Therapeutics announces $18M private placement » 08:0106/0406/04/21
Cyclerion Therapeutics announced a direct private sale of approximately $18M of Cyclerion shares of common stock to EcoR1 Capital, LLC, Slate Path Capital LP, MFN Partners, LP, Invus, Peter Hecht, Ph.D., Lincoln Park Capital Fund, LLC and Polaris Partners.
|Over a quarter ago|
Cyclerion Therapeutics announces highlights from webinar on CY6463 » 09:0904/2704/27/21
Cyclerion Therapeutics hosted a webinar to provide clinical updates for its first-in-class, CNS-penetrant soluble guanylate cyclase stimulator CY6463 in Alzheimer's Disease with Vascular pathology and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes. Supported by recent clinical and preclinical data, Cyclerion also discussed the potential for CY6463 to treat Cognitive Impairment Associated with Schizophrenia, with key insights from Dr. Andreas Reif on the role of the sGC pathway in the disease. In addition, Cyclerion introduced its latest development candidate CY3018, a differentiated, next-generation, CNS-penetrant sGC stimulator. Modulating a fundamental CNS signaling pathway: sGC stimulators amplify the power of the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate pathway signaling to address central aspects of disease pathophysiology. Preclinical data from CY6463 and extensive academic work validate the crucial role of the sGC pathway in brain physiology. Clinical data from the recent translational pharmacology study confirm the ability of CY6463 to impact brain oscillations, neuroinflammation and neurophysiological function. CY6463 Updates: Disease-relevant, biomarker-guided pipeline strategy: The company is advancing parallel, signal-seeking, exploratory studies in well-defined patient populations with cognitive impairment including neurodegenerative, neuropsychiatric, and mitochondrial diseases. CY6463 targets sGC, a proven druggable target, in critical brain regions and cell types linked to cognition and has demonstrated an impact on multiple biomarkers associated with cognition in previous Phase 1 studies. ADv clinical trial initiation: The U.S. Food and Drug Administration cleared the Investigational New Drug (IND) application for CY6463 in ADv, and the Company anticipates beginning to enroll patients in a 12-week Phase 2a clinical trial in patients with ADv by mid-2021, barring any COVID-19 related delays. This exploratory study is designed to evaluate safety, tolerability, and pharmacodynamic effects including impact on disease-relevant biomarkers. MELAS clinical trial advancement: This study is enrolling more slowly than initially projected, primarily due to COVID-19. Data from the exploratory 29-day open-label Phase 2a pilot study in patients with MELAS are now expected by year end 2021. Potential to treat CIAS with novel mechanism: Neuropsychiatric key opinion leader and expert in the neurobiology of nitric oxide and its relation to psychiatric disorders, Andreas Reif, M.D., Chair, Department of Psychiatry, University Hospital Frankfurt, discussed the sGC pathway and its role in cognitive function and CIAS. Reduced NO-sGC-cGMP signaling is linked to cognitive dysfunction in schizophrenia. Stimulation of sGC by CY6463 to amplify NO-sGC-cGMP signaling is a potential first-in-class approach for the treatment of CIAS. Cyclerion is planning to initiate a Phase 1b signal-seeking study in CIAS to evaluate safety and near-term impact on disease-relevant biomarkers. CY3018, a differentiated, next-generation CNS-penetrant sGC stimulator: Cyclerion shared information on the latest development candidate, CY3018. Preclinical data show increased CNS-exposure, with significantly increased cerebrospinal fluid to plasma ratio, compared to CY6463. This increased CNS distribution is mirrored by a higher level of pharmacological activity in the CNS relative to the periphery. The company is advancing CY3018 through IND-enabling development. Cash, cash equivalents, and restricted cash balance on March 31, 2021 was approximately $45 million, as compared to approximately $58 million on December 31, 2021. As of April 2021, Cyclerion has substantially streamlined its operating model to invest more fully in its priority opportunities in cognition and expects average monthly cash use for the foreseeable future to be approximately 50 percent that of 2020.
Cyclerion Therapeutics to hold a virtual corporate update » 07:5504/2704/27/21
Management holds a…
Management holds a corporate update on the Company's pipeline of novel candidates aimed at restoring cognitive function on April 27 at 8 am. Webcast Link