Vaccine company Valneva SE (Nasdaq: VALN) (Euronext Paris: VLA) said on Monday that the US Food and Drug Administration (FDA) has granted priority review to the Biologics License Application for its single-shot chikungunya vaccine candidate, VLA1553.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. Currently, there are no preventive vaccines or effective treatments available.
VLA1553 has been assigned a Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023.
Circio Holding and Entos Pharmaceuticals collaborate on circular RNA delivery
AKAGERA Medicines completes first cohort in phase 1 SAD/MAD study of AKG-100
Alzinova AB reports positive final Phase 1b results for ALZ-101 in Alzheimer's
Primrose Bio launches Prima RNApols ExTend RNA polymerase for long-template mRNA manufacturing
Merck's CAPVAXIVE approved by EC for pneumococcal disease prevention
Sanofi secures FDA fast track designation for chlamydia vaccine candidate
Anixa Biosciences secures US patent allowance for ovarian cancer vaccine
Valneva to supply IXCHIQ vaccine for chikungunya outbreak in La Réunion
Everest Medicines' EVM14 IND application receives US FDA approval
Clover Biopharmaceuticals' SCB-1019 IND application receives US FDA approval
Centivax partners with Emery Pharma on universal flu vaccine
Avance Biosciences registers with CLIA program
GSK receives approval from US FDA for Penmenvy 5-in-1 meningitis vaccine
hVIVO secures GBP2m contract for final stage of hMPV characterisation study
EU approves CSL and Arcturus Therapeutics' self-amplifying mRNA COVID-19 vaccine