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

NCT07450599

/ Not yet recruitingPhase 2

CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer

Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.
The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.
The main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).
The study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.
Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.
2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.
During the study, the doctors and their study team will:
* take blood and urine samples
* check the participants' health parameters
* do physical examinations
* check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
* take tumor samples
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
About 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.

Start Date15 Apr 2026

Sponsor / Collaborator

Bayer AG

NCT07142551

/ Not yet recruitingPhase 2IIT

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

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

Start Date20 Mar 2026

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

464

Literatures (Medical) associated with Darolutamide

01 Mar 2026·Biomaterials advances

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

Article

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

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

01 Feb 2026·ANTICANCER RESEARCH

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

Article

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

BACKGROUND/AIM:

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

PATIENTS AND METHODS:

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

RESULTS:

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

CONCLUSION:

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

01 Feb 2026·INTERNATIONAL JOURNAL OF UROLOGY

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

Article

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

ABSTRACT:

Background and Objective:

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

Methods:

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

Results:

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

Conclusion:

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

262

News (Medical) associated with Darolutamide

04 Mar 2026

·www.fiercepharma.com

Bayer looking at another year of 'resilience' before growth kicks in behind Nubeqa, Kerendia

Bayer's pharma business is taking shape behind growth products Nubeqa and Kerendia, but for one more year overall sales are likely to drop as the company expects the decline of its mature products Xarelto and Eylea to kick into higher gear in 2026. The primary growth drivers in Bayer’s pharma sector—Nubeqa and Kerendia—are performing even better than the company anticipated and their momentum is expected to continue in 2026. But that won’t lead to growth of Bayer’s pharma business overall this year as two contraction drivers—Xarelto and Eylea—are working in the opposite direction. This will be the last year of the sector’s “resilience phase,” Bayer’s pharma president Stefan Oelrich said during a quarterly conference call, which will set it up for growth in 2027.In a way, Bayer’s pharma business is the company in a microcosm. As the German conglomerate absorbs massive litigation charges related to its disastrous acquisition of Monsanto a decade ago and eyes a potential $7.25 billion settlement of Roundup lawsuits, a rebound is finally in sight.“We’re expecting a negative free cash flow this year, due to litigation-related payouts,” CEO Bill Anderson said. “That outlook is emblematic of the company’s current strategic position. Strong signs of progress but still working on a comprehensive turnaround.”Sales of prostate cancer treatment Nubeqa were up (PDF) 57% in 2025 to 2.4 billion euros ($2.7 billion). Meanwhile, kidney disease drug Kerendia achieved sales of 829 million euros ($936 million) in 2025, an increase of 79%, with a particularly notable year-over-year growth rate of 93% in the fourth quarter.“We’re well set for our next wave of growth, right into the next decade, driven by significant, sustained Nubeqa and Kerendia sales,” Oelrich said, also citing the launches of BridgeBio-partnered cardiomyopathy treatment Beyonttra and recently approved menopause drug Lynkuet, as well as the potential of investigational stroke medicine asundexian. On the flip side, sales of eye disease treatment Eylea were down 6% last year to 3.1 billion euros ($3.51 billion), with fourth-quarter sales falling by 16% year over year. Oelrich cited increased pricing pressures due to the market entry of biosimilars, which is being offset partially by an increase in volume, including a boost in the sales of the 8 mg, long-acting version of Eylea.“Biosimilar entry is not so much a volume erosion for us as it is much more a price erosion, and that’s really hard to beat,” Oelrich said.As for blood thinner Xarelto, which faces ongoing generic erosion, sales were down 33% in 2025 to $2.34 billion euros ($2.6 billion). The drug’s performance also saw a negative trend in the fourth quarter, with a year-over-year decline in the period of 39%.Bayer is expecting sales of both of the aging products to decline more rapidly in 2026, projecting a 20% to 25% slide in Eylea sales and a 35% to 40% drop for Xarelto.“We expect a modest contraction of our base business in 2026,” Oelrich said, adding that Bayer expects that top-line sales in the second half of the year will top those from the first half, setting the pharma sector to realize mid-single-digit growth in 2027. For 2025, Bayer’s pharma sector was down 2%, with sales falling to 17.83 billion euros ($20.1 billion). As for the fourth quarter, pharma sales were down 4% to 4.48 billion euros ($5.1 billion). Bayer’s consumer health unit showed a similar quarterly trend but to a higher degree, as sales for the year were down 1%, to 5.80 billion euros ($6.5 billion), while falling 7% in the fourth quarter to 1.46 billion euros ($1.6 billion).

AcquisitionBiosimilar

04 Mar 2026

·firstwordpharma.com

Bayer sees accelerating declines this year for Xarelto, Eylea

Bayer said Wednesday that it expects the erosion of Xarelto sales to "slightly accelerate" this year as the oral anticoagulant faces further competition from generics. Revenue from the product is forecast to fall by between 35% and 40% in 2026, compared to a roughly 33% decline last year to €2.3 billion ($2.7 billion).The company noted that Xarelto's performance in 2025 was impacted by competitive pressure from generics in Japan and Russia, in addition to ongoing at-risk launches in Europe.Bayer also expects lower overall sales of Eylea this year amid "significant" pricing pressure, with revenue from the anti-VEGF therapy predicted to fall by between 20% and 25%, versus a drop of 6% to €3.1 billion in 2025. Sales last year were also affected by lower prices, especially in Canada, the UK and Japan.Sales of the 2-mg version of Eylea — which is facing biosimilar competition — slipped 24% to €2.3 billion. Stefan Oelrich, head of Bayer's pharmaceuticals division, conceded that the company "may have slightly underestimated" the impact of biosimilars, but "will continue to closely observe and evaluate the evolving situation." Meanwhile, revenue from the newer, 8-mg version of Eylea surged 274% to €819 million, contributing 26% to the overall franchise, with "continued uptake" of the product set to continue in 2026. Oelrich said Bayer hopes to expand the higher dose version's contribution to the Eylea franchise to approximately 70%.Nubeqa, Kerendia outperform Offsetting the performance of Xarelto and Eylea, Bayer's growth products — led by prostate cancer drug Nubeqa and chronic kidney disease treatment Kerendia — helped the company's pharmaceutical division post a 2% increase in sales last year to €17.8 billion.Nubeqa sales rose 57% to €2.4 billion, while Kerendia climbed 79% to €829 million. "Nubeqa and Kerendia continued their significant growth momentum and finished the year ahead of our raised expectations," said Chief Financial Officer Wolfgang Nickl.For the coming year, Oelrich indicated that the momentum for Nubeqa and Kerendia is set to continue, with "expected growth of approximately 50% at constant currencies."Bayer also confirmed that it has removed ACTUS-101 from its pipeline, having previously disclosed that recruitment in a Phase I trial of the AAV gene therapy for late-onset Pompe disease had been halted. The company gained ACTUS-101 via the $4-billion takeover of Asklepios BioPharmaceutical (AskBio) in 2020.($1 = €0.85856075)

AcquisitionPhase 1Gene TherapyDrug ApprovalBiosimilar

26 Feb 2026

·investors.januxrx.com

Janux Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

Continued clinical execution across TRACTr programs JANX007 and JANX008 JANX007 enrolling in Phase 1b Taxane-naïve patient population in metastatic castration-resistant prostate cancer (mCRPC) JANX008 enrolling expansion cohorts in defined tumor settings Initiated Phase 1 study of JANX011 in healthy volunteers Entered collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic for solid tumors Appointment of William Go, M.D., Ph.D., as Chief Medical Officer Strong year-end cash position supporting continued pipeline execution JANX007 enrolling in Phase 1b Taxane-naïve patient population in metastatic castration-resistant prostate cancer (mCRPC) JANX008 enrolling expansion cohorts in defined tumor settings SAN DIEGO--(BUSINESS WIRE)-- Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “The past year marked a period of significant execution and progress for Janux as we continued to translate the promise of our tumor-activated platform into meaningful clinical and strategic advances. Recent JANX007 clinical results demonstrate clinical activity and a consistent and predictable safety profile in mCRPC and support continued advancement in taxane-naïve patients as well as other expansion cohorts,” said David Campbell, Ph.D., President and CEO of Janux. “In early 2026, we announced a collaboration with Bristol Myers Squibb that provides near-term capital and further validates the potential of our platform. We also continue to strengthen our team to support the next phase of clinical and pipeline growth. With additional product candidates entering the clinic in 2026, we believe Janux is well positioned to execute on our clinical strategy and continue to build long-term value for patients and shareholders.” BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress Janux presented updated interim Phase 1 data for JANX007 (PSMA-TRACTr) in December 2025. As of the October 15, 2025 data cutoff, 109 patients had been treated across Phase 1 cohorts:Durable clinical activity was observed across both once-weekly (QW) and every-two-week (Q2W) cohorts, with median radiographic progression-free survival (rPFS) ranging from 7.9 to 8.9 months. The rPFS in the Q2W cohort compared favorably to the QW expansion group. Data demonstrated high prostate-specific antigen (PSA) response rates including deep PSA declines. Anti-tumor activity was observed, with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients. Ongoing dose optimization of JANX007 monotherapy is focused on taxane-naïve mCRPC.The Phase 1 study also includes expansion cohorts evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, to further characterize safety and clinical activity in taxane-naïve mCRPC. Additional expansion cohorts are evaluating JANX007 monotherapy in patients with PARP inhibitor-refractory mCRPC, supporting assessment of activity in a high-unmet-need population. JANX008 (EGFR-TRACTr) continues to enroll in its Phase 1 clinical trial in a defined group of solid tumors, with expansion cohorts underway to further characterize safety and clinical activity. JANX011 (CD19-ARM) is actively enrolling its Phase 1 clinical trial in healthy volunteers. Durable clinical activity was observed across both once-weekly (QW) and every-two-week (Q2W) cohorts, with median radiographic progression-free survival (rPFS) ranging from 7.9 to 8.9 months. The rPFS in the Q2W cohort compared favorably to the QW expansion group. Data demonstrated high prostate-specific antigen (PSA) response rates including deep PSA declines. Anti-tumor activity was observed, with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients. The Phase 1 study also includes expansion cohorts evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, to further characterize safety and clinical activity in taxane-naïve mCRPC. Additional expansion cohorts are evaluating JANX007 monotherapy in patients with PARP inhibitor-refractory mCRPC, supporting assessment of activity in a high-unmet-need population. Strategic Collaboration In January 2026, Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen.Under the terms of the agreement, Janux is eligible to receive $50 million in upfront and near-term milestone payments, with the potential for additional development, regulatory and commercial milestones totaling approximately $800 million, as well as tiered royalties on global product sales, if successful. Janux will lead preclinical development through IND submission, with Bristol Myers Squibb assuming responsibility for subsequent clinical development and global commercialization. Under the terms of the agreement, Janux is eligible to receive $50 million in upfront and near-term milestone payments, with the potential for additional development, regulatory and commercial milestones totaling approximately $800 million, as well as tiered royalties on global product sales, if successful. Janux will lead preclinical development through IND submission, with Bristol Myers Squibb assuming responsibility for subsequent clinical development and global commercialization. Corporate & Leadership Janux recently announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, strengthening the Company’s clinical leadership as additional programs enter the clinic in 2026 and progress toward later-stage development. Upcoming Milestones The Company expects to provide additional clinical data for JANX007 in 2026 or present these data at a future medical meeting. The Company expects to provide an additional clinical update for JANX008 in 2026. The Company expects to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers by year-end 2026. FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of December 31, 2025, Janux reported cash and cash equivalents and short-term investments of $966.6 million, compared to $1.03 billion on December 31, 2024. Research and development expenses: Research and development expenses were $31.5 million for the quarter and $125.9 million for the year ended December 31, 2025, compared to $20.8 million and $68.4 million for the same quarter and year in 2024. General and administrative expenses: General and administrative expenses were $10.9 million for the quarter and $41.8 million for the year ended December 31, 2025, compared to $8.2 million and $41.0 million for the same quarter and year in 2024. Net loss: Net loss was $31.9 million for the quarter and $113.6 million for the year ended December 31, 2025, compared to $20.2 million and $69.0 million for the same quarter and year in 2024. About Janux Therapeutics Janux is a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid tumors. Janux is also advancing its first ARM platform clinical candidate, JANX011, a CD19-ARM for the potential treatment of autoimmune diseases in a Phase 1 study in healthy adult volunteers. Janux continues to generate a number of additional TRACTr, TRACIr, and ARM programs for potential future development. For more information, please visit www.januxrx.com and follow us on LinkedIn. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Janux’s ability to bring new treatments to cancer patients in need, expectations regarding the timing, scope and results of Janux’s development activities, including its ongoing and planned preclinical studies and clinical trials, and the potential benefits of Janux’s product candidates and platform technologies, expectations regarding the use of Janux’s platform technologies to generate novel product candidates and the strength of Janux’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, the risk that compounds that appear promising in early research do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Janux may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Janux faces, please refer to Janux’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Janux assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Janux Therapeutics, Inc. Condensed Balance Sheets (in thousands) December 31, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 52,334 $ 430,605 Short-term investments 914,233 594,568 Prepaid expenses and other current assets 9,320 8,493 Total current assets 975,887 1,033,666 Restricted cash 816 816 Property and equipment, net 3,852 4,864 Operating lease right-of-use assets 18,402 19,286 Other long-term assets 2,608 2,884 Total assets $ 1,001,565 $ 1,061,516 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 4,971 $ 4,026 Accrued expenses 17,633 11,684 Current portion of operating lease liabilities 2,393 1,749 Total current liabilities 24,997 17,459 Operating lease liabilities, net of current portion 19,746 21,276 Total liabilities 44,743 38,735 Total stockholders’ equity 956,822 1,022,781 Total liabilities and stockholders’ equity $ 1,001,565 $ 1,061,516 Janux Therapeutics, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Collaboration revenue $ — $ — $ 10,000 $ 10,588 Operating expenses: Research and development 31,548 20,806 125,896 68,388 General and administrative 10,853 8,216 41,771 41,047 Total operating expenses 42,401 29,022 167,667 109,435 Loss from operations (42,401 ) (29,022 ) (157,667 ) (98,847 ) Total other income — 8,806 — 29,853 Net loss $ (42,401 ) $ (20,216 ) $ (157,667 ) $ (68,994 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net 10,455 (5,668 ) 44,042 1,498 Comprehensive loss $ (31,946 ) $ (25,884 ) $ (113,625 ) $ (67,496 ) Net loss per common share, basic and diluted $ (0.51 ) $ (0.36 ) $ (1.83 ) $ (1.28 ) Weighted-average shares of common stock outstanding, basic and diluted 62,145,668 56,832,374 61,966,999 53,751,480 Investors: Chad Rubin Endurance Advisors crubin@enduranceadvisors.com 646.319.3261 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. jessica@litldog.com 858.344.8091

Phase 1License out/inFinancial StatementImmunotherapyExecutive Change

100 Deals associated with Darolutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hormone-dependent prostate cancer	European Union	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Iceland	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Liechtenstein	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Norway	Bayer AG	20 Mar 2023
Castration-sensitive prostate cancer	China	Bayer HealthCare Pharmaceuticals, Inc.	16 Mar 2023
Metastatic Prostate Carcinoma	Japan	Bayer AG	24 Feb 2023
Metastatic castration-resistant prostate cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	05 Aug 2022
Prostatic Cancer	Brazil	Bayer AG	01 Jan 2020
Castration-Resistant Prostatic Cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	30 Jul 2019

Developing

10 top R&D records.

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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06190899 (ASCO_GU2026)	Phase 1/2	Metastatic castration-resistant prostate cancer	56	Gedatolisib 120 mg + Darolutamide	ksyzpnlhbi(vciluduzht) = tfxdhbpayf mpislwtnmx (bqurwklqpd ) View more	Positive	26 Feb 2026
				Gedatolisib 180 mg + Darolutamide	huttxgdrha(gsybtmbdbv) = rtfwzgmvvj quwqkwxqfe (dliolucrcd ) View more
NCT02799602 (ARASENS, ASCO_GU2026)	Phase 3	Hormone-dependent prostate cancer	1,305	darolutamide+androgen deprivation therapy+docetaxel	snhnpvalji(obxgynamef) = nbohdtsjel ljjkszlxdp (uckxxttkri ) View more	Positive	26 Feb 2026
				placebo+androgen deprivation therapy+docetaxel	snhnpvalji(obxgynamef) = bqwjevchpt ljjkszlxdp (uckxxttkri ) View more
ASCO_GU2026	Not Applicable	Castration-Resistant Prostatic Cancer	96	enzalutamide	ounrzffgdw(wfebrlkcfm) = ezllglnkng bfuxtjtdjt (iexaatinnn ) View more	Positive	26 Feb 2026
				apalutamide	ounrzffgdw(wfebrlkcfm) = yjdimidvwf bfuxtjtdjt (iexaatinnn ) View more
NCT04736199 (ARANOTE, ASCO_GU2026)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide + ADT	kufxkyzggi(lfjykieqci) = faopprvnon yayxrjuvln (ytnerqxrsd ) View more	Positive	26 Feb 2026
				Placebo + ADT	kufxkyzggi(lfjykieqci) = gwxxksrcpm yayxrjuvln (ytnerqxrsd ) View more
ASCO_GU2026	Not Applicable	Prostatic Cancer	195	Abiraterone acetate	zjxtvjgzoc(qtwvtlcedd) = zkrwsisfkl glmfmwddtu (kjguexsrtn ) View more	Negative	26 Feb 2026
				Apalutamide	zjxtvjgzoc(qtwvtlcedd) = uldegxhkab glmfmwddtu (kjguexsrtn ) View more
NCT05526248 (ARAMON, ASCO_GU2026)	Phase 2	Castration-sensitive prostate cancer	23	Darolutamide 600 mg	oevgwnzsyq(jcoybgxxsw) = vnzilzprzz djyonlqsur (inqjqqaquu ) View more	Positive	26 Feb 2026
NCT05900973 (Daro-PET, ASCO_GU2026)	Phase 2	Localized Prostate Carcinoma	16	Darolutamide 600 mg	xzcdgtdsnv(ivhitubkec) = No adverse events were reported, and all patients completed treatment. elnficyouf (yvlheduoal )	Positive	26 Feb 2026
NCT05526248 (ARAMON, Pubmed \| Eur Urol Focus)	Phase 2	Castration-sensitive prostate cancer \| Non-metastatic prostate cancer	23	Darolutamide 600 mg	fubivwsntu(rzebdlvyhd) = Most AEs were grade 1/2, including feminizing AEs, occurring mainly during the first 6 months dkjkhqiugl (ctzoslgmkv )	Positive	01 Feb 2026
NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	Phase 3	Castration-Resistant Prostatic Cancer	1,509	Darolutamide + ADT	rpunykxlul(ephjpyqrvo): HR = 0.36 (95.0% CI, 0.26 - 0.48) View more	Positive	01 Jan 2026
				Placebo + ADT
ESMO_ASIA2025	Not Applicable	Hormone-dependent prostate cancer	8	Darolutamide + Trans-arterial chemoperfusion by Docetaxel + ADT	ujktztlrwg(cjxrjdsmox) = xownebnovl zfhqoopbjc (zcuznlgqbm ) View more	Positive	05 Dec 2025

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