Exelixis [NasdaqGS:EXEL] Sees US$555 Million Revenue With Earnings Up Sharply
Exelixis recently announced its impressive first-quarter earnings for 2025, with revenue and net income showing substantial growth. This financial performance, coupled with the FDA approval of CABOMETYX for new indications, likely contributed to the company's 12.65% share price increase over the last quarter. The company's share repurchase program announcement also adds potential upward pressure, reflecting confidence in its future prospects. Given the broader market's 12% annual increase and recent 4% rise, Exelixis's price movement aligns well with overall market trends, with its strong earnings and strategic product advancements adding supportive momentum.
Be aware that Exelixis is showing 1 possible red flag in our investment analysis.
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Exelixis's recent FDA approval and strong earnings performance have set a bullish investors' narrative, aligning with analysts' positive projections for revenue and earnings growth. Over the past three years, the company's total shareholder return was very large at 78.59%, indicating strong historical performance. In comparison, over the past year, Exelixis's stock outperformed the US Market, which returned 11.5%. This past performance suggests resiliency and an ability to drive growth, factors that may further encourage investor confidence as the company expands its cabozantinib indications and accelerates its Phase I pipeline development.
The approval and increased indications of CABOMETYX, combined with potential revenue growth driven by new oncology franchises, could significantly enhance Exelixis's revenue and earnings projections. Analysts forecast a revenue increase of 9.7% annually, with earnings expected to reach US$943 million by 2028. These developments support the recent strategic decisions, such as the share repurchase program, which may positively impact earnings per share by reducing outstanding shares. The current share price of US$36.86 shows a marginal discount of approximately 3.1% to analysts' consensus price target of US$38.05, reflecting market confidence in Exelixis being fairly valued at present. These projections underline the company's ambition to solidify its market position while highlighting underlying business challenges such as rising costs and competitive pressures.
Assess Exelixis' future earnings estimates with our detailed growth reports.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include NasdaqGS:EXEL.
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Yahoo
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Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpoints Denifanstat demonstrated a favorable safety and tolerability profile Denifanstat was 98% and 178% more effective than U.S. Food and Drug Administration (FDA)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline Denifanstat was 60% more effective than FDA-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat versus 11.6% for clascoterone cream, respectively The exceptional efficacy of denifanstat coupled with its favorable safety profile in the Phase III trial provides a potential major break-through for the treatment of acne HONG KONG, June 3, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, meets all primary, key secondary, and secondary endpoints in the Phase III clinical trial for the treatment of moderate to severe acne vulgaris (NCT06192264). The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg denifanstat oral tablet once daily or matching placebo for 12 weeks. Baseline characteristics were well balanced between denifanstat and placebo arms. Table 1 summarizes some of baseline characteristics. Primary, key secondary, and secondary endpoints can be found in Table 2. Primary endpoints included the percent treatment success (defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12), the percent reduction from baseline in total lesion count, and the percent reduction from baseline in inflammatory lesion count. At week 12, percent treatment success was 33.2% compared to 14.6% for placebo, p<0.0001, percent reduction from baseline in total lesion count was 57.4% compared to 35.4% for placebo, p<0.0001, and percent reduction from baseline in inflammatory lesion count was 63.5% compared to 43.2% for placebo, p<0.0001. The key secondary endpoint, percent reduction from baseline in non-inflammatory lesion count at week 12, was 51.9% compared to 28.9% for placebo, p<0.0001. Denifanstat demonstrated a favorable safety and tolerability profile following 12 weeks of once-daily oral administration at 50 mg. The incidence rates of treatment-emergent adverse events (TEAEs) were comparable between denifanstat and placebo. No incidence rates of TEAEs related to study drug in any category exceeded 10%. Only two categories of TEAEs had an incidence rate of more than 5% (6.3% dry skin in denifanstat-treated patients versus 2.9% in the placebo group; 5.9% dry eye in denifanstat-treated patients versus 3.8% in the placebo group). All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs (SAEs). No deaths were reported. The mechanisms of action of denifanstat for the treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Denifanstat's unique mechanism of action directly reduces one of the main underlying causes of acne which is the overproduction of sebum. This makes denifanstat unique as most other acne treatments do not treat the underlying cause of the condition. "We are extremely pleased with the topline results of our Phase III trial. Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count. We are excited to be submitting this innovative treatment with the China National Medical Products Administration (NMPA) soon." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. Table 3 highlights the excellent efficacy of denifanstat in a non-head-to-head comparison to other commonly used oral and topical acne treatments. Denifanstat demonstrated its exceptional efficacy across multiple key metrics compared to sarecycline, doxycycline and clascoterone cream. With regard to the placebo-adjusted percent treatment success and the placebo-adjusted percent reduction from baseline in inflammatory lesion count, denifanstat was 98% and 30% more effective than sarecycline, respectively, 178% and 178% more effective than doxycycline, respectively, and 60% and 59% more effective than clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in total lesion count, denifanstat was 189% and 85% more effective than doxycycline and clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in non-inflammatory lesion count, denifanstat was 411% and 102% more effective than sarecycline and clascoterone cream, respectively. Denifanstat has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile. Compared to other oral acne treatments, denifanstat provides outstanding efficacy with excellent safety. There is no potential for antibiotic resistance or off target effects which can occur with tetracycline derivatives and no reported denifanstat-related severe AEs such as hepatotoxicity, hearing impairment and depression which are seen with isotretinoin. Denifanstat should also provide better adherence to treatment compared to topical therapies: an estimated 30% to 40% of patients do not adhere to their topical treatments[1]. Denifanstat is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China. "The Phase III clinical trial results for denifanstat are highly encouraging. The data demonstrate statistically significant improvements in treatment outcomes for moderate-to-severe acne patients, with percent treatment success of 33.2%, total lesion count reduction of 57.4% from baseline, inflammatory and non-inflammatory lesion counts decreasing by 63.5% and 51.9%, respectively, while maintaining a favorable safety and tolerability profile. Denifanstat's first-in-class mechanism targeting FASN directly addresses a key cause for acne, establishing it as a groundbreaking therapeutic approach in acne treatment." said Prof. Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator of denifanstat Phase III trial for moderate to severe acne. [1] Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. Table 1. Baseline characteristics of Phase III trial of denifanstat Baseline characteristics 50 mg denifanstat, oral, oncedaily (n=240) Placebo, oral, once daily (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 Table 2. Efficacy endpoints of 50 mg denifanstat oral, once daily at week 12 versus placebo (intent-to-treat, ITT, analysis) Efficacy endpoints (1) 50 mg denifanstat, oral, once daily (n=240) Placebo, oral,once daily (n=240) Placebo adjusted p value Percent treatment success (2) (primary endpoint) 33.2 14.6 18.6 <0.0001 Percent reduction from baseline in total lesion count (primary endpoint) 57.4 35.4 22.0 <0.0001 Percent reduction from baseline ininflammatory lesion count (primary endpoint) 63.5 43.2 20.3 <0.0001 Percent reduction from baseline in non-inflammatory lesion count (key secondary endpoint) 51.9 28.9 23.0 <0.0001 Absolute reduction from baseline intotal lesion count (secondary endpoint) 58.3 36.2 22.1 <0.0001 Absolute reduction from baseline in inflammatory lesion count (secondaryendpoint) 26.6 18.4 8.2 <0.0001 Notes: (1) All efficacy endpoints are least square means.(2) Treatment success is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12. Table 3. Denifanstat compared to other commonly used acne treatments (not head-to-head comparison) Category Denifanstat (n=240) Sarecycline(1) (n=1002) Doxycycline(2) (n=216) Clascoterone cream(3) (n=722) Baseline characteristics Total lesion count 102.2 72.4 71.7 103.6 Inflammatory lesion count 42.1 30.0 33.6 42.7 IGA=3 (moderate), % 85.8 85.2 93.5 82.7 IGA=4 (severe), % 14.2 14.9 6.5 17.3 Efficacy endpoints at week 12 Placebo-adjusted percenttreatment success 18.6 9.4 6.7 11.6 Placebo-adjusted percent reductionfrom baseline in total lesion count 22.0 NA 7.6 11.9 Placebo-adjusted percent reductionfrom baseline in inflammatorylesion count 20.3 15.6 7.3 12.8 Placebo-adjusted percent reduction from baseline in non-inflammatorylesion count 23.0 4.5 NA 11.4 Notes: (1) The sarecycline data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Moore, A., et al., J Drugs Dermatol 2018 Vol. 17 Issue 9 Pages 987-996. The non- inflammatory lesion count data are from FDA ( The doxycycline data at week 16 are from Moore, A., et al., J Drugs Dermatol 2015 Vol. 14 Issue 6 Pages 581-6.(3) The clascoterone cream (1%) data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Hebert. A, et al., JAMA Dermatology 2020 Vol. 156 Issue 6, DOI: 10.1001/jamadermatol.2020.0465. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact: Peter VozzoICR Healthcare443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)pr@ ir@ View original content: SOURCE Ascletis Pharma Inc. 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
The Hill
an hour ago
- The Hill
FDA chief vows mifepristone probe
The Big Story Food and Drug Administration (FDA) head Marty Makary vowed to review the abortion drug mifepristone after previously saying he had no plans to take action on the drug. © Greg Nash, The Hill 'As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of an early pregnancy,' Makary wrote in a letter to Sen. Josh Hawley (R-Mo.). 'As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with professional career scientists at the Agency who review this data.' Hawley has repeatedly tried to pressure the Trump administration into reviewing mifepristone's safety. In April, the senator urged Makary to review new data released on the abortion medication and to 'restore critical safeguards' on its use. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has also pushed for a review of the drug. A spokesperson for HHS told The Hill Kennedy recently urged Makary to review new data on the drug as well. The new data Hawley referred to comes from a report released in April from the conservative think tank The Ethics and Public Policy Center. In the study, the group claims that 11 percent of people who undergo medication abortions experience an 'serious adverse event.' That percentage is 22 times larger than the rate that is currently listed on the drug's FDA label. Researchers have cast doubt on the study. One aspect of the study that has come under scrutiny is the source of its data. The study claims to have used more than 865,000 insurance claims from prescribed medication abortions to come up with its findings, but it does not share the source for those insurance claims. The study also breaks down serious adverse events into categories including sepsis, infection and emergency room visit, even though an ER visit alone does not count as an adverse event under the FDA definition. Most of the serious adverse events fall into a vague category of 'other abortion-specific complications.' Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech — every week we follow the latest moves on how Washington impacts your health. Did someone forward you this newsletter? Subscribe here. Essential Reads How policy will be impacting the health care sector this week and beyond: Trump administration rescinds emergency abortion guidance The Trump administration has rescinded guidance telling health care workers who provide abortions to save their patients' lives that they are protected under federal law. 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Yahoo
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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. 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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
