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Argenx–Forte acquisition expands autoimmune pipeline
Argenx agreed to acquire Forte Biosciences in a $2.2 billion all-cash deal, paying $77 per share for the Dallas-based autoimmune specialist. The transaction adds Forte’s lead asset FB102, an...
FDA scrutiny hits Capricor’s DMD cell therapy ahead of adcom
The FDA raised new questions about Capricor’s deramiocel effectiveness in Duchenne muscular dystrophy, according to briefing materials ahead of a Cellular, Tissue and Gene Therapies Advisory...
Freenome wins FDA approval for blood-based colorectal cancer screening
Freenome said the FDA has approved its SimpleScreen CRC blood test for colorectal cancer, marking a commercial milestone for blood-based screening using AI and cell-free DNA methylation. The test...
MapLight faces mixed Phase 2 schizophrenia results with dosing split
MapLight’s Phase 2 schizophrenia readout delivered overall success but undercut a key differentiation strategy as the once-daily regimen missed the primary endpoint. Twice-daily dosing met the...
Pairidex raises seed funding to commercialize RNA-based MRD test
Cancer diagnostics startup Pairidex raised $4.89 million in oversubscribed seed financing to advance FusionMRD, an RNA-based droplet digital PCR test for monitoring minimal residual disease in...
Oak Hill Bio plans Nasdaq entry via SPAC merger
Oak Hill Bio is set to reach the Nasdaq through a SPAC merger with RA Capital-sponsored Research Alliance Corporation III, a move aimed at funding an investigational rare disease candidate that...
OmniAge compendium maps aging biomarkers to clonal hematopoiesis
A Nature Communications study unveiled OmniAge, an “aging biomarkers” compendium that integrates multiple omics layers and uses biomarker mapping to investigate biological causality. The work...
CUDC-907 combination extends temozolomide response in resistant glioblastoma models
Preclinical research reports that CUDC-907 can improve temozolomide activity in glioblastoma by combining dual PI3K and HDAC inhibition. The study focuses on resistance mechanisms that limit...
Capricor, Legend leadership shifts add corporate volatility to gene therapy sector
Two separate leadership developments increased uncertainty across the gene therapy and CAR-T ecosystem. Legend Biotech said CEO Ying Huang abruptly resigned without naming a permanent replacement,...
Sarepta names Michael Severino CEO as turnaround efforts accelerate
Sarepta Therapeutics named Michael Severino, formerly CEO of Tessera Therapeutics, as its new chief executive starting Tuesday. The appointment follows Doug Ingram’s planned retirement and comes...
Immunology M&A
Argenx moved to expand beyond Vyvgart, announcing an all-cash $2.2 billion acquisition of Forte Biosciences. The deal values Forte at $77 per share and is set to close in the third quarter,...
Oncology clinical development and trial launches
GSK and the GOG Foundation kicked off the first patient in a global phase 3 trial for mocertatug rezetecan in platinum-resistant ovarian cancer. The study, GOG-3132/BEHOLD-Ovarian01 (NCT07286266),...
FDA review and advisory committee scrutiny in gene therapy
FDA reviewers raised new efficacy questions about Capricor’s Duchenne muscular dystrophy cell therapy, deramiocel, ahead of an advisory committee meeting. The agency said it could not confirm that...
FDA approval for cancer screening diagnostics
Freenome said the FDA approved its SimpleScreen CRC, a blood-based colorectal cancer screening test built on cell-free DNA signals. The company, which launched publicly last week, will rely on...
Schizophrenia therapy update and competitive positioning
MapLight Therapeutics lost value after disclosing mid-stage results for its schizophrenia drug that were described as positive overall but raised concerns for investors about differentiation. The...
Biomarker-driven early detection in ALS
Researchers reported that longitudinal plasma proteomics can identify markers that predict phenoconversion to clinically manifest ALS. In Nature Medicine, investigators analyzed data from the...
Regulatory and company leadership change
Legend Biotech abruptly changed leadership after CEO Ying Huang resigned, with Alan Bash named interim CEO. Legend said a comprehensive search for a permanent replacement is underway and that...
Biotech diagnostics funding
Cancer precision diagnostics startup Pairidex raised $4.89 million in a seed round to advance FusionMRD, an RNA-based droplet digital PCR blood test for monitoring minimal residual disease in...
Digital health and continuous monitoring in Parkinson’s
UC San Diego researchers reported a battery-free wearable patch that continuously monitors levodopa levels in Parkinson’s patients by sampling fingertip sweat. In a Proceedings of the National...
Biosecurity policy and screening standards
A synthetic DNA industry leader warned that biosecurity screening remains too dependent on voluntary compliance and called for national standards and enforcement. In a commentary, the author...