The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.

Start Date30 Dec 2025

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT07190300

/ RecruitingPhase 1/2

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Start Date24 Nov 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07244341

/ Not yet recruitingPhase 1

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).

Start Date20 Nov 2025

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

482

Literatures (Medical) associated with Darolutamide

01 Mar 2026·Biomaterials advances

PEGylated liposomes co-encapsulating darolutamide and hesperetin for enhanced prostate cancer therapy: 2D, 3D PC3 models and in-vivo evaluation

Article

Author: Khemchandani, Rahul ; Pawar, Avinash ; Pardhi, Ekta ; Mehra, Neelesh Kumar ; Smanthula, Gananadhamu ; Patil, Ruchita

In this study, a darolutamide and hesperetin co-loaded PEGylated liposomal formulation (DHLP) was developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The formulation was prepared using the ethanol injection method, followed by membrane extrusion through a 100 nm polycarbonate filter to ensure size uniformity. The optimized DHLP liposomal formulation exhibited a clear bluish appearance, with a mean particle size of 106.5 ± 3.2 nm, a polydispersity index of 0.128 ± 0.023, and a zeta potential of -14.10 ± 0.25 mV, indicating colloidal stability and uniformity. Spherical morphology was confirmed through microscopic analysis. High encapsulation efficiencies were achieved for both DA (90.1 ± 3.3 %) and HE (91.3 ± 2.7 %). For both medication, in vitro drug release experiments showed a sustained release profile from the DHLP. Cytotoxicity assessment in PC3 prostate cancer cells revealed a 2.83-fold increase in cytotoxicity compared to free DA solution, a 3.89-fold increase compared to free HE solution, and a 1.47-fold improvement over the combined DA-HE solution. The combination index value of 0.89 confirmed synergistic anticancer activity. DHLPs inhibited cell migration, increased ROS generation, and reduced 3D spheroid size, with enhanced cellular uptake contributing to improved therapeutic efficacy. In-vivo pharmacokinetic studies in BALB/c mice demonstrated a 1.7- and 3.4-fold increase in the plasma half-life of DA and HE, respectively, compared to their free drug solutions. Biodistribution studies revealed reduced accumulation of DHLP in vital organs compared to the free drug solution. Acute toxicity assessment at three dose levels showed no histopathological alterations, indicating a favorable safety profile. These results imply that DHLP is a potential nanocarrier system for the effective management of prostate cancer.

15 Dec 2025·INTERNATIONAL JOURNAL OF CANCER

Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases

Article

Author: Huang, Zhaohui ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Sha ; Li, Xinyu ; Huo, Xiaotong ; Wu, Junyan

Abstract:

Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025 = 4.12, IC 025 = 1.70, N = 30; EudraVigilance, ROR 025 = 11.54, IC 025 = 2.84, N = 55; JADER, ROR 025 = 2.90, IC 025 = 1.33, N = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N = 29, EudraVigilance, ROR 025 = 30.96, IC 025 = 3.74, N = 58; JADER, ROR 025 = 5.34, IC 025 = 1.85, N = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N = 38; EudraVigilance, ROR 025 = 25.06, IC 025 = 3.53, N = 55; JADER, ROR 025 = 0.62, IC 025 = 0.19, N = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N = 7; EudraVigilance, ROR 025 = 4.18, IC 025 = 1.02, N = 5; JADER, ROR 025 = 1.05, IC 025 = 0.45, N = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.

01 Dec 2025·The French journal of urology

French recommendations from the AFU Cancer Committee for prostate cancer: 2025 summary of changes

Review

Author: Dariane, Charles ; Neuzillet, Yann ; Peyrottes, Arthur ; Rozet, François ; Sargos, Paul ; Brureau, Laurent ; Ploussard, Guillaume ; Fromont, Gaëlle ; Barret, Eric ; Baboudjian, Michaël ; Turpin, Léa ; Rouprêt, Morgan ; Renard-Penna, Raphaële ; Roubaud, Guilhem ; Supiot, Stéphane ; Olivier, Jonathan ; Mathieu, Romain ; Fiard, Gaëlle

PURPOSE OF THIS DOCUMENT:

The Oncology Committee of the French Urology Association (CCAFU) is proposing a 2025 summary of recommendations' changes for the management of prostate cancer (PCa).

METHODS:

A systematic review of the literature from July 2024 to September 2025 was conducted by the CCAFU on the evolutions of diagnostic and therapeutic management of PCa evaluating the newly published references with their level of evidence.

RESULTS:

Biparametric MRI is an alternative to multiparametric MRI imaging to guide biopsy decision making provided that a high-quality imaging and radiology expertise is achieved. Transperineal biopsy is the recommended approach when technically feasible. Whole-gland HIFU in patients fulfilling the HIFI trial criteria is a treatment option for intermediate-risk PCa patients. In case of metastasis-directed therapy outside the context of symptoms for oligometastatic hormone-sensitive PCa (mHSPC) disease, at least 6 months of androgen deprivation therapy (ADT) should be given. In patients with high-risk BCR treated according to the EMBARK criteria, systemic treatment with monotherapy enzalutamide may be considered. The ARPI used in addition to ADT alone can be: abiraterone, apalutamide, darolutamide, enzalutamide. In the case of HRR alterations, the combination of niraparib and abiraterone may be proposed as first-line mHSPC. In the case of a positive radiolabelled PSMA ligand PET/CT scan in a patient progressing after at least one ARPI, internal radiotherapy using [¹⁷⁷ Lu]LuPSMA-617 may be proposed. In patients with no or mildly symptomatic bone metastatic castration-resistant PCa without visceral metastases, the combination of enzalutamide+6 cycles of radium-223 may be proposed.

CONCLUSION:

This 2025 summary of changes of French recommendations on PCa should help physicians to stay up-to-date with recent evolutions and aim to improve the management of PCa patients.

234

News (Medical) associated with Darolutamide

13 Nov 2025

·investors.oricpharma.com

ORIC® Pharmaceuticals Announces Completion of Dose Exploration Portion of ORIC-944 Phase 1b Clinical Trial and Continues to Demonstrate Potential Best-in-Class Efficacy and Safety

Efficacy data remain consistent with prior disclosure and continue to demonstrate broad and deep PSA responses, with 55% PSA50 response rate and 20% PSA90 response rate Rapid and deep ctDNA reductions were observed in 76% of patients and ctDNA clearance was observed in 59% of patients, underscoring potential for long-term treatment and survival benefit PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or with darolutamide Both combination regimens continue to demonstrate a safety and tolerability profile compatible with long-term dosing, with the vast majority of adverse events Grade 1 or 2 and consistent with PRC2 and AR inhibition SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced additional efficacy and safety data from the Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC). “We continue to be encouraged by ORIC-944 combination data, which further demonstrate its potential as a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer,” said Jacob M. Chacko, M.D., president and chief executive officer. “The tolerability and efficacy data to date provide compelling validation for the doses we’ve selected for the dose optimization portion of the Phase 1b trial. We look forward to sharing dose optimization data in 1Q 2026 ahead of initiating our first global Phase 3 registrational trial in mCRPC in the first half of next year.” ORIC-944 Phase 1b Dose Exploration Data Patients were previously treated with a median of three prior lines of therapy, including abiraterone acetate, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include background androgen deprivation therapy or first-generation AR inhibitors that the patients may have received. Patients were treated once daily with 400 mg, 600 mg, 800 mg, or 1,200 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA data for 20 patients with mCRPC includes 17 patients previously reported in May 2025. Circulating tumor DNA (ctDNA) was assessed for 17 patients with mCRPC who had available ctDNA samples and evidence of ctDNA at baseline prior to study entry. PSA response data and ctDNA data are as of September 22, 2025. Preliminary antitumor activity analysis PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide. PSA activity 55% of patients (11/20) achieved a PSA50 response, confirmed in 40% (8/20). 20% of patients (4/20) achieved a PSA90 response (all confirmed). ctDNA activity ctDNA serves as a useful biomarker to predict the duration of treatment benefit and survival in prostate cancer. Detectable ctDNA at baseline is associated with poor prognosis, and non-detectable ctDNA at baseline or upon treatment is associated with longer progression-free survival and overall survival. In the Phase 1b trial, 88% of patients had detectable ctDNA at baseline (higher than precedent trials with standard of care agents in comparable mCRPC patient populations), and ORIC-944 in combination with apalutamide or with darolutamide demonstrated: Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% of patients (13/17) achieving >50% ctDNA reduction. 59% of patients (10/17) achieved ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations. Preliminary safety analysis ORIC-944 in combination with apalutamide or with darolutamide continues to be well tolerated to date. Both combination regimens demonstrated a safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. As of the September 22, 2025 cutoff date, only one patient experienced a Grade 3 TRAE, and there were no Grade 4 or Grade 5 AEs attributed to ORIC-944, apalutamide or darolutamide. Next Steps Based on these efficacy and safety results, ORIC has selected provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg once daily of ORIC-944 in combination with 600 mg twice daily of darolutamide; and 600 mg, 800 mg and 1,200 mg once daily of ORIC-944 in combination with 240 mg once daily of apalutamide. Enrollment in the dose optimization portion of the trial is ongoing, and the company plans to announce preliminary dose optimization data in 1Q 2026. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC, which the company expects to initiate in 1H 2026. ORIC-944 Phase 1b Trial Design ORIC-944 is being evaluated in a Phase 1b dose optimization trial in combination with ERLEADA® (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA® (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and up to one prior chemotherapy. The primary objective of the trial is to determine the recommended Phase 2 dose (RP2D), and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity. About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain-penetrant inhibitor that selectively targets EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of ORIC-944; statements regarding the potential best-in-class properties of ORIC-944; clinical outcomes from combination studies with ORIC-944, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; next steps and anticipated program milestones, including timing of program and data updates and the initiation of the first ORIC-944 Phase 3 registrational trial in mCRPC; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-944, enozertinib or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on November 13, 2025, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact: Dominic Piscitelli, Chief Financial Officer dominic.piscitelli@oricpharma.com info@oricpharma.com

Phase 1Clinical ResultPhase 3

12 Nov 2025

·www.fiercepharma.com

As pharma sales stagnate, Bayer exec stands firm behind newer meds and latest launch Lynkuet

Despite the largely stagnant performance this past quarter, Bayer remains “encouraged by the resilience of our top line” in pharmaceuticals, CEO Bill Anderson said on a conference call Wednesday. With sluggish pharmaceutical sales in the third quarter coming in below analysts’ expectations, Bayer is acutely aware of the challenges facing its key unit.Nevertheless, at least as far as prescription drugs are concerned, the German conglomerate has reasons to be excited, including a fresh launch that is just now taking flight in the U.S.For the three months that ended in September, Bayer’s prescription drug sales grew a slim 0.4% on an adjusted basis to 4.3 billion euros (around $5 billion), with that showing working out to a 3.9% decline as reported, according to a Nov. 12 earnings presentation (PDF).Bayer’s branded drug sales missed Wall Street expectations, as well as the earnings forecasts set by analysts at Jefferies and ODDO BHF, according to notes reviewed by Fierce Pharma Wednesday.The sales stall can be chalked up in large part to tough quarters for Bayer’s blood and heart med Xarelto—which is facing generic competition—and its Regeneron-partnered ophthalmology blockbuster Eylea.Xarelto sales fell a steep 32.7% as reported in the third quarter to 540 million euros ($625 million), while Eylea’s haul of 731 million euros ($846 million) represented a 13.8% decline from the same period last year. Despite the largely stagnant performance this past quarter, Bayer remains “encouraged by the resilience of our top line” in pharmaceuticals, CEO Bill Anderson said on a conference call Wednesday. Anderson pointed to the strength of newer launches like prostate cancer med Nubeqa and the chronic kidney disease (CKD) therapy Kerendia, which recently scored an FDA nod in heart failure and benefited from increasing sales momentum in both China and the U.S.“[W]e’re aware that we have challenges to navigate, including declines in Xarelto sales, currency headwinds and some trade uncertainties,” Anderson caveated at the top of the call.Nevertheless, the company is “on track” to meet the upgraded guidance range it laid out this summer, Anderson said, which estimates that full-year sales will clock in between 45 billion euros and 47 billion euros.Looking ahead, Bayer anticipates 2026 Xarelto sales declines “in a similar percentage range as this year,” the company’s chief financial officer, Wolfgang Nickl, said on the earnings call. The situation around Eylea is murkier, Wolfgang admitted, suggesting that Bayer will continue to develop an understanding of the market dynamics as it strives to push the drug’s newer high-dose formulation, Eylea HD.Although Eylea may have had a choppy quarter, Stefan Oelrich, the head of Bayer’s pharmaceutical division, stressed that the company is “quite happy” with the performance of the drug’s high-dose formulation, noting that he expects Eylea HD “to take second place in the ophthalmology market” in Q4 behind the drug’s 2-mg dose. “The dynamics are intact,” he emphasized on the call.Still, one variable that remains “difficult to estimate” for Oelrich is “what’s going to happen everywhere around pricing,” which he noted is “somewhat outside of our control.”In recent weeks, several prominent drugmakers—including Pfizer, AstraZeneca, Novo Nordisk and Eli Lilly—have forged drug pricing deals with the United States government. The deals fall under President Donald Trump’s “most favored nation” pricing strategy and have prompted introspection about potential drug cost shifts in other geographies like continental Europe and the U.K. Launches gain steam It wasn’t all bad news for Bayer’s pharma division in the third quarter, with the German conglomerate’s newer launches Nubeqa and Kerendia continuing to deliver on the sales front.Nubeqa—first cleared in 2019 to treat prostate cancer—grew third-quarter sales nearly 50% to 622 million euros ($721 million), while Kerendia’s 221 million euro ($256 million) haul for the period amounted to roughly 75% sales growth over 2024.The newer meds’ growth looks here to stay, Oelrich stressed, with Bayer’s pharma chief forecasting “continuing good quarters” for Nubeqa in the coming months. Regarding Kerendia, Oelrich noted that he’s long stood behind the CKD and heart failure med’s “tremendous potential,” despite the drug suffering from a “slow start.”Initially approved for kidney disease in 2021, Kerendia picked up its second indication in heart failure over the summer.“When talking to my reps, especially in the U.S., we’re seeing very good reception of Kerendia in heart failure,” Oelrich said. Add to that the fact that the med is “synergistic to other therapies like SGLT2,” and Bayer believes that it has hit a sales “sweet spot” between the med’s two indications, Oelrich added.Bayer is also kicking off a fresh launch in its nonhormonal menopause symptom treatment Lynkuet, which passed muster with the FDA in late October. Oelrich was optimistic yet reserved about the drug’s market prospects, noting that “we’ll have to see a little bit how that goes.”That said, Bayer is “very bullish” on the product given its track record in women’s health, Oelrich said, commenting that he feels the timing to roll out a new menopause treatment is ideal and highlighting “quite surprising media response to our approval.”The first U.S. sales of Lynkuet were registered this week, and Bayer is now “getting ready to look at sequencing this into the rest of the world,” Oelrich explained.“This could be a good one,” Oelrich said of Lynkuet’s debut. “But it’s early days,” he cautioned, “so, let’s first do the work—and then let’s also celebrate a little bit like we’ve been doing on some of these other launches.”Bayer’s performance in the third quarter largely tracks with the rest of 2025; despite a stronger first quarter (PDF), Bayer’s pharma sales began to stall (PDF) in the second quarter and continued to chug along from July through September. The company has been undergoing a transformation under CEO Anderson, who took over in early 2023. In a bid to cut annual costs at the German conglomerate, Bayer had reduced its head count by more than 13,500 people under Anderson’s stewardship.But in what is undoubtedly a piece of good news for the remaining Bayer workforce, major cuts are likely in the rear view for now.“In terms of headcount reduction, we did the major surgery to get ourselves in the right place,” Anderson said of the restructure during Bayer’s call on Wednesday. With that in mind, the company still has “a lot of opportunities to go faster to make the system work for us,” the CEO explained.He caveated that there may still be “some continued reduction in total head count numbers” but stressed that the cuts will be more akin to “incremental attrition” than another “major surgery.”

Drug Approval

04 Nov 2025

·www.prnewswire.com

RedHill Announces $10.5 Million New York Supreme Court Judgment Win Now Final for Enforcement

RALEIGH, N.C. and TEL-AVIV, Israel, Nov. 4, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the New York Supreme Court's summary judgment in favor of RedHill against Kukbo Co. Ltd ("Kukbo") is now final and eligible for enforcement and foreign recognition, with no further appeal permissible following expiry of the appeal period. The Court has awarded more than $10.5 million in total to RedHill, comprised of the main judgment of approximately $8.6 million, now final and eligible for enforcement, and the award for legal fees and expenses of approximately $1.9 million (both include the principal amounts and accrued interest, to date) which remains subject to appeal until March 13, 2026. 9% annual statutory interest continues to accrue on both awards. In addition, RedHill has secured a Korean court attachment grant against Kukbo aimed at preventing Kukbo from disposing of assets prior to judgment enforcement. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[1], co-commercialized in the U.S. with Cumberland Pharmaceuticals. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential impact of Talicia. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company will not recover any or all of the funds from Kukbo or, if received, such recovery will be delayed, the risk that the strategic transaction with Cumberland will not bring the currently anticipated benefits to RedHill's global Talicia business or to RedHill's financial position, costs or its broader strategic objectives; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Corporate [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: . Logo: SOURCE RedHill Biopharma Ltd. 21% more press release views with Request a Demo

Phase 2Clinical ResultRadiation TherapyPhase 3

100 Deals associated with Darolutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Castration-sensitive prostate cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	03 Jun 2025
Hormone-dependent prostate cancer	European Union	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Iceland	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Liechtenstein	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Norway	Bayer AG	20 Mar 2023
Metastatic Prostate Carcinoma	Japan	Bayer AG	24 Feb 2023
Metastatic castration-resistant prostate cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	05 Aug 2022
Prostatic Cancer	Brazil	Bayer AG	01 Jan 2020
Castration-Resistant Prostatic Cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	30 Jul 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	France	Bayer AG	10 Apr 2025
Localized Prostate Carcinoma	Phase 3	Martinique	Bayer AG	10 Apr 2025
Recurrent Prostate Carcinoma	Phase 3	United States	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	China	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Japan	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Australia	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Austria	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Belgium	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Brazil	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Canada	Bayer AG	03 Apr 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05794906 (ARASTEP, Pubmed \| Future Oncol)	Phase 3	Non-metastatic prostate cancer	970	Darolutamide + ADT	atwnfnulrk(zkimepmilg) = kwvpzuwrgx tknoqoovet (twnyqbkuqk ) View more	Positive	14 Nov 2025
				Placebo + ADT	atwnfnulrk(zkimepmilg) = krjfulaoel tknoqoovet (twnyqbkuqk ) View more
NCT04122976 (DAROL, ESMO2025)	Not Applicable	Castration-Resistant Prostatic Cancer	799	Darolutamide	vsbpqqzinl(hdrsdfoijy) = buwfjhlzbt zdtjptxomz (vawrsgungk ) View more	Positive	17 Oct 2025
				Placebo	vsbpqqzinl(hdrsdfoijy) = zxjmvorzxv zdtjptxomz (vawrsgungk ) View more
ARAMIS (ESMO2025)	Phase 3	Castration-Resistant Prostatic Cancer	4,117	Darolutamide + ADT	zdoxumykrw(sjqqspihyd) = joojofiqyd doynmimacu (gkzocdzbcb )	Positive	17 Oct 2025
				Apalutamide + ADT	zdoxumykrw(sjqqspihyd) = rfosxdrwqk doynmimacu (gkzocdzbcb )
NCT06029036 (ESMO2025)	Phase 2	Neoadjuvant	53	Darolutamide + ADT	giiwennydn(ldpehimeoj) = girpulbkej hyhekpcpwf (timynucpqb ) View more	Positive	17 Oct 2025
NCT02799602 (ARASENS, ESMO2025)	Phase 3	Metastatic Prostate Carcinoma	847	Lead-in ADT used	uuwwwoqsix(dkmnimplkp) = xwhncrgwep hssmucrsey (ooonuecyzm ) View more	Positive	17 Oct 2025
				No lead-in ADT	uuwwwoqsix(dkmnimplkp) = wwushpnskh hssmucrsey (ooonuecyzm ) View more
ESMO2025	Not Applicable	Hormone-dependent prostate cancer	242	Darolutamide+ADT+DOC (DAR)	ugkujhcmcx(flylvmgkqr) = nombhmneff nnhovkejqw (kupzwoldfy, 51.0 - 72.9) View more	Positive	17 Oct 2025
				Abiraterone+ADT+DOC (ABI)	ugkujhcmcx(flylvmgkqr) = vwtyncmgel nnhovkejqw (kupzwoldfy, 32.0 - 63.0) View more
ESMO2025	Not Applicable	Castration-sensitive prostate cancer	455	Darolutamide + Docetaxel	hlnbsxfyuu(pxucbucqut) = paxxubaerq bjmwrkxmfo (jppnrdlvjr )	Positive	17 Oct 2025
				Apalutamide	hlnbsxfyuu(pxucbucqut) = crfgrxhhgn bjmwrkxmfo (jppnrdlvjr )
ESMO2025	Not Applicable	Hormone-dependent prostate cancer	1,189	ADT + Docetaxel + Darolutamide	ujqahbhcgw(nrhidltjjc): HR = 0.42 (95.0% CI, 0.21 - 0.82)	Positive	17 Oct 2025
				ADT + Docetaxel
NCT05526248 (ARAMON, CTgov)	Phase 2	Castration-sensitive prostate cancer \| Non-metastatic prostate cancer	28	Darolutamide(BAY1841788, Nubeqa)	aucilgstci(zedibgjidw) = pgfonrdvkq qdjnezogcp (fmgqgkxymq, jaxiqommaz - rxbcmwbtda) View more	-	15 Oct 2025
NCT04736199 (ARANOTE, CTgov)	Phase 3	Hormone-dependent prostate cancer	669	Androgen deprivation therapy (ADT)+Darolutamide (Nubeqa, BAY1841788) (Darolutamide+ADT)	ugntqxipwo(vznlqawkiu) = rsnqneqfkw uvwhnqemkk (wnofbdlgyo, ghrxpwlsod - bjqdabsabl) View more	-	08 Aug 2025
				Androgen deprivation therapy (ADT) (Placebo+ADT)	ugntqxipwo(vznlqawkiu) = rebumykiyw uvwhnqemkk (wnofbdlgyo, qicrhqllks - lzhhcvrdvx) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis