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What’s in Today’s Brief? (September 28th Preview)
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KRAS G12D licensing deal
Merck closed a large licensing agreement with China’s Scibrunch Therapeutics for an oncology candidate targeting KRAS G12D, paying $400 million upfront with development and commercialization milestones that could push the deal value above $2 billion. The program covers global rights to a preclinical oral inhibitor built around KRAS G12D mutation biology. The SciBrunch asset joins a growing set of KRAS G12D strategies in development, with Merck now positioned to advance the candidate through IND-enabling work and into clinical-stage testing across multiple tumor indications, subject to future progress-based payments. For investors, the transaction highlights continued appetite among big pharma for late-preclinical KRAS franchise expansion, particularly where companies can secure broad rights early and manage clinical development internally or via future collaborators.
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Wet AMD Phase 3 readouts for Kodiak
Kodiak Sciences reported Phase 3 success for two wet age-related macular degeneration programs, targeting Eylea (aflibercept) with individualized dosing strategies. The company said tarcocimab tedromer (Zenkuda) met primary endpoints and that tabirafusp alpha-tedromer (KSI-501) also achieved noninferiority versus Eylea in its Daybreak study. Kodiak disclosed that Zenkuda’s individualized approach enabled more than half of trial participants to extend injections to every six months, supporting the company’s plan to pursue longer dosing intervals. The biotech said it expects to request FDA approval for wet AMD and expand into additional eye indications later. The twin wins mark a turnaround after a prior Zenkuda Phase 3 readout that failed to match Eylea, repositioning Kodiak for potential market entry with a durability- and injection-frequency-focused profile.
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Hepatitis D Phase 3 catalyst and pipeline execution
Mirum Pharmaceuticals reported Phase 3 “victory” in chronic hepatitis delta, building momentum after its acquisition of the program. The company said more than half of patients treated with a once-weekly 300 mg regimen achieved the study’s primary “response” measures, strengthening Mirum’s path toward commercial positioning. Mirum’s update comes as it competes in a space that has seen renewed attention from multiple developers seeking differentiated regimens and durability of response. The company’s report reinforces that its manufacturing and regulatory strategy can support a near-term pathway to a new branded offering. While shares reacted unevenly in the report, the clinical readout increases the likelihood that Mirum can convert clinical differentiation into a clearer FDA filing timetable.
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Alzheimer’s tauopathy immune targeting in mice
Researchers at Washington University School of Medicine in St. Louis reported preclinical data showing that blocking CXCR3 can reduce T-cell infiltration and limit neurodegeneration in a mouse model of tauopathy. In the study, animals treated with an antibody to CXCR3 over several months showed about a 50% reduction in brain T-cell numbers and improved performance on memory testing. Notably, the approach did not change tau levels in the brain, suggesting the antibody’s effect is aimed at immune-mediated cell death rather than directly reducing pathological tau accumulation. The findings were published in Neuron alongside mechanistic conclusions that the CXCR3 axis is a critical target for mitigating CD4+ and CD8+ T-cell infiltration. For drug developers, the work adds to the growing emphasis on immunology as a modulator of tau-driven degeneration, offering a potential pathway for combination strategies with amyloid-directed agents already used in Alzheimer’s care.
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Off-the-shelf CAR-T for lupus reaches 1-year remission signals
Adicet Bio reported early clinical evidence that its off-the-shelf CAR-T approach, prula-cel, can induce complete kidney responses and remission in lupus nephritis patients. After one year of follow-up in an early-stage trial, the company said 50% of evaluable patients achieved a “complete” kidney response and 54% met a widely used remission criterion, including discontinuation of immunosuppressive drugs for many responders. Adicet also reported no serious cytokine release syndrome cases or neurological side effects in the data presented, though infections were observed in more than half of patients, with a subset experiencing Grade 3 or higher events. The company plans to initiate a pivotal study later this year. The program’s allogeneic, gamma delta T-cell design differentiates it from personalized alpha beta CAR-T approaches that have faced safety pauses in other lupus settings, positioning prula-cel as a potential logistics-friendly option if pivotal results confirm benefit and safety.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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