DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

Start Date01 Nov 2026

Sponsor / Collaborator

The University of Chicago

NCT07395804

/ Not yet recruitingNot Applicable

DAROlutamide DoUBlet Therapy in Daily Practice (DARO-DUB) - Real-world Evaluation of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Treated With Darolutamide Plus ADT in Germany

Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).
The usual treatment for this stage of prostate cancer is hormone therapy (called androgen-deprivation therapy or ADT) combined with another medicine that blocks the effect of male hormones on cancer cells, known as an androgen-receptor pathway inhibitor. Darolutamide is a newer type of androgen-receptor inhibitor.
The main goal of this study is to find out how well a combination of two treatments-darolutamide and hormone therapy (also called androgen-deprivation therapy or ADT)-works for men in Germany who have advanced prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study will look at how many men have very low or undetectable levels of a protein called prostate-specific antigen (PSA) in their blood after 12 months of treatment. PSA is a marker that doctors use to check how active prostate cancer is.
The study will also look at how long men live after starting this treatment, and will collect information about their health, the type of prostate cancer they have, and any other medicines they are taking. The study will last for 5 years. At the start of the study, the study doctor will collect information about each patient's background, such as age, other health problems, and details about their prostate cancer. This information will be taken from the patient's medical records if available. If some information is missing, the doctor may ask the patient directly.
Other information will be collected as the study goes on. This includes details about the patient's treatment, how they are doing during their regular medical visits, and any changes in their health. These check-ups and data collection will happen as part of the patient's usual care, including at the beginning of treatment, during treatment visits, follow-up visits, and at the end of the study observation period.

Start Date28 Feb 2026

Sponsor / Collaborator

Bayer AG

NCT07142551

/ Not yet recruitingPhase 2IIT

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

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 Date20 Feb 2026

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

464

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.

01 Feb 2026·ANTICANCER RESEARCH

Prolonged Castration Prior to Docetaxel Reduces Febrile Neutropenia in Patients With Metastatic Hormone-sensitive Prostate Cancer Receiving Triple Therapy

Article

Author: Higuchi, Kosuke ; Kanesaka, Manato ; Nakamura, Kazuyoshi ; Kurozumi, Akira ; Tamura, Takaaki ; Fukasawa, Satoshi ; Mikami, Kazuo ; Sazuka, Tomokazu ; Sakamoto, Shinichi ; Sato, Hiroaki ; Arai, Takayuki ; Azuma, Haruhito ; Takeshita, Nobushige ; Suzuki, Noriyuki ; Imamura, Yusuke ; Tsujino, Takuya ; Yamada, Yasutaka ; Shirafuji, Tomoki ; Yamamoto, Satoshi ; Sato, Kodai

BACKGROUND/AIM:

Triplet therapy, combining androgen deprivation therapy (ADT), darolutamide, and docetaxel has recently emerged as the standard first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC). Febrile neutropenia (FN) is a major clinical issue not only as a serious infection but also as a cause for early cessation or dose reduction of chemotherapy. However, little is known regarding the predictive factors for the development of FN in patients with mHSPC receiving triplet therapy.

PATIENTS AND METHODS:

This study enrolled 60 patients diagnosed with mHSPC across multiple institutions from 2023 to 2025. We examined clinical characteristics, treatment schedules, adverse events, and oncological outcomes. We focused particularly on the development of FN and used logistic regression analysis to investigate the predictive factors.

RESULTS:

The median age was 72 years old, and 43 patients (73.3%) had high-volume disease at diagnosis. Nine patients (15%) developed FN. Multivariate logistic regression analysis identified older age [≥75, p=0.0161; hazard ratio (HR)=7.49], high-volume disease (p=0.0335), and shorter interval from ADT to docetaxel (<40 days) (p=0.0389; HR=7.86) as independent predictive factors of the development of FN. Notably, prolonged castration period prior to docetaxel (≥40 days) significantly reduced the risk of FN from 23.5% to 3.8% (p=0.0001). Patients who developed FN tended to have shorter castration-resistant prostate cancer progression-free survival (CRPC-PFS) compared to those who did not (p=0.0812; HR=3.2).

CONCLUSION:

Older age and high-volume disease were independent risk factors for FN in patients with mHSPC receiving triplet therapy. A longer interval from ADT initiation to docetaxel (≥40 days) was associated with a significantly lower risk of FN, suggesting that extending the pre-docetaxel castration period is a practical, adjustable scheduling strategy to improve treatment safety. These findings may support treatment selection and proactive prevention of FN.

01 Feb 2026·INTERNATIONAL JOURNAL OF UROLOGY

Impact of Immunohistochemical PSA and Ki‐67 Expression on Prognosis in Metastatic Castration‐Sensitive Prostate Cancer

Article

Author: Urabe, Fumihiko ; Imai, Yu ; Umemori, Miyaka ; Sato, Shun ; Takahashi, Hiroyuki ; Iwamoto, Yuya ; Kimura, Takahiro ; Tashiro, Kojiro

ABSTRACT:

Background and Objective:

Treatment selection for metastatic castration‐sensitive prostate cancer (mCSPC) remains challenging, as reliable and practical biomarkers predicting response to androgen receptor pathway inhibitor (ARPI)‐based therapy are limited. We evaluated whether prostate‐specific antigen (PSA) and Ki‐67 expression in diagnostic biopsy specimens can predict oncologic outcomes in patients with mCSPC treated with ARPI–androgen deprivation therapy (ADT) doublet therapy, and whether these biomarkers can guide optimal treatment selection.

Methods:

This retrospective multicenter study included 58 patients with mCSPC who received ARPI–ADT doublet therapy between 2018 and 2024. Immunohistochemical staining for PSA and Ki‐67 was performed on diagnostic biopsy specimens. Receiver operating characteristic curve analyses were used to determine optimal cutoff values for predicting progression to castration‐resistant prostate cancer (CRPC). Survival outcomes were analyzed using the Kaplan–Meier method and Cox proportional hazards models. Exploratory analyses included patients treated with triplet therapy (ADT + docetaxel + darolutamide) or upfront docetaxel.

Results:

Low PSA expression, high Ki‐67 expression, and a bone metastasis extent of disease (EOD) score ≥ 3 were independently associated with shorter CRPC‐free survival (CRPC‐FS). Stratification by risk factors (0, 1, or 2) showed a stepwise decline in CRPC‐FS. In exploratory analyses, triplet therapy achieved the longest CRPC‐FS and progression‐free survival 2 among high‐risk patients, whereas no significant differences among treatment modalities were observed in the low‐risk group.

Conclusion:

Immunohistochemical PSA and Ki‐67 expression provide practical prognostic information for patients with metastatic castration‐sensitive prostate cancer. Combined assessment with EOD ≥ 3 identifies a high‐risk subgroup with unfavorable clinical outcomes.

258

News (Medical) associated with Darolutamide

2 hours ago

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Joint U.S. Commercialization of RedHill's Talicia® Commences

The full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. (THI), a jointly controlled entity of RedHill and Cumberland has started and is now being rolled out to support accelerated market penetration and expanded reach Focused on unlocking the full market potential of Talicia, the #1 branded U.S. gastroenterologist-prescribed H. pylori therapy1, THI and Cumberland will manage the launch and ongoing joint commercialization activities H. pylori infection affects 35% of the U.S. adult population and an estimated 1.6 million U.S. patients are treated annually2. Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy addressing antibiotic resistance and is recommended as an empiric first-line H. pylori therapy in the American College of Gastroenterology (ACG) Clinical Guideline3 RALEIGH, N.C. and TEL-AVIV, Israel, Feb. 25, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. ("THI") and Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), has started and is now being rolled out to support accelerated market penetration and expanded reach. This marks the operational launch of the joint commercialization model previously announced in October 2025, including Cumberland's $4 million strategic investment. Focused on unlocking the full market potential of Talicia, the #1 branded U.S. gastroenterologist-prescribed H. pylori therapy, THI, a RedHill and Cumberland jointly controlled operating entity (70/30 RedHill/ Cumberland ownership) will manage the launch and ongoing joint commercialization, in coordination with Cumberland. "H. pylori infection affects 35% of the U.S. adult population and is a leading cause of gastric cancer, responsible for approximately 11,000 related U.S. deaths a year," said Rick Scruggs, President of THI and RedHill's Chief Commercial Officer. "Patients should have access to the most effective, clinically differentiated, therapies designed to eradicate H. pylori infection on the first attempt, while mitigating the risk of antibiotic resistance. We are excited to propel Talicia into its next phase of growth in this expanding market. We are integrating key commercial resources and leveraging our combined expertise to balance stronger prescription growth with the delivery of operational efficiencies as we drive to ensure that more patients benefit from this important therapy." Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy designed to address growing antibiotic resistance concerns to other available therapies. It is listed as a first-line H. pylori treatment option in the 2024 American College of Gastroenterology (ACG) Clinical Guideline, which emphasizes using 14-day, "optimized" regimens for the first attempt to maximize cure rates and avoid the need for complex, less-effective salvage therapies4. It is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation. Talicia is also the only FDA-approved medication for H. pylori infection with an all-in-one formulation, with the added benefit of simple dosing. RedHill continues to work towards expanding patient access to Talicia globally. Efforts focused on potential new market entries in the UK and the Middle East, along with work to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams, are ongoing. About H. pylori H. pylori is a bacterial infection that affects approximately 35% of the U.S. adult population (an estimated 1.6 million U.S. patients are treated annually) rising to more than 50% globally[4]. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually5 and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases)6 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma7. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies8. About Talicia® Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health. 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 adults9, with a recent co-commercialization agreement 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 medical countermeasures including 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); (iii) RHB-102, with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America; and (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases. More information about the Company is available at / X.com/RedHillBio. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at . 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 the relationship with Cumberland on the commercialization 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 co-commercialization of Talicia with Cumberland may not provide the anticipated commercial and operational benefits to RedHill's global Talicia business or to RedHill's financial position, costs or its broader strategic objectives, including accelerating prescriptions, improving operational efficiencies and enabling more patients to benefit from Talicia; the risk regarding the Company's ability to maintain compliance with Nasdaq's listing requirements, including the minimum stockholders' equity requirement; 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. Category: Corporate [1] IQVIA XPO Data on file [2] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. [3] Chey W, Howden C, Moss S, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2024;119:1730-53. [4] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. [5] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). [6] Malfertheiner, P., Camargo, M.C., El-Omar, E. et al. Helicobacter pylori infection. Nat Rev Dis Primers 9, 19 (2023). [7] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. [8] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. [9] 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

Clinical ResultPhase 2Phase 3License out/inDrug Approval

24 Feb 2026

·www.prnewswire.com

K36 Therapeutics Highlights First-in-Human KTX-2001 Prostate Cancer Study Design at American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2026

KTX-2001 is being evaluated in the Phase 1 STRIKE-001 clinical trial both as a monotherapy and in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) CAMBRIDGE, Mass., Feb. 24, 2026 /PRNewswire/ -- K36 Therapeutics, Inc. ("K36"), a privately held, clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, today announced data from its Phase 1 clinical trial of KTX-2001 will be presented in a Trial in Progress poster at the ASCO Genitourinary Cancers Symposium, taking place February 26–28, 2026, in San Francisco, California. KTX-2001 is a first-in-class, orally administered, selective NSD2 inhibitor being evaluated in patients with metastatic castration-resistant prostate cancer (mCRPC) and represents the company's second NSD2 inhibitor to enter clinical development. The KTX-2001 Trial in Progress poster will highlight the scientific rationale, study design, patient population, and dose-escalation study of the first-in-human Phase 1 STRIKE-001 trial. Part A is designed to evaluate the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose(s) of KTX-2001 monotherapy. Part B will evaluate the safety and tolerability of KTX-2001 plus darolutamide to determine the recommended Phase 2 dose(s) for the combination. Secondary objectives include assessments of pharmacokinetics, pharmacodynamics, and preliminary clinical activity. "We are pleased to present the STRIKE-001 study design evaluating KTX-2001, an oral, first-in-class NSD2/MMSET inhibitor, in metastatic castration-resistant prostate cancer," said Wassim Abida, MD, PhD, of Memorial Sloan Kettering Cancer Center. "Preclinical findings support the rationale for targeting NSD2 in prostate cancer, where it has been associated with lineage plasticity, resistance to androgen receptor pathway inhibitors, and progression to treatment-emergent neuroendocrine disease. STRIKE-001 is designed to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of KTX-2001 as monotherapy and in combination with darolutamide in this setting." STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation of KTX-2001 monotherapy (Part A) and in combination with darolutamide, an oral, nonsteroidal androgen receptor inhibitor (Part B). ASCO Genitourinary Cancers Symposium, February 26– 28, 2026 Trial in Progress Poster Details: Title: Phase 1, dose-escalation study of KTX-2001 (an NSD2 inhibitor) alone and in combination with darolutamide for metastatic castration-resistant prostate cancer Abstract Number: TPS276 Poster Number: N12 Session Title: Trials in Progress Poster Session A: Prostate Cancer Presentation Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST) Location -Moscone Center (West), San Francisco Full abstract can be found at ASCO GU Meeting Website: About the KTX-2001 Phase 1 Clinical Trial (STRIKE-001) STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation evaluating KTX-2001 as a monotherapy (Part A) and in combination with darolutamide (Part B). K36 expects to enroll approximately 140 patients with mCRPC who have received prior androgen receptor inhibitors and prior chemotherapy. KTX-2001 is a small molecule, selective inhibitor of nuclear receptor binding SET domain protein 2 (NSD2, also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). KTX-2001 inhibits NSD2-mediated dimethylation of histone H3 at lysine 36 (H3K36me2), disrupting aberrant NSD2-dependent oncogenic pathways. About K36 Therapeutics, Inc. Founded in February 2021, K36 Therapeutics is a privately held biotechnology company backed by Atlas Venture, F-Prime, Eight Roads Ventures, Nextech and Bristol Myers Squibb. Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide. For more information, please visit and follow us on LinkedIn. Contacts: K36 Therapeutics Soo Bang [email protected] Media Sarah Sutton [email protected] SOURCE K36 Therapeutics 21% more press release views with Request a Demo

Phase 1ASCO

23 Feb 2026

·investors.oricpharma.com

ORIC® Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Updates

Reported rinzimetostat (formerly ORIC-944) Phase 1b data that continue to demonstrate potential best-in-class efficacy and safety in mCRPC; selected provisional RP2Ds and initiated dose optimization in combination with AR inhibitors Presented potential best-in-class enozertinib Phase 1b data demonstrating highly competitive systemic and intracranial activity in NSCLC patients with EGFR exon 20 and EGFR PACC mutations; selected Phase 3 monotherapy dose Raised $264 million from top-tier healthcare specialist funds; Cash and investments expected to provide runway into 2H 2028 and beyond anticipated primary endpoint readout for rinzimetostat Phase 3 study Expect to report multiple clinical data readouts for rinzimetostat and enozertinib in 2026, ahead of potential initiation of multiple registrational trials SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Feb. 23, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter and year ended December 31, 2025. “2025 was a transformational year for ORIC highlighted by clinical data that further demonstrated the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer,” said Jacob M. Chacko, M.D., president and chief executive officer. “Those data, along with substantially extended cash runway, position us well for 2026 and beyond as we advance our programs towards registrational studies.” 2025 Key Accomplishments Rinzimetostat: a potent and selective allosteric inhibitor of PRC2 Completed Phase 1b dose exploration in prostate cancer and selected provisional recommended Phase 2 doses (RP2Ds) of rinzimetostat to be tested in combination with the approved doses of darolutamide and apalutamide in dose optimization. Reported potential best-in-class efficacy and safety dose exploration data in combination with darolutamide and with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated: PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide. Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed). Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations. Both combination regimens demonstrated a clearly differentiated 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. Presented preclinical data at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics demonstrating potential utility of rinzimetostat combined with AR inhibition in castration-sensitive prostate cancer and combined with KRAS inhibition in KRAS G12C-mutant NSCLC and colorectal cancer models. PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide. Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed). Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations. Both combination regimens demonstrated a clearly differentiated 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. Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20 and EGFR PACC mutations Reported potential best-in-class efficacy and safety data from a Phase 1b trial of enozertinib at the ESMO Asia Congress 2025 in NSCLC patients with EGFR exon 20 and EGFR PACC mutations. Data demonstrated: Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks. Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC. Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases. Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations. Announced a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate enozertinib in combination with amivantamab and hyaluronidase-lpuj subcutaneous injection (SC amivantamab) for the 1L treatment of NSCLC patients with EGFR exon 20 mutations. Announced publication in Cancer Research of preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain penetrance, and antitumor activity across a broad range of EGFR exon 20 and PACC mutant models. Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks. Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC. Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases. Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations. Anticipated Program Milestones: ORIC anticipates the following upcoming milestones: Rinzimetostat in mCRPC: 1Q 2026: Combination dose optimization data with AR inhibitor 1H 2026: Initiate first global Phase 3 registrational trial in mCRPC 2H 2026: Program update Enozertinib in NSCLC: 2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab 2H 2026: 1L EGFR PACC monotherapy data 1Q 2026: Combination dose optimization data with AR inhibitor 1H 2026: Initiate first global Phase 3 registrational trial in mCRPC 2H 2026: Program update 2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab 2H 2026: 1L EGFR PACC monotherapy data Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $392.3 million as of December 31, 2025, which includes net proceeds of $124.4 million from a private placement financing in May 2025 and $117.6 million from the company’s ATM program in 2025. Subsequent to the quarter ended December 31, 2025, the company raised an additional $20.0 million in net proceeds from a healthcare specialist fund under the ATM program resulting in proforma cash and investments of $412.3 million as of December 31, 2025. The company expects its cash and investments to fund the current operating plan into 2H 2028. R&D Expenses: Research and development (R&D) expenses were $25.9 million for the three months ended December 31, 2025, compared to $32.0 million for the three months ended December 31, 2024, a decrease of $6.1 million. For the year ended December 31, 2025, R&D expenses were $109.8 million compared to $114.1 million for the same period in 2024, a decrease of $4.3 million. The decreases were due to lower rinzimetostat drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib. G&A Expenses: General and administrative (G&A) expenses were $8.7 million for the three months ended December 31, 2025, compared to $7.6 million for the three months ended December 31, 2024, an increase of $1.1 million. For the year ended December 31, 2025, G&A expenses were $33.2 million compared to $28.8 million for the same period in 2024, an increase of $4.4 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation. 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) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 and EGFR PACC mutations, being developed for NSCLC. 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, the continued clinical development of rinzimetostat (ORIC-944) and enozertinib; the potential advantages of rinzimetostat and enozertinib; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-class properties of rinzimetostat and enozertinib; the development plans and timelines for rinzimetostat and enozertinib; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational trials; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; 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 rinzimetostat, 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on February 23, 2026, 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 ResultFinancial StatementAACR

100 Deals associated with Darolutamide

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KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

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Indication	Country/Location	Organization	Date
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
Castration-sensitive prostate cancer	China	Bayer HealthCare Pharmaceuticals, Inc.	16 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

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	Phase 3	Castration-Resistant Prostatic Cancer	1,509	Darolutamide + ADT	xnlwawogki(gumuvtueci): HR = 0.36 (95.0% CI, 0.26 - 0.48) View more	Positive	01 Jan 2026
				Placebo + ADT
ARAMIS (ESMO_ASIA2025)	Phase 3	Castration-Resistant Prostatic Cancer	76	Darolutamide + androgen-deprivation therapy	rsowpxhrgu(fyfkmxmbtl) = nupmnphenf amgkicqnil (enqhbkgank ) View more	Positive	05 Dec 2025
ChiCTR2500096436 (DAPLOM, ESMO_ASIA2025)	Phase 2	Castration-sensitive prostate cancer	60	Darolutamide + ADT + prostate arterial docetaxel infusion	dpmennowkt(awcsyqzher) = rwgksmsfux jmwljnagua (gstydfhqes )	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Hormone-dependent prostate cancer	8	Darolutamide + Trans-arterial chemoperfusion by Docetaxel + ADT	yltzlmajqc(tijlkdmxgx) = fviwvooaqs zcelsgkzyn (lhxgsdqgga ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Hormone-dependent prostate cancer	25	Darolutamide + Docetaxel + ADT	kfaovtvymp(lavccxwnse) = hzrppogrvz akjsmidqlk (rwevjpovoa ) View more	Positive	05 Dec 2025
NCT05794906 (ARASTEP, Pubmed \| Future Oncol)	Phase 3	Non-metastatic prostate cancer	970	Darolutamide + ADT	sguasillgw(otsrvwtroi) = pmyggxmmxz qkprhmkvbp (qyqhwcjsuy ) View more	Positive	14 Nov 2025
				Placebo + ADT	sguasillgw(otsrvwtroi) = blrzkkrswk qkprhmkvbp (qyqhwcjsuy ) View more
NCT04122976 (DAROL, ESMO2025)	Not Applicable	Castration-Resistant Prostatic Cancer	799	Darolutamide	tcjlawhdct(qnlbkzcdeu) = tbnkneqpsc xpseuzjcls (oendqypevg ) View more	Positive	17 Oct 2025
				Placebo	tcjlawhdct(qnlbkzcdeu) = dauzdctytq xpseuzjcls (oendqypevg ) View more
ESMO2025	Not Applicable	Castration-sensitive prostate cancer	455	Darolutamide + Docetaxel	pwtijyrzdp(sobphpfysh) = lyamiqylyu bydihcstsz (wuhydvqogs )	Positive	17 Oct 2025
				Apalutamide	pwtijyrzdp(sobphpfysh) = jekmrhzywt bydihcstsz (wuhydvqogs )
NCT02799602 (ARASENS, ESMO2025)	Phase 3	Metastatic Prostate Carcinoma	847	Lead-in ADT used	brnlarailu(elmhknngaj) = nniastdxyd qbhizxeoof (cjtonpzell ) View more	Positive	17 Oct 2025
				No lead-in ADT	brnlarailu(elmhknngaj) = vtqbhujgfw qbhizxeoof (cjtonpzell ) View more
ESMO2025	Not Applicable	Hormone-dependent prostate cancer	242	Darolutamide+ADT+DOC (DAR)	nysvuyzrmp(jseyloiywj) = rrrxgovhoy jqgrqolfzv (ufjfhlfxyx, 51.0 - 72.9) View more	Positive	17 Oct 2025
				Abiraterone+ADT+DOC (ABI)	nysvuyzrmp(jseyloiywj) = clhkkhxvug jqgrqolfzv (ufjfhlfxyx, 32.0 - 63.0) View more

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