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

NCT07620041

/ Not yet recruitingPhase 1

A Phase 1 Study to Evaluate the C-QTc Interval of QLC5508, Compare the Pharmacokinetics of Two Different Formulations, and Assess Drug-Drug Interaction Potential in Participants With Advanced Solid Tumors

A clinical trial of QLC5508 for advanced solid tumors
The goal of this clinical trial is to learn if QLC5508 can be given safely to adults with advanced solid tumors. It will also learn how two different formulations of QLC5508 compare in the body, and whether other drugs affect QLC5508. The main questions it aims to answer are:
Does a single injection of QLC5508 change the heart's electrical activity (QTc interval)?
How do the test formulation and the reference formulation of QLC5508 compare in the body (pharmacokinetics)?
Do other drugs (itraconazole, darolutamide, or rifampicin) change how the body processes QLC5508?
Investigators will compare the test formulation to the reference formulation, and will also give QLC5508 together with itraconazole, darolutamide, or rifampicin to look for drug-drug interactions.
Participants will:
Receive QLC5508 by injection into a vein;
Join one of three groups: two groups will receive both formulations of QLC5508 at different times (crossover) and also take rifampicin or itraconazole; the third group will take darolutamide with QLC5508;
Have heart monitoring (Holter) during the first dose;
Undergo regular blood tests, safety checks, and immunogenicity testing (to see if the body develops antibodies against QLC5508).

Start Date05 Jun 2026

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

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 Date01 Jun 2026

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

516

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.

07 May 2026·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Triplet therapy versus androgen receptor pathway inhibitor–doublet therapy in metastatic castration-sensitive prostate cancer: a real-world multicenter retrospective comparison

Article

Author: Kimura, Takahiro ; Fujita, Naoki ; Urabe, Fumihiko ; Sasaki, Takaya ; Narita, Shintaro ; Yanagisawa, Takafumi ; Sato, Hiromi ; Hatakeyama, Shingo ; Tashiro, Kojiro ; Fukuokaya, Wataru ; Habuchi, Tomonori

Abstract:

Background:

Although pivotal trials have demonstrated the superiority of triplet therapy over androgen deprivation therapy (ADT)–docetaxel doublet therapy, direct comparisons between triplet and androgen receptor pathway inhibitor (ARPI)–ADT doublet therapy remain lacking in real-world practice. This study evaluated the comparative efficacy and safety of triplet versus ARPI-doublet therapy in patients with metastatic castration-sensitive prostate cancer (mCSPC).

Methods:

A total of 837 patients with de novo mCSPC treated between February 2018 and April 2025 were included: 121 received triplet therapy (darolutamide plus docetaxel with ADT), and 716 received ARPI-doublet therapy (abiraterone acetate, enzalutamide, or apalutamide with ADT). The primary endpoint was castration-resistant prostate cancer–free survival (CRPC-FS), and the secondary endpoints were progression-free survival 2 (PFS2) and treatment-related adverse events (TRAEs). Propensity score–based inverse probability of treatment weighting (IPTW) and multiple sensitivity analyses adjusted for baseline imbalances.

Results:

The median follow-up was 24 months. In the IPTW-adjusted analysis, triplet therapy significantly improved CRPC-FS compared with ARPI-doublet therapy (hazard ratio 0.52, 95% confidence interval 0.39–0.68; P < .001). Subgroup analysis demonstrated consistent benefits in patients with high-volume disease, while no CRPC events occurred in the low-volume subgroup. Sensitivity analyses using propensity score matching and truncated IPTW confirmed the robustness of these findings. Cancer-specific and overall survival were not assessable because of limited follow-up and few events in the triplet cohort. Regarding safety, triplet therapy was associated with higher rates of grade ≥ 3 TRAEs (48.8% vs 8.7%), mainly hematologic toxicities.

Conclusion:

Triplet therapy significantly prolonged CRPC-FS compared with ARPI-doublet therapy in patients with de novo mCSPC, particularly among those with high-volume disease. However, this benefit was accompanied by higher toxicity, underscoring the need to balance efficacy with safety. Longer follow-up is required to determine impacts on PFS2, cancer-specific survival, and overall survival.

303

News (Medical) associated with Darolutamide

12 Jun 2026

·www.prnewswire.com

RedHill's Opaganib Receives FDA Rare Pediatric Disease Designation for Neuroblastoma in Addition to Current Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to opaganib1 for the treatment of neuroblastoma, a type of cancer most commonly affecting babies and young children Rare pediatric disease designation provides for a Priority Review Voucher (PRV) subject to certain conditions This new designation is in addition to opaganib's current neuroblastoma orphan drug designation, providing for potential benefits such as accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers, tax credits and seven-years' marketing exclusivity, if approved New preclinical data, presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting, showed positive effects of opaganib as a potential add-on therapy in models of neuroblastoma and triple-negative breast cancer (TNBC)2 The neuroblastoma market is expected to be valued at approximately $3.5 billion in 20323 Opaganib is a novel, potentially broad acting, oral, small molecule drug with demonstrated safety & efficacy profiles4. It is in development for multiple oncology, viral (including Ebola virus disease (EVD)), inflammatory and diabetes and obesity-related indications June 9, 2026 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease (RPD) designation to opaganib for treatment of neuroblastoma (NB). "Receiving a cancer diagnosis is always distressing, but when it involves your child, it becomes profoundly devastating. There is an ongoing necessity to explore new alternatives that can augment treatment and enhance results for neuroblastoma, the most prevalent cancer in infants. In data from models of high-risk NB (HRNB), presented at AACR 2026, we saw positive effects of opaganib as a potential add-on to chemotherapy, showing an ability to directly destabilize a key oncogenic driver of neuroblastoma and other solid tumors, n-Myc, through increased ceremide production enhancing programmed cancer cell death (apoptosis)," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "This rare pediatric disease designation, supported by data from NB and other preclinical oncology models, along with a clinically demonstrated safety and tolerability profile adds to our belief that opaganib holds promise for improving outcomes in treating pediatric NB. We aim to further advance development following ongoing discussions with Penn State University and the Beat Childhood Cancer consortium." The FDA grant of rare pediatric disease designation to opaganib provides for a Priority Review Voucher (PRV), subject to certain conditions, and with opaganib's current neuroblastoma orphan drug designation also allows for the potential for seven years' marketing exclusivity, if approved, accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers and tax credits. The neuroblastoma market is expected to be valued at approximately $3.5 billion in 2032. Opaganib is a novel, potentially broad acting, oral, small molecule sphingosine kinase-2 (SPHK2) selective inhibitor drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral (including Ebola virus disease (EVD), inflammatory and diabetes and obesity-related indications. Neuroblastoma is a type of cancer most commonly affecting babies and young children. While rare, neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0–14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.5,6. Around 750 children in the United States are diagnosed with neuroblastoma each year7. Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall five-year survival of ~50%8. Neuroblastoma originates from immature nerve cells (neuroblasts), and most often forms in the adrenal glands - small organs that sit on top of the kidneys - but can also start in nerve cells in the abdomen, chest, neck, or pelvis. The exact cause of neuroblastoma is not well understood, but genetic mutations and abnormalities are known to play a role. Some cases may be linked to genetic syndromes or family history, although most occur sporadically without a clear inherited pattern. Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral (including Ebola virus disease), inflammatory, metabolic (diabetes and obesity) and additional indications. Opaganib's suggested mechanism of action, published in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis9. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms. 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 adults10, 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. 1Opaganib is an investigational new drug, not available for commercial distribution. 2Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi-org.libproxy1.nus.edu.sg/10.1158/1538-7445.AM2026-7879 3Evaluate Ltd 4Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767. https://doi-org.libproxy1.nus.edu.sg/10.3390/microorganisms12091767 5https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/books/NBK448111/#:~:text=Neuroblastoma%20is%20the%20most%20common,of%20pediatric%20cancer%2Drelated%20deaths 6Yan P, Qi F, Bian L, et al. Comparison of Incidence and Outcomes of Neuroblastoma in Children, Adolescents, and Adults in the United States: A Surveillance, Epidemiology, and End Results (SEER) Program Population Study. Med Sci Monit. 2020;26:e927218. Published 2020 Nov 29. doi:10.12659/MSM.927218. 7https://together.stjude.org/en-us/conditions/cancers/neuroblastoma.html 8Flaadt T, Rehm J, Simon T, Hero B, Ladenstein RL, Lode HN, Grabow D, Nolte S, Crazzolara R, Greil J, Ebinger M, Abele M, Holzer U, Döring M, Schulte JH, Bader P, Schlegel PG, Eyrich M, Lang P, Klingebiel T, Handgretinger R. Long-Term Outcomes and Quality of Life of High-Risk Neuroblastoma Patients Treated with a Multimodal Treatment Including Anti-GD2 Immunotherapy: A Retrospective Cohort Study. Cancers (Basel). 2025 Jan 5;17(1):149. doi: 10.3390/cancers17010149. PMID: 39796776; PMCID: PMC11720496. 9https://www.redhillbio.com/news/news-details/2025/RedHill-Announces-Initiation-of-Phase-2-Study-of-Opaganib-and-Darolutamide-in-Advanced-Prostate-Cancer/default.aspx 10Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultOrphan Drug

08 Jun 2026

·www.prnewswire.com

RedHill Launches Enforcement of $11 Million New York Supreme Court Final Judgment Against Kukbo

RALEIGH, N.C. and TEL-AVIV, Israel, June 8, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has commenced recognition and enforcement proceedings in Korea in respect of the New York Supreme Court's final judgment in favor of RedHill against Kukbo Co. Ltd ("Kukbo"), totaling approximately $10.9 million, and that Kukbo has now been served in those proceedings. In November 2025, the New York Supreme Court judgment on the principal award became final and eligible for enforcement and foreign recognition. The award to RedHill of legal fees and expenses is now also final following Kukbo's failure to perfect its appeal by the applicable deadline in March 2026. No further appeals are permissible with respect to either judgment. The Court awarded approximately $10.9 million in total to RedHill, comprised of the main judgment of approximately $8.9 million, and the award for legal fees and expenses of approximately $1.95 million, each including the principal amounts and accrued 9% statutory interest to date, which continues to accrue. RedHill had also previously secured a Korean court attachment grant against Kukbo aimed at preventing Kukbo from disposing of assets prior to judgment enforcement. Recognition and enforcement efforts are ongoing. Following service of the complaint in Korea, the Company now awaits Kukbo's response in the Korean proceeding and the further scheduling of the matter by the Korean court. No assurances can be provided regarding the timing of any recovery or the amount that may be recovered, including whether the Company will recover all or any portion of the awarded amounts. 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 EVD, 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. Visit / X.com/RedHillBio for more information about the Company 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 for the Company to succeed in its enforcement action against Kukbo and recovery any or all of the awards granted by the New York Supreme Court. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company will not 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 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: Corporate [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd. 21% more press release views with Request a Demo

Phase 2Clinical ResultPhase 3

03 Jun 2026

·www.biospace.com

Celcuity Inc. Announces Public Offering of Convertible Senior Notes Due 2032

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced a proposed underwritten public offering of $400,000,000 aggregate principal amount of its convertible senior notes due 2032 (the “Convertible Notes”). The Company intends to grant the underwriters of the offering a 30-day option to purchase up to an additional $60,000,000 aggregate principal amount of Convertible Notes, solely to cover over-allotments, if any. The Convertible Notes will be general, unsecured, senior obligations of the Company and interest will be payable semi-annually in arrears. The Convertible Notes will mature on August 1, 2032, unless earlier converted, redeemed or repurchased by the Company. Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock (the “Common Stock”) or a combination of cash and shares of Common Stock, at its election. The interest rate, conversion rate, offering price and other terms are to be determined upon the pricing of the Convertible Notes. The Company intends to use the net proceeds from the offering to repay in full all outstanding obligations under its amended and restated loan agreement with Oxford Finance, LLC, as collateral agent, and the lenders party thereto, and the remainder for working capital and general corporate purposes. General corporate purposes may include clinical trial expenditures, commercial launch expenditures, commercialization expenditures, research and development expenditures, capital expenditures, expansion of business development activities and other general corporate purposes . The Company may also use a portion of the proceeds for the potential acquisition of businesses, technologies, and products, although we have no current binding understandings, commitments, or agreements to do so. The closing of the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Jefferies, J.P. Morgan, TD Cowen and Guggenheim Securities are acting as joint book-running managers for the offering. LifeSci Capital is acting as lead manager for the offering. Craig-Hallum and Wolfe | Nomura Alliance are acting as co-managers for the offering. The Company has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the “SEC”) as well as a preliminary prospectus supplement with respect to the offering to which this communication relates. Before you invest, you should read the preliminary prospectus supplement and the prospectus in that registration statement and other documents the Company has filed with the SEC for more complete information about the Company and the offering. You may obtain these documents by visiting EDGAR on the SEC’s website at . Alternatively, the Company, any underwriter or any dealer participating in the offering will arrange to send you the preliminary prospectus supplement (or, when available, the final prospectus supplement) and the accompanying prospectus upon request to: Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com; and Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544 or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy the Convertible Notes, any shares of Common Stock issuable upon conversion of the Convertible Notes or any other securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration and qualification under the securities laws of such state or jurisdiction. “Wolfe | Nomura Alliance” is the marketing name used by Wolfe Research Securities and Nomura Securities International, Inc. in connection with certain equity capital markets activities conducted jointly by the firms. Both Nomura Securities International, Inc. and WR Securities, LLC are serving as underwriters in the offering described herein. In addition, WR Securities, LLC and certain of its affiliates may provide sales support services, investor feedback, investor education, and/or other independent equity research services in connection with this offering. ABOUT CELCUITY Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the PI3K/AKT/mTOR (“PAM”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of 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. The Company’s Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”), has reported detailed results for both Study 1, which evaluated patients with PIK3CA wild-type (“WT”) tumors, and Study 2, which evaluated patients with PIK3CA mutant-type (“MT”) tumors. The Company’s Phase 3 clinical trial, VIKTORIA-2, is ongoing and incorporates two independent studies, Study 1 and Study 2, evaluating two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib combined with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib combined with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. The Company’s Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. The Company is headquartered in Minneapolis, Minnesota. 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 offering and the proposed size and terms thereof; the Company’s ability to complete the offering on the anticipated timeline or at all and the anticipated use of the net proceeds therefrom; 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 U.S. Food and Drug Administration’s (the “FDA”) review of the Company’s New Drug Application (“NDA”) for gedatolisib, including the Prescription Drug User Fee Act (“PDUFA”) goal date assigned by the FDA; the ability of the Company’s data to support the filing of supplemental New Drug Application (“sNDA”) with the FDA and 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 obtain FDA approval 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 the Company’s 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 key 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 FDA’s review of the Company’s NDA for gedatolisib; the Company’s ability to obtain 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 on 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, and in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as such risks may be updated in the Company’s 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. CONTACTS: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com (415) 494-9924

Phase 3Clinical Result

100 Deals associated with Darolutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Hormone-dependent prostate cancer	78	Darolutamide plus ADT	kaxwqazjeh(jaeusdommg) = fipetlnpds cbotqkcmly (gykmijwfbj ) View more	Positive	29 May 2026
NCT04736199 (ARANOTE, ASCO2026)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide 600 mg	slgbbbwciv(cdunprvgld) = mjzphoffyu sfmxhnmejw (rfrhjpfuia ) View more	Positive	29 May 2026
				Placebo	slgbbbwciv(cdunprvgld) = rpmcnparpn sfmxhnmejw (rfrhjpfuia ) View more
ASCO2026	Phase 3	Hormone-dependent prostate cancer	13	Darolutamide therapy	xejgtruzke(yepzobtfcv): HR = 0.62 (95.0% CI, 0.55 - 0.7), P-Value = < 0.00001 View more	Positive	29 May 2026
				Control therapy
YHCG-006 (ASCO2026)	Not Applicable	Hormone-dependent prostate cancer	100	ADT, Darolutamide, and Docetaxel	tfsrrjrbgz(ofhphshdtq) = svqwduuxsz mpwlbceiwy (qmvdnipzna ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Castration-Resistant Prostatic Cancer	198	Enzalutamide	htcytjnlpm(lmjsygekev): P-Value = 1.0 View more	Positive	29 May 2026
				Darolutamide
ASCO2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	11,588	Darolutamide (doublet therapy)	dbyryewflg(ouuxsouwhf) = ueupylpcjz gbuhzosdft (ggbxecvfmm, 5.6 - 9.0) View more	Positive	29 May 2026
				Abiraterone (doublet therapy)	dbyryewflg(ouuxsouwhf) = pcdcfzhvkr gbuhzosdft (ggbxecvfmm, 10.0 - 11.4) View more
ASCO2026	Not Applicable	Castration-sensitive prostate cancer	726	Abiraterone + ADT	ytuyngexfb(mekpkwmosi) = All-cause mortality was also higher in the abiraterone group (OR 3.4; 95% CI, 2.3-5.1) nucpntfsan (azrdwnmgjh ) View more	Negative	29 May 2026
				Darolutamide + ADT
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	ugjryextcs(keznbunore) = bxtssiurlg yrvoetgiph (omijdyxgiv ) View more	Positive	29 May 2026
				Darolutamide 600 mg orally twice daily + Leuprolide acetate intramuscular injections (Female)	ugjryextcs(keznbunore) = dmnkuywtvm yrvoetgiph (omijdyxgiv ) View more
NCT04736199 (ARANOTE, Pubmed \| Lancet Oncol)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide + ADT	jjyxxenkgb(lmzpvcnyge) = 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. lwxnsebjdm (cxwcersicw ) 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	vztipbypyz(hdlaglwaaz) = prrcwglvyx xcimhvrgbf (buuwdmlhet ) View more	Positive	18 Mar 2026
				Enzalutamide	vztipbypyz(hdlaglwaaz) = rwpbihlgkd xcimhvrgbf (buuwdmlhet ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

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

Start your data trial now!

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

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis