Delcath Systems to File Its Second Quarter 2023 10-Q the Week of August 7 and Expects to Host a Conference Call the Following Week

Rhea-AI Summary

Delcath Systems, Inc. plans to report its 2Q23 earnings and issue its Form 10-Q the week of August 7, 2023. The company expects the FDA to review and take action on its HEPZATO™ KIT's new drug application by the August 14, 2023 Prescription Drug User Fee Act (PDUFA) date.

NEW YORK, Aug. 3, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that it plans to report the Company's 2Q23 earnings and issue its Form 10-Q the week of August 7, 2023. Subsequently, shortly after the FDA's decision on its HEPZATO™ KIT's new drug application ("NDA") resubmission, Delcath expects to hold a conference call to review the quarter and the details of the FDA action.  Delcath currently expects the FDA to finish their review and take action on the application by the August 14, 2023 Prescription Drug User Fee Act ("PDUFA") date.  

About Delcath Systems, Inc.

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT (melphalan hydrochloride for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is considered an investigational drug/device combination product regulated as a drug by the United States Food and Drug Administration (FDA). HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. In the US, HEPZATO KIT was the subject of a February 14, 2023 new drug application resubmission to FDA for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM), also known as metastatic uveal melanoma (mUM). FDA has established an August 14, 2023 PDUFA date for the resubmission. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

 

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SOURCE Delcath Systems, Inc.

FAQ

When will Delcath Systems, Inc. report its 2Q23 earnings?

Delcath Systems, Inc. plans to report its 2Q23 earnings the week of August 7, 2023.

What is the expected date for the FDA's decision on Delcath Systems, Inc.'s HEPZATO™ KIT's new drug application?

The FDA is expected to review and take action on Delcath Systems, Inc.'s HEPZATO™ KIT's new drug application by the August 14, 2023 Prescription Drug User Fee Act (PDUFA) date.