Akamis Bio has completed enrollment of 33 patients in its Phase 1b FORTRESS study of NG-350A combined with chemoradiotherapy for mismatch repair-proficient rectal cancer. Earlier results showed a 50% composite response in ten patients, while the full dataset is expected in the first half of 2027.
Coya Therapeutics plans to extend treatment beyond 48 weeks for eligible ALSTARS participants receiving COYA 302 for amyotrophic lateral sclerosis. The decision follows completion of targeted enrollment, while randomized efficacy results remain expected in early 2027 and a separate frontotemporal dementia study has been delayed.
Delve Bio has launched a plasma metagenomic sequencing service designed to identify DNA and RNA pathogens using a database covering more than 68,000 organisms. The test promises results the day after sample receipt, but plasma-specific diagnostic accuracy and clinical utility remain important questions.
Nemolizumab improved itching and sleep for a year in young children. Can Galderma expand its FDA label?
Vir Biotechnology and Gilead Sciences have agreed to develop three dual-masked T-cell engager programmes under a deal worth up to approximately $1.88 billion. The $90 million upfront package includes cash and equity, while most of the headline value depends on future development and commercial milestones.
The FDA has accepted Pierre Fabre's resubmitted application for tabelecleucel, setting a March 31, 2027 decision date. The review follows two rejection letters, including a January 2026 dispute over whether the ALLELE study adequately establishes effectiveness.
Sarepta has reported up to 80% knockdown of DMPK RNA in both the nucleus and cytoplasm of patient-derived muscle cells, alongside correction of abnormal RNA splicing in preclinical models. The findings address a central delivery challenge in myotonic dystrophy type 1, while an ongoing Phase 1/2 trial will determine whether the mechanism translates into patient
Cyted Health's DETECT-ME study reported 90% sensitivity and 86% specificity for Barrett's esophagus across 324 participants at 18 US sites. The capsule sponge test also identified all cases of dysplasia and esophageal adenocarcinoma in the reported analysis, although subgroup sizes and broader screening performance require careful interpretation.
JCR Pharmaceuticals has received conditional marketing authorization for IZCARGO in Kuwait, its second market outside Japan. The blood-brain barrier-penetrating enzyme therapy is designed to address both systemic and neurological features of Hunter syndrome, although its global Phase 3 programme remains ongoing.
Estrella has added Intermountain Health LDS Hospital as the fifth site in its Phase 1/2 STARLIGHT-1 study of EB103. Earlier testing found complete responses in five evaluable patients at the higher dose, but the small uncontrolled dataset and the company's financing position remain important development considerations.