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What’s in Today’s Brief? (May 29th Preview)
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Regulatory & clinical update: hepatitis B functional cure
GSK reported new late-stage hepatitis B data that it said supports a functional cure with bepirovirsen. In two Phase 3 trials in noncirrhotic chronic hepatitis B patients, GSK reported functional cure after discontinuation of nucleos(t)ide analog therapy at Week 72 in 19–20% of bepirovirsen recipients, compared with none in placebo arms. The NEJM-published results were based on fixed-duration bepirovirsen treatment after stopping background therapy at Week 48, using functional cure criteria that require sustained HBV DNA suppression and HBsAg loss. GSK highlighted that adverse events were more common in the bepirovirsen groups, with higher rates of grade 3 or higher lab abnormalities including alanine aminotransferase increases. GSK’s Chief Scientific Officer Tony Wood framed the data as potentially redefining treatment for chronic HBV, particularly by shifting the goal from ongoing viral suppression to a finite “functional cure” endpoint. If confirmed by regulator review and in real-world uptake, the dataset could strengthen bepirovirsen’s positioning against the current standard of long-term nucleos(t)ide analog therapy.
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Regulatory & clinical update: FDA clears AbbVie’s ADC for BPDCN
AbbVie won an FDA approval for Decnupaz (pivekimab sunirine) to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The antibody-drug conjugate is CD123-targeted and received clearance based on data from the global Cadenza Phase 1/2 study. The approval adds to AbbVie’s hematology pipeline momentum following its 2023 ImmunoGen acquisition, which brought the asset into AbbVie’s fold. BPDCN remains an ultra-rare, aggressive blood cancer with limited treatment options, and ADC approvals in this niche can accelerate both clinical adoption and future competitive positioning for CD123-directed programs. The decision also underscores how acquisition-driven ADC portfolios are translating into regulatory outcomes—potentially tightening timeline pressure for rivals with late-stage CD123 or similar myeloid-targeted conjugates.
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Dealmaking: Pfizer and Innovent expand early cancer portfolio
Pfizer struck a broad multiyear collaboration with Innovent Biologics covering up to 12 early-stage cancer programs, including eight from Innovent and four discovery options proposed by Pfizer. The structure places Innovent in discovery and early research, while Pfizer takes over global development after Phase 1 testing, with milestone-based economics and worldwide rights across most territories. The deal size was disclosed as up to $10.5 billion in total value, including a $650 million upfront payment. Pfizer and Innovent both cited antibody-drug conjugates and multispecific antibodies—modalities that are increasingly favored for expanding differentiation in solid tumor oncology. Strategically, the agreement reflects continued pharma reliance on China’s faster early-stage development engine, while giving Innovent a pathway to long-term royalty and development participation if programs advance successfully.
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Diagnostics & FDA: Tempus wins tumor-only indication for xT CDx
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The tissue-based 648-gene test can be used for comprehensive genomic profiling in solid tumors and functions as a companion diagnostic for colorectal cancer patients who may benefit from Eli Lilly’s Erbitux and Amgen’s Vectibix. Previously, xT CDx required a matched normal specimen; the new label allows the assay to run as tumor-only when matched blood or saliva is not available or viable. Tempus said the approval supports a shift toward running across its portfolio under pricing aligned with Advanced Diagnostic Laboratory Test frameworks. The company estimated an average selling price benefit of $200 starting in 2027, framing the regulatory change as both clinical flexibility and reimbursement strategy support.
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Oncology diagnostics: NY state approves Delfi’s liquid biopsy screening LDT
Delfi Diagnostics received approval from the New York State Department of Health to offer its FirstLook Lung blood-based laboratory-developed test for lung cancer screening. The approval allows the cfDNA-based assay to be marketed statewide while the company continues pursuing FDA clearance. Delfi said evidence from a clinical study of nearly 3,000 patients showed FirstLook Lung raised screening rates by nearly threefold, supporting its claim that the test can increase uptake in populations that are currently under-screened. The company described the move as an access-focused step, with testing available across all 50 U.S. states once fully approved. For biotech and medtech stakeholders, the approval adds to momentum for AI-assisted liquid biopsy and underscores state-level pathways that can precede federal authorization for some screening products.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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