On March 9, 2026 Johnson & Johnson reported that the European Commission (EC) has approved an indication extension for AKEEGA (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Patients with BRCA-mutated metastatic prostate cancer often experience rapid progression on the current standard of care, highlighting a significant unmet need for more personalised treatment approaches that address the underlying biology of their disease," said Dr. Elena Castro, Medical Oncologist, Hospital 12 de Octubre, Madrid* "Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression."

AMPLITUDE efficacy results

The approval is supported by data from the Phase 3 AMPLITUDE study, which evaluated the efficacy and safety of the niraparib/AAP combination compared with placebo plus AAP in 696 patients with mHSPC and homologous recombination repair (HRR) gene alterations.1 The primary analysis of the study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).1 Patients with BRCA1/2 mutations showed the greatest benefit of treatment with the niraparib/AAP combination (n=191), as after 30.7 months of follow-up, the median rPFS was not yet reached compared to 26 months in patients treated with the placebo plus AAP (n=196), corresponding to a reduction in the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001).1,3 Treatment with the niraparib/AAP combination also significantly prolonged the time to symptomatic progression in patients with BRCA mutations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001).1 The second interim analysis of overall survival was consistent with the first interim analysis and favoured the niraparib/AAP combination, with a 20 percent reduction in risk of death (HR 0.80, 95 percent CI, 0.58-1.11) in patients with BRCA mutations.3 Follow-up is ongoing.4

"This expanded indication for niraparib and abiraterone acetate reflects our commitment to delivering transformative innovation across the prostate cancer continuum," said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, Johnson & Johnson. "Niraparib and abiraterone acetate is the first precision-medicine combination treatment approved for patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer and is supported by strong clinical data demonstrating a clinically meaningful delay in disease progression."

AMPLITUDE safety results

The safety profile of the niraparib/AAP combination in mHSPC was consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which the niraparib/AAP combination is already authorised.1,5 The most common Grade 3/4 adverse events (AEs) with the niraparib/AAP combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low and adverse events were managed with dose modifications and supportive care.1

Data from the AMPLITUDE study were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and selected for inclusion in the Best of ASCO (Free ASCO Whitepaper) and ASCO (Free ASCO Whitepaper) Press Programme.6

"Today’s EC approval shifts the treatment paradigm and brings new hope to those facing a metastatic prostate cancer diagnosis," said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. "By bringing niraparib and abiraterone acetate earlier into the treatment pathway, in the hormone-sensitive setting, we can intervene at a point where it may have the greatest impact in helping change the trajectory of the disease for patients with BRCA1/2-mutated tumours."

About AMPLITUDE
AMPLITUDE (NCT04497844) is an ongoing, Phase 3, randomised, double-blind, placebo-controlled, international, multicentre study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual action tablet (DAT) formulation with prednisone plus ADT compared to matching oral placebo/abiraterone acetate in a DAT formulation with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic hormone-sensitive prostate cancer (mHSPC).4 The primary endpoint is radiographic progression-free survival (rPFS).4 The study enrolled 696 participants from 32 countries.1

About Niraparib and Abiraterone Acetate
This orally administered, DAT consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.3,4 Niraparib combined with abiraterone acetate and given with prednisone or prednisolone was authorised in April 2023 in the European Economic Area for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.5 Niraparib and abiraterone acetate is also approved in the USA, Canada, Switzerland, United Kingdom and many more countries. Additional marketing authorisation applications are under review across a number of countries globally.

In April 2016, Janssen Biotech, Inc. entered into a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2019), for exclusive rights to niraparib in prostate cancer.7

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using niraparib and abiraterone acetate, please refer to the Summary of Product Characteristics.3

About Metastatic Hormone-Sensitive Prostate Cancer
Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.

(Press release, Johnson & Johnson, MAR 9, 2026, View Source [SID1234663393])

On March 9, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage company focused on promising new therapies in oncology and obesity, reported a corporate update and reported financial results for the fourth quarter and year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our encouraging data readouts for CRB-701 and CRB-913 in the fourth quarter of 2025 set the stage for a potentially transformative 2026. This summer we anticipate key data readouts for both programs that we expect will elucidate their differentiated efficacy and safety profiles, as well as potential clinical utility and commercial opportunities," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "The clinical responses we are generating in HNSCC and cervical cancer patients with CRB-701, a highly stable Nectin-4 ADC, highlight its potential in treating these challenging tumor types. In parallel, the rapid weight loss and favorable GI tolerability we’ve seen with CRB-913 suggest it could provide a novel long-term weight management solution for people struggling with chronic obesity."

Key Corporate and Program Updates

CRB-701 is a next-generation, highly stable Nectin-4 targeting ADC being developed to treat HNSCC and cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CRB-701 for the treatment of both cancer types. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

Encouraging CRB-701 Phase 1/2 data in Q4 2025. Corbus presented dose optimization data at the 2025 European Society for Medical Oncology Congress (ESMO 2025). Highlights included:
Unconfirmed Objective Response Rate with CRB-701 at the 3.6 mg/kg dose: HNSCC – 47.6%, Cervical cancer – 37.5%, and Bladder – 55.6%.
Favorable safety and tolerability with no grade 4 or 5 treatment-related adverse events.
Markedly low levels of peripheral neuropathy and skin toxicity.
Link here for CRB-701 ESMO (Free ESMO Whitepaper) data press release and here for archived KOL event discussing the findings.

Anticipated catalysts for CRB-701 in 2026:
Provide update in Q1 2026 from discussions with FDA regarding registrational study protocols for HNSCC and cervical cancer.
Report monotherapy data in mid-2026 with a key focus being durability data and patient stratification.
Generate CRB-701 + Keytruda combination data in first line ("1L") HNSCC patients in Q4 2026.
CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.

Encouraging CRB-913 data in Q4 2025. Corbus completed a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study in December 2025. SAD portion: n=64 across 8 cohorts; MAD portion: n=48 across 4 cohorts. Highest SAD dose tested was 600 mg/day and highest MAD dose tested was 150 mg/day. Highlights include:
Weight loss of 2.9% (placebo adjusted) at 14-days in dedicated 150 mg/day obesity cohort (n=12). Weight loss started early and deepened with time. Safe and well-tolerated across all cohorts and all doses studied.
Very favorable GI profile with no reports of vomiting, constipation or nausea.
Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative.
Link here for Phase 1a study data press release and here for archived KOL event discussing the findings.

Anticipated catalyst for CRB-913 in 2026:
CANYON-1 Phase 1b dose-ranging 12-week study (n=240) expected to be completed in summer 2026.
CRB-601 is an anti-αvβ8 integrin monoclonal antibody (mAB) designed to block the activation of latent TGFβ in the tumor micro-environment to treat solid tumors.

Phase 1 dose escalation trial of CRB-601 completed in Q4 2025.
Preliminary monotherapy data were presented in November 2025 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025.
Corbus has deprioritized this program and does not plan to enroll additional patients.
Financial Results for the Quarter and Year Ended December 31, 2025

The Company reported a net loss of approximately $20.6 million, or a net loss per basic and diluted share of $1.25, for the three months ended December 31, 2025, compared to a net loss of $9.5 million, or a net loss per basic and diluted share of $0.78, for the three months ended December 31, 2024.

Operating expenses increased by $9.4 million to approximately $22.0 million for the three months ended December 31, 2025, compared to approximately $12.6 million for the three months ended December 31, 2024. The increase was primarily attributable to an increase in clinical development expenses.

The Company had $163.3 million of cash, cash equivalents, and investment on hand at December 31, 2025, which is expected to fund operations into 2028 based on planned expenditures. In the fourth quarter of 2025, the Company completed a public offering that raised a total of $75 million in gross proceeds.

(Press release, Corbus Pharmaceuticals, MAR 9, 2026, View Source [SID1234663392])

On March 9, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-µg treatment cohort at Day 57, representing the strongest treatment response observed in the study.

We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.

Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point.

The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.

The Company believes the dataset represents decision-grade evidence supporting advancement of the SkinJect program toward regulatory discussions and potential strategic partnerships.

Interpreting Clinical and Histological Endpoints

The SKNJCT-003 study evaluated two complementary efficacy endpoints:

• Clinical clearance — visual disappearance of the treated lesion
• Histological clearance — absence of tumor cells on excisional biopsy

The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving 73% clinical clearance and 40% histological clearance at Day 57. Taken together, the results suggest that a meaningful proportion of treated lesions achieved both visual and histological clearance, supporting the therapeutic potential of the SkinJect platform.

Interpreting Biological Activity in the Placebo Active Arm (P-MNA) Cohort:

The biological activity observed in the P-MNA is consistent with mechanisms well recognized in intratumoral device therapies and microneedle-based delivery systems, and is consistent with what the company had observed in the SKNJCT-001 Phase 1 safety and tolerability study in March of 2021, and the positively trending interim analysis of SKNJCT-003 in March of 2023 which demonstrated more than sixty (60) percent of clinical clearance.

Microneedle insertion into tumor tissue produces localized micro-injury that can trigger and amplify several biological processes, including:

• mechanical disruption of tumor architecture
• activation of wound-healing pathways
• localized immune signaling

Basal cell carcinoma is known to be a highly immunogenic tumor, and these localized biological responses can contribute to tumor regression even in the absence of an active therapeutic agent.

These mechanisms have been described in dermatologic oncology literature and reflect the inherent biological activity of microneedle-based delivery platforms.

Microneedle-based tumor disruption is increasingly recognized as a biologically active delivery platform, and the therapeutic contribution of the active drug should be interpreted on top of this device-mediated biological effect.

Importantly, the study demonstrated clear separation between the P-MNA cohort and the 200-µg treatment cohort at Day 57, where the active treatment group achieved 73% clinical clearance compared with 38% in P-MNA, supporting the additional therapeutic contribution of the drug delivered through the SkinJect microneedle system.

The Company believes that the dataset should be interpreted in the context of both:

Biologic activity from the microneedle delivery platform
Additional drug-related therapeutic effect
Potential Clinical Impact

Basal cell carcinoma is the most common cancer worldwide, with millions of lesions treated each year.

The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.

In clinical practice, lesions that achieve visual clearance are often monitored through routine dermatologic follow-up, reserving surgical procedures for lesions that recur or persist.

If confirmed in future studies, this approach could provide dermatologists with a minimally invasive treatment option that may reduce the need for Mohs surgery, the current surgical standard for many basal cell carcinomas.

The treatment approach may be particularly relevant for patients with Gorlin Syndrome, a rare genetic condition in which individuals may develop dozens or hundreds of basal cell carcinomas throughout their lifetime. For these patients, repeated surgical procedures can be extremely burdensome, impractical and potentially disfiguring; a non-invasive treatment could be transformative.

Dataset Supports Next Development Milestones

Based on the available data, the Company considers the current dataset to be decision-grade and supportive of the next phase of development. The Company intends to use these results to advance regulatory discussions with the Food and Drug Administration (the "FDA") and to accelerate partnering discussions, as further elaborated on below.

Advance regulatory discussions with the FDA

The Company plans to proceed toward an End-of-Phase-2 meeting with the FDA to determine the optimal registrational development pathway, where the clinical development strategy may include:

• continued evaluation of the 200-µg dose
• potential optimization of patch application duration
• evaluation of additional treatment sessions
• potential refinement of treatment intervals

Accelerate partnering discussions

The dataset also provides a foundation for ongoing discussions with potential strategic partners, particularly companies active in dermatology and oncology.

Management Commentary

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, commented:

"We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma. The separation observed in the 200-µg treatment cohort, combined with the known biological activity of microneedle-based delivery systems, provides a strong foundation for advancing the program toward regulatory discussions and potential strategic partnerships.

The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention."

Strategic Focus on Phase 2 De-Risking and Partnering

Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.

The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.

(Press release, Skinject, MAR 9, 2026, View Source [SID1234663391])

On March 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported the launch of an expanded research initiative evaluating combinations of its clinical-stage GSK-3β inhibitor elraglusib with emerging RAS-targeted therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Despite recent advances in RAS-targeted therapies, adaptive resistance mechanisms and pathway reactivation remain some of the key barriers to achieving durable responses in patients (Dilly et al., Cancer Discov 2024).

Based on the mechanisms of action, GSK-3 inhibition may represent a critical complementary strategy capable of enhancing RAS-targeted therapies by suppressing downstream survival signaling and resistance pathways, including

NF-κB–mediated survival signaling
MYC-driven transcriptional programs
metabolic adaptation and oxidative stress buffering
tumor microenvironment immune suppression
In addition, RAS-mutant tumors — particularly pancreatic cancer — are widely considered immunologically resistant. Preclinical research suggests that GSK-3β inhibition may enhance antigen presentation, activate T cells and NK cells, and reduce exhausted T-cells. By simultaneously targeting tumor intrinsic survival pathways and modulating the tumor immune microenvironment, the combination of elraglusib and RAS inhibitors has the potential to create a multi-modal therapeutic strategy designed to overcome resistance and expand clinical benefit in RAS-driven cancers.

Expanding the Strategic Opportunity for Elraglusib

Elraglusib is a best-in-class, highly selective GSK-3β inhibitor with broad potential across multiple oncology indications, including pancreatic cancer, melanoma, colorectal cancer, and sarcoma. The investigational product has been administered to more than 500 patients and is currently being evaluated in a Phase 2 trial in metastatic pancreatic cancer (mPDAC).

The combination strategy is designed to simultaneously block proliferative signaling through RAS inhibition and disrupt tumor survival pathways via elraglusib’s GSK-3β inhibition, potentially enhancing apoptotic signaling beyond the threshold achieved with RAS inhibition alone.

The combination program is expected to include in-vitro studies of elraglusib with select RAS inhibitors using tumor models of RAS resistance, in-vivo tumor regression and survival studies, and translational biomarker analysis. Initial data from the program are expected in Q2 2026, with additional results in 2H26.

While next-generation RAS inhibitors are making meaningful progress, the emerging data suggest that combination strategies will be required to maximize clinical benefit (Long et al., Cancer Res 2026). By targeting GSK-3 – a central regulator of tumor survival – the Company believes that elraglusib has the potential to enhance depth and durability of RAS-targeted therapies. Actuate is advancing this work with leading academic collaborators and potential industry partners, further positioning elraglusib as a potential foundational component of next-generation treatment paradigms for RAS-driven cancers.

(Press release, Actuate Therapeutics, MAR 9, 2026, View Source [SID1234663390])

On March 9, 2026 Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, reported a strategic expansion of its partnership with The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients. Through this partnership, Medidata AI Study Build technology will power Stemline’s oncology portfolio to initiate clinical trials faster to meet the urgent needs of people living with cancer. The announcement follows the milestone of Stemline launching its first oncology study entirely in-house, using the Medidata Data Experience.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AI for Impact
By transitioning to unified, AI-driven workflows, Stemline is further modernizing the trial lifecycle from protocol to patient. AI Study Build allows Stemline to leverage a vast clinical data set of more than 38,000 trials to automate configurations — reducing the time between protocol finalization and trial startup from months to weeks with:

Rapid study startups: Accelerating the study builds at an unprecedented pace
Internal agility: Empowering Stemline to build and launch future oncology studies independently, powered by the Medidata Data Experience
Stronger oncology research at speed: Delivering high-quality data faster to meet the urgent requirements of research into different cancers

"Stemline is deepening its commitment to advancing oncology research by embracing our established AI foundation and latest AI Study Build capabilities," said Wayne Walker, senior vice president, Data Experience, Medidata. "Stemline’s commitment to adopting Medidata AI-powered technologies sets a high bar for how sponsors can independently harness a unified platform to accelerate the delivery of new therapies for patients. Together, we are setting a new standard for how oncology trials are built and executed."

"Innovation is at the core of our mission to bring transformational treatments to patients, and we recognize the impact of Medidata AI to further streamline our workflows," said Elcin Barker Ergun, CEO of the Menarini Group. "Our expanded partnership with Medidata supports our internal expertise, enabling us to advance crucial research and reflecting the urgency of our team in bringing new options to patients as quickly and safely as possible."

A Foundation of Trusted Collaboration
This expansion builds upon a 14-year relationship between the Menarini Group and Medidata. While the Menarini Group has long utilized the Medidata platform — including Medidata Rave EDC and Medidata eCOA — to manage the end-to-end cycle of its clinical studies, the move to Medidata AI Study Build marks a significant transition. By combining the Menarini Group’s clinical expertise with Medidata’s established AI and Data Experience leadership, Stemline is positioned to advance its oncology portfolio with unprecedented speed and independence.

(Press release, Medidata, MAR 9, 2026, View Source [SID1234663389])