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

NCT07649421

/ Not yet recruitingPhase 2IIT

A Multicenter, Prospective, Randomized Controlled Phase II Trial of PSMA PET/CT-Guided Stereotactic Body Radiotherapy Combined With Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer

This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy. Participants whose cancer has not progressed and who still have active tumor lesions on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) will then be randomly assigned to one of two groups. One group will continue darolutamide plus androgen deprivation therapy. The other group will receive stereotactic body radiotherapy (SBRT) to all active tumor lesions identified by PSMA PET/CT, while continuing darolutamide plus androgen deprivation therapy. The main purpose of this study is to find out whether adding PSMA PET/CT-guided SBRT can help participants live longer without tumor growth seen on scans or death. The study will also evaluate prostate-specific antigen (PSA) changes, time to castration-resistant prostate cancer, overall survival, side effects, and quality of life.

Start Date01 Aug 2026

Sponsor / Collaborator

West China Hospital

[+1]

NCT07538843

/ Not yet recruitingNot Applicable

A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage

In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.
This study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.
The study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.
To learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.

Start Date30 Jul 2026

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

522

Literatures (Medical) associated with Darolutamide

01 Jun 2026·Clinical Genitourinary Cancer

Real-World Effectiveness and Treatment Persistence of Darolutamide, Apalutamide, and Enzalutamide in Non-Metastatic Castration-Resistant Prostate Cancer: A Multicenter Study

Article

Author: Urabe, Fumihiko ; Kimura, Takahiro ; Yata, Yuji ; Kawano, Shota ; Yamada, Hiroki ; Hashimoto, Masaki ; Imai, Yu ; Kurawaki, Shiro ; Otsuka, Takashi ; Mori, Keiichiro ; Iwamoto, Yuya ; Atsuta, Mahito ; Miyajima, Keiichiro ; Hara, Shuhei ; Ishikawa, Mimu ; Tsuzuki, Shunsuke ; Yanagisawa, Takafumi ; Fukuokaya, Wataru ; Kurokawa, Gaku ; Nakazono, Minoru ; Shimomura, Tatsuya

INTRODUCTION:

Three androgen receptor signaling inhibitors (ARSIs), darolutamide (DAR), apalutamide (APA), and enzalutamide (ENZ), are standard treatments for non-metastatic castration-resistant prostate cancer (nmCRPC); comparative real-world data on treatment persistence and safety remain limited.

PATIENTS AND METHODS:

We retrospectively analyzed 343 Japanese patients with nmCRPC treated with DAR (n = 92), APA (n = 64), or ENZ (n = 187) across 16 institutions. Oncological outcomes, including PSA progression-free survival (PSA-PFS) and PFS, were compared using multivariable Cox regression to adjust for baseline imbalances. Treatment persistence was evaluated by time to treatment discontinuation (TTD) and reasons for discontinuation.

RESULTS:

The ENZ group had significantly worse baseline characteristics than the other groups. After multivariable adjustment, DAR showed consistently favorable hazard ratios for PSA progression (HR, 0.55, P = .038) and disease progression (HR, 0.59, P = .047) compared with ENZ; however, these differences were attenuated and no longer statistically significant after PSM (PSA-PFS HR, 0.62, P = .119), suggesting broadly comparable oncological outcomes across agents. Median TTD was significantly shorter in the APA group (11.0 months) compared with the DAR (27.0 months) and ENZ (25.0 months) groups (P = .019). Discontinuation due to adverse events was significantly more frequent in APA (51.6%) than DAR (19.6%) or ENZ (18.8%), primarily due to skin rash. Among discontinuers, AEs were the primary reason in 82.5% of APA, 42.9% of DAR, and 41.7% of ENZ.

CONCLUSION:

In this real-world cohort, all 3 ARSIs demonstrated broadly comparable oncological outcomes, consistent with PSM. The principal differentiator was treatment persistence: APA was limited by markedly shorter TTD (median 11.0 months), primarily driven by skin rash; this difference was numerically preserved after PSM, though it did not reach statistical significance in the smaller matched sample. The high frequency of APA-related rash (46.9%) is consistent with prior Japanese/East Asian reports, including the integrated SPARTAN/TITAN Japanese analysis, and should be prioritized in treatment selection and patient counseling.

01 Jun 2026·EUROPEAN JOURNAL OF CANCER

Efficacy and safety of darolutamide in combination with androgen deprivation therapy and docetaxel in European patients from the phase 3 ARASENS trial

Article

Author: Hussain, Maha ; Littleton, Natasha ; Tombal, Bertrand ; Shore, Neal ; Bögemann, Martin ; Verholen, Frank ; Mendez-Vidal, Maria J ; Fizazi, Karim ; Smith, Matthew R ; Srinivasan, Shankar ; Saad, Fred ; Kopyltsov, Evgeny

BACKGROUND:

In ARASENS, risk of death was significantly reduced by 32.5% with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.57-0.80; p < 0.001) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We assessed efficacy and safety of darolutamide in European patients from ARASENS.

METHODS:

Patients were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. Primary endpoint was overall survival. Secondary endpoints included time to metastatic castration-resistant prostate cancer (mCRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent systemic antineoplastic therapy, and safety.

RESULTS:

In ARASENS, 472 (36%) patients were from Europe; 240 received darolutamide and 232 received placebo. Patient baseline characteristics were similar to those of the overall population. Darolutamide reduced the risk of death by 37% (HR, 0.63; 95% CI, 0.48-0.83), and delayed time to mCRPC, time to pain progression, time to first SSE, and time to initiation of subsequent systemic antineoplastic therapy compared with placebo. Incidences of serious treatment-emergent adverse events (TEAEs) were lower with darolutamide versus placebo (37.9% vs. 43.1%) compared with the overall population (44.8% vs. 42.3%).

CONCLUSION:

In European patients with mHSPC, darolutamide improved overall survival and secondary endpoints including time to mCRPC and time to pain progression. Darolutamide was well tolerated with similar incidence of TEAEs between treatment groups. Efficacy and safety findings in European patients were consistent with the overall ARASENS population.

01 Jun 2026·International Journal of Clinical Oncology

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; trastuzumab deruxtecan for solid tumors, talazoparib for prostate cancer, sacituzumab govitecan for breast cancer, darolutamide for salivary gland cancer, risovalisib for ovarian cancer, and mosunetuzumab plus polatuzumab vedotin for lymphoma

Author: Matsumura, Noriomi

307

News (Medical) associated with Darolutamide

15 hours ago

·www.biospace.com

Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

REVTORPYK (gedatolisib) REVTORPYK (gedatolisib) vial and box REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and fulvestrant and REVTORPYK combined with fulvestrant reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant among patients with PIK3CA wild-type advanced or metastatic breast cancer Celcuity to host webcast and conference call today Tuesday, July 14, 2026, at 5:30 p.m. EDT MINNEAPOLIS, July 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that the U.S. Food and Drug Administration (“FDA”) approved REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval. “The PI3K/AKT/mTOR, or PAM, pathway is one of the most important targets in cancer, but comprehensively inhibiting it has stymied researchers and drug developers for nearly two decades,” said Brian Sullivan, CEO and co-founder of Celcuity. “REVTORPYK addressed this 20-year challenge by becoming the first pan-PI3K, mTORC1/2 inhibitor approved by the FDA. We are thankful for the opportunity to make this important new therapy available to patients with HR+/HER2- locally advanced or metastatic breast cancer.” HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers. 1 Among this breast cancer subtype, approximately 60% have PIK3CA wild-type disease. 2 “For patients with HR+/HER2- locally advanced or metastatic breast cancer, there is an urgent need for new treatment options that can meaningfully increase the likelihood of survival without disease progression or death,” said Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head, Division of Hematology and Oncology, University of Washington, School of Medicine and co-principal investigator for the VIKTORIA-1 trial. “With the approval of REVTORPYK, oncologists now have an effective new treatment option for these patients.” The approval of REVTORPYK is based on positive clinical results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, an open-label, global, randomized clinical trial evaluating the efficacy and safety of REVTORPYK plus fulvestrant, with or without palbociclib, for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 therapy and an aromatase inhibitor. In the VIKTORIA-1 trial, median progression free survival (“PFS”) with the REVTORPYK triplet (REVTORPYK plus palbociclib and fulvestrant) was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate (“ORR”) of the REVTORPYK triplet was 32% compared to 1% with fulvestrant and the median duration of response (“DOR”) was 17.5 months. For the REVTORPYK doublet (REVTORPYK plus fulvestrant), the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the REVTORPYK doublet was 28% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response. “Today’s approval of REVTORPYK addresses a significant unmet need for the thousands of patients affected each year by HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “We are deeply grateful to the patients and their caregivers, investigators and clinical study teams, and Celcuity team members who made this advancement possible.” Celcuity anticipates commercial launch in late Q3 2026. Based on the company’s commitment to ensuring broad, affordable, and unrestricted patient access to REVTORPYK, we have designed a comprehensive patient support program. To make REVTORPYK available to patients prior to commercial launch, those who are eligible will be able to enroll in Celcuity’s expanded access program. Celcuity plans to submit in Q3 2026 a supplemental New Drug Application (“sNDA”) to the FDA for REVTORPYK for the treatment of HR+/HER2-, PIK3CA mutated, locally advanced or metastatic breast cancer, following at least one line of endocrine therapy based on results from the mutant cohort of the Phase 3 VIKTORIA-1 trial. Results for this study were recently presented in a late-breaking abstract oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Following the sNDA submission, Celcuity intends to submit VIKTORIA-1 data for marketing authorization of gedatolisib to other regulatory authorities around the world. REVTORPYK is also being studied in the ongoing Phase 3 VIKTORIA-2 clinical trial incorporating two independent studies evaluating two separate patient cohorts with HR+/HER2- locally advanced or metastatic breast cancer who are treatment-naive in the advanced setting. Webcast and Conference Call Information The Celcuity management team will host a live webcast and conference call on Tuesday, July 14, 2026, at 5:30 p.m. EDT / 4:30 p.m. CDT to discuss the FDA approval of REVTORPYK. Those who would like to participate may access the live webcast here , or register in advance for the teleconference here . A replay of the webcast will be available on the Celcuity website. About REVTORPYK (gedatolisib) REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT. 3.4.5 REVTORPYK is in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration resistant prostate cancer. Indication Statement REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fastingblood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose. Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment. ADVERSE REACTIONS REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils. REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea. USE IN SPECIFIC POPULATION Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility. Please see full Prescribing Information , including Patient Information , for REVTORPYK. You may report side effects related to Celcuity products to Celcuity Medical Information at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088 or . © 2026 Celcuity Inc. All rights reserved. REVTORPYK and its logo are trademarks of Celcuity, Inc. US-G1B-26-023407/26 About Celcuity Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Forward Looking Statements This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s sNDA for gedatolisib, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding the timing of and its ability to commercialize gedatolisib; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for gedatolisib; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. References: National Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025). Anderson, E. et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer, Int J Breast Cancer. 2020 Jun 20;2020:3759179. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. Contacts: For Investors: Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com (415) 494-9924 For Media: Sam Brown LLC Laura Morgan, lauramorgan@sambrown.com (951) 333-9110 A photo accompanying this announcement is available at

14 Jul 2026

·investors.oricpharma.com

ORIC® Pharmaceuticals Announces Initiation of Himalayas-1 Phase 3 Trial in mCRPC Evaluating Rinzimetostat in Combination with NUBEQA® (Darolutamide), Supported by Clinical Collaboration with Bayer

Initiated Himalayas-1 global Phase 3 trial in patients with mCRPC previously treated with abiraterone Entered into a clinical trial collaboration and supply agreement with Bayer to provide darolutamide for Himalayas-1 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, July 14, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the initiation of the Himalayas-1 global Phase 3 registrational trial in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone and announced a clinical trial collaboration and supply agreement with Bayer AG (“Bayer”). Himalayas-1 Global Phase 3 Registrational Trial Initiation ORIC previously presented dose optimization data for rinzimetostat in combination with darolutamide and selected 400 mg once daily rinzimetostat as the recommended Phase 3 dose (RP3D). Following End-of-Phase 1 interactions with the FDA and other global health authorities, ORIC finalized the trial protocol and has initiated the Himalayas-1 global Phase 3 registrational trial. The Himalayas-1 trial is expected to enroll approximately 600 patients from over 250 sites in 25 countries, randomized 1:1 to receive the RP3D of 400 mg once daily rinzimetostat (with or without food) in combination with darolutamide versus physician’s choice of an androgen receptor (AR) inhibitor or docetaxel. The primary endpoint is radiographic progression-free survival, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes. Clinical Trial Collaboration and Supply Agreement with Bayer Under the terms of the agreement, ORIC will conduct and sponsor the Himalayas-1 trial and Bayer will provide their AR inhibitor, NUBEQA® (darolutamide), at no cost for use in the trial in combination with rinzimetostat. This agreement does not grant Bayer any license, option, or other rights to rinzimetostat and ORIC retains full global development and commercial rights to rinzimetostat. “Given the significant unmet need in prostate cancer and the potential best-in-disease clinical profile that rinzimetostat has continued to demonstrate, the initiation of our Himalayas-1 Phase 3 trial represents an important milestone toward establishing rinzimetostat as a potentially practice-changing therapy for patients,” said Jacob M. Chacko, M.D., president and chief executive officer. “This collaboration with Bayer strengthens our global operational readiness by securing access to darolutamide for Himalayas-1 and underscores our shared interest in evaluating this regimen for patients with prostate cancer.” 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, 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 insertion and EGFR atypical 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, expectations and plans regarding the Himalayas-1 global Phase 3 registrational trial in mCRPC evaluating rinzimetostat in combination with NUBEQA® (darolutamide); the continued clinical development of rinzimetostat; the potential advantages of rinzimetostat; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-disease profile of rinzimetostat; 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 ORIC’s limited operating history; ORIC’s ability to complete clinical trials for, obtain approvals for and commercialize rinzimetostat; delays or difficulties in the enrollment and/or maintenance of patients in the Himalayas-1 clinical trial; changes in ORIC’s plans to develop and commercialize rinzimetostat; the potential for clinical trials of rinzimetostat to differ from preclinical, initial, interim, preliminary, expected or prior clinical trial 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, including its agreement with Bayer; 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 May 4, 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 3License out/in

18 Jun 2026

·www.prnewswire.com

RedHill Biopharma Announces Up To $19.4 Million Private Placement

$6 million upfront with up to approximately $13.4 million of potential aggregate gross proceeds upon the exercise in full of warrants TEL AVIV, Israel & RALEIGH, N.C., June 18, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 8,571,429 American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten thousand (10,000) ordinary shares of the Company, series A-1 warrants to purchase up to an aggregate of 8,571,429 ADSs and series A-2 warrants to purchase up to an aggregate of 8,571,429 ADSs, at a combined purchase price of $0.70 per ADS (or ADS equivalent in lieu thereof) and accompanying warrants in a private placement. The Series A-1 warrants have an exercise price of $0.86 per ADS, are exercisable immediately and have a term of five years following the Effectiveness Date (as defined below), and the Series A-2 warrants have an exercise price of $0.70 per ADS, are exercisable immediately and have a term of 18 months following the Effectiveness Date. The private placement is expected to close on June 22, 2026, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to the Company from this offering are expected to be approximately $6 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A-1 warrants and the series A-2 warrants, if fully exercised on a cash basis, will be approximately $13.4 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants. The Company intends to use a portion of the net proceeds to support a potential strategic product acquisition and the balance for working capital, research and development and general corporate purposes. No definitive acquisition agreement has been executed, and any such transaction would remain subject to completion of definitive documentation, financing and other customary conditions. There can be no assurance that any such transaction will be completed. The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the ordinary shares of the Company represented by ADSs underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities issued in the private placement and ordinary shares of the Company represented by ADSs underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date"). This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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], with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). 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, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations intended for medical countermeasure development including for Ebola virus disease, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-102 (Bekinda®), 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 Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) 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 (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. 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, the consummation of the offering and the satisfaction of customary closing conditions related to the offering, the use of proceeds therefrom, the potential exercise of the series warrants and potential proceeds therefrom, potential acquisition of strategic products, statements regarding the potential submission of Talicia® for UK Marketing Authorisation and any approval thereof and statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. 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: market and other conditions, the risk that the MAA submission for Talicia may not be approved; the risk that the Company will not succeed in its enforcement action against Kukbo, and if successful may not recover all or any of awards granted by the New York Supreme Court; the risk that opaganib does not receive a priority review voucher, marketing exclusivity or accelerated development and review times; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; 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) the Company's ability to collect on its judgment against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) 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 27, 2026. 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: Financials [1]Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma [email protected] SOURCE RedHill Biopharma Ltd. 21% more press release views with Request a Demo

Clinical ResultPhase 2

100 Deals associated with Darolutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

10 top approved records.

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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

10 top R&D records.

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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
PSMA-Positive Prostatic Cancer	Phase 3	United States	Orion Oyj	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	United States	Bayer HealthCare Pharmaceuticals, Inc.	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	United States	Bayer Healthcare Co., Ltd.	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	Japan	Bayer HealthCare Pharmaceuticals, Inc.	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	Japan	Bayer Healthcare Co., Ltd.	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	Japan	Orion Oyj	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	Australia	Orion Oyj	03 Apr 2023
PSMA-Positive Prostatic Cancer	Phase 3	Australia	Bayer Healthcare Co., Ltd.	03 Apr 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Hormone-dependent prostate cancer	78	Darolutamide plus ADT	fedzwdkyye(lcrpqsxtov) = dvfyuhpxjm tfvfmyskpb (yaegmvthst ) View more	Positive	29 May 2026
ASCO2026	Phase 3	Hormone-dependent prostate cancer	13	Darolutamide therapy	qvruhcvtnx(dgygdybsae): HR = 0.62 (95.0% CI, 0.55 - 0.7), P-Value = < 0.00001 View more	Positive	29 May 2026
				Control therapy
ASCO2026	Not Applicable	Castration-Resistant Prostatic Cancer	198	Enzalutamide	liwwdxhagy(ojaxiqxfdr): P-Value = 1.0 View more	Positive	29 May 2026
				Darolutamide
NCT05669664 (ETCTN 10553, ASCO2026)	Phase 2	AR Positive Salivary Gland Neoplasms androgen receptor (AR) positive	20	Darolutamide 600 mg orally twice daily + Leuprolide acetate intramuscular injections	xxpotikrpx(tzkzfnaotn) = rcbcfdiogh lypggtjrzl (mmbsvkoizz ) View more	Positive	29 May 2026
				Darolutamide 600 mg orally twice daily + Leuprolide acetate intramuscular injections (Female)	xxpotikrpx(tzkzfnaotn) = uxcbylmqkd lypggtjrzl (mmbsvkoizz ) View more
YHCG-006 (ASCO2026)	Not Applicable	Hormone-dependent prostate cancer	100	ADT, Darolutamide, and Docetaxel	mccevondyz(hxnmapixdt) = dhuigfftwt wwvgapyafg (xejwwbvucx ) View more	Positive	29 May 2026
NCT04736199 (ARANOTE, ASCO2026)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide 600 mg	ytezgrawos(awkmeezgcb) = xkqiwalusf dzigqfwmqt (xuoqoilris ) View more	Positive	29 May 2026
				Placebo	ytezgrawos(awkmeezgcb) = lzuajsvrbz dzigqfwmqt (xuoqoilris ) View more
ASCO2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	11,588	Darolutamide (doublet therapy)	ethlptfref(iftsxxeasf) = mfojjxrtwp amsneabtvz (ivyhntzpgd, 5.6 - 9.0) View more	Positive	29 May 2026
				Abiraterone (doublet therapy)	ethlptfref(iftsxxeasf) = srlriagvhx amsneabtvz (ivyhntzpgd, 10.0 - 11.4) View more
ASCO2026	Not Applicable	Castration-sensitive prostate cancer	726	Abiraterone + ADT	xvqvudaldy(oghlggxkbs) = All-cause mortality was also higher in the abiraterone group (OR 3.4; 95% CI, 2.3-5.1) abyigwhuxj (ywjdglqtju ) View more	Negative	29 May 2026
				Darolutamide + ADT
NCT04736199 (ARANOTE, Pubmed \| Lancet Oncol)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide + ADT	mzgeuuvomn(dysdxqnssy) = Darolutamide delayed time to pain progression (HR 0·72; 95% CI 0·54–0·96) and extended time to deterioration in FACT-P total score (HR 0·76; 0·61–0·94) versus placebo. nznbzwrbit (miaputejsa ) View more	Positive	01 May 2026
				Placebo + ADT
NCT06013475 (DEAR-EXT, Pubmed \| Prostate Cancer Prostatic Dis)	Not Applicable	Castration-Resistant Prostatic Cancer	1,375	Darolutamide	yjluqxrtta(vnrjeijwsw) = qpdwgcbzfd ltbdbiwbru (squmqlkihh ) View more	Positive	18 Mar 2026
				Enzalutamide	yjluqxrtta(vnrjeijwsw) = dkvmwgqdop ltbdbiwbru (squmqlkihh ) View more

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