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What’s in Today’s Brief? (July 10th Preview)
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GSK and Hansoh score a Phase 3 survival win for B7-H3 ADC in China
GSK reported that its Hansoh-partnered antibody-drug conjugate risvutatug rezetecan (ris-rez) met the primary endpoint in a Phase 3 study in China in advanced or relapsed small-cell lung cancer. The ADC, targeting B7-H3, improved overall survival versus standard-of-care topotecan, which positions the therapy as a key part of both companies’ B7-H3 oncology strategy. GSK said the study also showed statistically significant and clinically meaningful improvements across secondary measures such as delaying tumor progression, while describing the safety profile as manageable. Company disclosure also highlighted that it is the first time a B7-H3-targeted ADC has clearly lengthened survival in a Phase 3 trial in any tumor type. The results are expected to support a China regulatory filing, with Hansoh holding commercial rights in China, Hong Kong, Macau and Taiwan. GSK retains ownership elsewhere and said a global Phase 3 program in extensive-stage SCLC is underway, with readouts planned next year. The Phase 3 milestone also reinforces GSK’s recent push into oncology via China-linked deals, including an earlier $185 million upfront payment for majority rights to ris-rez and a separate B7-H3 program mo-rez that is also in late-stage development.
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AstraZeneca and Ionis take a Phase 3 cardiomyopathy setback
AstraZeneca said its partner Ionis’ antisense therapy Wainua (eplontersen) failed a pivotal Phase 3 trial in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). The drug did not beat placebo on a composite endpoint that included cardiovascular death and recurrent cardiovascular events, dealing another blow to the increasingly competitive heart-disease gene-silencing category. Rival approaches from Alnylam and BridgeBio have benefited from the competitive opening created by the failure. The loss also follows the broader industry lesson that sustained transthyretin knockdown does not necessarily translate into clinical event reduction within the trial timeline. A separate report noted that stock reaction in both AstraZeneca and Ionis was negative in early trading following the topline results. Roche’s recent Huntington’s and AstraZeneca’s current ATTR-CM outcomes together show how quickly sentiment can turn when Phase 3 endpoints do not land. For biotech investors and pipeline operators, the event increases the premium on robust Phase 3 design that captures both biomarker effect and clinically meaningful endpoints in ATTR-CM populations.
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ARPA-H puts $160M behind bespoke gene editing for rare pediatric diseases
ARPA-H announced THRIVE, a program committing up to $160 million over five years to develop custom gene editing therapies for rare genetic pediatric diseases. The agency described THRIVE as designed to accelerate patient-ready treatments by supporting multiple technical approaches, clinical trial designs and deployment models. ARPA-H will fund seven different teams, each facing deadlines for starting clinical trials by year three of the program. The initiative is aligned with ARPA-H’s “moonshot” mandate to move beyond incremental steps and compress the timeline from early development toward clinical testing. The program’s structure blends platform diversity with execution milestones, aiming to ensure that promising approaches reach first-in-human testing. For sponsors, it signals ARPA-H willingness to underwrite both the biology and the operational trial engineering challenges that often stall rare-disease programs. The THRIVE announcement also follows prior U.S. government efforts to increase rare-disease trial throughput, but the scale and gene-editing focus make it a notable funding signal for editing-focused biotechs and academic groups building translational pathways.
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FDA-approved gene therapy Otarmeni to be provided free by Regeneron
Regeneron said it will provide its FDA-accelerated gene therapy Otarmeni (lunsotogene parvec) for genetic hearing loss free of charge to eligible U.S. patients. The company said the decision was made possible by success across its broader portfolio, and it framed the move around increasing access for infants and children treated under the accelerated approval pathway. Otarmeni is an AAV-delivered in vivo therapy targeting variants in the OTOF gene and was approved for patients aged 10 months through 16 years, based on the open-label CHORD Phase I/II trial. Regeneron reported that 80% of patients showed improved hearing after a single dose in the trial. While the pricing decision is expected to reduce barriers to uptake, it also drew ethical scrutiny from parts of the deaf community. Gallaudet University said it has established a gene editing think tank to discuss the implications of gene therapy availability and commercialization. For the biotech sector, the move is likely to sharpen debate on pricing, access and ethical frameworks for rare-disease gene therapies—particularly those cleared under accelerated pathways and supported by orphan designations.
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CARB-X and CGD design a 10-year $60M market-shaping fund for neonatal sepsis diagnostics
CARB-X is backing a market-shaping effort to accelerate the development of point-of-care diagnostics for neonatal sepsis. A Center for Global Development (CGD) program called NeoTest will use a hybrid “push and pull” funding design with $60 million over 10 years to bridge the gap between diagnostic innovators and real-world adoption. CGD and CARB-X identified 43 firms developing neonatal sepsis tests or diagnostics that could potentially be adapted for newborns at or near point of care, and they interviewed 24 candidates in advanced stages of development. The planned facility includes $20 million in milestone payments for innovation, $10 million for implementation support to unlock demand, and $30 million reserved for advanced uptake through per-test top-ups. The target product profile emphasizes rapid, low-complexity assays that can rule in or rule out sepsis in newborns up to 59 days old in low-resource settings. Program leadership framed the structure as particularly suited to antimicrobial resistance priorities. The initiative matters for biotech diagnostics because it attempts to de-risk both R&D milestones and commercialization economics—often the two bottlenecks that prevent otherwise promising tests from reaching routine clinical use.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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