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Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
Delcath Systems reported first-quarter 2022 results, highlighting a net loss of $8.2 million, up from $6.7 million year-over-year. Total revenue remained static at $0.3 million, primarily from CHEMOSAT sales in Europe. R&D expenses increased to $4.2 million, while SG&A expenses rose to $3.6 million. Notably, the company plans to file an NDA for HEPZATO in Q3 2022 following a pre-NDA meeting with the FDA. Additionally, data from a recent study showed a hepatic disease control rate of 88.9% for CHEMOSAT among uveal melanoma patients.
Delcath Systems, Inc. (Nasdaq: DCTH) announced the acceptance of a poster presentation for the FOCUS Phase 3 Trial results at the upcoming ASCO 2022 Annual Meeting in Chicago, running from June 3-7, 2022. The session will focus on the use of Percutaneous Hepatic Perfusion (PHP) with Melphalan in patients with liver metastases from ocular melanoma. The presentation, led by Dr. Jonathan Zager, is scheduled for June 6, 2022.
Delcath's PHP system is designed for targeted high-dose chemotherapy delivery to the liver, addressing unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, a leader in interventional oncology, announced a conference call to discuss its Q1 2022 financial results. The event is scheduled for May 10, 2022, at 8:30 AM ET. Participants can join by dialing in or via webcast. Delcath’s proprietary PHP system delivers high-dose chemotherapy specifically for liver cancers, including metastatic ocular melanoma, under the brand names HEPZATO in the U.S. and CHEMOSAT in Europe. This innovative approach minimizes systemic exposure while targeting cancer effectively, highlighting the company's commitment to advancing cancer treatment.
Delcath Systems, traded as DCTH, will participate in the Canaccord Genuity Horizons in Oncology Conference on April 14, 2022, at 3:00 PM ET. The event will feature a fireside chat and management will engage in virtual one-on-one meetings. Delcath focuses on treating liver cancers using its proprietary percutaneous hepatic perfusion (PHP) system, currently under development in the U.S. as HEPZATO KIT for metastatic ocular melanoma. In Europe, the PHP system is approved as CHEMOSAT to treat various liver cancers.
Delcath Systems, focused on interventional oncology, will participate in the Lytham Partners Spring 2022 Investor Conference. Key events include a presentation on April 4, 2022, at 11:00am ET, and a panel discussion on April 5, 2022, at 2:00pm ET, addressing technologies in cancer treatment. The company is known for its proprietary percutaneous hepatic perfusion system aimed at treating liver cancers, notably under the names HEPZATO in the U.S. and CHEMOSAT in Europe.
Delcath Systems reported its business highlights and financial results for Q4 and full-year 2021 on March 25, 2022. The company updated positive Phase 3 trial results for the HEPZATO Kit, confirmed a mid-year NDA resubmission to the FDA, and resumed sales of CHEMOSAT in Europe. Q4 product revenue was approximately $0.2 million, with a net loss of $5.3 million, an improvement from Q4 2020. For the year, product revenue totaled $1.3 million, while the net loss increased to $25.6 million. As of December 31, 2021, cash and equivalents totaled $27 million.
Delcath Systems (Nasdaq: DCTH) will host a conference call on March 25, 2022, at 8:30 AM ET, to discuss fourth quarter and full year results for 2021. Participation is available via phone or online. The webcast link provides additional access for investors globally.
Delcath specializes in interventional oncology, focusing on liver cancers. Their proprietary PHP system delivers high-dose chemotherapy with minimal systemic exposure, and is known as HEPZATO KIT in the U.S. and CHEMOSAT in Europe.
Delcath Systems, Inc. (DCTH) will present at the 34th annual Roth Conference on March 14, 2022, at 3:30 PM PT. The presentation focuses on the company's innovative treatment for liver cancers, specifically the percutaneous hepatic perfusion (PHP) system, known as HEPZATO in the U.S. for metastatic ocular melanoma. In Europe, this system is marketed as CHEMOSAT. A webcast of the presentation will be available online. For further inquiries or one-on-one meetings, interested parties are encouraged to contact Delcath's investor relations.
Delcath Systems, Inc. (Nasdaq: DCTH) announced that its CHEMOSAT Hepatic Delivery System received certification under the new EU Medical Device Regulation (MDR) as of February 28, 2022. This transition from Class IIb to Class III signifies enhanced scrutiny, requiring more evidence on safety and performance. CHEMOSAT had previously been certified under the Medical Device Directive since 2012. The MDR ensures greater oversight, including post-marketing surveillance and unique device identification. The device is utilized for treating various liver cancers in major medical centers.
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.