Sesen Bio's Bladder Cancer Trial Wrecked By Misconduct: Stat News

by Vandana Singh, Benzinga Editor

August 18, 2021 1:45 PM | 1 min read

Sesen Bio Inc SESN said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum.
But the rejected filing includes several violations and investigator misconduct, STAT News reported.
Related: Sesen Bio Stock Crashes As FDA Shoots Down Its Bladder Cancer Pitch.
The 130-patient study had more than 2,000 violations, 215 classified as major, STAT reported.
Independent monitors also reported three investigators to the FDA for a “serious noncompliance” that “placed subjects at risk of harm.”
A patient died in 2016 of liver failure related to the drug, and two years later, the company said that there were no drug-related deaths at a urology conference.
Price Action: SESN shares are down 13.6% at $1.30 during the market session on the last check Wednesday.