biotech
Oncolytics Biotech Provides Update on Special Meeting of Shareholders
Oncolytics Biotech; special meeting; shareholders; rescheduling; government shutdown; jurisdiction change; Nevada; corporate update
Eli Lilly to Acquire Adverum Biotechnologies in Gene Therapy Deal; Captain T Cell Secures €20M Funding
Eli Lilly; Adverum Biotechnologies; Acquisition; Gene therapy; Ixo-vec; Contingent Value Rights (CVR); Ophthalmology; Captain T Cell; Financing; Biotech investment
MapLight Therapeutics Announces Pricing of $17/share IPO; to Raise Over $250 Million, Begins Trading on Nasdaq
MapLight Therapeutics; IPO; Initial Public Offering; Nasdaq; MPLT; Schizophrenia; Alzheimer’s disease psychosis; CNS disorders; Phase 2 clinical trials; Biotech
METiS BioTech Announces China’s First AI-Enabled Formulation Drug Candidate to Complete Phase III Clinical Trial
METiS BioTech; AI; drug formulation; Phase III; pseudobulbar affect (PBA); China; nanodelivery; AiTEM; clinical milestone
Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease
Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback
FDA Rejects CUTX-101 for Rare Copper Deficiency Due to Manufacturing Issues
FDA rejection; Menkes disease; CUTX-101; copper deficiency; manufacturing deficiencies; Cyprium Therapeutics; Sentynl Therapeutics; Fortress Biotech
IO Biotech Sheds 50% of Staff After FDA Blocks Cancer Vaccine Approval Path
IO Biotech; layoffs; cancer vaccine; FDA rejection; Cylembio; Phase 3 trial; melanoma; regulatory setback; cost cutting; clinical trial
IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025
Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop
Trinity Biotech Repositions for AI-Driven Growth with CGM+ Biosensor Platform
Trinity Biotech; CGM+; AI-powered healthcare; digital health; continuous glucose monitor; wearable biosensor; multi-sensor data; predictive analytics; personalized medicine; chronic disease management