Novartis to Acquire Myricx Bio; Roche’s Divarasib Tops Approved KRAS G12C Inhibitors in Phase III NSCLC Trial; Otsuka Reports Positive Two-Year Phase 3 Results for VOYXACT in IgA Nephropathy; Revolution Medicines Reports Early Clinical Data for Zoldonrasib Combination Regimens at ESMO GI 2026; Can-Fite Completes Patient Enrolment for Interim Analysis in Pivotal Phase 3 Psoriasis Trial

Novartis to Acquire Myricx Bio to Expand Next-Generation ADC Portfolio

Novartis has signed an agreement to acquire Myricx Bio, a privately owned biotechnology company based in the UK that is developing a novel class of antibody-drug conjugates (ADCs) featuring N-myristoyltransferase inhibitor (NMTi) payloads.

The acquisition is expected to enhance Novartis’ oncology pipeline by adding next-generation targeted conjugates with an innovative payload mechanism. Myricx’s technology is designed to selectively deliver an NMTi payload to cancer cells, offering a differentiated approach that could overcome some of the challenges associated with widely used ADC payloads, including topoisomerase I (TOPO-1) inhibitors. The company’s lead candidates target B7-H3 and HER2 and are being developed for the treatment of multiple solid tumors.

“ADCs have transformed cancer therapy, but there is still a significant need for novel payload technologies that can overcome resistance and broaden treatment options,” said Fiona Marshall, President of Biomedical Research at Novartis. “Myricx Bio’s NMTi payload platform introduces a unique mechanism of action that has the potential to expand the application of ADCs across a wide range of tumors. This acquisition aligns with our strategy of investing in innovative platforms, similar to our work in radioligand therapies, to develop more durable and impactful treatments for patients.”

N-myristoyltransferase (NMT) is a key enzyme involved in maintaining the activity of proteins that support cancer cell growth and survival. By blocking NMT, Myricx’s payload is designed to interfere with essential cellular functions required by tumor cells. Preclinical studies indicate that the NMTi payload demonstrates broad activity against solid tumors, including models resistant to TOPO-1 inhibitors, suggesting it could extend the effectiveness of ADCs in indications where current payload technologies have shown limitations.

Beyond strengthening its current oncology portfolio, the acquisition also provides Novartis with the opportunity to establish NMTi, pending successful clinical validation, as a new ADC payload class that could be leveraged across multiple therapeutic targets and future drug conjugate platforms.

Roche’s Divarasib Delivers Superior Outcomes in Head-to-Head Phase III NSCLC Trial

Roche reported positive topline findings from the Phase III Krascendo 1 trial evaluating divarasib, its investigational next-generation KRAS G12C inhibitor, versus the first-generation approved KRAS G12C inhibitors sotorasib and adagrasib in patients with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC). The trial achieved both its primary endpoint and key secondary endpoint, with divarasib demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS). The treatment’s safety profile was consistent with earlier studies, with no new safety concerns identified. The most frequently reported treatment-related adverse events were manageable and reversible.

“The superior survival benefit observed in this global head-to-head study of KRAS G12C inhibitors underscores divarasib’s potential to improve outcomes for patients with KRAS G12C-mutated non-small cell lung cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “These findings support divarasib’s potential to become the new standard of care for previously treated patients with this molecularly defined subtype of lung cancer.”

There remains a substantial unmet need for more effective therapies in KRAS G12C-mutated NSCLC. The KRAS G12C mutation is among the most common KRAS alterations, occurring in approximately 14% of NSCLC patients, and is associated with poorer clinical outcomes.

Roche is continuing to expand the Phase III clinical development program for divarasib in NSCLC, evaluating the therapy both as a standalone treatment and in chemotherapy-free combination regimens across multiple stages of disease and treatment settings. Divarasib received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in 2022 and was granted Orphan Drug Designation for KRAS G12C-mutated NSCLC in 2026.

The complete results from the Krascendo 1 study will be presented at a forthcoming scientific congress and submitted to regulatory authorities to support potential approvals and expedite access to divarasib for eligible patients with KRAS G12C-mutated NSCLC.

Otsuka Announces Positive Two-Year Phase 3 VISIONARY Data Supporting Long-Term Kidney Protection with VOYXACT

Otsuka Pharmaceutical reported positive topline findings from its Phase 3 VISIONARY study evaluating VOYXACT (sibeprenlimab-szsi) in adults with primary IgA nephropathy (IgAN). The trial met its key kidney function endpoint, demonstrating statistically significant stabilization of renal function over two years, with evidence of improvement based on the annualized eGFR slope and changes from baseline. The results are consistent with the 2025 KDIGO IgAN guidelines, which recommend limiting kidney function decline to near-normal physiological rates.

VOYXACT also maintained a favorable safety profile comparable to placebo, consistent with previously reported interim data. Otsuka plans to submit the complete VISIONARY results to global regulatory agencies, including a supplemental Biologics License Application (sBLA) to the U.S. FDA seeking traditional approval. The company also intends to present the findings at an upcoming scientific meeting.

According to John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Otsuka Pharmaceutical Development & Commercialization, the two-year Phase 3 data demonstrate clinically meaningful and statistically significant preservation of kidney function, highlighting VOYXACT’s potential to slow or halt disease progression rather than simply manage symptoms. He added that the findings further support selective APRIL inhibition as a disease-modifying strategy that targets the underlying mechanisms of IgAN while avoiding broad B-cell depletion, with the potential to improve long-term renal outcomes.

VOYXACT became the first selective APRIL inhibitor approved by the U.S. FDA in November 2025 through the accelerated approval pathway after significantly reducing proteinuria versus placebo at nine months in the VISIONARY trial. The newly reported 24-month eGFR results strengthen evidence that selective APRIL inhibition can modify disease progression by reducing production of pathogenic IgA through targeted modulation of B-cell activity without extensive B-cell depletion. Together with previously reported improvements in galactose-deficient IgA1 (Gd-IgA1), proteinuria, and hematuria, these findings reinforce VOYXACT’s potential to deliver durable clinical benefits for patients with IgAN.

Revolution Medicines Announces Phase 1/2 Clinical Results for Zoldonrasib Combination Regimens in RAS G12D Metastatic Pancreatic Cancer

Revolution Medicines, Inc. has reported findings from two Phase 1/2 clinical studies investigating zoldonrasib, its oral, RAS(ON) G12D-selective covalent inhibitor, in combination treatment strategies for patients with RAS G12D-mutated metastatic pancreatic ductal adenocarcinoma (PDAC). The data, scheduled for presentation in a proffered paper session at the 2026 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress, highlight two therapeutic approaches: zoldonrasib combined with standard-of-care chemotherapy in treatment-naïve patients and zoldonrasib paired with daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in previously treated patients.

Commenting on the results, Alan Sandler, M.D., Chief Development Officer at Revolution Medicines, said the positive outcomes from the Phase 3 RASolute 302 trial established clinical proof of RAS(ON) inhibition with daraxonrasib in second-line metastatic pancreatic cancer and laid the groundwork for expanding this strategy across additional RAS mutations, treatment settings, and combination regimens. According to Sandler, the ESMO GI data provide compelling proof-of-concept for two zoldonrasib-based treatment strategies in RAS G12D-positive disease: combining zoldonrasib with standard chemotherapy for first-line patients and pairing it with daraxonrasib in previously treated patients. These findings support the company’s two Phase 3 development programs in previously untreated metastatic RAS G12D PDAC—the ongoing RASolute 305 trial evaluating zoldonrasib plus chemotherapy and the planned RASolute 309 trial assessing the zoldonrasib-daraxonrasib combination.

Zoldonrasib is an investigational oral RAS(ON) G12D-selective covalent tri-complex inhibitor designed to target the most common RAS mutation, G12D, which accounts for approximately 29% of all RAS-driven cancers. An estimated 61,000 patients in the United States are diagnosed annually with RAS G12D-mutated cancers, yet no approved targeted therapies currently exist for this population. The candidate is being studied both as a standalone treatment and in combination with other therapies, including daraxonrasib and standard-of-care regimens, across lung and gastrointestinal cancers.

Daraxonrasib is an investigational oral RAS(ON) multi-selective, non-covalent tri-complex inhibitor developed to address cancers driven by multiple RAS mutations, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer. The U.S. Food and Drug Administration (FDA) has granted daraxonrasib both Breakthrough Therapy and Orphan Drug designations for previously treated metastatic PDAC harboring G12 mutations. The therapy has also been selected for the FDA Commissioner’s National Priority Voucher pilot program, which aims to expedite the development and regulatory review of treatments addressing critical national healthcare priorities.

Daraxonrasib is currently being evaluated in a global Phase 3 registrational program comprising four clinical trials, including the completed RASolute 302 study and three ongoing studies in patients with metastatic PDAC and RAS-mutant NSCLC.

Can-Fite Marks Major Progress in Phase 3 Psoriasis Program with Completed Interim Analysis Enrolment

Can-Fite BioPharma Ltd. has completed the enrollment of the first 247 participants in its pivotal Phase 3 clinical trial investigating Piclidenoson as a treatment for moderate-to-severe plaque psoriasis. With enrollment reaching this milestone, the study has progressed to its pre-planned interim analysis phase, conducted under a protocol agreed upon with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim review will assess the efficacy and safety data generated from the enrolled patients, with findings anticipated in Q4 2026 or Q1 2027.

The pivotal Phase 3 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and therapeutic efficacy of Piclidenoson in patients with moderate-to-severe plaque psoriasis. Participants receive either 3 mg oral Piclidenoson tablets or placebo twice daily. The study’s co-primary endpoints include the percentage of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and the percentage attaining a Static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 16.

Piclidenoson is a first-in-class oral agonist of the A3 adenosine receptor (A3AR) that works by targeting inflammatory pathways involved in psoriasis. In contrast to injectable biologic therapies, the drug is administered orally and has demonstrated a favorable safety profile across more than 1,500 patients treated in clinical studies, supporting its potential as a long-term maintenance therapy.

Commenting on the achievement, Motti Farbstein, Chief Executive Officer of Can-Fite, said the enrollment milestone represents significant progress for the company’s pivotal psoriasis program. He noted that the study is being conducted under a regulatory framework agreed with both the FDA and EMA, providing a well-defined pathway toward potential approval. Farbstein added that Piclidenoson’s oral formulation, established safety profile, and suitability for chronic use distinguish it from existing treatment options and could offer an important new therapy for people living with psoriasis.

The global market for psoriasis treatments continues to grow, driven by rising disease prevalence and increasing demand for therapies that combine long-term safety, efficacy, and convenience. Can-Fite believes Piclidenoson’s differentiated oral small-molecule approach positions it to address significant unmet needs in this expanding therapeutic landscape.