- Delcath Systems Inc DCTH shares are rising over 23% as FDA accepted its new drug application resubmission for HEPZATO Kit (melphalan hydrochloride for Injection/Hepatic Delivery System) seeking approval for unresectable hepatic-dominant metastatic ocular melanoma (mOM).
- The FDA also communicated to Delcath that they consider the submission a complete class 2 response, and the PDUFA date for the resubmission is August 14, 2023.
- The resubmission is in response to the FDA's September 12, 2013, Complete Response Letter (CRL).
- The Hepzato Kit is a drug-device combination product to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.
- Concurrently, the company raised $85 million in gross proceeds through a private placement that includes initial upfront funding of $25 million.
- Aggregate financing is expected to be sufficient to fund the company through the potential approval of HEPZATO and commercialization.
- "We are gratified with the support from both our existing investors and our new investors, all of whom are highly regarded healthcare-focused funds. Their support, potentially totaling up to $85 million, subject to satisfaction of milestones, we believe validates the clinical relevance of and the commercial opportunity for Hepzato in metastatic ocular melanoma. Further, it positions Delcath to execute on HEPZATO commercialization plans upon potential FDA approval," said Gerard Michel, CEO of Delcath.
- "Finally, we eagerly await the publication of interim results from the phase II portion of the CHOPIN study which should provide critical additional information about the potential utility of CHEMOSAT used in sequence with immune checkpoint inhibitors," Michel added.
- Price Action: DCTH shares are up 23.55% at $5.98 on the last check Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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