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KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the initiation of VICTOR (VerICiguaT in adults with ChrOnic heart failure and Reduced ejection fraction), a pivotal Phase 3 randomized, placebo-controlled cardiovascular clinical trial of VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event. Recruitment for the VICTOR trial has begun. The study is slated to enroll approximately 6,000 adults with chronic heart failure and reduced ejection fraction who have not been hospitalized for heart failure for 6 months or received outpatient IV diuretic use within 3 months prior to randomization. The primary efficacy endpoint is the time to first event of cardiovascular death or hospitalization for heart failure (NCT05093933). Based on the VICTORIA study, VERQUVO (vericiguat) was approved by the U.S. Food and Drug Administration (FDA) in January 2021 to reduce the risk of cardiovascular death (CVD) and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics, in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The VERQUVO label contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see “Selected Safety Information” below. “The VICTOR study will assess initiating vericiguat earlier in the heart failure journeys of certain patients,” said Dr. Javed Butler, the Patrick H. Lehan Chair in Cardiovascular Research, and professor and chairman of the department of medicine at the University of Mississippi Medical Center. Like the VICTORIA trial, Merck and Bayer AG will serve as co-sponsors for the VICTOR trial. The study will be executed by Merck. VICTOR is expected to take 39 months to complete, and the trial will include patients from 34 countries at approximately 500 sites around the world. Every effort is being made to ensure that the patient population studied in the trial represents the diverse nature of people who may be diagnosed with chronic heart failure and reduced ejection fraction of less than 40% who have not had a recent worsening heart failure event. “The initiation of the Phase 3 VICTOR study reflects our commitment to finding additional options for a chronic heart failure condition that affects more than 3 million people in the U.S. each year,” said Dr. Joerg Koglin, vice president, Global Clinical Development and Therapeutic Area Head, Cardiovascular for Merck Research Laboratories. “Along with our partners at Bayer, we look forward to studying vericiguat in a more stable chronic heart failure population than was studied in the Phase 3 VICTORIA study.” Selected Safety Information for VERQUVO (vericiguat) tablets (2.5 mg, 5 mg, and 10 mg) WARNING: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm. VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. VERQUVO is contraindicated in pregnancy. Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose. In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension (16% vs 15%) and anemia (10% vs 7%). Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension. There are no data on the presence of VERQUVO in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO. About Heart Failure with Reduced Ejection Fraction Heart failure with reduced ejection fraction (HFrEF), formerly known as systolic heart failure, is characterized by the compromised ability of the heart to pump blood sufficiently during its contraction phase. In the U.S., approximately 6.2 million adults (20 years of age and older) have heart failure, and approximately 50% of heart failure patients have HFrEF. An observational, cohort analysis of PINNACLE registry data showed that approximately half of patients with worsening chronic HFrEF are rehospitalized within 30 days of a worsening event, and an estimated one in five patients with worsening chronic HFrEF will die within two years. About Merck For more than 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at and Medication Guide at .

Oct. 18, 2021 15:00 UTC Laura Genatossio Appointed Senior Vice President and General Manager, Europe Alana Darden Powell Promoted to Vice President, Corporate Communications Mark Niemaszek Named Senior Vice President, Corporate Planning Ted Chan Promoted to Senior Vice President, Associate General Counsel and Head of Intellectual Property IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the appointment of Laura Pala Genatossio as senior vice president and general manager, Europe. The company also announced the promotion of Alana Darden Powell as vice president, corporate communications, and Mark Niemaszek as senior vice president, corporate planning. Genatossio, Darden Powell and Niemaszek join the Urovant Sciences executive leadership team and report to Urovant Sciences President and Chief Executive Officer James Robinson. In addition, Ted Chan has been promoted to senior vice president, associate general counsel and head of intellectual property, reporting to General Counsel Ryan Card. “I am very pleased to welcome Laura Genatossio to Urovant Sciences to lead our company’s ambitious plans to expand our corporate presence in Europe. She brings a global mindset gained from the commercial leadership roles she has held outside the U.S. in the global biopharmaceuticals industry,” said Jim Robinson, president and chief executive officer of Urovant Sciences. “This is an exciting time for all of us at Urovant Sciences, and our newly appointed senior leadership team members at Urovant will help drive our company’s growth and evolution so that we may bring medical breakthroughs to more patients around the world.” Genatossio will be responsible for leading the European business strategy and operations for Urovant Sciences and will be based at the company’s European headquarters office in Basel, Switzerland. Most recently, Genatossio was vice president and general manager in Europe, Middle East and Africa for Sarepta Therapeutics, where she was responsible for leading regional strategy and operations, including medical affairs and administration, as well as local commercial, market access and patient affairs functions. Earlier in her career, she held global strategic marketing roles with Aegerion Pharmaceuticals, and served as interim country manager for Aegerion in Canada. Prior to her roles with Aegerion, Genatossio held brand leadership roles at Astra Zeneca for the company’s oncology and cardiovascular portfolios in Europe. Genatossio holds an MBA in marketing, with honors, from the University of Massachusetts College of Management, and a Bachelor of Arts in business law, with honors, from Bologna University. Darden Powell will be responsible for leading the Urovant Sciences internal and external corporate communications programs and serves as a member of the Urovant executive leadership team. Darden Powell joined Urovant in May 2019 as executive director of marketing, transitioning to executive director of business unit operations, communications, and alliance management in September 2020. Previously, she served as senior director for consumer marketing at Avanir Pharmaceuticals, where she was responsible for consumer marketing and brand public relations programs supporting the company’s neurology franchise. Prior to that, Darden Powell spent over eleven years at Allergan, supporting the BOTOX® neurology and urology franchises in roles spanning consumer and professional marketing, communications, and sales. Darden Powell holds a Bachelor of Science from Auburn University and an MBA in marketing from Brandman University. Niemaszek joined Urovant Sciences in 2020 as vice president of commercial operations. In his new role, he takes on additional responsibilities for driving execution of the company’s geographic expansion, enterprise-wide, long-range strategic planning and budget process, infrastructure investment planning, and program integration. Niemaszek brings extensive sales, marketing, and operations experience from decades of experience in the global biopharmaceuticals industry. Niemaszek previously served as vice president of U.S. commercial operations for Astellas, where he led the development of enterprise capabilities for the Astellas global business across a range of brands, sales teams, and business units. Niemaszek also held prior roles leading the accounting department, as well as the sales, marketing and medical affairs operations for Fujisawa Pharmaceutical. Niemaszek holds a Bachelor of Arts in finance/economics from St. Joseph’s College and an MBA in international business from Roosevelt/DePaul University. Chan will continue to oversee global intellectual property protection as the company expands its presence and operations to new geographic regions. Prior to joining Urovant Sciences in 2018, Chan served as senior patent counsel for Allergan, where he managed the international patent portfolio for the neurology and urology franchises, extended patent exclusivity for the company’s key marketed and development products, enforced and defended patents in patent litigation and post-grant patent proceedings, and conducted due diligence on the company’s global business development targets. Earlier in his career, Chan managed the international patent and trademark portfolio for Biovail Corporation (now Bausch Health Companies). Prior to joining the biopharma industry, Chan served in private practice, focusing on patent prosecution matters in the biopharma and medical device industries. He earned a Bachelor of Science in biology from Western University and a J.D. from the University of Victoria. About Urovant Sciences Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The Company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at . About Sumitovant Biopharma Ltd. Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products including GEMTESA® for overactive bladder and RETHYMIC® for pediatric congenital athymia, and has advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is the majority-shareholder of Myovant (NYSE: MYOV) whose marketed products include ORGOVYX® for advanced prostate cancer and MYFEMBREE® for uterine fibroids. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit . About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at . To read our news release, visit urovant.com/news-releases.

Company to discuss clinical updates for CY6463, including Phase 2a studies in ADv and MELAS, and plans to initiate Phase 1b clinical trial in CIAS Neuropsychiatric key opinion leader, Andreas Reif, M.D. to discuss role of sGC pathway in CIAS Webcast scheduled for Tuesday, April 27th from 8 – 9 a.m. EDT CAMBRIDGE, Mass., April 20, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, will host a webinar on Tuesday, April 27th at 8 a.m. EDT with a live Q&A. The Company will provide a corporate update on clinical programs for its first-in-class CNS penetrant soluble guanylate cyclase (sGC) stimulator, CY6463, in Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). Supported by recent clinical and preclinical data, Cyclerion will discuss the potential for CY6463 to treat Cognitive Impairment Associated with Schizophrenia (CIAS). In addition, neuropsychiatric key opinion leader, Andreas Reif, M.D., Chair, Department of Psychiatry, University Hospital Frankfurt, will discuss the sGC pathway, its role in cognitive function and CIAS. Dr. Reif is the author of more than 400 scientific publications and has conducted extensive research in the mechanisms of nitric oxide synthase and applications to the clinic, particularly in psychiatry. Cyclerion will also introduce its latest development candidate CY3018, a differentiated, next-generation CNS-penetrant sGC stimulator. “At Cyclerion, we are forging new paths to identify novel therapies for patients with cognitive impairment,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “We look forward to sharing more details about the sGC pathway and its role in cognition, our current clinical programs, and the expansion of our pipeline with the collective goal of restoring cognitive function.” Webcast Information To register for the webinar, please click here. The live event can be accessed by visiting the investors' section of the Cyclerion website at . An archived replay will also be available on the company website. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead molecule is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Cognitive Impairment Associated with Schizophrenia (CIAS). Cyclerion is also advancing CY3018, a next generation sGC stimulator. For more information about Cyclerion, please visit and follow us on Twitter (@Cyclerion) and LinkedIn ( ). 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. 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. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021. 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. Investors Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com Media Amanda Sellers Verge Scientific Communications asellers@vergescientific.com