Novartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche's own BTK inhibitor fenebrutinib.

Original title: “Novartis’ Rhapsido cuts MS progression in Phase 3 trial, teeing up Roche battle”

Australian teams advance first‑in‑human multiple myeloma therapy

Original title: “Koala trial doses first patient with novel KMA‑targeting CAR‑T”

Designation supports development for post‑hepatectomy liver failure

Original title: “Heparegenix wins orphan drug status for darizmetinib”

Daraxonrasib, an oral RAS inhibitor therapy, achieved durable responses in pretreated patients with RAS-mutant non-small cell lung cancer (NSCLC) in a Phase 1/2 trial led by The University of Texas MD Anderson Cancer Center. Chemotherapy with docetaxel remains a common standard treatment option for patients with RAS-mutant NSCLC whose disease has progressed after platinum-based chemotherapy and immunotherapy. Historical studies in this setting have reported response rates of 9 to 14%, median progression-free survival (PFS) of 3 to 4.5 months, and median overall survival (OS) of approximately 9 to 12 months. This highlights a significant need for new treatment options for these patients. How effective was daraxonrasib in this lung cancer trial? The most clinically relevant results were observed in 38 patients with NSCLC treated with 160-220 mg. The study, published today in The New England Journal of Medicine, was led by David Hong, M.D., deputy chair of Investigational Cancer Therapeutics. “Immunotherapy has improved outcomes for many patients with non-small cell lung cancer, but the majority of these cancers eventually progress,” Hong said. “At that point, the few treatment options available to these patients often have modest clinical benefit and substantial toxicities, so these early results are encouraging.” This trial was funded by Revolution Medicines. A full list of collaborating authors and their disclosures can be found with the full paper in The New England Journal of Medicine. Immunotherapy has improved outcomes for many patients with non-small cell lung cancer, but the majority of these cancers eventually progress. At that point, the few treatment options available to these patients often have modest clinical benefit and substantial toxicities, so these early results are encouraging. At the recommended Phase 3 dose, 51% of patients experienced an adverse effect at grade 3 or higher, with 71% experiencing dose modifications and 10% having to discontinue treatment. The most common adverse effects were rash, which occurred in 90% of patients (8% grade 3 or above) and gastrointestinal issues, including diarrhea, nausea and vomiting (73%, 62% and 54% respectively overall, each less than 10% grade 3 or above). What are the next steps for daraxonrasib in lung cancer? The initial data from this trial, which were presented at the 2025 European Lung Congress, prompted the Phase 3 trial now underway.

Original title: “Daraxonrasib demonstrates initial antitumor activity in RAS-mutant lung cancer | UT MD Anderson”

Notably, Novartis revealed that remibrutinib wasn’t associated with the kind of liver-related side effects other BTK inhibitors like it have encountered.

Original title: “Novartis says MS pill succeeds in two large studies”

Though Alumis still sees a path forward in lupus, the result made its drug the latest TYK2 blocker to struggle in conditions beyond psoriasis and psoriatic arthritis.

Original title: “Alumis’ TYK2 drug fails in key lupus study”

GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA's recent approval for Moderna’s mRNA flu vaccine.

Original title: “GSK to launch Phase 3 trial for mRNA-based flu vaccine amid resurgence for the modality”

Novartis suspended multiple studies of a CAR T candidate after three patients who received the therapy suffered fatal cases of immune effector cell-associated hemophagocytic syndrome. BMS, meanwhile, paused some CAR T trials after separately observing “transient and reversible inflammatory events" with its therapy.

Original title: “Novartis pauses CAR T studies due to 3 deaths; BMS follows suit after safety events”

EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have…

Original title: “Voluntary data submission pilot to advance innovative alternatives to animal testing”

New treatment reduces pathogenic IgG while preserving B‑cell function

Original title: “IMAVVY approved as first targeted therapy for wAIHA”

Phase 2 study to assess muscarinic M1 agonist in Alzheimer’s cognition

Original title: “Nxera partner gains acceptance for NBI‑1117567”