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Futuristic Grenade Launcher From Colt And Northrop Grumman Seen Being Fired For First Time

Futuristic Grenade Launcher From Colt And Northrop Grumman Seen Being Fired For First Time

Yahoo16-05-2025

Northrop Grumman has released a brief video clip showing an individual shooting a new 25mm precision grenade launcher it has been working on together with gunmaker Colt. This appears to be the first time we've seen a working prototype of the weapon being fired. It is one of several designs being pitched to meet U.S. Army requirements for a highly computerized Precision Grenadier System (PGS) that soldiers could use to engage ground targets, including ones behind cover, as well as help shield themselves from the growing threats posed by drones.
The footage of the grenade launcher being tested was included in a video montage, seen in the social media post below, that Northrop Grumman put out earlier this week to highlight 'the latest in Bushmaster Chain Gun technology, advanced ammunition and counter-uas [uncrewed aerial systems] solutions.'
Inspired by innovation, perfected with precision.Together with our teammates, we recently demonstrated the latest in Bushmaster® Chain Gun® technology, advanced ammunition and counter-uas solutions.These live-fire scenarios highlighted the depth of our innovations – reliable,… pic.twitter.com/UURCzuvHF7
— Northrop Grumman (@northropgrumman) May 13, 2025
In general, the new grenade launcher has the look of an oversized rifle. It is semi-automatic and feeds from a five-round box magazine. The barrel is between 14 and 15 inches long, and the overall weight is under 15 pounds, Colt has previously told Defense News.
In the recently released video clip from Northrop Grumman, the gun is seen fitted with a Vortex Optics XM157 computerized optic, which the U.S. Army is already acquiring to go along with its new 6.8x51mm XM7 rifles and XM250 light machine guns.
In April, at the Modern Day Marine exposition in Washington, D.C., Northrop Grumman representatives told TWZ's Howard Altman that the company has been focused primarily on developing a family of specialized ammunition to go along with the launcher. Colt has been leading the development of the weapon itself, a mockup of which was shown at the event.
'We're responsible for integration. We went to Colt to help design this [the grenade launcher],' Michael O'Hara, Senior Manager for Tactical Weapons Solutions & Strategy at Northrop Grumman, explained. 'These specialized rounds is [sic; are] all Northrop Grumman, and then we're working with different types of smart optics.'
The mockup of the grenade launcher at Modern Day Marine was equipped with a SMASH-series computerized optic from Israeli firm Smartshooter. SMASH-series optics have been steadily gaining traction across the U.S. military and elsewhere globally in recent years, with a particular eye toward improving the ability of individual shooters to engage small drones. O'Hara also specifically mentioned Vortex Optics as another source of 'smart optics.'
'The program is focused primarily, currently, at surface-to-surface [targets]. So we're able to take out targets down-range that are hidden behind objects. That's the whole purpose of the weapon system,' O'Hara added. 'We are also taking that functionality and taking the prox[imity] capability of the ammo and going to go against UAS. So, for like squad-level/platoon-level protection, a rifleman would be able to utilize this [to] engage UAS, small UASs, for protection.'
The U.S. Army has said its plan for the future Precision Grenadier System (PGS) envisions 'a Soldier portable, shoulder fired, semi-automatic, magazine fed, integrated armament system (weapon, ammunition, fire control) that enables rapid, precision engagements to destroy personnel targets in defilade and in the open with increased lethality and precision compared to legacy grenade launchers, while also not impacting Soldier mobility,' according to a contracting notice the service put out in February. 'The PGS is anticipated to be deployed as a Soldier's primary weapon system, providing organic, close-quarters combat, counter-defilade, and counter-UAS capabilities through a family of ammunition to ranges in concert with the rest of the squad's battlespace, and requiring minimal resupplies to support. This capability shall provide overmatch to comparable threat grenade launchers in near-peer formations in future operating environments to include urban, jungle, woodland, subterranean, and desert, in day, night, or obscured conditions.'
Previous PGS contracting notices have also called for a weapon with an overall length of no more than 34 inches, a weight of 14.5 pounds or less, and an effective range of at least 1,640 feet (500 meters). The PGS also needs to be able to fire rounds along a relatively flat trajectory, with the goal of making it easier to engage targets accurately. The desired maximum range for the PGS is notably greater than that offered by the M203 and M320 grenade launchers currently in Army service, which also fire 40x46mm rounds along a more arced trajectory. Unlike the PGS, the M230 and M320 are both designed to be attached under the barrels of existing standard infantry rifles, though the Army also fields the latter in a stand-alone configuration.
The Army wants a family of specialized ammunition to go along with the PGS that includes a so-called 'Counter Defilade Round' that can 'precisely and quickly defeat personnel targets' behind cover, which would be an air-bursting design. As Northrop Grumman's O'Hara noted, with the help of a proximity fuze, rounds designed for counter-defilade use could also be employed against drones. Armor-piercing, shotgun-like 'close quarters battle' anti-personnel canister, and training rounds are expected to go along with the PGS, as well.
It is important to remember that the Army's current PGS effort follows the cancellation of work on a similarly advanced 25mm grenade launcher, designated the XM25 and nicknamed 'The Punisher,' back in 2018. Work on the XM25 began in the mid-2000s as an outgrowth of an abortive next-generation infantry weapons program called the Objective Infantry Combat Weapon (OICW) that started in the 1990s. Given the stated PGS weight requirement, it is interesting to note that the XM25's 14-pound weight was cited as contributing to its ultimate cancellation. The cost of the grenade launcher and its advanced programmable ammunition, as well as its physical bulk, were also factors.
At least two other grenade launchers are being pitched to the Army now for PGS. These are the Squad Support Rifle System (SSRS) from Barrett Firearms and MARS, Inc., and FN America's PGS-001. The SSRS and the PGS-001 could have an additional leg up thanks to being the two finalists in the Army's xTechSoldier Lethality challenge that wrapped up in 2023. You can read more about what is known about those designs here.
AUSA 23 – FN USA's PGS-001 Precision Grenadier System https://t.co/ItLtkeulGB pic.twitter.com/J3Q1UHkTAZ
— Soldier Systems (@soldiersystems) October 10, 2023
What the Army's timeline now for settling on a PGS design and fielding it is unclear. The aforementioned contracting notice put in February was tied to PGS, but was specifically about a Prototype Project Opportunity described as 'a risk reduction effort separate from the Precision Grenadier Program of Record with the goal of developing technologies associated with the current capability gap.'
The Army clearly still has an active interest in the capabilities that PGS could offer, now further spurred on by the ever-growing threats that drones present. Though the danger posed by drones is not new, it has been very pointedly observed in the ongoing conflict in Ukraine, as well as other hotspots around the world in recent years.
The recently released video shows that Northrop Grumman and Colt are continuing in their development of one grenade launcher design that could meet the Army's PGS needs.
Howard Altman contributed to this story.
Contact the author: joe@twz.com

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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

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

Business Wire

time20 minutes ago

  • Business Wire

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

WHIPPANY, N.J.--(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 Oncolog y. 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 Trial 7 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 C max 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 Bayer BAYER, 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.

Army surpasses fiscal 2025 recruiting goal 4 months ahead of schedule
Army surpasses fiscal 2025 recruiting goal 4 months ahead of schedule

Yahoo

time26 minutes ago

  • Yahoo

Army surpasses fiscal 2025 recruiting goal 4 months ahead of schedule

The Army announced on Tuesday that it "surpassed" its fiscal year 2025 recruiting goal of bringing in 61,000 recruits, and there are still four months left to go. This year's goal is more than 10% higher than the 55,000 recruits targeted in fiscal 2024, demonstrating a surge in interest and enthusiasm for Army service. Recent recruiting momentum has seen average contracts per day exceeding last year's levels by as much as 56% during the same period. The Army has not reached its recruiting goals this early in the year since 2014, Army officials said in a statement. Army Chief of Staff Gen. Randy George and Army Secretary Dan Driscoll spoke about reaching their recruiting goal on Monday, while speaking on a panel at the AI Expo in Washington, D.C. Trump's Revamped Coast Guard Surges With 'Skyrocketing' Recruiting To Secure Maritime Borders: Dhs Memo Both men spoke about the coming summer months historically being the best for recruiting and both are scheduled to appear on Capitol Hill on Wednesday to testify on the Army's FY26 budget. Read On The Fox News App "Today the U.S. Army met our FY25 recruiting goals a whole four months ahead of schedule," Driscoll said on Tuesday. "I want to thank the commander in chief, President Trump, and Secretary of Defense Hegseth for their decisive leadership and support which helped make this feat possible. "I'm also extremely proud of the recruiters, leaders and other advocates who helped us smash this goal," he continued. "America's young women and men are proud of our country and want to serve in the U.S. Army and the results speak for themselves." Army May Slash 90,000 Troops As Pentagon Faces Budget Cuts And Strategic Shake-up: Report Driscoll acknowledged that the Army had experienced recruiting and retention challenges, though he said those days are behind the branch "thanks to the Herculean efforts of our recruiters, drill sergeants and leaders across the U.S. Army." Having already reached its goal, the Army will continue to recruit, though those who sign up will go into the delayed entry program. The branch said in February that 350 soldiers had enlisted every day in December. Special Operations Commanders Issue Warning About Us Enemies' 'Impressive' Tech Advancements In October 2023, the Army unveiled a series of sweeping changes to its recruiting enterprise, including an expanded focus on a larger share of the labor market and the creation of a specialized talent acquisition workforce. The Army had surged medical providers to Military Entrance Processing Stations across the country to help make the enlistment process more efficient, and leveraged innovative new technologies to reach expanded audiences and help identify candidates interested in military service. There was also a notable expansion of the branch's Future Soldier Preparatory Course, which helps potential recruits overcome academic and physical fitness barriers to service, while allegedly "not sacrificing quality for quantity." Still, the U.S. military missed its recruiting goals by 41,000 in 2023. In 2024, the Army announced it was cutting its force by 24,000 in a restructuring to "help the service fight in future wars." The almost 5% of jobs cut affected posts that remained empty, according to the Army. Fox News Digital's Alexandra Koch and Stephen Sorace contributed to this article source: Army surpasses fiscal 2025 recruiting goal 4 months ahead of schedule

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