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  • Delcath (DCTH) Gains Market Attention After Positive Study Results

    Delcath (DCTH) Gains Market Attention After Positive Study Results

    The stock value of Delcath Systems, Inc. (NASDAQ: DCTH) has significantly increased as a consequence of the publication of encouraging findings from an independent investigation. DCTH shares have increased by 10.42% as of the latest current-market check, hitting $10.07 on US stock charts.

    Delcath announced Release of a notable independent study

    Delcath Systems announced today that a noteworthy retrospective research has been published in the *Annals of Surgical Oncology*. Researchers from Tampa, Florida’s Moffitt Cancer Center conducted a study to look at the efficacy of treating hepatic metastases from uveal melanoma using Delcath’s HEPZATO KIT, which contains melphalan and the Hepatic Delivery System (HDS).

    The study was tilted “Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma.”

    Key DCTH Study Findings

    Compared to immunotherapy and other liver-directed therapies, the HEPZATO KIT improves progression-free survival and provides greater disease control in the liver, according to a trial including thirty patients. In particular, patients who received HEPZATO KIT as a second-line treatment had an OS of 18.4 months, compared to 22.4 months for those treated with it as a first-line therapy.

    When used as a first-line treatment, the HEPZATO KIT achieved a median Hepatic Progression-Free Survival (hPFS) of 17.6 months, surpassing the 8.8 months observed with immunotherapy and the 9.2 months seen with other liver-directed therapies. In the second-line therapy setting, the median hPFS with HEPZATO KIT was not reached, indicating superior outcomes compared to the alternatives.

    Implications and Future Directions

    First-line HEPZATO KIT therapy had a median overall Progression-Free Survival (PFS) of 15.4 months; immunotherapy had an 8.8-month PFS and other liver-directed therapies had a 9.2-month PFS. The HEPZATO KIT produced a median PFS of 22.2 months for second-line treatment, which was higher than the median PFS of 14.7 months and 7.5 months for immunotherapy and other liver-directed alternatives.

    These results underscore the efficacy of melphalan/HDS in managing liver-dominant metastatic uveal melanoma. Delcath Systems plans to further investigate the integration of melphalan/HDS with systemic therapies to enhance patient outcomes and continue advancing treatment options.

  • Delcath (DCTH): Extended-Hours Surge After A Business Update

    Delcath (DCTH): Extended-Hours Surge After A Business Update

    Delcath Systems, Inc. (NASDAQ: DCTH) observed an upward trajectory in its stock value during the extended trading session on Tuesday. The after-hours market saw a 6.22% surge, elevating Delcath stock to $2.39. This positive movement partially offset the earlier 24.50% decline, settling the regular session at $2.25. The surge was instigated by the release of the company’s quarterly results and a comprehensive business update.

    Delcath presented key business highlights and financial outcomes for the third quarter concluding on September 30, 2023. Regarding business developments, DCTH emphasized the receipt of approval from the US Food and Drug Administration (FDA) for the HEPZATO KIT (melphalan)/Hepatic Delivery System.

    This recognition positions the kit as an endorsed liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) featuring unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease.

    Furthermore, Delcath successfully raised approximately $35 million by exercising all Tranche A warrants issued as part of the previously announced March 29, 2023, financing. An additional $25 million is available upon reaching $10 million in quarterly revenue.

    DCTH also highlighted an independent investigative publication, presenting a retrospective comparative study of the CHEMOSAT Hepatic Delivery System. The study, focusing on Melphalan percutaneous hepatic perfusion (PHP) and Selective Internal Radiation Therapy (SIRT), revealed a statistically significant difference in median overall survival—301 days for SIRT and 516 days for PHP.

    Additionally, Delcath shared that independent investigators at Leiden University have recruited 55 out of the planned 76 patients in the CHOPIN trial. This trial assesses the impact of combining CHEMOSAT and immune checkpoint inhibitors in treating metastatic uveal melanoma, with full enrollment expected by mid-2024.

    Anticipating a January launch of the HEPZATO KIT, Delcath has been diligently building its commercial team and collaborating with potential treatment centers. The company received positive feedback from the medical oncologist community and is confident that, by the end of 2024, at least 15 centers will actively treat metastatic uveal melanoma patients with the HEPZATO KIT.

  • Is There Anything Driving Delcath Systems (DCTH) Stock Up 73% Today?

    Delcath Systems Inc. (NASDAQ: DCTH) has manifested a notable ascent on the trading landscape today, displaying a remarkable surge of 76.32% and attaining a trading price of $5.50 as per the most recent observation.

    This surge in valuation follows a previous closing price of $3.12 for Delcath stock during the preceding trading session. The upward trajectory of DCTH shares is intrinsically linked to a recent regulatory milestone.

    Delcath Systems (DCTH) has announced that it has garnered the approval of the United States Food and Drug Administration (FDA) for the HEPZATO KIT, a therapeutic intervention encompassing melphalan and a Hepatic Delivery System.

    This therapeutic configuration has received FDA endorsement for its application as a targeted remedy for adult patients grappling with the complex medical scenario of metastatic uveal melanoma (mUM), specifically those cases wherein hepatic metastases occupy an area of the liver accounting for less than 50% of its total mass.

    This approval extends to instances where the spread of the disease is confined to extraneous regions like the bone, lymph nodes, subcutaneous tissues, or lung, amenable to surgical resection or radiation.

    Metastatic uveal melanoma (mUM) represents a rare and formidable manifestation of cancer, with an annual incidence within the United States approximated at 1,000 cases. The liver is implicated in 90% of these cases, often leading to life-threatening liver failure.

    Notably, the National Comprehensive Cancer Network (NCCN) guidelines stipulate liver-directed therapeutic modalities for mUM patients harboring liver-based metastatic lesions. The HEPZATO KIT has gained singular distinction as the solitary liver-focused therapy to garner FDA sanction for addressing mUM.

    Moreover, the procedural technique of percutaneous hepatic perfusion (PHP), facilitated by the HEPZATO KIT, is already endorsed within the purview of NCCN guidelines.

    With the anticipation of commercial availability slated for the fourth quarter, the company is poised to make its therapeutic offering accessible to the medical community. Patients will continue to be included in treatment through the medium of the Expanded Access Program (EAP) sites.

    Additionally, the augmentation of Delcath’s human capital is underscored by the recent appointments of Vojislav Vukovic, MD, Ph.D., as Chief Medical Officer, Sandra Pennell as Senior Vice President of Finance, and Zac MacLean as Director of Sales and Strategy. Simultaneously, the company continues its dedicated efforts in patient care across its 3 Expanded Access Program sites.

  • Why Delcath Systems, Inc. (DCTH) stock is falling today?

    Why Delcath Systems, Inc. (DCTH) stock is falling today?

    Delcath Systems, Inc. (DCTH) announced its fourth-quarter 2020 results after which the DCTH stock price happened to be down by 24.54% to drop at $12.28 a share as of this writing. At the previous trading session, DCTH stock was performing well and gained 1.37% at closing. Let’s understand more about the current scenarios.

    Fourth Quarter 2020 Results:

    • DCTH stock product revenue reduced to $379 thousand in the fourth quarter of 2020 as compared to $398 thousand in the same quarter of the previous year.
    • Selling, general and administrative expenses increased by $2.4 million to reach $4.5 million in the last three months of 2020 as compared to $2.1 in the same period of 2019.R&D expenses showed no change and were totaled $2.7 million.
    • Operating expenses surged to $7.3 million while these were $4.8 million in the same period of 2019.
    • DCTH suffered a net loss of $7.0 million in the fourth quarter of 2020 while it recorded a net income of $12.5 million in the same period of 2019.
    • DCTH stock had cash, cash equivalents, and restricted cash of $28.8 million as of 31 December 2020 and it used  $4.6 million cash in its operating activities during the last three months of 2020 while this cash was recorded as $5.4 million for operational activities of 2019.

    Business Highlights in last three months:

    • Delcath Systems was performing phase three FOCUS Clinical Trial of HEPZATO in patients suffering from Metastatic Ocular The results were positive and above expectations. This preliminary analysis includes 87% of patients and final results are expected to come soon in the future.
    • DCTH started consulting engagement for the selection of a portfolio of follow-on-indications in order to increase HEPZATO Kit and CHEMOSAT platform value.
    • DCTH stock completed a public offering of shares of its common stock which resulted in gross proceeds of $22.2 million.
    • Gerard Michel was appointed as the Chief Executive officer by the Delcath stock while Kevin Muir was assigned the role of Vice President for commercial

    Conclusion

    Things are going against the DCTH stock after the earnings release by Delcath Systems. Product revenue was reduced in 2020 while expenses were increased over the year. It would be interesting to see how new management would drive Delcath in the future.