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), an interventional oncology company specializing in liver cancer treatments, has scheduled its first quarter 2025 earnings conference call for May 8, 2025, at 8:30 AM Eastern Time. The call will discuss financial results for the quarter ending March 31, 2025.
Participants can join via toll-free number (1-877-407-3982) or international line (1-201-493-6780). A webcast will be available, and a replay will be archived on the company's website following the call.
Delcath Systems (NASDAQ: DCTH) has published a comparative analysis from the randomized portion of their Phase 3 FOCUS study in the Annals of Surgical Oncology. The study evaluated Melphalan/Hepatic Delivery System (Melphalan/HDS) against best alternative care (BAC) in patients with unresectable metastatic uveal melanoma.
Key findings from the 72 treated patients (40 Melphalan/HDS; 32 BAC) showed significant improvements with Melphalan/HDS:
- Median progression-free survival: 9.1 months vs 3.3 months for BAC
- Median overall survival: 18.5 months vs 14.5 months for BAC
- Objective response rate: 27.5% vs 9.4% for BAC
- Disease control rate: 80.0% vs 46.9% for BAC
- Median hepatic progression-free survival: 11.4 months vs 3.3 months for BAC
The safety profile was consistent with prior reports, primarily showing hematologic effects, with no treatment-related deaths reported.
Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology with a focus on treating primary and metastatic liver cancers, has announced its upcoming participation in the CG Horizons in Oncology Virtual Conference. The presentation is scheduled for April 7, 2025, at 10:00 a.m. ET. Interested investors are advised to contact their Canaccord representative to participate in the event.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced equity inducement grants to six new employees who joined in January and February 2025. The grants include options to purchase 264,000 shares of common stock under the company's 2023 Inducement Plan.
The stock options were granted on February 28, 2025, with an exercise price of $14.17 per share, matching the closing price of Delcath's common stock on that date. The vesting schedule includes one-third of options vesting after the first year, with the remaining two-thirds vesting in equal monthly installments over 24 months. The options have a ten-year term and require continued employment for vesting.
Delcath Systems (NASDAQ: DCTH) reported strong financial results for Q4 and full year 2024. The company achieved total revenue of $15.1M in Q4 and $37.2M for the full year, with HEPZATO KIT generating $13.7M and $32.3M respectively. CHEMOSAT contributed $1.4M in Q4 and $4.9M for the year.
The company demonstrated solid financial metrics with 86% gross margins in Q4 and 83% for the year. Q4 showed positive adjusted EBITDA of $4.6M, while reporting a net loss of $3.4M. The full-year net loss was $26.4M with an adjusted EBITDA loss of $2.5M.
Operationally, Delcath expanded to 16 active centers and received FDA clearance for a Phase 2 trial of HEPZATO in liver-dominant metastatic colorectal cancer. The company ended 2024 with a strong cash position of $53.2M, bolstered by $41.3M from warrant exercises, and operates debt-free.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced it will host a conference call to discuss its fourth quarter and full year 2024 financial results. The call is scheduled for March 6, 2025, at 8:30 AM Eastern Time.
Participants can join the call using toll-free number 1-877-407-3982 for domestic callers or 1-201-493-6780 for international callers. A webcast will be available, and a replay will be archived on the company's website following the call.
Delcath Systems (DCTH) announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for treating metastatic uveal melanoma (mUM). The NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma, expanding from its previous limitation to patients with metastases confined to the liver.
This update aligns with HEPZATO KIT's label and is particularly significant as over 90% of mUM patients develop liver metastases. A Phase 3 FOCUS trial subgroup analysis showed no significant differences in objective response rate, progression-free survival, or overall survival between patients with and without extrahepatic disease. HEPZATO KIT and CHEMOSAT are designed to administer high-dose chemotherapy to the liver.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced its participation in the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference. The conference will take place from February 11-12, 2025, at The Cliff Lodge in Snowbird, Utah. The company's management team will be in attendance at this significant healthcare industry event.
Delcath Systems (NASDAQ: DCTH) has released preliminary financial results for Q4 and full-year 2024. The company reported Q4 revenue of approximately $15.1 million and full-year revenue of $37.2 million. Their primary product, HEPZATO KIT™, generated Q4 revenue of $13.7 million and full-year revenue of $32.3 million, while CHEMOSAT® contributed $1.4 million in Q4 and $4.9 million for the full year.
The company expects gross margins to range between 80%-85%. As of December 31, 2024, Delcath maintained a strong financial position with $53.2 million in cash, cash equivalents, and short-term investments, with no debt. Complete financial results and a detailed business update will be provided during their annual financial results release on March 6, 2025.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company granted stock options to purchase 30,000 shares of common stock to a new employee who joined on November 4, 2024.
The options, granted on December 31, 2024, have an exercise price of $12.04 per share, matching Delcath's closing stock price on that date. The vesting schedule includes one-third of the options vesting after one year, with the remaining two-thirds vesting in equal monthly installments over the following 24 months. The options have a ten-year term and require continued employment for vesting.