Delcath Sys Stock Price, News & Analysis

Delcath Systems, Inc. (Nasdaq: DCTH) announced its decision to resume direct responsibility for the sales, marketing, and distribution of the CHEMOSAT^® Hepatic Delivery System in Europe effective March 1, 2022. This move comes after medac GmbH held the license for the product since December 2018. Delcath aims for a smooth transition to ensure patient access to CHEMOSAT, a proprietary device that delivers high-dose chemotherapy to the liver while managing systemic exposure. The product has been used in major medical centers for treating liver cancers since its EU launch in 2012.

Delcath Systems (Nasdaq: DCTH) announced its participation in two upcoming virtual investor conferences. The first is the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 17, 2022, at 11:00 AM ET, which will not be webcast. The second event is the 2022 SVB Leerink Global Healthcare Conference on February 18, 2022, at 9:20 AM ET, which will be available via webcast. Delcath focuses on interventional oncology, particularly using its proprietary PHP system for treating liver cancers.

Delcath Systems (Nasdaq: DCTH) announced the appointment of Anthony Dias as the new Vice President of Finance. Bringing over 20 years of financial leadership experience in the healthcare sector, Dias will oversee the company's financial planning, reporting, accounting, and treasury. Previously, he held senior finance roles at Advanced Group and PAREXEL, where he was instrumental in a $5.5 billion sale. Alongside his appointment, Delcath granted him options to purchase 30,000 shares, with a vesting schedule linked to his continued employment.

Delcath Systems announced promising results from a retrospective study on the use of its CHEMOSAT® Hepatic Delivery System for patients with liver dominant metastatic uveal melanoma. The study revealed a hepatic disease control rate of 88.9%, a hepatic response rate of 66.7%, and an overall response rate of 60.5% across 81 patients. Following a median follow-up of 12.9 months, the median progression-free survival (PFS) was 8.4 months and overall survival (OS) was 14.9 months. The study emphasized a favorable safety profile with no fatal treatment-related adverse events.

Delcath Systems, Inc. (NASDAQ: DCTH) has appointed David Hoffman as General Counsel and Corporate Secretary. Hoffman brings over 20 years of biotechnology legal experience, previously serving at Vericel Corporation and Sunovion Pharmaceuticals. His expertise spans healthcare law, compliance, and business transactions. CEO Gerard Michel emphasized Hoffman's contributions as essential for advancing Delcath's mission to commercialize therapies targeting liver cancers. Delcath focuses on innovative treatments including the HEPZATO KIT, designed for localized chemotherapy delivery.

Delcath Systems (DCTH), an interventional oncology company, has announced its participation in the H.C. Wainwright BioConnect Virtual Investor Conference from January 10-13, 2022. The presentation will be available on-demand starting at 7:00 AM ET on January 10. Delcath will also hold one-on-one investor meetings during the event. The company focuses on innovative treatments for liver cancers, utilizing its proprietary percutaneous hepatic perfusion system, HEPZATO, in the U.S. and CHEMOSAT in Europe.

Delcath Systems announced encouraging results from the phase 3 FOCUS study of its treatment HEPZATO for metastatic ocular melanoma.

The study showed a median duration of response of 14 months, with an overall response rate (ORR) of 31.4% and a 12-month survival hazard ratio (HR) of 0.37 (p=0.01) compared to the Best Alternative Care (BAC) arm.

HEPZATO also demonstrated a disease control rate of 65.7% and improved progression-free survival (PFS) compared to BAC. A new NDA submission is anticipated by mid-2022.

Delcath Systems, Inc. (Nasdaq: DCTH) announced an upcoming Investor Update Meeting on December 2, 2021, focusing on its investigational drug/device combination product, HEPZATO KIT. The meeting will feature discussions on the FOCUS trial results and the clinical experience with CHEMOSAT, detailing unmet needs in treating liver cancers. A panel of leading physicians will present key topics including PHP quality of life and future clinical development plans. This event underscores Delcath's commitment to innovative solutions for liver cancer treatment.

Delcath Systems (Nasdaq: DCTH) reported its Q3 2021 results, highlighting key developments including a $20 million debt facility and FDA approval for an expanded access protocol for HEPZATO™ Kit. Product revenue increased to $522,000, up from $466,000 year-over-year. However, the company faced a net loss of $7.1 million compared to $5.0 million in Q3 2020. Operating expenses rose to $7.0 million, influenced by stock option expenses. Cash reserves improved to $29 million from $11.1 million a year prior. Delcath plans to file its HEPZATO NDA mid-2022 and hosted an investor update on December 2.