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Immunology M&A: Argenx buys Forte Biosciences to add anti-CD122 antibody FB102
Argenx agreed to acquire Forte Biosciences in a $2.2 billion all-cash deal, taking control of Forte’s anti-CD122 monoclonal antibody FB102 and expanding Argenx’s immunology portfolio. FB102...
FDA oncology oversight: Replimune’s RP-1 faces renewed efficacy concerns ahead of adcom
FDA staff reiterated concerns that Replimune’s investigational melanoma therapy RP-1 lacks adequate evidence of efficacy ahead of a Cellular, Tissue and Gene Therapies advisory committee...
Regulatory change: FDA expands Simtriyo label in adult and pediatric ADHD
Otsuka won U.S. FDA approval for Simtriyo (centanafadine), granting the once-daily extended-release capsule a label for attention deficit hyperactivity disorder (ADHD) in adults and children aged...
Clinical trial: Mayo-led Phase 3 suggests intravesical cretostimogene grenadenorepvec may delay cystectomy
A Mayo Clinic–led international Phase 3 trial reported in The Lancet Oncology suggests an intravesical oncolytic immunotherapy, cretostimogene grenadenorepvec, may help some patients with...
FDA diagnostics approval: Freenome’s SimpleScreen CRC gets U.S. green light; Abbott to commercialize
The FDA approved Freenome’s blood-based colorectal cancer screening test, SimpleScreen CRC, enabling the company to move from clinical studies to commercial deployment. Freenome said the test is...
Oncology drug development: casdatifan shows durable tumor responses in Phase 1 ccRCC trial
Early Phase 1 results in Nature reported durable tumor responses from casdatifan, an investigational oral HIF-2α inhibitor being developed for advanced clear cell renal cell carcinoma...
Cell therapy regulatory pressure: Capricor’s deramiocel faces FDA skepticism ahead of DMD adcom
FDA briefing documents again raised questions about the efficacy of Capricor’s Duchenne muscular dystrophy cell therapy deramiocel ahead of an advisory committee meeting. The FDA said it could...
AI + biosensing startup: Epitel raises $26M for wireless EEG seizure monitoring
Epitel raised $26 million in a Series B round to expand market access for its wireless electroencephalogram (EEG) platform aimed at seizure monitoring outside hospitals. The Remi remote EEG...
Diagnostics & genomics infrastructure: EMA selects TrialAssure tool to anonymize public clinical trial documents
The European Medicines Agency selected TrialAssure’s ANONYMIZE platform as an official anonymization tool for market authorization holders to redact public clinical trial documents. EMA said the...
Platform finance: Nova Biomedical acquires NanoCellect assets to broaden cell line development workflow
Nova Biomedical acquired certain NanoCellect assets to expand its cell line development portfolio, adding microfluidic cell sorting capabilities used in gentle cell selection and isolation. The...
Cancer diagnostics approval and commercialization rights
Freenome said the FDA has approved its SimpleScreen blood-based colorectal cancer screening test, marking the company’s first commercial authorization. The test is for adults 45 and older at...
Immunology M&A reshapes autoimmune pipeline
Argenx agreed to acquire Forte Biosciences for $2.2 billion in an all-cash deal, valuing Forte at $77 per share. The purchase brings Forte’s anti-CD122 monoclonal antibody FB102 into Argenx’s...
FDA cautions on cell therapy efficacy ahead of advisory vote
FDA staff told advisers that Capricor’s deramiocel data do not adequately demonstrate the treatment works in Duchenne muscular dystrophy ahead of a Cellular, Tissue and Gene Therapies advisory...
FDA challenges on melanoma gene therapy for systemic benefit
FDA staff reiterated concerns that Replimune’s investigational RP1 program for melanoma lacks sufficient evidence to support approval. In briefing documents for a forthcoming advisory committee...
Company funding for pivoting clinical-stage ophthalmology asset
Claris Bio raised $118 million to advance its eye drop candidate CSB-001 into pivotal trials for limbal stem cell deficiency. The biotech, spun out of Harvard corneal disease research led by Reza...
US trial network push uses regulatory quality signals
CRO Veristat urged the FDA to use first-in-human (FIH) clinical hold rates as a quality metric when selecting organizations for its new qualified research institution (QRI) network. The argument...
AI-enabled diagnostic platform funding for COPD
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’s approach focuses on...
Late-stage decision reshuffles oncology pipeline at Incyte
Incyte scrapped its Phase 1 JAK2V617F inhibitor, INCB160058, after reviewing available data on safety, efficacy, and pharmacokinetics. The company said it “prioritize[s] its next-generation...
Regulatory operations: EMA selects AI anonymization tool
The European Medicines Agency selected TrialAssure’s ANONYMIZE platform as an official tool to redact public clinical trial documents under Policy 0043. EMA will deploy AI-assisted detection with...
Ongoing clinical program restart via gene therapy with dietary drug synergy
Researchers at Fudan University reported that targeted AAV gene therapy delivering Pcsk5 to injured mouse hearts, combined with semaglutide (GLP-1), improved cardiac repair after myocardial...