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) will host a conference call on November 4, 2025 at 8:30 AM Eastern Time to discuss results for the third quarter ended September 30, 2025. Participants should dial in 5–10 minutes early using the provided toll-free or international numbers or join the live webcast. A replay of the webinar will be available shortly after the call and archived on the company website.
Delcath Systems (NASDAQ: DCTH) reported preliminary Q3 2025 results and updated 2025 guidance. Q3 total CHEMOSAT and HEPZATO KIT revenue was approximately $20.5 million (HEPZATO $19.2M; CHEMOSAT $1.3M). Q3 gross margin is expected to be 87%, net income $0.8 million, adjusted EBITDA $5.3 million, and operating cashflow roughly $4.8 million. Cash, cash equivalents and short-term investments were approximately $88.9 million with no debt as of September 30, 2025.
Full-year 2025 revenue guidance is $83 million to $85 million, reflecting an approximate 150% treatment volume increase versus 2024. Management cites NDRA discounts and summer seasonality for the Q3 decline and will discuss Phase 2 CHOPIN trial results on a conference call on October 20, 2025.
Delcath Systems (NASDAQ: DCTH) announced results from the investigator-initiated Phase 2 CHOPIN trial in metastatic uveal melanoma showing that adding ipilimumab and nivolumab to CHEMOSAT/HDS percutaneous hepatic perfusion (PHP) met the primary endpoint of one-year progression-free survival.
Key results: one-year PFS 54.7% (combination) vs 15.8% (PHP); median PFS 12.8 vs 8.3 months; HR 0.34 (P<0.001). One-year OS similar (~82%); median OS 23.1 vs 19.6 months; OS HR 0.39 (P=0.006). Best overall response 76.3% vs 39.5% (P<0.001). Grade ≥3 treatment-related AEs higher in combination (81.6% vs 40.5%).
Delcath Systems (NASDAQ:DCTH), focused on liver cancer treatments, announced that results from their investigator-initiated CHOPIN Phase 2 trial will be presented at the ESMO 2025 Annual Congress. The presentation will be delivered by Principal Investigator Dr. Ellen Kapiteijn from Leiden University Medical Center.
The trial evaluates the combination of systemic immunotherapy (ipilimumab and nivolumab) with Delcath's CHEMOSAT® Hepatic Delivery System for treating metastatic uveal melanoma patients. The presentation is scheduled for October 18, 2025, at 3:20 p.m. CET, and the poster will be available on Delcath's investor relations website following the ESMO embargo lift.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company, has granted equity inducement awards to three new employees who joined in June 2025. The awards consist of options to purchase 78,000 shares of common stock at an exercise price of $11.02 per share, matching the closing price on August 29, 2025.
The options, granted under Delcath's 2023 Inducement Plan, will vest over three years, with one-third vesting after the first year and the remainder vesting monthly over the following 24 months. The ten-year term options were awarded in compliance with Nasdaq Listing Rule 5635(c)(4).
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced its upcoming participation in two major investor conferences. Management will attend the Wells Fargo Healthcare Conference on September 4, 2025, in Boston, and the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, in New York.
Delcath Systems (NASDAQ:DCTH) has initiated dosing in a global Phase 2 clinical trial evaluating HEPZATO™ for liver-dominant metastatic colorectal cancer (mCRC). The study will assess HEPZATO in combination with standard care versus standard care alone in third-line treatment, enrolling approximately 90 patients across 20+ sites in the US and Europe.
The trial's primary endpoint results for hepatic progression-free survival are expected by mid-2028, with overall survival data in late 2028. The addressable market comprises 6,000-10,000 patients annually in the United States with significant liver disease burden.
Delcath Systems (Nasdaq: DCTH) reported strong Q2 2025 financial results, with total revenue reaching $24.2 million, a significant increase from $7.8 million in Q2 2024. The company's HEPZATO KIT™ generated $22.5 million in revenue, while CHEMOSAT® contributed $1.7 million. Notable achievements include net income of $2.7 million, compared to a previous year's loss of $13.7 million, and positive adjusted EBITDA of $9.8 million.
The company activated three new U.S. centers, bringing the total to 20 active centers, with 10 additional centers accepting referrals. For fiscal year 2025, Delcath projects total revenue between $93-96 million, representing over 150% growth from 2024, with gross margins of 83-85%. The company maintains a strong financial position with $81.0 million in cash and no debt.
Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology treatments for liver cancers, has announced its participation in the Canaccord Genuity 45th Annual Growth Conference. The event will take place on Tuesday, August 12, 2025 at The InterContinental Boston in Boston, MA.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company focused on liver cancer treatments, has granted equity inducement awards to three new employees who joined in June 2025. The awards consist of options to purchase 52,500 shares of common stock at an exercise price of $13.60 per share.
The options, granted under Delcath's 2023 Inducement Plan, will vest over three years with one-third vesting after the first year and the remainder vesting monthly over the following 24 months. The options have a ten-year term and require continued employment for vesting.