Bio News
Replimune shares plunged 40% after an FDA briefing document flagged uncertainty about the efficacy of RP1, the company’s melanoma treatment. Reviewers said the lack of a control group made it impossible to confirm a tumor-response benefit and made the survival data difficult to interpret. RP1 is scheduled for an advisory committee review on the 30th, while Leerink Partners predicted that a negative vote was likely. The drug has already been rejected for approval twice.
BIOBOOK TEAM
biobookmedia@biobook.co.krAspen Neuroscience and Bambusa Plan U.S. IPOs; Developers of Parkinson’s and Bispecific Antibody Therapies
St. Jude Identifies Cell Marker for High-Risk Neuroblastoma
University of Texas at Austin Develops Flexible Electrode for Recording Brain Waves for a Month Without Shaving Hair
Revolution Medicines Shares Fall 6.3% on Concerns About RASONK’s KRAS Subgroup
GSK Adopts Chai Discovery AI Model After Wet-Lab Validation
Teva Wins FDA Approval for Long-Acting Olanzapine Beltruzza for Schizophrenia
Peptone nears end of two-year Lilly technology evaluation…follow-on deal could be pivotal
HLB Pharmaceutical Completes 60.8 Billion Won Rights Offering, Bets on New Hyangnam Plant as Management Participation Grows
Song Young-sook sells 86 billion won stake; buyer is daughter’s one-person company — Is a second round of Hanmi control battle looming?
