Delcath surges on FDA approval for cancer treatment

Delcath Systems

15/08/2023 12:04

** Delcath's  DCTH.O  shares surge 61% to $5 premarket
    ** Co says U.S Food and Drug Administration on Monday
approved its drug-device combination treatment for adult
patients with a rare type of eye cancer known as metastatic
uveal melanoma (mUM)
    ** mUM is a form of cancer that affects melanocytes in the
eye that later spread to other parts of the body primarily the
liver 
    ** FDA approved use of its Hepzato Kit, which comprises 
DCTH's Hepatic Delivery System to administer a chemotherapy drug
directly to a patient's liver - DCTH 
    ** DCTH says approval comes with a boxed warning of toxicity
related to the procedure and bone marrow suppression
    ** BTIG analysts said the approval was a "big win" for DCTH
and do not expect the boxed warning to hinder use of the
drug-device product
    ** Co plans to make Hepzato Kits commercially available in
Q4 
    ** Up to last close, shares down 13.3% YTD 

 (Reporting by Christy Santhosh in Bengaluru)
 ((Christy.Santhosh@thomsonreuters.com))