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) presented new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ at the ESMO Congress. The trial evaluated the efficacy and safety of HEPZATO KIT™ in patients with metastatic uveal melanoma (mUM). Key findings include:
1. No significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with and without extrahepatic lesions or based on prior therapy.
2. Consistent ORR and PFS regardless of liver tumor burden, but worse OS with more extensive liver involvement.
3. Objective tumor responses observed throughout the entire treatment period.
4. Consistent rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs), indicating no cumulative toxicity.
These results support the favorable benefit-risk profile of HEPZATO KIT™ for mUM patients with treatment options.
Delcath Systems (Nasdaq: DCTH), a company specializing in interventional oncology for liver cancer treatment, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for Wednesday, September 11, 2024, at 11:00 a.m. Eastern Time. Delcath's management team will engage in a fireside chat during the conference, which will take place at the Lotte New York Palace Hotel in New York City.
This participation provides an opportunity for Delcath Systems to showcase its focus on treating primary and metastatic liver cancers to potential investors and industry professionals. The H.C. Wainwright conference is a significant platform for companies in the healthcare and life sciences sectors to present their latest developments and strategies.
Delcath Systems, Inc. (Nasdaq: DCTH) announced positive results from an independent study on liver-directed therapy for uveal melanoma patients. The study, published in Therapeutic Advances in Medical Oncology, showed that first-line liver-directed therapies, including Delcath's CHEMOSAT® Hepatic Delivery System, significantly improved melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma.
Key findings include:
- Patients receiving first-line liver-directed therapy (N=89) had a median MSS of 28 months, compared to 10 months for those receiving first-line systemic therapy (N=45)
- Patients diagnosed between 2016-2021 and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months, compared to 20 months for those diagnosed between 2005-2015
Delcath Systems, Inc. (Nasdaq: DCTH) announced positive outcomes from an independent study on hepatic perfusion for uveal melanoma patients. The study, conducted by researchers at Moffitt Cancer Center, compared Delcath's HEPZATO KIT™ to immunotherapy and other liver-directed therapies. Key findings include:
1. Overall Survival (OS): Median OS of 22.4 months for first-line therapy and 18.4 months for second-line therapy with HEPZATO KIT.
2. Hepatic Progression-Free Survival (hPFS): First-line HEPZATO KIT showed 17.6 months median hPFS, outperforming immunotherapy (8.8 months) and other therapies (9.2 months).
3. Progression-Free Survival (PFS): First-line HEPZATO KIT demonstrated 15.4 months median PFS, surpassing immunotherapy and other therapies.
The study suggests HEPZATO KIT provides better disease control and improved progression-free survival for patients with hepatic metastases from uveal melanoma.
Delcath Systems (Nasdaq: DCTH) announced promising results from an independent study on its CHEMOSAT® Hepatic Delivery System for liver tumors. The study, conducted at the University Hospital of Leipzig, Germany, evaluated 33 patients with various cancers, including uveal melanoma and cholangiocarcinoma. Key findings include:
- A 91% disease control rate
- 18.2% of patients achieved complete response in the liver
- Median hepatic progression-free survival of 52 weeks across all patients
- 69 weeks median hPFS in uveal melanoma patients
- 38 weeks median hPFS in cholangiocarcinoma patients
The study highlights the efficacy and safety of repeated CHEMOSAT treatments, showing potential as an essential tool for managing primary and secondary liver tumors.
Delcath Systems (Nasdaq: DCTH) announced a poster presentation at the 2024 ESMO Congress in Barcelona, Spain. The presentation, scheduled for September 14, 2024, will showcase data from the FOCUS Phase 3 study, focusing on the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients with unresectable metastatic uveal melanoma (mUM).
The poster, titled 'Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results,' will highlight the treatment's effectiveness across six patient subgroups. This presentation represents an important opportunity for Delcath to share its research findings with the international oncology community at one of the field's most prestigious conferences.
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company, has announced the granting of an equity award as a material inducement to employment. The grant, approved by the Company's Compensation Committee, includes the right to purchase 23,000 shares of Delcath's common stock. The options were granted on July 31, 2024, with an exercise price of $8.62, matching the closing price of Delcath's common stock on that date.
The vesting schedule for the options is as follows: one-third will vest on the first anniversary of the grant date, with the remaining two-thirds vesting in equal monthly installments over the following 24 months. The options have a ten-year term and are subject to the employee's continued employment with Delcath. This award was granted in accordance with Nasdaq Listing Rule 5635(c)(4) and the terms of the Company's 2023 Inducement Plan.
Delcath Systems (Nasdaq: DCTH) reported Q2 2024 results, with total revenue of $7.8 million, including $6.6 million from HEPZATO KIT™ sales in the US and $1.2 million from CHEMOSAT sales in Europe. The company activated three new HEPZATO KIT treating centers in Q2, bringing the total to eight active centers. Delcath received New Technology Add-on Payment status for HEPZATO from CMS, published key results from the Phase 3 FOCUS study, and announced the acceptance of the FOCUS study efficacy analysis for presentation at the upcoming ESMO conference. The company ended the quarter with $19.9 million in cash and investments.
R&D expenses were $3.4 million, down from $3.6 million in Q2 2023, while SG&A expenses increased to $6.8 million from $4.8 million, primarily due to commercial launch activities. CEO Gerard Michel expressed optimism about HEPZATO KIT's adoption and its potential as a key therapeutic approach for metastatic uveal melanoma patients.
Delcath Systems (Nasdaq: DCTH) has announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™. This approval, effective from October 1, 2024, will support the adoption of this innovative liver-directed therapy under the CMS Inpatient Prospective Payment System.
The NTAP designation will help cover costs associated with HEPZATO KIT for eligible Medicare inpatients, ensuring broader access to this treatment. The HEPZATO KIT is a combination product that delivers high-dose chemotherapy directly to the liver while minimizing systemic exposure, indicated for treating adult patients with unresectable hepatic-dominant metastatic uveal melanoma.
Delcath Systems (Nasdaq: DCTH), an interventional oncology company focusing on liver cancer treatments, has announced its participation in two upcoming investor conferences. The company will attend the BTIG Virtual Biotechnology Conference on August 6, 2024, which will be held virtually. Additionally, Delcath will present at Canaccord Genuity's 44th Annual Growth Conference on August 14, 2024, at 9:30 am Eastern Time in Boston, MA.
These conferences provide Delcath Systems with opportunities to showcase its advancements in liver cancer treatment and engage with investors. The company's participation in both virtual and in-person events demonstrates its commitment to maintaining strong investor relations and promoting its innovative oncology solutions.
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