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 announced financial results for the fourth quarter and year ended December 31, 2025.

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"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 [SID1234663414])

On March 9, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported a collaboration with Etcembly Ltd, a biotechnology company applying advanced machine learning to T cell receptor (TCR) discovery and engineering.

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Highlights:

AI-enabled collaboration to engineer KKLC1-targeting TCRs for Zelluna’s TCR-NK platform
Builds on successful engineering of MAGE-A4 TCR underpinning ZI-MA4-1, approved for clinical testing in February 2026
Expands pipeline with validated solid tumour antigen expressed across multiple difficult-to-treat cancers
AI-guided in silico engineering to enhance specificity, potency and development efficiency
The collaboration will focus on the engineering of high-affinity, tumour-specific TCRs targeting KKLC1, a validated cancer antigen found in multiple difficult-to-treat solid tumours. The engineered receptors will be fully owned by Zelluna and developed for use within Zelluna’s proprietary TCR-NK platform. In-vitro data demonstrating safety, specificity and functional activity is now expected in Q4 2026.

This collaboration builds on Zelluna’s successful engineering of a T cell receptor (TCR) designed to recognise the cancer antigen MAGE-A4. This receptor is the targeting module of the company’s lead product candidate ZI-MA4-1, which in February 2026 received approval from the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) to initiate clinical testing. By engineering receptors targeting KKLC1, Zelluna is expanding its product portfolio beyond MAGE-A4 and can thereby address a broader spectrum of solid cancers and patients.

"Our lead product candidate ZI-MA4-1 is built on an affinity enhanced receptor that recognises cancer cells with the MAGE-A4 protein. We developed this receptor in our first highly successful collaboration with Etcembly," said Luise Weigand, Chief Scientific Officer of Zelluna. "We are now delighted to continue our collaboration on our next programme targeting KKLC1. By combining artificial intelligence with our cell therapy platform, we aim to develop highly precise and potent treatments for solid cancers."

"Our first collaboration with Zelluna demonstrated what AI-guided TCR engineering can achieve: a clinically approved receptor in a fraction of conventional timelines. We are excited to apply EMLy again to expand Zelluna’s pipeline and address cancers that desperately need new treatment options" commented Michelle Teng, Founder and CEO of Etcembly.

(Press release, Zelluna Immunotherapy, MAR 9, 2026, View Source [SID1234663398])

On March 9, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that compelling data describing new clinical opportunities for its lead drug narmafotinib was presented at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics in Los Angeles, California on Friday March 6.

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The poster presentation discloses preclinical data demonstrating that the Company’s best-in-class FAK inhibitor narmafotinib enhances the activity of a new class of drugs called kRAS inhibitors in various models of cancer. In particular, the data indicates that narmafotinib blocks resistance pathways that can emerge with kRAS inhibitor treatment, thereby enhancing efficacy and durability of response.

A copy of the poster is available on the Company’s website.

Inhibitors of mutant kRAS proteins are an exciting new class of drug in development for the treatment of lung, colon and pancreatic cancer, amongst others. There are currently over 50 different kRAS inhibitors undergoing clinical studies across the globe. Despite promising mid-stage clinical data, however, side-effects of these drugs can be significant and treatment-emergent resistance is commonplace.

Dr Chris Burns, CEO of Amplia, commented, "We are excited to present our research findings at this specialist conference focused on RAS inhibition in cancer. We believe there is significant clinical potential in combining narmafotinib with kRAS inhibitors and will be discussing our findings with pharma and biotech companies actively working in this space."

(Press release, Amplia Therapeutics, MAR 9, 2026, View Source [SID1234663397])

On March 9, 2026 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the new drug applications (the "NDAs") for the company’s product, toripalimab injection (subcutaneous injection [code: JS001sc]), for 12 indications in the treatment of tumors has been accepted by the National Medical Products Administration ("NMPA"). JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.

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According to data released by GLOBOCAN 2022, in 2022, there were 4.8247 million new cancer cases and 2.5742 million cancer-related deaths in China. Immunotherapy (I-O), represented by anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various malignant tumors, including lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal carcinoma. Now, immunotherapy covers nearly all stages of treatment for cancer patients, encompassing adjuvant/neoadjuvant treatment for early-stage tumors, consolidation treatment after radical chemoradiation for locally advanced tumors, and first-line to last-line treatments for advanced tumors. Currently, most immunotherapy drugs in China are administered intravenously, and this not only requires lengthy infusion times, but also imposes significant inconveniences on patients. There is an urgent clinical need for more convenient administration methods for immunotherapy.

Independently developed by Junshi Biosciences, JS001sc injection is a subcutaneous injection based on the marketed product toripalimab injection (code: JS001) that is expected to enhance convenience for patients. The 12 indications in the JS001sc NDAs cover all currently approved indications of toripalimab injection in the Chinese Mainland.

The NDA is mainly based on the JS001sc-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by principal investigator Professor Lin WU from Hunan Cancer Hospital. The study aimed to compare the exposure, efficacy and safety of JS001sc plus chemotherapy versus JS001 plus chemotherapy for the first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer ("NSCLC"). The results showed that JS001sc’s exposure was non-inferior to that of JS001 with comparable efficacy and safety profiles. JS001sc-002-III-NSCLC was the first phase 3 clinical study of domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation. Further details will be presented at an upcoming international academic conference.

Professor Lin WU said, "The JS001sc-002-III-NSCLC study, as China’s first Phase 3 clinical trial of a domestically developed PD-1 monoclonal antibody in a subcutaneous formulation, confirmed that the subcutaneous administration method achieved statistical non-inferiority in drug exposure compared with intravenous administration, while demonstrating comparable efficacy and safety. This milestone not only validates the scientific rationale behind the pharmaceutical development of the subcutaneous formulation, but also provides a novel administration pathway for cancer immunotherapy at the clinical level. In the current era of holistic cancer management, treatment convenience and improved quality of life have become critical clinical priorities. The development and application of subcutaneous injection formulations are expected to significantly reduce dosing time, optimize healthcare resource allocation, and offer new technical support for advancing hierarchical medical systems and home-based treatment management. We anticipate the early approval of the subcutaneous formulation of toripalimab, which will further enrich China’s cancer immunotherapy landscape and ultimately benefit a broader population of cancer patients."

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "We are excited that the NMPA has formally accepted the NDA for JS001sc covering all approved indications of TUOYI (toripalimab). This signifies JS001sc’s potential to address multiple tumor types, including NSCLC, nasopharyngeal carcinoma, esophageal cancer, renal cancer, and liver cancer. It also marks another critical milestone in expanding toripalimab’s innovative and clinical value. As a subcutaneous formulation, JS001sc will substantially enhance dosing convenience, optimize patient treatment experiences, and improve long-term therapy adherence. Moving forward, we will actively advance the regulatory review process, consistently centering patient needs. Using our clinical evidence, we hope to leverage evidence-based medicine to advance high-quality development of China’s cancer therapies, ultimately delivering more accessible, convenient, and high-quality treatment options to patients."

About JS001sc

JS001sc is a subcutaneous injection formulation developed by Junshi Biosciences based on the marketed product toripalimab injection (code: JS001). It is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage and is expected to bring convenient administration to patients. The 12 indications in the NDAs of JS001sc covers all currently approved indications of toripalimab injection in the Chinese Mainland.

(Press release, Shanghai Junshi Bioscience, MAR 9, 2026, View Source [SID1234663396])

On March 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.

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Key findings include:

Tolerability profile supported by dosimetry and low-grade non-hematologic events.
Lesion dosimetry indicates no difference in absorbed dose profile across cohorts.
No adverse drug-drug interactions observed in TLX591-Tx combinations.
Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts.
The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.
Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).

ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice1. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities2. Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, "These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy."

David N. Cade, MD, Group Chief Medical Officer, Telix added, "Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved."

Summary results

ProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts:

Cohort 1 (11 patients): TLX591-Tx + enzalutamide.
Cohort 2 (11 patients): TLX591-Tx + abiraterone.
Cohort 3 (14 patients): TLX591-Tx followed by docetaxel.
Safety and tolerability

An acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies.
All 36 patients received both doses of TLX591-Tx per protocol, no new safety signals were observed.
Almost all treatment-emergent non-hematologic events were Grade 1 or Grade 2. The most prevalent were fatigue (53%), nausea (28%) and dry mouth (25%).
Hematologic events were transient and manageable.
Grade 3 thrombocytopenia (14%) and neutropenia (22%), and Grade 4 thrombocytopenia (31%) and neutropenia (25%) events were in line with the profile expected for this class of therapy and extent of disease.
Dosimetry and biodistribution

Radiation exposure to key organs was well below established safety limits3.
Limited dose to salivary glands and kidneys.
Lesion dosimetry demonstrated uptake across tumor sites and across all cohorts.
Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging which demonstrated prolonged tumor retention.
No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance.
About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET4 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI.

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies5, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys6. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs7.

Additional information on the Phase 3 ProstACT Global study can be found at: View Source

(Press release, Telix Pharmaceuticals, MAR 9, 2026, View Source [SID1234663395])