Agenus (AGEN) Withdraws Balstilimab BLA
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 8/16/2026
- S&P 500 ends lower as investors weigh data, Middle East tensions
- BofA's Hartnett explains why Wall Street is trading with 'no fear'
- Oil rises after US threatens indefinite blockade of Iran; set for weekly gains
- Are KOSPI and SOX in a bubble? Citi answers
- Could Intel return to the red-hot memory market after $20B raise and recent hire?
- S&P 500 ends lower as investors weigh data, Middle East tensions
- SanDisk upgraded at JPMorgan after investor day; shares climb
- BofA's Hartnett explains why Wall Street is trading with 'no fear'
- BOJ eyeing September rate hike, faster pace of tightening, sources say
- Micron: New Street upgrades to buy, says memory is no longer a cyclical story
Agenus Provides Update on Balstilimab Development
October 22, 2021 8:00 AM EDTCompany voluntarily withdraws BLA at FDAs recommendation following full approval of pembrolizumab, which came four months earlier than FDA goal dateBalstilimab achieved trial endpoints with 20% response rates in PD-L1 positive patients, versus 14% reported in pembrolizumabs label; Agenus successfully completed 3 FDA pre-approval inspections for the PDUFA date of Dec. 16, 2021Agenus plans to launch expanded access programs to give patients access to balstilimab in several countries, including the USAgenus will discontinue its ongoing confirmatory trial (BRAVA) in this population, which is expected to reduce R&D expenses by over $100MAccelerated... More
