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.
The Delcath Systems Inc (DCTH) news page on Stock Titan aggregates company announcements, clinical updates, and financial disclosures for this interventional oncology business focused on primary and metastatic liver cancers. Delcath’s communications frequently highlight developments related to its proprietary hepatic delivery technologies, HEPZATO KIT and the CHEMOSAT Hepatic Delivery System for Melphalan, which are used in percutaneous hepatic perfusion (PHP) procedures.
Investors and observers can use this news feed to follow earnings reports and financial updates, including quarterly and preliminary revenue results, product revenue from HEPZATO KIT in the United States and CHEMOSAT in Europe, gross margin commentary, and discussions of non-GAAP measures such as adjusted EBITDA. The company also issues releases on capital allocation and corporate actions, such as authorization of share repurchase programs and equity inducement grants under stock incentive plans.
A significant portion of Delcath’s news flow centers on clinical and scientific developments. Recent announcements describe subgroup analyses from the Phase 3 FOCUS study of Melphalan/Hepatic Delivery System in unresectable metastatic uveal melanoma, the Phase 2 CHOPIN trial evaluating CHEMOSAT with ipilimumab and nivolumab, real-world evidence from retrospective analyses of metastatic uveal melanoma patients, and a 10-year single-center experience with CHEMOSAT in liver-dominant disease. The company also highlights expert narrative reviews discussing PHP with melphalan using HEPZATO KIT, including patient selection, technique, and outcomes.
Additional updates include participation in investor conferences and scheduling of earnings calls, providing context for how Delcath communicates with the capital markets. For users tracking DCTH, this page offers a centralized view of regulatory, clinical, and financial news that shapes the company’s progress in liver-directed oncology therapies. Bookmark this feed to monitor new data releases, product-related publications, and ongoing disclosures from Delcath Systems Inc.
Delcath Systems (Nasdaq: DCTH) announced inclusion of its CHEMOSAT Hepatic Delivery System for Melphalan (M-PHP) as a recommended liver-directed regional therapy in the April 2026 ESMO–EURACAN clinical practice guideline for uveal melanoma. The guideline also cites two Phase 3 trials showing improved hepatic and overall progression-free survival and lists M-PHP first among regional options for multifocal liver-only metastases.
The guideline assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 for select patients and recognizes HEPZATO KIT as a Category 2A option for hepatic-dominant metastatic uveal melanoma.
Delcath Systems (NASDAQ:DCTH) will participate in the Society of Interventional Radiology 2026 Annual Scientific Meeting in Toronto, April 11–15, 2026.
The company’s Hepatic Delivery System for percutaneous hepatic perfusion (PHP) appears in three presentations on April 13 and April 15, 2026, featuring physicians from Massachusetts General Hospital, Thomas Jefferson University, and University of Wisconsin. Abstracts are available on the company website under Scientific Meetings.
Delcath Systems (Nasdaq: DCTH) announced publication of the CHOPIN randomized Phase 2 trial in The Lancet Oncology showing improved outcomes when combining percutaneous hepatic perfusion (PHP) with ipilimumab and nivolumab in metastatic uveal melanoma.
Key results: 1-year PFS 54.7% vs 15.8% (HR 0.34; p=0.0002), median PFS 12.8 vs 8.3 months, median OS 23.1 vs 19.6 months (HR 0.39; p=0.0065), ORR 76.3% vs 39.5%. Higher grade ≥3 toxicity in the combination arm (82% vs 41%) and one treatment-related death were reported.
Delcath (Nasdaq: DCTH) reported strong 2025 results with $85.2M revenue and $2.7M GAAP net income for the full year, plus $25.1M adjusted EBITDA. Fourth-quarter revenue was $20.7M and gross margins were 85%–86%. The company ended 2025 with $91.0M cash and no debt, repurchased 628,572 shares for $6.0M, and guided 2026 revenue to at least $100M with 84%–87% gross margins.
Clinical and commercial momentum included ~140% HEPZATO procedure-volume growth, 28 active centers, and published CHOPIN and FOCUS study results supporting adoption.
Delcath Systems (Nasdaq: DCTH) will hold a conference call on February 26, 2026 at 8:30 AM Eastern Time to discuss fourth quarter and full year results for the period ended December 31, 2025.
Participants can join by toll-free or international dial-in or via webcast; a replay will be archived on the company website.
Delcath Systems (Nasdaq: DCTH) announced management will attend the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on January 27, 2026, at the Cliff Lodge in Snowbird, Utah.
The appearance signals management engagement with investors and industry peers; no financial results, presentations, or new regulatory updates were announced.
Delcath Systems (Nasdaq: DCTH) granted equity inducements under Nasdaq Listing Rule 5635(c)(4) to four new employees who began work in November or December 2025. The company issued 36,250 Restricted Stock Units (RSUs) under its 2023 Inducement Plan, with grants dated January 2, 2026. Vesting: one-third on the first anniversary of the grant and the remaining two-thirds in equal annual installments over the next two years, subject to continued employment on each vesting date. The awards were approved by the Compensation Committee and issued pursuant to the Plan and Nasdaq rules.
Delcath (Nasdaq: DCTH) reported preliminary, unaudited results for Q4 and full-year 2025. Total revenue is expected to be approximately $20.7M in Q4 and $85.2M for FY2025. HEPZATO KIT revenue is expected at $19.0M (Q4) and $78.8M (FY), while CHEMOSAT revenue is expected at $1.7M (Q4) and $6.4M (FY). The company repurchased 628,572 shares for $6.0M under a $25.0M buyback program. Cash and short-term investments were approximately $91.0M with no debt as of December 31, 2025. Procedure volume for HEPZATO grew ~140% in 2025 versus 2024. Final audited results and a detailed update will be released on the company’s annual call.
Delcath Systems (Nasdaq: DCTH) announced publication of subgroup analyses from the Phase 3 FOCUS study of HEPZATO KIT (melphalan/Hepatic Delivery System) in unresectable metastatic uveal melanoma, published December 31, 2025.
Key findings in 91 treated patients: higher ORR when tumor burden was below the median (51.1% vs 22.2%, p=0.008); longer median PFS for lower tumor burden (11.3 vs 5.8 months, p=0.007); longer OS with smaller liver involvement, lower tumor burden, and low/normal LDH (p=0.032, p=0.008, p=0.019 respectively). Safety was consistent across subgroups with no treatment-related deaths.
Delcath Systems (Nasdaq: DCTH) announced publication of a 10-year, single-center retrospective study reporting outcomes for 38 patients with liver-dominant metastatic uveal melanoma treated with 99 percutaneous hepatic perfusion (PHP) procedures using the CHEMOSAT Hepatic Delivery System for melphalan.
Key outcomes: median overall survival 29.1 months from first PHP (95% CI: 18.4–38.9), 1-/2-/3-year OS of 79.5%/53.2%/28.5%, no treatment-related deaths, procedure-related adverse events ≥2 in 10.5%, and a numerical OS improvement with ≥3 cycles (29.8 vs 21.4 months; p=0.058) with each additional cycle associated with HR=0.414 (~40% lower risk of death).