|Bid||2.6400 x 1800|
|Ask||2.6800 x 1400|
|Day's Range||2.6100 - 2.7200|
|52 Week Range||1.6900 - 14.7700|
|Beta (5Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 03, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||4.00|
Shares of clinical-stage biotech Cyclerion Therapeutics (NASDAQ: CYCN) are down by an eye-popping 48% as of noon EDT Wednesday. The small-cap biotech's stock is crashing in response to a negative midstage trial result for its sickle cell disease candidate olinciguat. Sickle cell disease is a rare blood disorder with limited treatment options.
Cyclerion Therapeutics Inc (NASDAQ: CYCN) shares are pulling back sharply following a couple of clinical trial updates from the company.What Happened: Cambridge, Massachusetts-based Cyclerion said its mid-stage investigational asset olinciguat did not show adequate activity to support further internal clinical development of it as a potential treatment for sickle cell disease.Olinciguat, a vascular sGC stimulator, was found to be well tolerated across all dose ranges, top-line results from the Phase 2 STRONG-SCD study showed.Separately, the company announced positive results from a Phase 1 translational pharmacology study of IW-6463, a soluble guanylate cyclase stimulator being developed for CNS disorders.IW-6463, while found safe and generally well-tolerated, also resulted in meaningful improvements in certain neurophysiological and objective performance measures that are associated with age-related cognitive decline and neurodegenerative diseases, Cyclerion said.Effects on cerebral blood flow and markers of bioenergetics were not observed in this study.Related Link: FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: AnalystWhat's Next: Cyclerion intends to complete analysis of the results of the STRONG-SCD olinciguat study and present or publish them in a future forum.In the wake of the fiasco with the sickle cell disease indication, the company plans to focus on treatments for serious diseases of the central nervous system.With the Phase 1 IW-6463 results supporting the investigational compound's ongoing development, Cyclerion said it will soon begin enrolling its Phase 2 clinical trial in mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes.The company also said it will use the information gleaned from the translational pharmacology study and the previous Phase 1 study of IW-6463 to take up further clinical development activities, including initiation of a planned Phase 2 clinical trial in Alzheimer's disease with vascular pathology in 2021, as well as to explore other potential indications.Cyclerion shares were slumping 45% to $3.88, their lowest level since early August.See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Study results do not support further internal developmentCAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company, today announced top-line results from its STRONG-SCD study of olinciguat, an investigational, orally-administered, once daily, vascular sGC stimulator for the potential treatment of sickle cell disease (SCD). Olinciguat was generally well tolerated across all dose ranges. Results did not demonstrate adequate activity to support further internal clinical development. Cyclerion intends to complete its analysis of the study results and present or publish them in a future forum. “We would like to thank all of the sickle cell patients who participated in the STRONG-SCD study, the SCD advocacy community, and the investigators and study staff who focused their time and efforts on helping us better understand the potential of olinciguat in sickle cell disease,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “While we are disappointed that we won’t be contributing a much-needed new treatment option for SCD, we are continuing to analyze the data to understand several potential biomarker signals, including inflammation, as we explore partnership options for this program.”As described in the Company’s IW-6463 press release also issued today, Cyclerion expects to be focused on the development of treatments for serious diseases of the central nervous system (CNS).About STRONG-SCD Study The STRONG-SCD study is a randomized, placebo-controlled, dose-ranging Phase 2 study of 70 participants designed to evaluate safety, tolerability, and pharmacokinetics of olinciguat, compared to placebo, as well as to explore effects on daily symptoms and biomarkers of disease activity when dosed over a 12-week treatment period.About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines for people with serious diseases of the central nervous system (CNS). Cyclerion’s lead program is IW-6463, a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's Disease with Vascular pathology (ADv).For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).Forward Looking Statement This press release 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 statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements about the results and conduct of our Phase 2 proof-of-concept clinical trial of olinciguat; our interpretation of the data from the clinical trial; the potential further evaluation of olinciguat; the potential strategic options for olinciguat; the clinical potential of olinciguat; our future business focus; advancing our other clinical trials; and the business and operations of Cyclerion. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Q filed on May 4, 2020 and the Form 10-Q filed on August 3, 2020.Investors Carlo Tanzi, Ph.D. Kendall Investor Relations email@example.comMedia Amanda Sellers Verge Scientific Communications firstname.lastname@example.org