Welcome to our dedicated page for Delcath Sys news (Ticker: DCTH), a resource for investors and traders seeking the latest updates and insights on Delcath Sys stock.
Delcath Systems Inc (NASDAQ: DCTH) specializes in innovative liver cancer therapies through its proprietary drug-device combination. This page provides investors and medical professionals with direct access to all official company announcements, including clinical trial milestones, regulatory updates, and strategic partnerships.
Discover the latest developments in Delcath's hepatic delivery system and melphalan hydrochloride treatments. Our curated news collection features FDA communications, European commercialization progress, and peer-reviewed research findings – essential resources for understanding the company's position in interventional oncology.
Key updates on: Clinical trial phases | Regulatory approvals | Financial results | Medical conference presentations | Partnership announcements. Bookmark this page to monitor Delcath's advancements in targeted chemotherapy delivery and liver cancer treatment protocols.
Delcath Systems (Nasdaq: DCTH) announced promising initial results from the Phase 1b CHOPIN trial, where 85.7% showed Best Overall Response and a 100% Disease Control Rate in patients with advanced uveal melanoma. The median progression-free survival reached 22.4 months with all seven patients alive at follow-up. Additionally, updates on the FOCUS trial revealed consistent interim efficacy data, while a quality of life analysis presented no significant overall changes post-treatment. These results underline the potential of Delcath's percutaneous hepatic perfusion therapy as a viable option for challenging cancer cases.
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.