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Regulatory approvals - rare inflammatory disease drug
The FDA cleared Roivant’s brepocitinib, marketed as Lisraya, for adults with dermatomyositis—marking a major regulatory step for the company’s once-daily, oral inhibitor approach. The decision...
Oncology regulation and pipeline - ADC fast-track
The FDA granted fast track designation to CytomX Therapeutics’ varsetatug masetecan (Varseta-M; CX-2051), an EpCAM-directed masked antibody-drug conjugate for relapsed/refractory metastatic...
Biopharma funding and capital markets - Moderna raises for oncology
Moderna moved to bolster its oncology research footprint with a $2.6 billion fundraising round, an upsized offering designed to support continued drug development and pipeline expansion. The...
Biopharma funding - Gates Foundation invests in maternal health protein target discovery
The Gates Foundation committed up to $35 million to Profound Therapeutics to accelerate biomarker and drug target discovery for preeclampsia and eclampsia. The investment includes an initial $20...
Partnerships and licensing - DualityBio and Genentech in ADC pact
Genentech (Roche) and DualityBio entered a collaboration and license agreement centered on DualityBio’s DUPAC payload platform for next-generation antibody-drug conjugates. Genentech will fund the...
Molecular diagnostics reimbursement - MRD assay gains Medicare coverage
NeoGenomics won expanded Centers for Medicare and Medicaid Services MolDX coverage for its RaDar ST tumor-informed MRD assay, extending the test’s use into immunotherapy response monitoring for...
Biotech IP and legal - Parse and Scale/10x single-cell patents
A Delaware jury found that Parse Biosciences, a Qiagen subsidiary, willfully infringed three Scale Biosciences patents that were acquired by 10x Genomics in 2025, while also upholding the validity...
Corporate finance and restructuring - bankruptcy filing
BioXcel Therapeutics filed for Chapter 11 bankruptcy after concluding it could not secure sufficient funding to continue operations through the end of August. The company previously signaled...
Clinical immunotherapy - CAR T in rheumatoid arthritis remission signal
A first-in-human Phase 1 trial at Charité—Universitätsmedizin Berlin reported that CD19 CAR T-cell therapy pushed severe, treatment-refractory seropositive rheumatoid arthritis into remission in a...
FDA approvals – rare inflammatory disease
Roivant’s Priovant Therapeutics won U.S. FDA approval for Lisraya (brepocitinib), a once-daily oral pill targeting JAK1 and TYK2, for adults with dermatomyositis. The clearance marks the first...
Oncology – ADC development accelerates at FDA
CytomX Therapeutics received FDA fast track designation for varsetatug masetecan (Varseta-M; CX-2051), an EpCAM-directed masked antibody-drug conjugate, for relapsed/refractory metastatic...
Immuno-oncology – checkpoint blockade without key dendritic cells
Researchers at Hokkaido University and collaborators reported that immune checkpoint blockade can still trigger the first wave of tumor rejection even when cDC1 dendritic cells are absent. Their...
Oncology – functional genomics maps asciminib resistance
A genetic study mapped broad, convergent resistance mechanisms to asciminib in chronic myeloid leukemia (BCR::ABL1), identifying 279 resistance mutations. The work showed that escape can come from...
Platform and pipeline – RNA/DNA sequencing dispute in single-cell tech
A U.S. jury found that Parse Biosciences, a subsidiary of Qiagen, willfully infringed three patents tied to Scale Biosciences technology—acquired by 10x Genomics in 2025—while also upholding...
M&A and deals – Roche taps DualityBio for next-gen ADC payloads
Genentech inked a collaboration and license agreement with DualityBio centered on the DUPAC platform for next-generation ADCs aimed at topoisomerase-1 resistance. DualityBio is set to receive $45...
Biopharma financing – Moderna raises for cancer push
Moderna launched an upsized financing plan to support its oncology work, including cancer research investments alongside its broader mRNA platform strategy. The offering followed a separate series...
Regulatory and clinical – AstraZeneca/Amgen Tezspire nears new indication in EoE
AstraZeneca and Amgen said Tezspire (tezepelumab) cleared coprimary endpoints and all key secondary endpoints in a phase 3 trial for eosinophilic esophagitis (EoE). The Crossing study result...
Clinical development and trial execution – expanding Phase 1 WEE1 inhibitor program
Aprea Therapeutics is accelerating enrollment in its Phase 1 dose-escalation study of APR-1051, a WEE1 kinase inhibitor in DNA damage response, after early signs of clinical activity. The company...
Biotech startup and diagnostics – MRD test gains CMS coverage
NeoGenomics said its tumor-informed RaDar ST MRD assay received expanded coverage from CMS’ MolDX program to include immunotherapy response monitoring for late-stage solid tumors. The test uses...
Regulatory wins: rare disease approvals and updates
FDA cleared Priovant’s Lisraya (brepocitinib) for dermatomyositis, marking the first approval for a Roivant subsidiary drug licensed from Pfizer and expanding the company’s rare-inflammation...