Sumitomo Pharma America, Inc.

Rodney Peete joins the Time to Go™ campaign as the newest GEMTESA Go-Getter, alongside wife Holly Robinson Peete, encouraging men and women to speak up about their overactive bladder symptoms and explore treatment options, like GEMTESA® (vibegron) MARLBOROUGH, Mass., June 30, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) today announced the expansion of its Time To Go™ campaign, introducing former professional quarterback and overactive bladder (OAB) patient Rodney Peete as its newest partner, in support of GEMTESA® (vibegron). Continue Reading Rodney Peete and Holly Robinson Peete Time To Go™ Campaign Logo Starting this month, Men's Health Month, Rodney will join his wife of 30 years and fellow OAB patient, Holly Robinson Peete, as a GEMTESA Go-Getter, or brand ambassador. Through their partnership, they'll share their personal experiences with symptom management, emphasizing the importance of openly discussing chronic conditions like OAB and their symptoms with loved ones and medical professionals. "As I got older, I started noticing I was making more frequent trips to the bathroom — I couldn't even make it through an inning of a baseball game," said Rodney Peete. "I convinced myself it was all part of aging. Through some prodding, and a whole lot of support, my wife Holly pointed out my symptoms and urged me to see a doctor. Her experience before discovering GEMTESA, a treatment option that has helped to manage her OAB symptoms, opened the door to have an honest conversation without embarrassment. That kind of support made all the difference — it turned something I was quietly dealing with into something we could manage together, with compassion, towards each other." GEMTESA is a prescription medicine for the treatment of OAB in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH), with symptoms of urge urinary incontinence, urgency, and frequency. OAB causes sudden urges to urinate that are difficult to control and can result in leakage, as well as frequent urination — usually eight or more times a day.1 Overactive bladder can disrupt everyday life with approximately 16% of men and 17% of women in the U.S. experiencing symptoms,3 which can be bothersome and disruptive. The introduction of Rodney Peete, who has both OAB and BPH, comes on the heels of SMPA's 2024 U.S. Food and Drug Administration (FDA) approval of GEMTESA for men with OAB who are also receiving pharmacological therapy for BPH, making GEMTESA the first and only beta-3 agonist approved to treat men living with OAB and being treated for BPH.4 And with 46% of men citing embarrassment as the primary barrier to being completely honest with their doctors,2 The Peetes' partnership is that much more relevant. "It's important we create a space where people feel supported and are empowered to speak openly about their symptoms and experiences with OAB," said Alana Darden Powell, Vice President of Marketing for SMPA. "Rodney represents men everywhere who are impacted by OAB but might too embarrassed or scared to talk about it. It's our hope that by welcoming him as a Go-Getter alongside Holly, we can demonstrate the importance of communication and encourage everyone to seek help when help is needed." Holly's story, as well as additional patient stories, are currently featured on the Time to Go website. Rodney's personal story and roadmap to how he's navigating his symptoms, including treatment with GEMTESA, will be available on the Time to Go website later this year. "Since starting GEMTESA my symptoms have lessened, and I've been able to get back to doing things I love with fewer interruptions and less worry about the next bathroom break," said Holly Robinson Peete, actor and activist. "My experience with OAB is what led me to recognize something was off with Rodney. I noticed changes in his habits, frequent bathrooms trips and delays before outings. I was happy to help Rodney get to the bottom of his symptoms. If there's one thing we've learned after 30 years of marriage, it's that open communication and support of your partner is paramount. I'm excited to be on this journey with him and have him join me in raising awareness for this chronic condition." People experiencing OAB symptoms are encouraged to talk to their doctor to get a diagnosis and determine the best treatment option(s) to help them manage the condition. To learn more about OAB and GEMTESA, or hear from other GEMTESA Go-Getters, visit TimeToGo.com. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).1 About 33 million U.S. adults experience the bothersome symptoms of OAB.5 About GEMTESA GEMTESA®(vibegron) is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH): urge urinary incontinence: a strong need to urinate with leaking or wetting accidents urgency: the need to urinate right away frequency: urinating often It is not known if GEMTESA is safe and effective in children. IMPORTANT SAFETY INFORMATION Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA. Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. What are the possible side effects of GEMTESA? GEMTESA may cause serious side effects including: inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing. Stop using GEMTESA and tell your doctor right away. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see accompanying full Product Information . About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. ©2025 Sumitomo Pharma America, Inc. All rights reserved. GEM-US-0234-25 06/25 References: Mayo Clinic. (2025, February 4). Overactive bladder – Symptoms and causes. Mayo Clinic. Mayo Clinic Cleveland Clinic. (2019, September 4). Cleveland Clinic survey: Men will do almost anything to avoid going to the doctor. Cleveland Clinic Newsroom. Stewart, W. F., Van Rooyen, J. B., Cundiff, G. W., Abrams, P., Herzog, A. R., Corey, R., Hunt, T. L., & Wein, A. J. (2003). Prevalence and burden of overactive bladder in the United States. World Journal of Urology, 20(6), 327–336. Sumitomo Pharma America, Inc. (2024, December 23). Sumitomo Pharma America announces U.S. FDA approval of GEMTESA® (vibegron) for men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. Gomelsky, A., & Dmochowski, R. R. (2010). Update on the management of overactive bladder: Patient considerations and adherence. Open Access Journal of Urology, 3, 7–17. SOURCE Sumitomo Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– Nuvisertib (TP-3654), an investigational highly selective oral PIM1 kinase inhibitor, is being evaluated in patients with relapsed or refractory myelofibrosis (MF) – – Nuvisertib demonstrated symptom and spleen responses correlating with cytokine modulation in the preliminary Phase 1/2 data recently presented at the European Hematology Association (EHA) 2025 Congress – MARLBOROUGH, Mass., June 12, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to nuvisertib (TP-3654) for the treatment of patients with intermediate or high-risk myelofibrosis (MF). The FDA Fast Track Designation is granted to investigational therapies being developed to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Nuvisertib is an oral, investigational, highly selective inhibitor of PIM1 kinase, which demonstrated clinical activity including symptom and spleen responses correlating with cytokine modulation in the updated preliminary Phase 1/2 data presented at the European Hematology Association (EHA) 2025 Congress in Milan, Italy. MF, a serious and rare type of blood cancer, is characterized by the buildup of fibrous tissues in the bone marrow which is caused by dysregulation in the Janus-associated kinase (JAK) signaling pathway. The clinical manifestations of MF include an enlarged spleen, debilitating symptoms and reduction in hemoglobin and/or platelets. MF affects 1 in 500,000 people worldwide.1 "This positive momentum for nuvisertib signals strong promise in our pipeline and reflects our dedication to addressing unmet medical needs on behalf of patients with myelofibrosis and their families," said Tsutomu Nakagawa, Ph.D, President and Chief Executive Officer of SMPA. "Receiving FDA Fast Track Designation for nuvisertib in the treatment of myelofibrosis reinforces our confidence in its potential as a treatment option for patients facing a poor prognosis with limited treatment options. We are committed to working closely with the FDA to progress the clinical development of nuvisertib and bring an alternative treatment option to patients with myelofibrosis." Updated data from the ongoing Phase 1/2 study of nuvisertib in patients with relapsed/refractory MF were presented at the EHA Congress on June 12, 2025. Preliminary data showed that nuvisertib monotherapy appears to be well tolerated with no dose-limiting toxicities (DLTs). Evaluable patients showed clinical activity including a ≥25% spleen volume reduction (SVR25) in 22.2% of patients and a ≥50% reduction in total symptom score (TSS50) of 44.4% of patients, as well as improvement of bone marrow fibrosis (42.9% patients), hemoglobin (24% patients) and platelet count (26.7% patients). Data also showed that nuvisertib treatment led to significant cytokine modulation [reduction of pro-inflammatory cytokines (e.g. EN-RAGE, MIP-1β) and increase of anti-inflammatory cytokines (e.g. adiponectin)], which demonstrated significant (p<0.001) correlation with symptom and spleen responses. Preclinical2 and emerging clinical data support the development of nuvisertib in combination with JAK inhibitors for the treatment of patients with MF. "The data observed to date demonstrate promising clinical activity for nuvisertib and the strong potential for selective PIM1 inhibition to slow the progression of myelofibrosis," said Jatin Shah, MD, Chief Medical Officer, Oncology. "Patients with myelofibrosis are in need of new therapeutic approaches, including combination treatment options, that can provide increased and durable response rates with limited hematologic adverse events. The FDA Fast Track Designation reinforces the potential of nuvisertib to provide clinical benefits for patients with myelofibrosis, an unmet medical need." About Nuvisertib (TP-3654) Nuvisertib (TP-3654) is an oral investigational selective inhibitor of PIM1 kinase, which has shown potential antitumor and antifibrotic activity through multiple pathways, including induction of apoptosis in preclinical models.2,3 Nuvisertib was observed to inhibit proliferation and increase apoptosis in murine and human hematopoietic cells expressing the clinically relevant JAK2 V617F mutation.3 Nuvisertib alone and in combination with ruxolitinib showed white blood cell and neutrophil count normalization, and also reduced spleen size and bone marrow fibrosis in JAK2 V617F and MPLW515L murine models of myelofibrosis.2 The safety and efficacy of nuvisertib is currently being clinically evaluated in a Phase 1/2 study in patients with intermediate and high-risk myelofibrosis (NCT04176198). The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to nuvisertib for the indication of myelofibrosis in May 2022. The Japan Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in November 2024. About Sumitomo Pharma Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. The Sumitomo corporate symbol mark is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. ©2025 Sumitomo Pharma America, Inc. All rights reserved. References U.S. National Library of Medicine. (n.d.). Primary myelofibrosis: Medlineplus Genetics. MedlinePlus. Dutta A., Nath D, Yang Y, et al. Genetic ablation of Pim1 or pharmacologic inhibition with TP-3654 ameliorates myelofibrosis in murine models. Leukemia. 2022; 36 (3): 746-759. doi: 10.1038/s41375-021-01464-2. Foulks JM, Carpenter KJ, Luo B, et al. A small-molecule inhibitor of PIM kinases as a potential treatment for urothelial carcinomas. Neoplasia. 2014;16(5):403-412. 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- $60 million Series A led by Atlas Venture, and founded by an expert team of physicians and scientists - VIM0423, a potential first-in-class oral medicine for isolated dystonia, is currently being studied in a Phase 1 clinical trial; Phase 2 planned for fourth quarter of 2025 May 29, 2025 -- Vima Therapeutics, a clinical-stage biotechnology company focused on oral therapies for movement disorders, launched today with a $60M Series A financing led by Atlas Venture, with participation from Access Industries and Canaan. With a patient-focused approach, and highly experienced leadership team, Vima is advancing VIM0423, a potential first-in-class oral therapy for dystonia that targets the underlying cause in the central nervous system. “Currently, there are no existing treatments that address the root cause of dystonia, leaving many patients to struggle with symptoms that severely impact their function and quality of life. As a neurologist, I have firsthand experience treating people with dystonia and its devastating consequences, witnessing the significant need for a safe and effective oral treatment,” said Bernard Ravina, MD, MS, founder and chief executive officer of Vima. “With deep expertise and a strong commitment to the dystonia community, our team is focused on delivering an effective oral therapy that helps every patient with dystonia regain control of their movement.” Vima aims to usher in a new era of treatment for movement disorders that targets the underlying biology. Dystonia occurs in both adults and children and shares underlying biology with other movement disorders, which together affect over one million people in the United States alone. It is a chronic, disabling condition characterized by involuntary muscle contractions in one or more parts of the body. Isolated dystonia, where dystonia is the primary neurological symptom, affects over 100,000 people in the United States. Vima’s lead candidate, VIM0423, is designed to target muscarinic cholinergic receptors in the brain with improved pharmacology, efficacy, and safety. Drugs that target muscarinic receptors are clinically used in movement disorders but are markedly limited by poor tolerability, which results in reduced efficacy. “From its inception as a seed investment in Atlas’ incubator, Vima was formed with a singular focus: to change the lives of patients with dystonia,” said David Grayzel, MD, co-founder and chair of Vima’s board of directors, and partner at Atlas Venture. “Having assembled an exceptional team of drug developers, Dr. Ravina and our head of R&D, Dr. Judith Dunn, are now bringing to the clinic a potential first-in-class therapy with the potential to be an impactful new medicine.” Bernard Ravina, MD, MS, founder and chief executive officer, has over 25 years of drug development experience in government, academia, and industry, and was a practicing neurologist specializing in movement disorders. He has served in leadership positions at Biogen, Voyager Therapeutics, and Praxis Medicines. Judith Dunn, PhD, president and head of R&D, has 30+ years of drug development experience and has held leadership roles in biotech and pharma, including global head of clinical development at Roche. Jessica Fees, chief financial officer, brings over 20 years of finance and strategic leadership experience in the biotech industry. Prior to Vima, she served as chief financial officer at Surface Oncology. Ariel D. Jasie, JD, chief business officer and general counsel, has over 20 years of industry experience and has served as chief business officer and general counsel to multiple private biotech companies. Tushar Misra, PhD, chief technical officer, has been in the pharmaceutical industry for over 30 years and has worked across the entire value chain from R&D to Commercialization, with leadership roles at many companies, including Wyeth, Sepracor, and Takeda. Vima Therapeutics is a clinical-stage biotechnology company pioneering a new era in the treatment of dystonia and related movement disorders by advancing an oral therapy designed to help patients with dystonia improve control of their movement by targeting the root cause of the disease. Founded and incubated at Atlas Venture by physicians and scientists with deep expertise in movement disorders, Vima is advancing VIM0423 – a potential first-in-class oral therapy – in a Phase 1 clinical trial, with plans to initiate Phase 2 by the fourth quarter of 2025. Vima Therapeutics is headquartered in Cambridge, Massachusetts. The content above comes from the network. if any infringement, please contact us to modify.