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Swyshare Launches Recordit – A Simple Yet Powerful Screen Recorder Built for All Your Recording Needs

Swyshare Launches Recordit – A Simple Yet Powerful Screen Recorder Built for All Your Recording Needs

LOS ANGELES, Calif., May 28, 2025 (SEND2PRESS NEWSWIRE) — Swyshare, a growing innovator in digital creativity tools, today announced the release of Recordit, a simple yet powerful screen recorder designed for users who need fast, efficient, and high-quality screen capture. Whether you're recording online meetings, tutorial videos, gameplay, or presentations, Recordit provides the tools you need in an intuitive, no-fuss interface.
'With Recordit, we focused on making screen recording as simple and effective as possible,' said Jesse Lau, CEO of Swyshare. 'Creating high-quality recordings is simple, even if you're not tech-savvy. By using Recordit, anyone can produce clear, confident screen recordings.'
EXPLORE THE KEY FEATURES OF SWYSHARE RECORDIT:
BUILT FOR VERSATILITY
Whether you're a student recording lectures, a business professional saving a webinar, or a gamer sharing highlights, Swyshare Recordit is built to handle a wide range of recording scenarios with ease.
AVAILABILITY AND COMPATIBILITY
Swyshare Recordit is available now for both Windows (Windows 10 or later) and macOS ( macOS 11 or later). Users can download Recordit today from the Swyshare official website.
PRICE:
Swyshare Recordit is available through three flexible licensing options:
All plans include unlimited recording time, watermark-free exports, free updates, and customer support. Try it worry-free – Swyshare includes a 30-day money-back guarantee.
Upgrade Recordit: https://www.swyshare.com/recordit/buy/
ABOUT SWYSHARE
Swyshare is committed to developing lightweight, user-friendly tools that empower users to create, share, and communicate more effectively. From screen capture to media management, Swyshare software helps users make the most of their digital experiences.
For more information, visit:
https://www.swyshare.com/
https://www.swyshare.com/recordit/
MULTIMEDIA:
YouTube video: https://www.youtube.com/watch?v=ehIJceml__o&t=8s
IMAGE LINK for media:
https://www.swyshare.com/wp-content/uploads/recordit-send2press-banner.png
Image caption: Easily record any on-screen activity with Recordit.
NEWS SOURCE: Swyshare
###
MEDIA ONLY CONTACT:
(not for publication online or in print)
Jesse Lau
Micromatrix Technology Limited and Swyshare Inc.
EMAIL: [email protected]
PHONE: 1-868-231-0095
###
Keywords: Software, Swyshare Recordit, screen recorder, recording, software, LOS ANGELES, Calif.
This press release was issued on behalf of the news source (Swyshare) who is solely responsibile for its accuracy, by Send2Press® Newswire. Information is believed accurate but not guaranteed. Story ID: S2P126537 APNF0325A
To view the original version, visit: https://www.send2press.com/wire/swyshare-launches-recordit-a-simple-yet-powerful-screen-recorder-built-for-all-your-recording-needs/
© 2025 Send2Press® Newswire, a press release distribution service, Calif., USA.
RIGHTS GRANTED FOR REPRODUCTION IN WHOLE OR IN PART BY ANY LEGITIMATE MEDIA OUTLET - SUCH AS NEWSPAPER, BROADCAST OR TRADE PERIODICAL. MAY NOT BE USED ON ANY NON-MEDIA WEBSITE PROMOTING PR OR MARKETING SERVICES OR CONTENT DEVELOPMENT.
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U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer
U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer

Business Upturn

timean hour ago

  • Business Upturn

U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer

U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer Darolutamide is the first and only in the U.S. and FDA-approved androgen receptor inhibitor (ARi) for the treatment of patients with hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT), with or without chemotherapy. This third approval is based on positive results from the pivotal Phase III ARANOTE trial and broadens the indication profile of darolutamide in mHSPC, enabling its use in combination with ADT, with or without chemotherapy (docetaxel). Darolutamide plus ADT reinforces the established safety and tolerability profile of darolutamide for prostate cancer patients across all approved indications. Orion's collaboration partner Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC. With this approval, darolutamide plus ADT is indicated in the U.S. for the treatment of adult patients with mHSPC either with or without docetaxel. In addition, darolutamide is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.1 In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide.1 Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.2 Darolutamide, under the brand name Nubeqa®, is already approved in mHSPC in combination with ADT and docetaxel in over 85 markets around the world. It's also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world. An approval process in the EU for the treatment of mHSPC in combination with ADT (without docetaxel) is already underway by Bayer. Nubeqa achieved blockbuster status in September 2024, with annual sales reported by Bayer reaching EUR 1.52 billion for the full year of 2024. Darolutamide is developed jointly by Orion and Bayer. About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of adverse events in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT. About darolutamide Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and the growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans support darolutamide's low potential for blood-brain barrier penetration. Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile in both registrational studies in mHSPC where the incidences of adverse events were roughly similar to the respective comparator arm. Darolutamide is a treatment option for doctors and patients, considering its tolerability and low risk of drug interaction. A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. About metastatic hormone-sensitive prostate cancer At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed.3,4,5 For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi). Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival. Contact person: Tuukka Hirvonen, Investor Relations tel. +358 10 426 2721 References Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed: September 2024. James ND et al. Lancet 2024; 403: 1683–722. Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938. Buzzoni C et al. Eur. Urol. 2015;68:885–890. Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finland Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.

Appian Connected Claims 2.0 Transforms Insurance Claims Management with AI
Appian Connected Claims 2.0 Transforms Insurance Claims Management with AI

Yahoo

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  • Yahoo

Appian Connected Claims 2.0 Transforms Insurance Claims Management with AI

Appian is named a 'Leader' in Everest Group's 'AI-enabled Claims Management Systems for Property & Casualty (P&C) Insurance – Products PEAK Matrix®' for 2025 LONDON, June 4, 2025 /PRNewswire/ -- Appian (NASDAQ: APPN) today announced the launch of Connected Claims 2.0, an AI-powered solution designed to provide a unified claims workflow. Everest Group also named Appian a Leader in AI-enabled Claims Management Systems for Property & Casualty (P&C) Insurance – Products PEAK Matrix® Assessment 2025. Connected Claims 2.0 leverages Appian's Case Management Studio, AI agents, and data fabric to offer streamlined, data-driven, and AI-powered automated processes. Driven by rapid digital transformation, the global insurance claims services processing market is projected to reach $638.3 billion by 2032. Connected Claims 2.0 will support insurers through this growth with a unified claims workflow that accelerates processing, enhances fraud detection, combats inconsistent handling, data management issues and improves customer satisfaction. Connected Claims 2.0 offers a fully integrated, AI-powered platform with customisable workflows and a superior user experience, featuring a single pane of glass, AI-powered data insights, real-time data access, and automated regulatory compliance management. Appian's Connected Claims solution brings powerful AI-driven support to every adjuster, making it easier to manage the demands of a document-heavy claims environment. With capabilities like data classification, document summarisation, contextual chat, and next-best-action recommendations, AI accelerates work and improves decision-making. The next generation of the solution introduces the Appian AI Document Centre, enabling users to easily train models to extract data from unstructured documents. 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This approach enables insurers to easily access powerful AI capabilities exactly when and where they're needed—with just a few clicks. "Appian's Connected Claims solution, built on its low-code platform, combines AI-driven document processing, seamless third-party integrations, and configurable accelerators to deliver rapid time-to-value for P&C insurers," said Aurindum Mukherjee, Practice Director at Everest Group. "Strong integration support across payment, risk, and fraud systems, coupled with proven success driving accelerated business value for insurers and high client satisfaction for implementation and support, underpins Appian's position as a Leader in Everest Group's AI-enabled Claims Management Systems PEAK Matrix® Assessment 2025." "We are launching Appian Connected Claims 2.0 to meet the urgent need for speed and early value realisation as the insurance industry tackles complexity, " said Jake Sloan, Global Vice President of Insurance, Appian. "Our solution drives digital-first claims innovation, aligning with core admin cloud modernisation for early value realisation. It's configurable, rapidly deployable, and leverages the latest powerful AI in Process to accelerate cycles, combat fraud, and personalise customer experiences. Connected Claims 2.0 empowers insurers to transform operations, balancing efficiency and accuracy with superior customer satisfaction, truly leading the evolution of claims management." Connected Claims 2.0 supports insurance companies, from claims adjusters, fraud detection teams, customer service representatives, regulatory compliance teams, to IT and operations teams. About Appian Appian is The Process Company. We deliver a software platform that helps organisations run better processes that reduce costs, improve customer experiences, and gain a strategic edge. Committed to client success, we serve many of the world's largest companies across various industries. For more information, visit [Nasdaq: APPN] Follow Appian: LinkedIn, X (Twitter) DisclaimerLicensed extracts taken from Everest Group's PEAK Matrix® Reports, may be used by licensed third parties for use in their own marketing and promotional activities and collateral. Selected extracts from Everest Group's PEAK Matrix® reports do not necessarily provide the full context of our research and analysis. All research and analysis conducted by Everest Group's analysts and included in Everest Group's PEAK Matrix® reports is independent and no organization has paid a fee to be featured or to influence their ranking. To access the complete research and to learn more about our methodology, please visit Everest Group PEAK Matrix® Reports. About Everest GroupEverest Group is a leading global research firm helping business leaders make confident Group's PEAK Matrix® assessments provide the analysis and insights enterprises need to make critical selection decisions about global services providers, locations, and products and solutions within various market segments. Likewise, providers of these services, products, and solutions, look to the PEAK Matrix® to gauge and calibrate their offerings against others in the industry or market. Find further details and in-depth content at View original content: SOURCE Appian Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

U.S. FDA Approves NUBEQA® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer
U.S. FDA Approves NUBEQA® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer

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U.S. FDA Approves NUBEQA® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer

NUBEQA® is the first and only androgen receptor inhibitor (ARi) approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC) with or without chemotherapy. Approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated NUBEQA plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 46% compared to placebo plus ADT. These results were consistent with the established safety profile of NUBEQA. WHIPPANY, N.J., June 03, 2025--(BUSINESS WIRE)--Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001).1 The randomized, double-blind, placebo-controlled Phase III ARANOTE trial was designed to assess the efficacy and safety of NUBEQA plus ADT in patients with mCSPC.1 A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (N=446) or placebo (N=223) twice daily in addition to ADT.1 NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2 "Clinical data from the ARANOTE trial supporting this new regimen showed that NUBEQA plus ADT demonstrated powerful efficacy in men with mCSPC," said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM) and principal investigator of the ARANOTE trial. "Today's approval further expands physicians' options for using NUBEQA with and without docetaxel in this setting, providing a potential new choice for patients." Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 in the U.S., and about 375,000 men died from the disease worldwide.4,5 Prostate cancer diagnoses are projected to increase to 2.9 million worldwide by 2040.6 "This approval, which is supported by strong clinical data, reaffirms NUBEQA as an important therapy for men with prostate cancer and underscores our commitment to delivering meaningful outcomes for patients and their families," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "We thank the scientists, doctors, patients and their families who made it possible to provide this new treatment option for metastatic castration-sensitive prostate cancer." Results from the Phase III ARANOTE trial, presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology.1 Results of the radiographic progression-free survival (rPFS) analysis were consistent across prespecified subgroups, including a 40% risk reduction (HR 0.60, 95% CI: 0.44-0.80) with NUBEQA plus ADT in patients with high-volume mCSPC and a 70% risk reduction (HR 0.30, 95% CI: 0.15-0.60) in patients with low-volume disease.1 The results were consistent with the established safety profile of NUBEQA. Rates of serious adverse events were similar between the treatment arms (24% for NUBEQA plus ADT compared to 24% for placebo plus ADT).1,2 Discontinuation due to treatment-emergent adverse events (TEAEs) was 6% for patients treated with NUBEQA plus ADT compared to 9% in patients receiving placebo plus ADT.1,2 About the ARANOTE Trial7 The randomized, double-blind, placebo-controlled Phase III ARANOTE trial study assessed the efficacy and safety of NUBEQA plus ADT in patients with mCSPC. A total of 669 patients were randomized to receive 600 mg of NUBEQA twice daily or matching placebo in addition to ADT. The primary endpoint was rPFS, measured as time from randomization to date of first documented radiographic progressive disease or death due to any cause, whichever occurs first. About NUBEQA® (darolutamide)2 NUBEQA® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic castration-sensitive prostate cancer (mCSPC) Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo. In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – Seizure occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%). In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%). In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%). Drug Interactions Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers. Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed. Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information. About Metastatic Castration-Sensitive Prostate Cancer Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 men in the U.S., and nearly 375,000 men died from the disease worldwide.4,5 At the time of diagnosis, most men have localized prostate cancer, in which their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this castration-sensitive, or hormone-sensitive, disease. Approximately 10% of men will already present with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), when first diagnosed.8,9,10 Men with mCSPC will start their treatment with hormone therapy, such as ADT, an androgen receptor inhibitor (ARi) plus ADT, or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mCSPC will eventually progress to castration-resistant prostate cancer (CRPC), which is associated with limited survival.11,12 About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 BayerBAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports, which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Saad F, et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the Phase III ARANOTE trial. J Clin Onc. 2024;42(36):4271-4281. NUBEQA® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; June 2025. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed June 2025. Prostate Cancer: Statistics. Accessed June 2025. American Cancer Society. Cancer Facts & Figures 2024. Accessed June 2025. James ND, et al. The Lancet Commission on prostate cancer: planning for the surge in cases. Lancet. 2024;403:1683-1722. NCT04736199. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). Accessed June 2025. Piombino C, et al. De novo metastatic prostate cancer: are we moving toward a personalized treatment? Cancers (Basel). 2023;15(20):4945. Helgstrand JT, et al. Trends in incidence and 5-year mortality in men with newly diagnosed, metastatic prostate cancer - A population-based analysis of 2 national cohorts. Cancer. 2018;124(14):2931-2938. Buzzoni C, et al. Metastatic prostate cancer incidence and prostate-specific antigen testing: new insights from the European Randomized Study of Screening for Prostate Cancer. Eur Urol. 2015;68:885-890. Siegel DA, et al. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017. MMWR Morb Mortal Wkly Rep. 2020;69:1473-1480. Hahn AW, et al. Metastatic castration sensitive prostate cancer: optimizing patient selection and treatment. Am Soc Clin Oncol Educ Book. 2018;23;38:363-371. View source version on Contacts Media: Polina Miklush, Tel +1 862.431.8817Email: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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