On August 19, 2026 Hematogenix, a global specialty laboratory and contract research organization focused on oncology and hematopathology, announced that its proprietary Next Generation Flow Cytometry (NGF) assay for MM MRD served as the analytical method for the pivotal efficacy endpoint supporting the U.S. Food and Drug Administration’s (FDA) accelerated approval of Bristol Myers Squibb’s ZENBEXUS (iberdomide). ZENBEXUS is the first CELMoD therapy approved by the FDA for multiple myeloma.

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The FDA-approved prescribing information for ZENBEXUS states that minimal residual disease (MRD)-negative complete response, the trial’s major efficacy outcome measure, was assessed "based on a threshold of 10⁻⁵ using a Hematogenix Next Generation Flow Cytometry assay." In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) achieved an MRD-negative complete response rate of 41%, compared with 21% for patients treated with daratumumab, bortezomib, and dexamethasone (DVd) — a statistically significant improvement (p<0.0001) that formed the basis of the FDA’s approval decision.

"Being named directly in the FDA label for the first approved therapy in a novel drug class is a meaningful validation of the precision and scientific rigor our laboratory brings to this new era of innovative therapies," said Dr. Hytham Al-Masri, President and CEO of Hematogenix. "Multiple myeloma treatment is moving toward MRD negativity as a defining measure of treatment success, and we are proud that our MM MRD flow cytometry platform is trusted to generate the data that regulators, physicians, and patients relying upon."

MRD negativity, measured at a sensitivity threshold of one residual tumor cell among 100,000 normal cells, is increasingly recognized by regulatory authorities as a surrogate endpoint capable of supporting accelerated approval pathways in multiple myeloma, a use case for which specialized, standardized assay methodology is essential. Hematogenix’s NGF MRD platform for MM, AML and CLL is designed to meet the sensitivity, reproducibility, and regulatory-grade standards required for these registrational endpoints across sponsors’ global multicenter trial sites.

This milestone reflects Hematogenix’s broader positioning as an agile, specialized reference laboratory and CRO supporting registrational-grade endpoints for major pharmaceutical sponsors, with CAP-accredited and CLIA certified laboratories across the globe, including the United States, United Kingdom, Malaysia, and China.

About ZENBEXUS (iberdomide) ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on MRD-negative complete response at any time; continued approval may be contingent upon verification of clinical benefit in confirmatory trials. ZENBEXUS carries a Boxed Warning for embryo-fetal toxicity and serious venous and arterial thromboembolism and is available only through the ZENBEXUS REMS program. Full prescribing information, including additional warnings and precautions, is available from Bristol Myers Squibb.

On August 19, 2026 BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) and Mesenkia Therapeutics reported that the companies have signed a research collaboration agreement to explore a novel antibody-based approach for glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer, where effective delivery of large molecules to the brain remains a major challenge.

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The collaboration combines BioArctic’s proprietary BrainTransporter technology with an antibody, developed with Mesenkia’s KITAIbodies platform. The antibody targets HVEM[1], a protein found on the surface of certain glioblastoma tumor cells, including tumor stem cells. By addressing these cells, which are thought to contribute to tumor recurrence and treatment resistance, the project aims to unlock new treatment possibilities for patients with a very high unmet medical need.

Under the agreement, BioArctic will be responsible for generating a novel drug candidate by combining its BrainTransporter technology with Mesenkia’s antibody. BioArctic and Mesenkia thereafter plan to perform preclinical studies to validate the concept and, based on the results of these studies, decide on next steps.

This research collaboration represents an important step in expanding BioArctic’s BrainTransporter pipeline into oncology and further validates the platform’s potential beyond neurodegenerative diseases. It also builds on BioArctic’s core expertise in development and delivery of pharmaceuticals to the brain.

"We are excited to broaden our research and take a first step into oncology through this collaboration," said Gunilla Osswald, Chief Executive Officer of BioArctic. "Glioblastoma remains one of the most challenging cancers to treat, with limited therapeutic options and poor prognosis for those affected. By combining our BrainTransporter technology with Mesenkia’s innovative antibody approach, we aim to target key disease-driving mechanisms to develop new ways to treat this devastating disease."

"This agreement marks an important step for Mesenkia and creates clear opportunities to explore a new treatment strategy for patients with glioblastoma together with BioArctic. The need for new treatments is substantial, particularly given the challenge of delivering medicines to tumor cells throughout the brain. By combining Mesenkia’s antibody expertise with BioArctic’s BrainTransporter technology, we can address one of the disease’s key barriers in a new way. We look forward to advancing the concept together with BioArctic, with the long-term goal of enabling better treatment options for patients and their loved ones," said Moa Fransson, Chief Executive Officer of Mesenkia.

(Press release, Mesenkia Therapeutics, AUG 19, 2026, View Source [SID1234670234])

On August 19, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the efficacy and safety of IDE892, its investigational, potential best-in-class MTA-cooperative PRMT5 inhibitor, in combination with GDC-7035 (RG6620), Genentech’s KRAS G12D inhibitor, in patients with pancreatic ductal adenocarcinoma (PDAC) harboring both an MTAP-deletion and a KRAS G12D mutation. Genentech will sponsor the clinical combination study, and IDEAYA will supply IDE892.

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"We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor IDE397, pan-RAS inhibitors, KRAS G12D inhibitors, and IDEAYA’s lead CDKN2A compound," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE892 has potential best-in-class properties, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding and lack of brain penetrance intended to maximize its therapeutic window, and favorable drug-like properties to enable rational combinations with IDE397, pan-RAS inhibitors, KRAS-mutant specific therapies, and IDEAYA’s CDKN2A lead molecule. IDE892 has a CYP3A4 IC50 greater than 45 micromolar and did not show time dependent inhibition of any of the 7 major cytochrome P450s (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4) based on full kinetic CYP inactivation assays, positioning IDE892 as a potential best-in-class MTA-cooperative PRMT5 combination partner. IDEAYA is evaluating IDE892 in a Phase 1 dose escalation and expansion clinical trial in MTAP-deleted solid tumors and has initiated a Phase 1 combination cohort in NSCLC and other solid tumors with IDE397, IDEAYA’s proprietary MAT2A inhibitor. IDEAYA also plans to initiate a Phase 1 combination cohort with Roche’s RG6505 in MTAP-deleted, RAS-mutant PDAC in 2H 2026. The collaboration announced today adds GDC-7035 as an additional KRAS-directed combination partner for IDE892 in MTAP-deleted, KRAS G12D positive PDAC.

MTAP deletions and KRAS G12D mutations are estimated to co-occur in up to approximately 15% of PDAC patients. Combining a PRMT5 inhibitor with a KRAS G12D mutant-specific inhibitor may have the potential to drive deeper and more durable responses for those PDAC patients with co-occurring alterations, who currently have no approved targeted treatment options.

Under the clinical collaboration, IDEAYA and Genentech each retain all commercial rights to their respective compounds, including as monotherapy and as combination therapies. There will be joint governance to oversee the clinical supply collaboration.

(Press release, Ideaya Biosciences, AUG 19, 2026, View Source [SID1234670233])

On August 19, 2026 Hengrui Pharma ("Hengrui" or "the Company") reported its financial results for the first half of 2026. During the reporting period, innovative drugs remained the Company’s key growth driver, while globalization initiatives continued to validate the global value of Hengrui’s innovation portfolio.

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Financial Highlights

In the first half of 2026, Hengrui reported revenue of RMB15.46 billion. Drug sales revenue was RMB13.95 billion, representing a year-over-year increase of 1.87%. Innovative drug sales increased by 16.38% year-over-year and accounted for 63.16% of total drug sales, with non-oncology innovative drug sales increasing by 73.97% year-over-year and emerging as an increasingly important growth driver.

Net profit attributable to shareholders of the listed company was RMB4.47 billion, up 0.34%. R&D investment totaled RMB4.61 billion, representing 29.8% of revenue.

Pipeline and Regulatory Highlights

Hengrui continued to advance its pipeline in China during the reporting period, obtaining seven innovation-related approvals, including two Class 1 innovative medicines, one Class 2 innovative medicine and four additional indications. At the end of the reporting period, nine marketing applications had been accepted for review by China’s National Medical Products Administration, while 17 clinical programs had advanced to Phase III, 22 to Phase II, and 10 innovative assets had entered Phase I clinical development.

Hengrui also reported progress across its metabolic pipeline. Two Phase III studies of ribupatide injection, a GLP-1/GIP dual receptor agonist, in China for type 2 diabetes reported positive topline results, supporting a planned NDA submission. HRS-7535, an oral small molecule GLP-1 receptor agonist, met all primary and key secondary endpoints at Week 44 in a China Phase III obesity study, with continued weight loss through Week 50 and mean body-weight reduction of up to 11.1%. An NDA submission is planned.

Global Partnerships and Business Development

Hengrui continued to advance its globalization strategy through diversified collaboration models. Since 2023, the Company has completed 13 overseas business development transactions, including out-licensing, NewCo and strategic alliances, with a total potential transaction value of approximately US$42 billion. These collaborations include leading global pharmaceutical companies such as BMS, GSK and others.

Among the diversified collaboration models Hengrui has explored, NewCo has also seen important progress in 2026. Kailera Therapeutics completed its Nasdaq IPO in April 2026, becoming one of the largest biotech IPOs at the time. Braveheart Bio also successfully listed on the Nasdaq Global Market on August 6, 2026.

Scientific Recognition

During the reporting period, 204 research findings related to Hengrui products were published in academic journals and received international recognition. Hengrui participated in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for the 16th consecutive year, with 91 studies accepted, including 11 oral presentations—a new high for the Company. Research in non-oncology areas was also presented at major international congresses, including the American Diabetes Association, International Stroke Conference, World Congress of Nephrology‌, American College of Cardiology, American Academy of Dermatology, and European Alliance of Associations for Rheumatology.

Outlook

Looking ahead, Hengrui will continue to advance its innovation and globalization strategy, while further pursuing its dual-growth strategy across oncology and chronic diseases. The Company will strengthen its global R&D capabilities, pursue diversified international collaboration models, and continue to focus on delivering sustainable long-term value and bringing more high-quality innovative therapies to patients worldwide.

(Press release, Hengrui Pharmaceuticals, AUG 19, 2026, View Source [SID1234670232])

On August 19, 2026 Monteris Medical, the leader in minimally invasive neurosurgery with its NeuroBlate System for magnetic resonance-guided laser interstitial thermal therapy (LITT), reported the publication of the largest prospective dataset to date of patients undergoing LITT from its LAANTERN* study. Published in the distinguished Journal of Clinical Oncology (JCO), this ninth manuscript from LAANTERN analyzes outcomes from 787 tumor patients treated exclusively with NeuroBlate across 25 U.S. centers, establishing a new benchmark for clinical evidence in minimally invasive neurosurgery and highlighting key factors linked to increased survival.

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This LAANTERN analysis demonstrates that extent of ablation (EOA) is a critical determinant of survival, particularly in newly diagnosed glioblastoma and recurrent metastatic tumors. Patients who achieved ≥91% tumor ablation experienced significantly longer progression-free and overall survival, establishing EOA as a central driver of post-LITT outcomes in newly diagnosed glioblastoma brain tumors.

"LAANTERN advances how LITT is understood and applied in neuro-oncology," said Dr. Eric C. Leuthardt, principal investigator of LAANTERN, lead author of the study and a professor of neurological surgery at Washington University School of Medicine in St. Louis. "I was an early investigator of this technology, and long-term outcomes from this large cohort will help us identify the patients who are most likely to benefit from this therapeutic option." Leuthardt treats patients at Siteman Cancer Center, based at Barnes-Jewish Hospital and WashU Medicine, and is a research member of Siteman.

LAANTERN is the first – and remains the only – prospective multicenter study of this magnitude dedicated to LITT, with more than 1,000 patients enrolled and followed for up to five years. This latest publication from the LAANTERN study underscores Monteris’ sustained leadership and long-term commitment to generating rigorous, high-quality clinical evidence, culminating in outcomes data of unprecedented scale and significance for the field of minimally invasive neurosurgery.

NeuroBlate’s advanced engineering, including cooled laser probes that enable larger ablation volumes and the SideFire directional probe, which is specifically designed to address irregularly shaped lesions, optimizes the likelihood of achieving high EOA in real-world clinical practice.

For metastatic brain tumors, the study observed that earlier intervention, while lesions remain smaller, confers a survival advantage. This insight is particularly impactful for patients and providers as they make treatment decisions.

"These data show that timing matters," added Dr. Leuthardt. "Treating metastatic lesions earlier, before volume becomes prohibitive, improves patient outcomes and strengthens the role of LITT as a proactive cytoreductive option rather than a treatment of last resort."

Consistent with other publications from the LAANTERN study, patients undergoing NeuroBlate LITT experienced short hospital stays and rapid postoperative recovery, with the vast majority avoiding intensive care. Functional status and quality of life were largely preserved over time, with a favorable safety profile characterized by low complication and infection rates and few readmissions. Additional benefits included reductions in seizure burden and decreased reliance on steroids and anticonvulsant medications, supporting NeuroBlate as a minimally invasive option that promotes fast recovery while maintaining quality of life – areas of great importance to patients with brain tumors.

"Prior to the LAANTERN study, there was a lack of real-world evidence to support broad care team adoption, payer confidence and guideline inclusion," said Christa Seligman, senior director of clinical sciences at Monteris Medical. "It has been incredibly rewarding to lead a field that once did not have this foundation and to see that effort result in a publication of this caliber. Because of the dedicated LAANTERN clinical investigators and their patients, we are proud and humbled to continue leading with high-quality evidence that advances patient care."

*About LAANTERN

LAANTERN (Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System, NCT02392078) is a post-market study designed to evaluate the performance and utilization of the NeuroBlate System to generate real-world evidence and guide standard of care practice. This is the first prospective multicenter laser ablation study. All sites operated under an IRB-approved protocol and received rigorous data monitoring to ensure quality and consistency. LAANTERN enrolled over 1,000 patients in the United States and followed them up to five years. Outcomes included safety, quality of life, health economics, procedural outcomes, seizure freedom, and survival.

About the NeuroBlate System

Monteris Medical develops and markets innovative MR‑guided laser ablation systems that enable minimally invasive, robotically controlled brain surgery – often referred to as laser ablation, LITT (laser interstitial thermal therapy) or SLA (stereotactic laser ablation). The company’s NeuroBlate System is designed for adults and children aged two and older and uses laser technology to precisely destroy abnormal brain tissue, including certain brain tumors and specific areas of the brain that cause seizures due to epilepsy. NeuroBlate is the only LITT platform with a robotic interface that supports the targeted, safe delivery of laser energy and is studied prospectively. Multicenter publications on NeuroBlate show that patients typically experience short hospital stays, low rates of complications, improved quality of life and outcomes comparable to open surgical resection.

(Press release, Monteris Medical, AUG 19, 2026, View Source [SID1234670231])