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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) 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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Delcath Systems, Inc. announces the granting of an equity award to an individual as an inducement for employment, totaling 30,000 shares of common stock with an exercise price of $4.77. The options vest over a two-year period and are subject to the employee's continued employment.
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Delcath Systems, Inc. increases its 2024 Treatment Site Activation Guidance to 20 sites and reports business highlights and financial results for Q4 and FY 2023. The company achieved significant milestones, including the first commercial use of HEPZATO KIT™, site activations, updated guidance, CMS approval, patient access program launch, private placement financing, and new COO appointment. Financially, Delcath had cash equivalents of $32.5 million as of December 31, 2023, with total revenue of $0.5 million for Q4 and $2.1 million for FY 2023.
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Delcath Systems, Inc. closes a private placement, selling 876,627 shares of common stock and 1,008,102 pre-funded warrants, raising approximately $7 million. The company plans to use the proceeds for working capital and general corporate purposes.
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Delcath Systems, Inc. (DCTH) to host conference call to discuss Q4 and year-end results for 2023 and provide business update.
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Delcath Systems, Inc. (DCTH) appoints Martha S. Rook as Chief Operating Officer, bringing over 25 years of industry experience in molecular biology and biologics development. Ms. Rook's background includes leadership roles at insitro and Sigilon Therapeutics, with a focus on complex combination products. She also spent 13 years at MilliporeSigma. The Company granted Ms. Rook an equity award of 125,000 shares of common stock.
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Delcath Systems, Inc. (DCTH) announces a private placement transaction with accredited investors, issuing common stock and pre-funded warrants, expecting gross proceeds of $7 million. The company plans to utilize the funds for working capital and general corporate purposes.
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FAQ

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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212.28M
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Surgical and Medical Instrument Manufacturing
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