Delcath Announces FDA's Acceptance Of NDA Resubmission Of Hepzato Kit

(RTTNews) - Delcath Systems, Inc. (DCTH) announced the FDA has accepted its new drug application resubmission for HEPZATO Kit seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma. The FDA consider the submission a complete class 2 response. The PDUFA date for the resubmission is August 14, 2023. The HEPZATO Kit is a drug-device combination product comprised of the drug melphalan and device HDS constituent parts.

Delcath Systems also announced it has signed securities purchase agreements with certain healthcare-focused institutional investors that will provide up to $85 million in gross proceeds to Delcath through a private placement that includes initial upfront funding of $25 million. The financing is expected to enable the company to have sufficient cash past its anticipated PDUFA date of August 14, 2023, and fund the commercialization of HEPZATO, if approved.

Separately, the company recorded a fourth quarter net loss of $8.5 million, $0.86 per share compared to a net loss of $5.3 million, $0.69 per share, for the same period in 2021. Product revenue was approximately $0.6 million, compared to $0.2 million for the prior year period, from sales of CHEMOSAT in Europe. Analysts on average had expected the company to post a loss of $0.76 per share, according to figures compiled by Thomson Reuters. Analysts' estimates typically exclude special items.

Shares of Delcath Systems are up 6% in pre-market trade on Monday.

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