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What’s in Today’s Brief? (May 29th Preview)
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Cancer ADC/Targeted therapy regulatory approvals
AbbVie won FDA approval for its CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), following the company’s 2023 purchase of ImmunoGen. The approval, based on data from the global Cadenza study, adds another ADC into a fast-growing ultra-rare hematology segment where durable responses are the central bar. In parallel, AbbVie’s ADC strategy continued to draw attention after another FDA clearance tied to an ImmunoGen-era pipeline. The BPDCN approval expands the company’s label footprint in a disease with limited treatment options and underscores the continued regulatory traction of CD123-directed conjugates.
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Hepatitis B functional cure—late-stage results
GSK reported Phase 3 results for bepirovirsen (B-Well 1 and B-Well 2) in chronic hepatitis B, saying 19% to 20% of treated patients achieved a functional cure after stopping nucleos(t)ide analog therapy. GSK framed the outcome as a potential step toward deeper, fixed-duration regimens in a field where “functional cure” remains the key clinical endpoint. In the trials, none of the placebo-assigned patients met the functional cure definition. Treatment was associated with higher adverse-event rates, including alanine aminotransferase elevations, with grade 3 or higher events in 16% of the bepirovirsen group versus 3% on placebo—data that will shape clinician risk-benefit discussions and regulator review.
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FDA diagnostics expansion—tumor-only comprehensive profiling
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, allowing comprehensive genomic profiling to be run when matched normal (blood or saliva) is unavailable. The assay covers 648 genes and includes microsatellite instability assessment using tumor-only material—an operational change aimed at widening access for real-world specimens. Tempus said the expanded label enables migration of its solid-tumor DNA portfolio to FDA-approved Advanced Diagnostic Laboratory Test pricing and forecasted an average selling price benefit of $200 starting in 2027. The decision also positions Tempus as the first lab to hold companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling.
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Multiple myeloma late-stage wins—mezigdomide and teclistamab
Bristol Myers Squibb disclosed detailed Phase 3 results showing its cereblon E3 ligase modulator mezigdomide more than doubled progression-free survival in relapsed or refractory multiple myeloma in the SUCCESSOR-2 trial. BMS reported an 18-month average PFS in the mezigdomide arm versus 8.3 months in the comparator, cutting the risk of progression or death by 52%—with side effects higher but described as manageable. Separately, teclistamab delivered landmark international Phase 3 readouts in MajesTEC-9 for patients relapsing after initial therapy, with the program designed to deepen remissions through bispecific activity. Together, the updates reflect continued momentum for myeloma bispecifics and cereblon-based therapies aimed at improving depth and durability of response.
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Obesity market access—CVS formulary moves for Lilly and Novo
CVS Caremark moved to place Lilly’s oral obesity drug Foundayo on its formularies starting June 1, while adding back Zepbound as a preferred option starting Oct. 1. Novo Nordisk’s Wegovy pill and injection were retained as preferred, meaning both companies now hold preferred coverage positions across CVS’s largest commercial payer channel. The decision is expected to expand access and shift the competitive balance in the U.S. GLP-1 and obesity drug market, reversing an earlier advantage Novo gained through a CVS formulary arrangement. Analysts said the change increases the addressable pool for Lilly’s two products and improves market reach for employers using CVS Caremark.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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