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What’s in Today’s Brief? (July 3rd Preview)
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FDA clears first neurostimulation device for PTSD veterans via VA
Neurovalens won FDA de novo clearance for its Modius Spero wearable neuromodulation device for PTSD symptoms, giving U.S. veterans access through the Department of Veterans Affairs this summer. The device is designed for at-home use with 30-minute daily sessions over as little as four weeks. The clearance marks a first approval for this category of technology for PTSD, following Neurovalens’ submission for the intended patient use profile. The company said PTSD is a high-risk condition with no prior approvals or clearances for this type of neuromodulation approach.
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Vertex expands pediatric access for sickle cell gene therapy; United Therapeutics buys thymus cell startup
Vertex’s Casgevy received authorization for children, enabling use for sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent β-thalassemia in younger patients. The update expands the gene-therapy label into pediatric populations, increasing the addressable market for curative hematology treatments. Separately, United Therapeutics agreed to pay $140 million to acquire Thymmune Therapeutics, a preclinical thymic cell therapy company. Thymmune’s approach converts human induced pluripotent stem cells into thymic cells aimed at restoring T-cell function, with its lead program THY-100 currently in preclinical development for congenital athymia.
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Genentech claims head-to-head Phase 3 edge for KRAS G12C inhibitor divarasib in NSCLC
Roche’s Genentech reported superior Phase 3 results for divarasib (KRAS G12C inhibitor) in previously treated non-small-cell lung cancer, with the Phase 3 Krascendo-1 trial showing clinically meaningful improvements in overall survival and progression-free survival versus approved therapies. Genentech said the results had no new safety signals and that most treatment-related side effects were manageable and reversible. Genentech expects to submit the Phase 3 data to regulators and present details at an upcoming medical meeting. The company previously received breakthrough therapy designation for divarasib in 2022 and orphan drug designation in 2026 for KRAS G12C NSCLC.
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Regenerative medicine deal: Ipsen acquires Memo Therapeutics for BK polyomavirus kidney transplant nephropathy antibody
Ipsen agreed to acquire Memo Therapeutics for up to €700 million, adding potravitug, Memo’s Phase II monoclonal antibody targeting the BK virus VP1 capsid protein. The asset is aimed at BK polyomavirus associated nephropathy in kidney transplant recipients, where reactivation can undermine transplant outcomes. Potravitug received FDA fast track designation in 2023 and orphan drug designation in the EU in December 2025. Ipsen said the acquisition strengthens its rare disease pipeline and leverages transplant-focused R&D and development experience.
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AstraZeneca and CSPC return for another kidney drug discovery pact worth up to $1.7B
AstraZeneca expanded its China collaboration with CSPC Pharmaceutical through a kidney-focused drug discovery pact. AstraZeneca will pay CSPC $30 million upfront to jointly discover and develop two kidney disease candidates. The agreement comes less than six months after AstraZeneca completed another major biobucks-style collaboration with CSPC, underscoring AstraZeneca’s intent to deepen its interface with the Chinese partner for multiple asset programs.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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