Relugolix

SMPA reinforces commitment to the urology community with findings from studies across overactive bladder and advanced prostate cancer portfolios MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sumitomo Pharma America, Inc. (SMPA) today announced the presentation of new data from its urology and oncology portfolios at the American Urological Association (AUA) 2026 Annual Meeting, held on May 15–18 in Washington, D.C. The presentations include a featured subgroup analysis of the phase 3 COURAGE trial evaluating vibegron in older men, along with real-world evidence from the OPTYX study of relugolix in advanced prostate cancer. “Our presence at AUA 2026 underscores our deep-rooted commitment to advancing scientific understanding for patients managing complex urologic conditions,” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “By focusing on patient populations at particular risk, such as men over 75 with overactive bladder and on pharmacologic treatment for benign prostatic hyperplasia, and those navigating the complexities of advanced prostate cancer, we aim to provide clinicians with the robust data they need to make informed, patient-centered treatment decisions.” Safety and efficacy outcomes with vibegron are comparable in older and younger patients Data presented includes a poster on a subgroup analysis of the placebo-controlled phase 3 COURAGE trial, which evaluated the efficacy and safety of once-daily vibegron 75 mg in men with symptoms of overactive bladder (OAB) who were also receiving pharmacologic therapy for benign prostatic hyperplasia (BPH) (stable dose of α-blocker ± 5α-reductase inhibitors). The analysis found that men ≥75 years experienced clinically meaningful reductions from baseline at week 24 in average daily number of micturitions and urgency episodes with vibegron (n=92) compared with placebo (n=100). Micturitions were –2.3 in the vibegron group compared with –1.5 in the placebo group, and urgency episodes were –3.6 in the vibegron group compared with –2.3 in the placebo group. These results were comparable to the outcomes observed in men <75 years. Vibegron was generally well tolerated in this older population, with a safety pro to that observed in men <75 years. “Older men often face the dual challenge of managing OAB symptoms while on existing therapies for BPH. These findings are encouraging as they demonstrate that vibegron can provide meaningful symptomatic relief in this specific, often harder-to-treat population, with a safety pro to that of younger patients,” said Dr. Sender Herschorn, M.D., Professor of Surgery/Urology at the University of Toronto and lead author of the poster. Additional data presented in treatment of OAB and advanced prostate cancer In a separate podium presentation, SMPA shared a subgroup analysis from the COURAGE trial evaluating the effect of vibegron on sexual function in men. SMPA, in a poster presentation, also shared an interim analysis of testosterone suppression and recovery from the OPTYX study, a prospective, long-term observational study of relugolix (monotherapy and combination) in a real-world setting. Presentation Details Title Details IP15-20: Efficacy and safety of vibegron in men ≥75 years of age with symptoms of overactive bladder on pharmacotherapy for benign prostatic hyperplasia: a subgroup analysis of the COURAGE trial Poster Presentation Presenter: Dr. Sender Herschorn, MD, University of Toronto IP38-21: Testosterone suppression and recovery in patients with advanced prostate cancer treated with relugolix: an interim analysis of the OPTYX study Poster Presentation​ Presenter: Dr. Benjamin Lowenritt, MD, FACS, Chesapeake Urology PD26-08: Evaluating sexual function in men treated with vibegron for overactive bladder while on pharmacological therapy for benign prostatic hyperplasia: exploratory analysis from the phase 3 COURAGE trial​ Podium Presentation​ Presenter: Dr. Kenneth Peters, MD, Urology, Corewell Health William Beaumont University Hospital About GEMTESA ® (vibegron) In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since December 2020. GEMTESA was approved in December 2024, for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). GEMTESA works by selectively targeting beta-3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. 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 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB. 2 INDICATIONS AND USAGE GEMTESA ® is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. Angioedema Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see full Prescribing Information . ABOUT ORGOVYX ® (relugolix) ORGOVYX ® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer. IMPORTANT SAFETY INFORMATION Contraindication ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components. Warnings and Precautions QT/QTc Interval Prolongation: Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Hypersensitivity: Angioedema was reported in 0.2% of patients treated with ORGOVYX in HERO. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported post-marketing with ORGOVYX. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated. Embryo-Fetal Toxicity: The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX. Laboratory Testing: Therapy with ORGOVYX results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after ORGOVYX may be affected. The therapeutic effect of ORGOVYX should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured. Adverse Reactions Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in ≥0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX. Most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) in patients receiving ORGOVYX were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), fatigue (26%), aspartate aminotransferase increased (18%), constipation (12%), and diarrhea (12%). Drug Interactions Co-administration of ORGOVYX with an oral P-gp inhibitor increases relugolix exposure, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a 360 mg loading dose on the first day and continue with 120 mg once daily. Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily. Please see full Prescribing Information for ORGOVYX. 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.) focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With 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 . The Sumitomo corporate symbol mark is a registered 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. ORGOVYX ® and its logo are registered trademarks of Sumitomo Pharma Co. Ltd., used under license. ©2026 Sumitomo Pharma America, Inc. All rights reserved. References Overactive bladder – symptoms and causes. Mayo Clinic. February 4, 2025. Accessed May 6, 2026. Gomelsky A, Dmochowski RR. Update on the management of overactive bladder: patient considerations and adherence. Open Access J Urol. 2011;3:7-17. doi:10.2147/OAJU.S7233 GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025 Contacts For further information: SMPA CONTACT: Dave Murdoch, Sumitomo Pharma America, Inc., david.murdoch@us.sumitomo-pharma.com , +1 (774) 405-5570

→ Anthropic keeps deepening its ties to the biopharma industry, appointing Novartis CEO Vas Narasimhan to its board. The AI giant recently acquired Coefficient Bio , a New York-based stealth AI biotech. Narasimhan, who has led Novartis since 2018 and previously served as PhRMA’s chair, will bring a healthcare industry perspective to a board that also includes former Microsoft and General Motors CFO Chris Liddell , and Netflix co-founder Reed Hastings . → Obesity pill developer Structure Therapeutics has hired Matthew Lang as COO and general counsel. Lang was most recently chief legal officer at obesity player Metsera , where he helped choreograph the biotech’s acquisition by Pfizer for $7.6 billion upfront last year. Perhaps Structure is contemplating a similar deal, or perhaps it felt it needed a new lawyer on board after Novo Nordisk ’s recent legal travails. Novo was forced to sue Hims & Hers alleging patent infringement after the compounder launched a copycat of its oral Wegovy pill in February. The two companies eventually reached a truce, but Structure might want to guard against a similar situation emerging if its GLP-1 pill, called aleniglipron , gains approval too. The asset recently generated highly promising Phase 2 data. Lang spent more than six years with Myovant and helped guide the development, approval and sale of endometriosis drug Myfembree and prostate cancer therapy Orgovyx . He was also chief business and legal officer at Lyell Immunopharma . → ADC specialist Kivu Bioscience had been operating without a CEO since it spun out of Synaffix in 2024 . But president and COO Mohit Trikha has been the voice of the company from the beginning, and his appointment as CEO this week was billed as a “natural next step” by chairman Daniel O’Connell . Trikha has pharma experience from AbbVie as its head of oncology early development from 2017-22, and he was also a venture partner at Apple Tree Partners , which has since filed for bankruptcy. He used to sit on the board at Replicate Bioscience and Galvanize Therapeutics , two biotechs from the ATP portfolio. → Cardiff Oncology has officially tapped Mani Mohindru as permanent CEO, and it has recruited Josh Muntner as CFO. When Cardiff released mixed Phase 2 data for its colorectal cancer drug onvansertib , Mohindru replaced Mark Erlander on an interim basis that same day and finance chief James Levine stepped down. Mohindru will keep her spot on the board of directors. Muntner held the CFO post at Imvax and Mesoblast before coming to Cardiff last week. He won’t be the new guy for much longer, because Ajay Aggarwal will become COO on April 27. Aggarwal has spent the last four and a half years with Aclaris Therapeutics as head of clinical development. → Prime Medicine is finally getting a new CFO in Svetlana Makhni , who is joining the gene editing company from Marengo Therapeutics . The move comes after Prime’s former finance chief Allan Reine became CEO last May as part of a broader revamp . Prime earlier this year reversed course and said it would continue to develop a previously shelved therapy for a rare condition called chronic granulomatous disease. The company also expects to enter the clinic soon for two liver disease programs. → Parabilis Medicines has introduced Helen Ho as chief business and strategy officer, and promoted Tom Kotarakos to CFO. Ho is the latest Blueprint Medicines exec to find a new home, serving as CBO until it was sold to Sanofi . “After taking some time off to reflect on what I wanted my next chapter to look like, I knew I wasn’t just looking for a role,” Ho wrote in a LinkedIn post . “For me, it’s identifying the right problem to solve, the very best people to solve it with, and the opportunity to be part of something truly extraordinary. This is what led me to Parabilis Medicines.” Kotarakos joined Mathai Mammen ’s crew as SVP of finance in 2021, when it was named FogPharma and led by Greg Verdine . Kotarakos’ LinkedIn page says he was elevated to CFO in February, a month after Parabilis announced a $305 million Series F. → Jack O’Meara ’s brain drug company Aerska has appointed co-founder Stuart Milstein as chief platform officer, and added Sonoma Biotherapeutics COO Lisa Taylor Ash to its board. Milstein brings RNA experience from Alnylam , Korro Bio and Sail Biomedicines . Aerska is developing targeted RNA treatments for brain diseases like Alzheimer’s and Parkinson’s, and debuted in October with $21 million in seed funding. → Corbus Pharmaceuticals medical chief Dominic Smethurst will resign on June 30, according to an SEC filing . Smethurst took this job in early 2024 after three years as CMO of Bicycle Therapeutics . Corbus reported Phase 1a data in December for its CB1 inverse agonist CRB-913 in obesity, and it’s also developing a Nectin-4 ADC called CRB-701 . → ALX Oncology ’s CD47 aspirations have run into some potholes , while other biotechs have similarly been foiled in the space. But the South San Francisco biotech keeps plugging away with evorpacept , and it’ll do so with Jeff Knight as chief development and operating officer. On April 10, Knight resigned from the same position at Crinetics Pharmaceuticals , which now sells the acromegaly treatment Palsonify . The Amgen vet was SVP, portfolio management, alliance management and corporate operations at the end of a three-year run with Poseida Therapeutics . → Zealand Pharma has signed up Eric Rojas as its new head of investor relations. Rojas joins the company at a tricky time: Its share price slid more than 30% after its Roche -partnered amylin analog posted weaker-than-expected mid-stage data last month. He has held senior investor relations positions at companies including Stoke Therapeutics , Vertex and Shire . Zealand has another shot on goal with its obesity and fatty liver disease drug survodutide , though that is being developed by Boehringer Ingelheim under the partners’ licensing deal. Phase 3 obesity data on survodutide, a GLP-1 and glucagon agonist, are due in the summer. → Harbour BioMed — Chinese biotech partner to the stars — has lined up Bristol Myers Squibb and Merck alum Adam Zong as president. Zong was the founding CEO of Hengrui Therapeutics in the US and then president and COO of Seven & Eight Biopharmaceuticals from 2017-21. Harbour BioMed has teamed up with Bristol Myers, AstraZeneca , Otsuka and others, with an R&D engine that’s humming along in I&I diseases and immuno-oncology. → As Idorsia searches for a CEO, Amer Joseph will go to the Swiss biotech on May 1 as CMO and head of global clinical development. Alberto Gimona , who worked with Jean-Paul Clozel at Actelion in the 2010s, is retiring after four years of leading global clinical development and seven years overall at Idorsia. Joseph handled global clinical development duties for Chiesi and had two separate stints at Bayer (with a brief stop at GSK in between). Clozel has filled in as interim CEO since Srishti Gupta ’s departure . → Evotec has made its second major hire this month, naming Ingrid Müller as COO. Müller was VP of portfolio strategy & execution at fellow German company CureVac until rival BioNTech bought the vaccine maker for $1.25 billion. She also spent eight years with Sanofi, culminating in her role as SVP, global procurement outsourcing & external manufacturing. While Müller starts her new job at Evotec on May 1, ex- Iktos CBO Ashiq Khan is settling in as chief commercial officer. → Matthew Gall is replacing Daniella Beckman as CFO of targeted cancer drug developer Tango Therapeutics . Gall is joining Tango after a brief stop at eye therapy developer Kalaris Therapeutics in the same role. Tango has also hired MorphoSys vets Yen-Ching Chua as chief development operations officer, and Janice Kapty as SVP of corporate strategy and project leadership. Tango’s shares $TNGX jumped 20% this week following a highly promising Phase 3 readout from Revolution Medicines ’ pancreatic cancer drug. Tango is studying its PRMT5 inhibitor vopimetostat in combination with Revolution Medicines’ treatments in both pancreatic and lung cancers, and expects to have initial data from that combination trial this year. → Charles Morris has replaced Jane Huang as CMO of Prelude Therapeutics , which shelved its SMARCA2 degrader program in favor of a KAT6A degrader to treat ER+ breast cancer. Morris took on the same responsibilities at Lava Therapeutics , Celyad Oncology and Radius Health . No word on what’s next for Huang, who joined Prelude in 2022 after six years at BeOne Medicines (then known as BeiGene ). → Former Acorda medical chief Burkhard Blan k has reunited with Ron Cohen at Oryon Cell Therapies . Blank will serve as Oryon’s CMO, leaving his post at MannKind Corporation . Oryon is one of a handful of biotech companies developing Parkinson’s cell therapies derived from stem cells. Blank brings experience developing Parkinson’s drugs from his time at Acorda, where he oversaw the Phase 3 program and approval for Inbrija , as well as from Boehringer Ingelheim. His new role comes after longtime Acorda leader Cohen joined Oryon as CEO earlier this year as the company raised $21 million. → Harmony Biosciences has followed up its appointment of COO Peter Anastasiou by hiring Glenn Reicin as finance chief. This is Reicin’s fourth CFO job this decade, following stops at Sigilon Therapeutics , now-defunct Alladapt Immunotherapeutics and AstraZeneca’s oral GLP-1 partner Eccogene . Reicin succeeds Sandip Kapadia , who had held this position for the past five years. → With the demise of iTeos Therapeutics behind her, Yvonne McGrath has moved on to French protein degradation biotech Enodia Therapeutics as CSO. McGrath was promoted to CSO at iTeos in 2022, but it had to shut down last year as the TIGIT field continues to take on water. Enodia kicked off 2026 with a €20.7 million seed round. → Wolfram Brugger has been named CMO at Swedish gene therapy maker Asgard Therapeutics . Brugger led clinical development at CAR-T cell therapy shop Autolus and helped develop the lymphoma drug tafasitamab at MorphoSys. Incyte shelled out $25 million for the full global rights to tafasitamab, now marketed as Monjuvi . Johnson & Johnson Innovation – JJDC and Novo Holdings contributed to Asgard’s €30 million Series A in March 2024. Is another round of financing on the horizon? → On the heels of Inhwan Kim ’s promotion, Boulder, CO biotech Enveda has installed Christopher Porter as SVP, clinical operations. Porter just completed a stint at Theravance Biopharma as VP of development strategy and innovation, and he arrives at a critical juncture after Enveda released the first clinical data for its atopic dermatitis hopeful ENV-294 . → Prothena has promoted Annie Kingston to chief strategy officer and Michael Isaacs to general counsel. Kingston celebrates her third anniversary with the company this month and she’s been VP, corporate strategy and chief of staff since March 2025. Isaacs was elevated to deputy general counsel in 2023 and he’ll get started in his new role when current legal chief Michael Malecek leaves in June. → Rytelo maker Geron has selected Tim Williams as chief legal officer. Williams had been busy with legal work as general counsel at Vanda Pharmaceuticals since 2018. Vanda’s motion sickness drug Nereus was approved as 2025 drew to a close, after the company dropped a lawsuit against the FDA over a partial clinical hold of the drug. → Adagene has welcomed ex- J&J oncology exec Peter Lebowitz to its scientific and strategic advisory board. Lebowitz runs Endpoints 11 winner Third Arc Bio , which raised a $165 million Series A in July 2024 and is partnering with Adagene on “masked” T cell engagers. → Ottimo Pharma CEO David Epstein has joined the board of directors at Frontier Medicines , which hasn’t pulled the trigger on an IPO yet and raised a Series C round in 2024. Epstein chairs the board at newly public biotech Agomab and ran Seagen when it was purchased by Pfizer. → In other boardrooms, Aktis Oncology is bringing in Daiichi Sankyo veteran Glenn Gormley , while Helen Kim and Oleg Nodelman will depart on May 26; Orum Therapeutics has added ex-Bicycle and Repare Therapeutics CMO Maria Koehler and Locust Walk ’s Geoff Meyerson ; Anika Therapeutics chair Cheryl Blanchard has clinched a spot at Xilio Therapeutics ; and Edwin Moses will be chairman of Oxford, UK-based Greywolf Therapeutics after chairing the board at Amgen’s M&A prize Dark Blue Therapeutics . Andrew Dunn contributed to this edition. 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