Delcath Sys Stock Price, News & Analysis

Delcath Systems (NASDAQ: DCTH) announced the appointment of Kevin Muir as Vice President of Commercial Operations, effective immediately. Muir has a strong background in interventional oncology, having previously helped grow BTG's sales from $40 million to $180 million. Delcath's CEO, Gerard Michel, highlighted Muir's experience as a key asset for the anticipated launch of HEPZATO, pending FDA approval. The company expects topline data from the pivotal FOCUS trial in early 2021, with a potential NDA resubmission and U.S. launch in 2022.

Delcath Systems reported its Q3 2020 results, highlighting key advancements in its interventional oncology business. The FDA conditionally accepted the name HEPZATO™ KIT for its treatment option. In the FOCUS trial, 91 patients received treatment, with topline data expected in early 2021. The executive team was bolstered by Gerard Michel's appointment as CEO. Product revenue increased to $340K from $216K year-over-year. Operating expenses decreased to $5.3 million, while net loss improved to $5.0 million compared to $7.5 million in Q3 2019. Cash reserves stood at $11.1 million.

Delcath Systems announces management participation in the Oppenheimer Fall MedTech Summit on November 12, 2020, focusing on liver-directed treatments for cancer. The interventional oncology company, trading under NASDAQ symbol DCTH, is known for its investigational product, Melphalan Hydrochloride, designed for high-dose chemotherapy delivery via the Delcath Hepatic Delivery System (Melphalan/HDS). While not FDA-approved in the U.S., the system is marketed in Europe as Delcath CHEMOSAT and demonstrates ongoing efficacy studies for various liver cancers.

Delcath Systems, Inc. (NASDAQ: DCTH) announced a conference call on November 11, 2020, at 8:30 AM ET to discuss its third quarter results for the period ending September 30, 2020. The call can be joined via phone or online streaming. Delcath focuses on liver-directed treatments for cancer, utilizing its investigational product, Melphalan Hydrochloride with the Delcath Hepatic Delivery System. The product is currently undergoing the Phase 3 FOCUS Trial for treating hepatic-dominant ocular melanoma, although it has not yet received FDA approval for the U.S. market.

Delcath Systems, Inc. (NASDAQ: DCTH) announced a 72% overall response rate in a prospective phase II study for patients with metastatic ocular melanoma confined to the liver. The study utilized the CHEMOSAT Hepatic Delivery System with Melphalan, showing a median overall survival of 19.1 months. The findings will be discussed during a KOL call on November 5, 2020, with Dr. Mark Burgmans from Leiden University Medical Center. Notably, while grade 3 or 4 hematologic events were common, they were manageable with no treatment-related deaths reported.

Delcath Systems, Inc. (NASDAQ: DCTH) appointed Gerard Michel as the new CEO effective October 1, 2020, succeeding John Purpura, who becomes COO. Michel, with over 30 years in the pharmaceutical industry, previously served at Vericel Corporation, contributing to its growth into a commercial leader. He aims to advance Delcath's Melphalan/HDS product for treating metastatic ocular melanoma, targeting a New Drug Application resubmission in mid-2021. The company also granted Michel stock options to align his interests with shareholder value.

Delcath Systems, focused on liver-directed treatments, announced its participation in two investor conferences. The first is the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 4:30 PM EDT, featuring a live webcast. The second event is the Oppenheimer Fall Healthcare Life Science & Med Tech Summit on September 23, 2020. Virtual one-on-one meetings with management can be scheduled. Delcath's investigational product, Melphalan Hydrochloride for Injection, targets liver cancer treatment and has not yet received FDA approval.

Delcath Systems, a company specializing in interventional oncology for liver cancers, will present at the LD Micro 500 Virtual Conference on September 1, 2020, at 3:00 PM ET. A live webcast of this presentation will be publicly accessible and archived for 90 days. Delcath is known for its innovative treatment Melphalan Hydrochloride, designed for high-dose localized chemotherapy, and is conducting Phase 3 clinical trials for various liver cancers, including intrahepatic cholangiocarcinoma. The company’s system is marketed in Europe under the name Delcath CHEMOSAT.

Delcath Systems (NASDAQ: DCTH) reported its Q2 2020 financial results, highlighting a net loss of $4.3 million, improving from a $6.0 million loss the previous year. Product revenue rose to $262,000, up from $221,000. The company completed a $22 million public offering aimed at funding a Phase 3 trial for Melphalan/HDS in metastatic ocular melanoma (mOM). Delcath also emphasized plans for NDA submission by mid-2021 and further clinical studies in liver-dominant cancers, with cash resources sufficient until mid-2021.