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Product launches and clinical validation in immuno-oncology
Argenx agreed to acquire Forte Biosciences in a cash deal valued at about $2.2 billion, aiming to add Forte’s anti-CD122 antibody FB102 to its immunology portfolio. The acquisition is structured...
FDA and regulatory review turbulence for cell therapies
The FDA reiterated major concerns over Replimune’s investigational melanoma gene therapy RP1, questioning whether available evidence supports efficacy after advisers review the company’s...
Clinical-stage turnaround bets in the Alzheimer’s pipeline
ProMIS Neurosciences reported interim safety data from a blinded analysis of an Alzheimer’s clinical trial combining its amyloid-targeting approach with placebo. The company said the pooled rate...
Late-stage and pivotal development commitments for oncology drug conjugates
Hansoh Pharmaceutical and its partner GSK reported that risvutatug rezetecan (ris-rez) met the primary endpoint in a Phase III study (ARTEMIS-011) in third-line osteosarcoma, adding to earlier...
IPO pipeline momentum in sleep apnea pharmacotherapy
Apnimed filed its S-1 for an initial public offering as it prepares for commercialization of its oral obstructive sleep apnea therapy, Oxnimbi (AD109). The biotech plans to raise up to $160...
Cell therapy manufacturing scale-up via CDMO partnerships
Cellares and Papillon Therapeutics announced a partnership designed to scale manufacturing for Papillon’s CRISPR-based cell therapy PPL-001 for Friedreich’s ataxia. The work centers on...
Precision diagnostics expansion in colorectal cancer screening
Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, received FDA approval, and Abbott will exclusively commercialize the assay starting this fall. Freenome said the test is...
Digital and sensor-based monitoring moving into clinical care workflows
UC San Diego researchers reported a battery-free fingertip sweat patch that continuously monitors levodopa medication levels in people with Parkinson’s disease, with sweat-based measurements...
Regenerative ophthalmology gets late-stage funding push
Claris Biotherapeutics raised $118 million in funding and outlined a Phase 3 development plan for CSB-001, an eye drop therapy targeting limbal stem cell deficiency. The company said it aims to...
FDA policy and governance shifts around advisory panels and trial evidence
FDA reminded investors about risks tied to advisory panels, citing two companies facing briefing-document scrutiny and sharp stock reactions ahead of FDA meetings. The update highlighted how...
Regulatory / Safety review for next-gen immunotherapies
FDA staff reiterated concerns that Capricor’s Duchenne muscular dystrophy stem-cell therapy deramiocel did not meet Phase 3 objectives, according to FDA briefing materials ahead of an advisory...
Strategic M&A in immunology
Argenx agreed to acquire Forte Biosciences for about $2.2 billion in cash, moving to add Forte’s anti-CD122 antibody FB102 to its immunology pipeline. The deal values Forte at $77 per share and is...
Expanding molecular diagnostics with FDA-backed screening
Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, received U.S. FDA approval, marking the first commercial use of the company’s AI-enhanced cfDNA methylation approach. The...
Novel drug development in late-stage trials
Altimmune reported statistically significant Phase 2 results for pemvidutide (pemvi) in alcohol use disorder, showing a reduction in heavy drinking days versus placebo. The company positioned the...
Company acquisition and lab automation for next-gen sequencing workflows
In lab workflow expansion, SPT Labtech’s CEO Rob Walton and Illumina’s Sandy Ottensmann discussed efforts to simplify NGS automation for smaller oncology research labs. The focus is on bringing...
Medical device and AI monitoring investments
Epitel raised $26 million in a Series B to expand market access for its wireless EEG seizure monitoring system. The Remi remote EEG platform is built for home monitoring, enabling continuous...
Diagnostics innovation in oncology screening
Pairidex raised $4.89 million seed funding to accelerate commercialization of FusionMRD, an RNA-based droplet digital PCR blood test for minimal residual disease monitoring in gene fusion-driven...
Regulatory and precision-medicine infrastructure
EMA selected TrialAssure’s ANONYMIZE platform as an official anonymization tool to redact public clinical trial documents under Policy 0043. The AI-assisted system will be used to protect...
R&D funding for platform expansion in genetic testing tools
Lucid Genomics partnered with Genetic Alliance to expand access to advanced genomic analysis for underserved patients suspected of rare disease. Under the collaboration, Lucid will share its...
Corporate biotech leadership and governance shifts
Legend Biotech said CEO Ying Huang resigned without naming a permanent replacement, and appointed Carvykti head Alan Bash as interim CEO. The move extends recent volatility around the company’s...