FDA Agrees with OncoGenex' Phase 3 AFFINITY Protocol Amendment
FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 6/13/2026
- Wall Street ends higher as SpaceX's market debut dominates
- SpaceX prices historic IPO at $135/share in largest ever new listing
- 'Ocean of opportunity': Wolfe initiates SpaceX at Buy ahead of historic IPO
- UBS cuts gold price forecasts on delayed Fed easing outlook
- Brent falls to lowest since March on expected peace deal
- NASDAQ adds five companies to NASDAQ-100 index in quarterly rebalance
- Super Micro Computer establishes $1.25 billion stock sale agreement
- Wall Street ends higher as SpaceX's market debut dominates
- 'Ocean of opportunity': Wolfe initiates SpaceX at Buy ahead of historic IPO
- SpaceX Shares Indicated To Open At $155
OncoGenex Pharma (OGXI) Announces FDA Agreement on Proposed Phase 3 AFFINITY Amendment
June 10, 2015 7:02 AM EDTOncoGenex Pharma (NASDAQ: OGXI) announced that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed amendment to the Phase 3 AFFINITY protocol and statistical analysis plan. The amendment includes the addition of a co-primary endpoint designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (CRPC).
"There are limited effective treatment options for men with metastatic CRPC who have risk factors for poor outcomes and who fall into a poor prognosis... More
