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Delcath Systems Inc - DCTH STOCK NEWS

Welcome to our dedicated page for Delcath Systems news (Ticker: DCTH), a resource for investors and traders seeking the latest updates and insights on Delcath Systems stock.

Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.

HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.

In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.

Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.

Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.

As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.

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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.

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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.

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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.

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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.

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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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Delcath Systems (Nasdaq: DCTH), an interventional oncology company specializing in liver cancer treatments, has announced its upcoming second quarter 2024 earnings call. The call is scheduled for August 5, 2024, at 4:30 PM Eastern Time. Investors and interested parties can participate by dialing the provided toll-free or international numbers. A webcast of the call will also be available, with a replay accessible on the company's website shortly after the event concludes.

This earnings call will provide insights into Delcath's financial performance and operational updates for the quarter ended June 30, 2024. As a company focused on innovative liver cancer treatments, the call may offer valuable information on Delcath's progress in the oncology field and its market position.

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Delcath Systems (Nasdaq: DCTH) reported its Q1 2024 financial results and business highlights on May 14, 2024. The company recognized $3.1 million in total revenue, a significant increase from $0.6 million in Q1 2023, driven by sales of HEPZATO KIT and CHEMOSAT. Delcath updated its U.S. center activation guidance to 20 by end of 2024, activated six new centers, and has five more preparing for activation. The company raised $7.0 million in a private placement and has cash reserves totaling $27.2 million.

Delcath appointed Martha S. Rook, Ph.D., as COO and received a permanent J-code and pass-through payment status for HEPZATO KIT from CMS effective April 1, 2024. Research and development expenses decreased to $3.7 million, while selling, general, and administrative expenses rose to $8.8 million, mainly due to commercial launch activities. The company also published pivotal Phase 3 FOCUS study results on HEPZATO KIT for treating unresectable metastatic Uveal Melanoma in the Annals of Surgical Oncology.

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Delcath Systems, Inc. (Nasdaq: DCTH) will host a conference call on May 14, 2024, to discuss first quarter results. The company focuses on interventional oncology for liver cancers.

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Delcath Systems, an interventional oncology company, announced positive results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma. The study showed a significantly higher Overall Response Rate of 36.3% compared to historical controls, with a Disease Control Rate of 73.6% and a Complete Response Rate of 7.7%. Secondary endpoints included Duration of Response, Progression-free Survival, and Overall Survival. The study also reported comparable safety and tolerability with no treatment-related deaths.

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Delcath Systems, Inc. (Nasdaq: DCTH) granted equity awards to two individuals as inducements for employment, totaling 33,000 shares of common stock, with an exercise price of $5.20. The options vest over a 24-month period and have a ten-year term, subject to continued employment.

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FAQ

What is the current stock price of Delcath Systems (DCTH)?

The current stock price of Delcath Systems (DCTH) is $9.39 as of November 15, 2024.

What is the market cap of Delcath Systems (DCTH)?

The market cap of Delcath Systems (DCTH) is approximately 254.1M.

What is the primary focus of Delcath Systems Inc.?

Delcath Systems Inc. focuses on the treatment of primary and metastatic liver cancers using proprietary products like the HEPZATO KIT™ and CHEMOSAT® Hepatic Delivery System.

What is the HEPZATO KIT?

The HEPZATO KIT is a combination of Hepzato (melphalan) for Injection and the Hepatic Delivery System, designed to deliver high-dose chemotherapy directly to the liver with minimal systemic exposure.

Where is the HEPZATO KIT approved for use?

The HEPZATO KIT is approved by the FDA for use in the United States to treat adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases.

What is the CHEMOSAT® Hepatic Delivery System?

In Europe and the UK, Delcath markets the CHEMOSAT® Hepatic Delivery System, a device-only configuration for administering high-dose chemotherapy to the liver.

How many CHEMOSAT treatments have been performed in Europe?

Over 250 CHEMOSAT treatments have been performed at more than 20 leading European cancer centers.

What recent milestones has Delcath Systems Inc. achieved?

Recent milestones include the first commercial use of HEPZATO KIT, securing a permanent J-code for the product, and closing a $7 million private placement.

What was the outcome of the pivotal Phase 3 FOCUS study?

The FOCUS study demonstrated that the HEPZATO KIT significantly improved overall response rates and progression-free survival for patients with metastatic uveal melanoma.

What support does Delcath offer for patients seeking HEPZATO KIT treatment?

Delcath has launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment.

How does the HEPZATO KIT minimize systemic exposure?

The Hepatic Delivery System in the HEPZATO KIT isolates the liver and filters hepatic venous blood during melphalan infusion and washout, reducing systemic toxicity.

How does Delcath Systems Inc. support its commercial strategy in Europe?

Delcath aims to grow clinical adoption of CHEMOSAT in major European markets and leverage physician experience to support reimbursement appeals.

Delcath Systems Inc

Nasdaq:DCTH

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DCTH Stock Data

254.11M
31.97M
2.71%
38.13%
4.46%
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