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FDA review and trial evidence for skin cancer therapy
FDA staff reiterated concerns about Replimune’s RP1 investigational skin cancer therapy ahead of an advisory committee meeting. In briefing documents, the agency said the company’s third attempt...
Biotech financing to advance rare eye disease drug into pivotal testing
Claris Bio emerged with $118 million in new funding to drive two pivotal trials for its corneal disease eye drop program. The company said it will move to Phase 3 testing for CSB-001, targeting...
Argenx acquisition expands immunology pipeline with Forte’s anti-CD122
Argenx agreed to acquire Forte Biosciences for $2.2 billion in cash, a move designed to expand its immunology pipeline with FB102, an anti-CD122 monoclonal antibody. The deal values Forte at $77...
FDA approval for blood-based colorectal cancer screening with Abbott commercialization
Freenome said the FDA approved its SimpleScreen CRC blood-based colorectal cancer screening test, enabling commercialization plans with Abbott under an exclusive U.S. arrangement. The company’s...
Altimmune mid-stage alcohol-use disorder data for GLP-1/glucagon agonist
Altimmune said its GLP-1/glucagon agonist pemvidutide reduced drinking in people with moderate-to-severe alcohol use disorder in a Phase 2 trial. In the RECLAIM study, patients received weekly...
Capricor faces FDA questions on DMD cell therapy efficacy ahead of adcom
The FDA questioned the efficacy of Capricor’s deramiocel in Duchenne muscular dystrophy ahead of an advisory committee meeting. A review team said it was unable to identify enough evidence that...
Maplight’s schizophrenia program stumbles on once-daily regimen
Maplight Therapeutics’ once-daily schizophrenia program disappointed investors after Phase 2 results failed to meet the primary endpoint, despite positive overall safety and efficacy signals under...
Hospital and device trial evidence for Claris-like innovation in neonatal care workflows (neonatal POCUS standardization)
Researchers reported that standardizing lung ultrasound use in neonatal intensive care units could improve consistency in detecting and tracking respiratory problems. The study focuses on...
Germany scales genomics-guided precision medicine pilot toward large enrollment
Germany’s genomics-guided precision medicine pilot, genomeDE’s Model Project for Comprehensive Diagnostics and Therapy Selection by Means of Genome Sequencing, has gained momentum with near-term...
AI and trial-execution risk signals for first-in-human studies
CRO Veristat told BioXconomy that the FDA should incorporate first-in-human clinical hold rates into decisions about joining the agency’s qualified research institution (QRI) network. Veristat...
Immunology M&A
Argenx agreed to acquire Forte Biosciences in a $2.2 billion cash deal, buying its anti-CD122 monoclonal antibody FB102 program as a potential “pipeline-in-a-product” expansion. The offer values...
Oncology clinical development
GSK and the GOG Foundation began enrolling the first patient in a global Phase 3 trial testing mocertatug rezetecan in platinum-resistant ovarian cancer. The study, GOG-3132/BEHOLD-Ovarian01...
FDA regulatory scrutiny and advisory committee
Ahead of an FDA advisory committee meeting, the agency is questioning the efficacy of Capricor’s Duchenne muscular dystrophy cell therapy deramiocel. The FDA’s briefing indicates the company did...
Regulatory approval for cancer screening
Freenome said the FDA approved its SimpleScreen CRC blood-based test for colorectal cancer, with Abbott set to exclusively commercialize it starting this fall. The assay is positioned as a...
AI-enabled diagnostics for respiratory disease
Tidalsense raised $19 million to scale N-Tidal Diagnose, an AI-based platform designed to identify chronic obstructive pulmonary disease in about five minutes. The company is positioning the...
AI-driven drug safety in Alzheimer’s trials
Interim blinded safety results from ProMIS Neurosciences’ amyloid-targeting Alzheimer’s trial indicate low rates of brain bleeding and no incidences of brain swelling signals associated with more...
Cancer precision diagnostics startup funding
Pairidex raised $4.89 million in oversubscribed seed financing to support FusionMRD, an RNA-based droplet digital PCR blood test for monitoring minimal residual disease in gene fusion-driven blood...
Biopharma leadership and market impact
Legend Biotech announced CEO Ying Huang stepped down without a permanent replacement in place, naming Alan Bash as interim CEO to ensure continuity around Carvykti commercialization. Investors...
Antiviral/immune engineering in oncology
Celloram and collaborators described PROTEXI, a dendritic-cell vaccine concept that repurposes immune memory generated by SARS-CoV-2 infection and vaccination to drive anti-tumor responses....
Aging and biomarker discovery
Du, Ling, Tong and colleagues introduced OmniAge, a Nature Communications compendium mapping aging-associated biomarkers across multiple omics layers and linking those patterns to causal...