Delcath Systems Inc. (NASDAQ: DCTH) has manifested a notable ascent on the trading landscape today, displaying a remarkable surge of 76.32% and attaining a trading price of $5.50 as per the most recent observation.
This surge in valuation follows a previous closing price of $3.12 for Delcath stock during the preceding trading session. The upward trajectory of DCTH shares is intrinsically linked to a recent regulatory milestone.
Delcath Systems (DCTH) has announced that it has garnered the approval of the United States Food and Drug Administration (FDA) for the HEPZATO KIT, a therapeutic intervention encompassing melphalan and a Hepatic Delivery System.
This therapeutic configuration has received FDA endorsement for its application as a targeted remedy for adult patients grappling with the complex medical scenario of metastatic uveal melanoma (mUM), specifically those cases wherein hepatic metastases occupy an area of the liver accounting for less than 50% of its total mass.
This approval extends to instances where the spread of the disease is confined to extraneous regions like the bone, lymph nodes, subcutaneous tissues, or lung, amenable to surgical resection or radiation.
Metastatic uveal melanoma (mUM) represents a rare and formidable manifestation of cancer, with an annual incidence within the United States approximated at 1,000 cases. The liver is implicated in 90% of these cases, often leading to life-threatening liver failure.
Notably, the National Comprehensive Cancer Network (NCCN) guidelines stipulate liver-directed therapeutic modalities for mUM patients harboring liver-based metastatic lesions. The HEPZATO KIT has gained singular distinction as the solitary liver-focused therapy to garner FDA sanction for addressing mUM.
Moreover, the procedural technique of percutaneous hepatic perfusion (PHP), facilitated by the HEPZATO KIT, is already endorsed within the purview of NCCN guidelines.
With the anticipation of commercial availability slated for the fourth quarter, the company is poised to make its therapeutic offering accessible to the medical community. Patients will continue to be included in treatment through the medium of the Expanded Access Program (EAP) sites.
Additionally, the augmentation of Delcath’s human capital is underscored by the recent appointments of Vojislav Vukovic, MD, Ph.D., as Chief Medical Officer, Sandra Pennell as Senior Vice President of Finance, and Zac MacLean as Director of Sales and Strategy. Simultaneously, the company continues its dedicated efforts in patient care across its 3 Expanded Access Program sites.
