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 2025

Sponsor / Collaborator

The University of Chicago

NCT06592924 / Not yet recruitingPhase 3IIT

A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Start Date15 Jan 2025

Sponsor / Collaborator

Canadian Cancer Trials Group

[+4]

NCT06625970 / Not yet recruitingPhase 3IIT

A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)

PEACE 7 is an international, multicenter, randomized, open-label phase III study that aims at evaluating the efficacy and safety of darolutamide and of stereotactic dose escalated prostate radiotherapy in patients with localised prostate cancer and high-risk features of relapse (defined as patients with at least 2 high-risk criteria from National Comprehensive Cancer Network (NCCN) classification) using a factorial (2x2) design.
The primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with ADT and pelvic nodal radiotherapy in terms of metastasis-free survival (MSF).
Patients will be randomized (1:1:1:1) to receive either:
* Arm A (Standard arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy
* Arm B (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy + darolutamide
* Arm C (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT
* Arm D (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT + darolutamide
Patient will receive systemic treatments (ADT and/or darolutamide) during 2 years where visits on site are planned at D45, D90, D180 and then every 3 months for checkups and follow prostate specific antigen (PSA) level.
Metastasis-free survival (MFS) is defined as the time interval from randomization to the date of the appearance of metastasis (on next generation imaging) or death (from any cause), whichever occurs first. Radiographic evaluation will be carried out at the time of biochemical failure (Phoenix criteria) or in case of clinical suspicion. After biochemical failure (Phoenix criteria) radiographic evaluation on next generation imaging (prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan (any European Medicines Agency (EMA) approved PSMA tracer)) will be performed every 6 months until a metastatic site of relapse is identified and will be repeated at each subsequent PSA progression.

Start Date01 Jan 2025

Sponsor / Collaborator

UNICANCER

[+1]

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

283

Literatures (Medical) associated with Darolutamide

01 Dec 2024·Prostate cancer and prostatic diseases

Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer

Article

Author: Vjaters, Egils ; Kuss, Iris ; Aspegren, John ; Tammela, Teuvo L ; Garcia, Jorge A ; Bono, Petri ; Protheroe, Andrew ; James, Nicholas D ; Shore, Neal ; Kataja, Vesa ; Fizazi, Karim ; Joensuu, Heikki ; Priou, Frank ; Jones, Robert Hugh ; Fiala-Buskies, Sabine ; Matsubara, Nobuaki ; Lesimple, Thierry ; Beuzeboc, Philippe

Abstract:

Background:

In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.

Methods:

Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.

Results:

All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1.

Conclusions:

Long-term darolutamide treatment was well tolerated; no new safety signals observed.

Tweetable abstract:

In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.

14 Nov 2024·JOURNAL OF MEDICINAL CHEMISTRY

Identification of Oral Bioavailable Coumarin Derivatives as Potential AR Antagonists Targeting Prostate Cancer

Article

Author: Yu, Yanzhen ; Liao, Jinbiao ; Hou, Tingjun ; Sheng, Rong ; Qin, Yiyang ; Fu, Weitao ; Li, Dan ; Zhang, Minkui ; Cai, Lvtao ; Liao, Jianing ; Le, Kaixin

Androgen receptor (AR) is a crucial driver of prostate cancer (PCa), but acquired resistance to AR antagonists significantly undermines their clinical efficacy. We previously discovered coumarin derivative 1, which is capable of disrupting AR ligand-binding domain dimers, offering the potential for overcoming resistance. However, its poor oral bioavailability limited further development. In this study, comprehensive structure optimizations led to compound 4a (IC₅₀ = 0.051 μM), which exhibited comparable AR antagonistic activity to enzalutamide (IC₅₀ = 0.060 μM) and demonstrated excellent selectivity over other nuclear receptors in vitro. Especially, 4a showed superior efficacy against AR^F876L/T877A and AR^W741C mutants compared to darolutamide and enzalutamide. Moreover, 4a exhibited favorable pharmacokinetic profiles (F = 66.24%) in vivo and significant tumor growth inhibition in an LNCaP xenograft mouse model upon oral administration. These results highlight the potential of 4a as a promising oral AR antagonist for overcoming drug resistance in PCa.

04 Nov 2024·CANCER RESEARCH

LX1 Dual Targets AR Variants and AKR1C3 in Advanced Prostate Cancer Therapy

Article

Author: Mohammed, Shabber ; Xing, Enming ; Xu, Desiree H. ; Gao, Allen C. ; Leslie, Amy R. ; Sharifi, Masuda ; Cheng, Jeffrey ; Gao, Richard Y. ; Ning, Shu ; Lou, Wei ; Yang, Rui ; Lombard, Alan P. ; Schaaf, Zachary A. ; Armstrong, Cameron M. ; Cheng, Xiaolin ; Li, Pui-Kai ; Liu, Chengfei ; Wu, Chun-Yi ; Mitsiades, Nicholas ; Han, Xiangrui

Abstract:

The development of resistance to current standard-of-care treatments, such as androgen receptor (AR) targeting therapies, remains a major challenge in the management of advanced prostate cancer. There is an urgent need for new therapeutic strategies targeting key resistant drivers, such as AR variants like AR-V7, and steroidogenic enzymes, such as aldo–keto reductase 1C3 (AKR1C3), to overcome drug resistance and improve outcomes for patients with advanced prostate cancer. Here, we have designed, synthesized, and characterized a novel class of LX compounds targeting both the AR/AR variants and AKR1C3 pathways. Molecular docking and in vitro studies demonstrated that LX compounds bind to the AKR1C3 active sites and inhibit AKR1C3 enzymatic activity. LX compounds were also shown to reduce AR/AR-V7 expression and to inhibit their target gene signaling. LX1 inhibited the conversion of androstenedione into testosterone in tumor-based ex vivo enzyme assays. In addition, LX1 inhibited the growth of cells resistant to antiandrogens including enzalutamide (Enza), abiraterone, apalutamide, and darolutamide in vitro. A synergistic effect was observed when LX1 was combined with antiandrogens and taxanes, indicating the potential for this combination in treating resistant prostate cancer. Treatment with LX1 significantly decreased tumor volume, serum PSA levels, as well as reduced intratumoral testosterone levels, without affecting mouse body weight. Furthermore, LX1 was found to overcome resistance to Enza treatment, and its combination with Enza further suppressed tumor growth in both the CWR22Rv1 xenograft and LuCaP35CR patient-derived xenograft models. Collectively, the dual effect of LX1 in reducing AR signaling and intratumoral testosterone, along with its synergy with standard therapies in resistant models, underscores its potential as a valuable treatment option for advanced prostate cancer.Significance: LX1 simultaneously targets androgen receptor variants and the steroidogenic enzyme AKR1C3, offering a promising approach to combat drug resistance and enhancing therapeutic efficacy in conjunction with standard treatments for advanced prostate cancer.

134

News (Medical) associated with Darolutamide

21 Nov 2024

·www.businesswire.com

U.S. FDA Accepts Supplemental New Drug Application for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer

WHIPPANY, N.J.--( BUSINESS WIRE )--Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) NUBEQA ® (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC). 2 “ Bayer is dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease, and today’s acceptance of our sNDA application for NUBEQA plus ADT for the treatment of patients with mHSPC brings us closer to adding an additional treatment option for NUBEQA to benefit those living with mHSPC,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “ If approved, this would expand the indication for NUBEQA in patients with mHSPC to include NUBEQA both with and without chemotherapy, providing physicians and their patients with an additional NUBEQA treatment option in this setting. We are working closely with the FDA to bring this additional NUBEQA treatment option to patients as soon as possible.” The sNDA application is based on positive results from the Phase III ARANOTE trial. Data from the trial were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology . NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. About the ARANOTE Trial 1 The ARANOTE trial (NCT04736199) was a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of NUBEQA plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 669 patients were randomized to receive 600mg of NUBEQA twice daily or matching placebo in addition to ADT. The primary endpoint of this study was radiological progression-free survival (rPFS), measured as time from the date of randomization to the date of first documentation of radiological disease progression or death due to any cause, whichever occurs first. Secondary endpoints included overall survival (time from randomization to the date of death from any cause), time from randomization to the date of first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. About NUBEQA ® (darolutamide) 2 NUBEQA ® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. In addition to the ARANOTE trial, NUBEQA is being evaluated in a robust clinical development program, which includes studies across various stages of prostate cancer, including in the ARASTEP Phase III trial evaluating NUBEQA plus ADT versus ADT alone in HSPC patients with high-risk biochemical recurrence (BCR) and no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline, as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov. INDICATIONS NUBEQA ® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure. In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury. Drug Interactions Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use. Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed. Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate. NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information . About Metastatic Hormone-Sensitive Prostate Cancer Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. 3 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide. 4,5 At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed. 6,7,8 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . © 2024 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at www.pharma.bayer.com Our online press service is just a click away: www.bayer.us/en/newsroom Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on X: https://X.com/BayerUS Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Journal of Clinical Oncology (ascopubs.org). Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial . https://ascopubs-org.libproxy1.nus.edu.sg/doi/10.1200/JCO-24-01798 . September 2024. NUBEQA (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023. Hyuna S et al. Ca Cancer J Clin 2021 ; 71:209–249. Prostate Cancer: Statistic. Cancer.Net. https://www.cancer.net/cancer-types/prostate-cancer/statistics . September 2024. American Cancer Society. Cancer Facts & Figures 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html . September 2024. Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938. Buzzoni C et al. Eur. Urol. 2015;68:885–890.

Phase 3Clinical Result

14 Nov 2024

·www.globenewswire.com

Celcuity Inc. Reports Third Quarter Financial Results and Provides Corporate Update

The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the third quarter ended September 30, 2024 and other recent business developments. “Enrollment in our VIKTORIA-1 study remains robust and on-track. The PIK3CA wild-type cohort is 100% enrolled, and enrollment in the PIK3CA mutant cohort is on plan,” said Brian Sullivan, CEO and co-founder of Celcuity. “Based on our current forecast of reaching the event thresholds that will trigger primary analysis in both the PIK3CA wild-type and mutant cohorts, we expect to report topline data for the PIK3CA wild-type cohort sometime in late Q1 2025 or during Q2 2025 and to report topline data for the PIK3CA mutant cohort in the second half of 2025.” Third Quarter 2024 Business Highlights and Other Recent Developments The VIKTORIA-1 Phase 3 clinical trial expects to provide topline data for the PIK3CA wild-type cohort in late Q1 2025 or during Q2 2025 and for the PIK3CA mutant cohort in the second half of 2025. VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.The PIK3CA wild-type cohort is 100% enrolled and enrollment of the PIK3CA mutant cohort is on-track relative to plan. The VIKTORIA-2 Phase 3 clinical trial remains on track to enroll its first patient in Q2 2025. The VIKTORIA-2 study is a global Phase 3 open-label randomized clinical trial evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant.Prior to the initiation of the Phase 3 portion of the trial, a safety run-in study will be conducted in 12-36 participants to assess the safety profile of gedatolisib in combination with ribociclib and fulvestrant.Site qualification activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track. The Phase 1b/2 clinical trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), is ongoing and expected to report preliminary data in Q2 2025. Overall survival data from the B2151009 Phase 1b clinical trial will be presented at the San Antonio Breast Cancer Symposium (SABCS), taking place December 10-13, 2024. Details of the poster presentation are as follows: Abstract Title: Overall survival in patients with HR+/HER2- advanced breast cancer treated in a phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy (SESS-1510)Presentation Number: P4-08-25Date/Time: Thursday, December 12, 5:30 PM CST Additional nonclinical data further characterizing the mechanism of action of gedatolisib and its effect on breast cancer cell metabolic functions will also be presented at the SABCS. Abstract Title: Mechanism of action of gedatolisib in combination with fulvestrant and/or palbociclib in estrogen receptor positive breast cancer models (SESS-989)Abstract Title: Different effects of gedatolisib versus single-node PI3K/AKT/mTOR pathway inhibitors on breast cancer cell metabolic functions (SESS-997) In October, Cancers published results of nonclinical studies in gynecological cancer cell line models highlighting the differences between single-node inhibitors of the PI3K/AKT/mTOR pathway and gedatolisib. The published manuscript is available online and on the publications section of Celcuity’s website. Third Quarter 2024 Financial Results Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2024, compared to the third quarter ended September 30, 2023. Total operating expenses were $30.1 million for the third quarter of 2024, compared to $18.9 million for the third quarter of 2023. Research and development (R&D) expenses were $27.6 million for the third quarter of 2024, compared to $17.5 million for the prior-year period. Of the approximately $10.1 million increase in R&D expenses, $6.3 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial, the Phase 1b/2 trial and the initiation of the VIKTORIA-2 Phase 3 trial, and $3.8 million was related to increased employee and consulting expenses. General and administrative (G&A) expenses were $2.5 million for the third quarter of 2024, compared to $1.4 million for the prior-year period. Employee and consulting related expenses accounted for $0.9 million of the increase. Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million. Net loss for the third quarter of 2024 was $29.8 million, or $0.70 loss per share, compared to a net loss of $18.4 million, or $0.83 loss per share, for the third quarter of 2023. Non-GAAP adjusted net loss for the third quarter of 2024 was $27.6 million, or $0.65 loss per share, compared to non-GAAP adjusted net loss of $17.3 million, or $0.78 loss per share, for the third quarter of 2023. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release. Net cash used in operating activities for the third quarter of 2024 was $20.6 million, compared to $12.7 million for the third quarter of 2023. At September 30, 2024, Celcuity reported cash, cash equivalents and short-term investments of $264.1 million. Webcast and Conference Call Information The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2024 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 or 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1688854&tp_key=0b14db1255. A replay of the webcast will be available on the Celcuity website following the live event. About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR 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- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter. Forward-Looking Statements This press release contains statements that constitute "forward-looking statements" including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; revenue expectations; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to Celcuity's lead product candidate, gedatolisib, and its CELsignia platform; our anticipated use of cash; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, our ability to access capital upon favorable terms or at all, and those risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 27, 2024. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law. View source version of release on GlobeNewswire.com Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 ICR HealthcarePatti Bank, patti.bank@icrhealthcare.com(415) 513-1284 Celcuity Inc.Condensed Balance Sheets September 30, 2024 December 31, 2023 (unaudited) Assets Current Assets: Cash and cash equivalents$12,603,289 $30,662,774 Investments 251,455,468 149,919,974 Other current assets 8,379,682 10,007,849 Total current assets 272,438,439 190,590,597 Property and equipment, net 338,787 228,782 Operating lease right-of-use assets 259,744 400,019 Total Assets$273,036,970 $191,219,398 Liabilities and Stockholders' Equity: Current Liabilities: Accounts payable$9,158,778 $5,076,699 Operating lease liabilities 175,226 184,950 Accrued expenses 16,974,725 8,927,094 Total current liabilities 26,308,729 14,188,743 Operating lease liabilities 95,699 225,922 Note payable, non-current 96,923,914 37,035,411 Total Liabilities 123,328,342 51,450,076 Total Stockholders' Equity 149,708,628 139,769,322 Total Liabilities and Stockholders' Equity$273,036,970 $191,219,398 Celcuity Inc.Condensed Statements of Operations(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating expenses: Research and development$27,587,483 $17,488,236 $70,732,017 $42,512,811 General and administrative 2,472,416 1,409,801 6,104,803 3,988,248 Total operating expenses 30,059,899 18,898,037 76,836,820 46,501,059 Loss from operations (30,059,899) (18,898,037) (76,836,820) (46,501,059) Other (expense) income Interest expense (3,343,989) (1,372,132) (7,005,284) (3,929,140)Interest income 3,612,099 1,865,629 8,716,040 5,499,555 Other income, net 268,110 493,497 1,710,756 1,570,415 Net loss before income taxes (29,791,789) (18,404,540) (75,126,064) (44,930,644)Income tax benefits - - - - Net loss$(29,791,789) $(18,404,540) $(75,126,064) $(44,930,644) Net loss per share, basic and diluted$(0.70) $(0.83) $(1.96) $(2.05) Weighted average common shares outstanding, basic and diluted 42,793,047 22,117,626 38,299,548 21,920,147 Cautionary Statement Regarding Non-GAAP Financial Measures This press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance, as they exclude stock-based compensation expense, non-cash interest expense, and non-cash interest income from net loss and net loss per share. Management excludes these items because they do not impact Celcuity’s cash position, which management believes better enables Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management’s method of calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as an indicator of Celcuity’s performance or as a measure of liquidity and cash flows. Celcuity Inc.Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss andGAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 GAAP net loss$(29,791,789) $(18,404,540) $(75,126,064) $(44,930,644)Adjustments: Stock-based compensation Research and development(1) 1,190,424 660,706 3,000,641 1,954,689 General and administrative(2) 740,777 447,931 1,672,418 1,704,213 Non-cash interest expense(3) 730,741 520,794 1,891,139 1,523,699 Non-cash interest income(4) (473,584) (480,520) (1,112,420) (439,331)Non-GAAP adjusted net loss$(27,603,431) $(17,255,629) $(69,674,286) $(40,187,374) GAAP net loss per share - basic and diluted$(0.70) $(0.83) $(1.96) $(2.05)Adjustment to net loss (as detailed above) 0.05 0.05 0.14 0.22 Non-GAAP adjusted net loss per share$(0.65) $(0.78) $(1.82) $(1.83) Weighted average common shares outstanding, basic and diluted 42,793,047 22,117,626 38,299,548 21,920,147 (1) To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.(2) To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.(3) To reflect a non-cash charge to other expense for amortization of debt issuance and discount costs and PIK interest related to the issuance of a note payable.(4) To reflect a non-cash adjustment to other income for accretion on investments.

Financial StatementPhase 1Phase 3Phase 2

12 Nov 2024

·www.globenewswire.com

ORIC® Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Updates

Presented preclinical data further supporting the potential best-in-class profile of ORIC-114 to treat EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR Conference Announced clinical collaborations with multiple strategic partners to support ongoing trial evaluating ORIC-944 in combination with AR inhibitors for the treatment of prostate cancer Cash and investments of $282.4 million expected to fund operating plan into late 2026 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter ended September 30, 2024. “We are encouraged by the growing evidence supporting the potential best-in-class profiles of ORIC-114 and ORIC-944, and we continue to steadily advance both programs towards the initiation of registrational studies next year,” said Jacob M. Chacko, M.D., president and chief executive officer. “Preclinical data presented at the ENA conference highlighted ORIC-114's potential for superior potency and selectivity in targeting EGFR exon 20 insertions and other atypical mutations, building on previously reported clinical data in NSCLC patients. For ORIC-944, the clinical trial collaboration and supply agreements we secured with Bayer and Johnson and Johnson have helped us further advance our combination studies in prostate cancer. We remain laser-focused on execution across our clinical and preclinical pipeline and look forward to reporting updated data in 2025.” Third Quarter 2024 and Other Recent Highlights: ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor Presented preclinical data demonstrating potential best-in-class properties, including potency and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.Expect to report updated Phase 1b data in the first half of 2025. ORIC-944: a potent and selective allosteric inhibitor of PRC2 Initiated dosing of ORIC-944 in combination with NUBEQA® (darolutamide) and in combination with ERLEADA® (apalutamide) in the ongoing Phase 1b trial for prostate cancer in first half of 2024.Entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson to support the ongoing Phase 1b trial of ORIC-944 in combinations with AR inhibitors for the treatment of prostate cancer. Corporate Highlights: Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs. Third Quarter 2024 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $282.4 million as of September 30, 2024, which the company expects will be sufficient to fund its operating plan into late 2026.R&D Expenses: Research and development (R&D) expenses were $31.2 million for the three months ended September 30, 2024, compared to $22.4 million for the three months ended September 30, 2023, an increase of $8.8 million. For the nine months ended September 30, 2024, R&D expenses were $82.1 million, compared to $60.7 million for the nine months ended September 30, 2023, an increase of $21.4 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs, including additional non-cash-stock-based compensation.G&A Expenses: General and administrative (G&A) expenses were $7.1 million for the three months ended September 30, 2024, compared to $6.3 million for the three months ended September 30, 2023, an increase of $0.8 million. For the nine months ended September 30, 2024, G&A expenses were $21.2 million, compared to $18.7 million for the nine months ended September 30, 2023, an increase of $2.6 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation. About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, being developed for multiple myeloma. Beyond these three product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. 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 StatementsThis press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of ORIC-114 and ORIC-944; statements regarding the potential best-in-class properties of ORIC-114; ORIC-114 clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114, ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-114, ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational studies; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, 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 Officerdominic.piscitelli@oricpharma.cominfo@oricpharma.com ORIC PHARMACEUTICALS, INC.CONDENSED BALANCE SHEETS(in thousands, except share and per share amounts) September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash, cash equivalents and short-term investments$272,369 $208,187 Prepaid expenses and other current assets 7,059 4,410 Total current assets 279,428 212,597 Long-term investments 9,998 26,852 Property and equipment, net 3,091 2,862 Other assets 9,553 9,696 Total assets$302,070 $252,007 Liabilities and Stockholders' Equity Current liabilities: Accounts payable$4,249 $944 Accrued liabilities 16,999 19,514 Total current liabilities 21,248 20,458 Other long-term liabilities 6,828 7,461 Total liabilities 28,076 27,919 Total stockholders' equity 273,994 224,088 Total liabilities and stockholders' equity$302,070 $252,007 ORIC PHARMACEUTICALS, INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(in thousands, except share and per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development$31,202 $22,388 $82,102 $60,691 General and administrative 7,116 6,294 21,223 18,661 Total operating expenses 38,318 28,682 103,325 79,352 Loss from operations (38,318) (28,682) (103,325) (79,352) Other income, net 3,752 3,204 11,785 6,985 Net loss$(34,566) $(25,478) $(91,540) $(72,367)Other comprehensive income: Unrealized gain on investments 978 198 464 922 Comprehensive loss$(33,588) $(25,280) $(91,076) $(71,445)Net loss per share, basic and diluted$(0.49) $(0.44) $(1.32) $(1.46)Weighted-average shares outstanding, basic and diluted 70,542,684 57,402,226 69,417,672 49,424,418

Phase 1Financial StatementExecutive ChangeAACR

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
Metastatic Prostate Carcinoma	JP	Bayer AG	24 Feb 2023
Metastatic castration-resistant prostate cancer	US	Bayer HealthCare Pharmaceuticals, Inc.	05 Aug 2022
Prostatic Cancer	BR	Bayer AG	01 Jan 2020
Castration-Resistant Prostatic Cancer	US	Bayer HealthCare Pharmaceuticals, Inc.	30 Jul 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-sensitive prostate cancer	NDA/BLA	US	Bayer AG	26 Sep 2024
Localized Prostate Carcinoma	Phase 3	-	Bayer AG	01 Jan 2025
Recurrent Prostate Carcinoma	Phase 3	US	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	CN	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	JP	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	AU	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	AT	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	BE	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	BR	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	CA	Bayer AG	03 Apr 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04736199 (ARANOTE, ESMO2024) Manual	Phase 3	Hormone-dependent prostate cancer	669	darolutamide+androgen-deprivation therapy	rhsxezaczt(pesxotvejk): HR = 0.54 (95% CI, 0.41 - 0.71), P-Value = <0.0001 View more	Positive	16 Sep 2024
				Placebo+androgen-deprivation therapy
NCT04736199 (ARANOTE, PipelineReview) Manual	Phase 3	Hormone-dependent prostate cancer	669	darolutamide	xpkhaskorw(rqqxikmrrx) = Has met its primary endpoint of radiological progression-free survival (rPFS). iktjjoxbfc (imursqxxyk ) Met View more	Positive	17 Jul 2024
NCT02799602 (ARASENS, ASCO2024)	Phase 3	Hormone-dependent prostate cancer	1,305	Darolutamide 600 mg	eukybpvlbg(cmopyjfxzp) = inheaivuvg mzyqmevvcz (cunacwrqoo )	Positive	24 May 2024
				Placebo	eukybpvlbg(cmopyjfxzp) = sbehqxmwtn mzyqmevvcz (cunacwrqoo )
ASCO2024	Not Applicable	Castration-sensitive prostate cancer	10	Darolutamide + Chemotherapy + ADT	dgukcksilj(nycxvedwsj) = 5 patients (50%) presented asthenia nghdomryuh (cwaklvgdxh ) View more	Positive	24 May 2024
NCT04122976 (DAROL, AUA2024) Manual	Not Applicable	Castration-Resistant Prostatic Cancer	550	Darolutamide	vufzpqpjlt(mxbueutzss) = ihleygyfdw fngjnpkxwl (ulxebuvdhg ) View more	Positive	01 May 2024
MP60-18 (AUA2024)	Not Applicable	Castration-sensitive prostate cancer	319	DARO plus ADT (doublet therapy [DT])	jolteauwlo(xydxifteuw) = gqfcughswa anhmwgwreu (mqzxhdssyz ) View more	Positive	01 May 2024
ARASENS (ASCO_GU2024) Manual	Phase 3	Castration-sensitive prostate cancer	-	DarolutamiDocetaxeltaxel + ADT	rypqscmfoo(xxzqkqkiio) = reuqyrgbpm fgfiypkxdm (ocdutjgcyr, 6.54 - 9.14) View more	Positive	25 Jan 2024
				DarolutamidecetDocetaxelT	rypqscmfoo(xxzqkqkiio) = pcoxpkiojx fgfiypkxdm (ocdutjgcyr, 4.92 - 6.96) View more
ARASENS (ESMO_ASIA2023)	Phase 3	Metastatic castration-resistant prostate cancer	1,305	Darolutamide 600 mg	zlfrwvireo(xburyhefnf): HR = 0.64 (95% CI, 0.41 - 0.99) View more	Positive	02 Dec 2023
				Placebo
NCT02799602 (ARASENS, ESMO2023)	Phase 3	Castration-sensitive prostate cancer	1,306	Darolutamide 600 mg	rwantaetro(wiegvjyhal): HR = 0.2 (95% CI, 0.15 - 0.27) View more	-	22 Oct 2023
				Placebo
NCT04157088 (DaroAcT, CTgov)	Phase 2	Castration-Resistant Prostatic Cancer \| Metastatic castration-resistant prostate cancer	30	Darolutamide (Nubeqa, BAY1841788)	nygeufurju(wsiciozjeb) = ctklkcgxkf kybquwlgpw (zjjpthwsyr, wwlaedczxd - wmlknnsmiq) View more	-	04 Aug 2023

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