Delcath Systems Inc

+0.02 (+0.30%)
Regulatory, Earnings Announcements

Delcath Systems Inc Announces Positive Phase 3 Trial Results For Hepzato™ In Liver-Dominant Metastatic Ocular Melanoma

Published: 12/02/2021 14:23 GMT
Delcath Systems Inc (DCTH) - Delcath Systems, Inc. Announces Positive Phase 3 Focus Trial Results for Hepzato™ in Liver-dominant Metastatic Ocular Melanoma, Including Initial Survival Data Analysis.
Delcath Systems - on Final Analysis of Primary Orr Endpoint, Hepzato Further Exceeded Predefined Threshold for Success With Median Duration of Response of 14 Months.
Delcath Systems Inc - Intend to Study Hepzato in Additional Indications in Near Future.
Delcath Systems Inc- Disease Control Rate of 73.6% Versus 37.5% for Patients in Bac Arm for Hepzato Study.
Delcath Systems Inc - As of the Analysis, Survival at 12-months in Evaluable Patients Was 75% in Hepzato Arm Versus 47% for Bac.
Delcath Systems Inc - Hepzato Had Statistically Significant Improvements Over Bac in Predefined Exploratory Analyses on Orr, Dcr and Pfs.
Delcath Systems Inc - NDA Resubmission for Hepzato Expected by Mid-2022.
Delcath Systems Inc- Median Progression Free Survival of 9.03 Months Versus 3.12 Months for Bac Arm in Hepzato Study.
Revenue is expected to be $0.52 Million
Adjusted EPS is expected to be -$1.01

Next Quarter Revenue Guidance is expected to be $0.45 Million
Next Quarter EPS Guidance is expected to be -$1.05

More details on our Analysts Page.