Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer [Yahoo! Finance]
Delcath Systems, Inc. (DCTH)
US:NASDAQ Investor Relations:
delcath.com/investors
Company Research
Source: Yahoo! Finance
of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic colorectal cancer (mCRC). With the FDA's review complete, Delcath is now authorized to initiate patient enrollment. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the second half of 2025. The trial's primary endpoint, hepatic progression-free survival (hPFS), i
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News
- Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal CancerBusiness Wire
- Delcath Systems Stock (NASDAQ:DCTH) Among the Best Multibagger Stock to Buy Heading into 2025 [Yahoo! Finance]Yahoo! Finance
- Delcath Systems, Inc. (NASDAQ: DCTH) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $22.00 price target on the stock.MarketBeat
- Delcath Systems Inc (DCTH) Q3 2024 Earnings Call Highlights: Strong Revenue Growth and ... [Yahoo! Finance]Yahoo! Finance
- Delcath Systems Reports Third Quarter 2024 Results and Business HighlightsBusiness Wire
DCTH
Earnings
- 11/8/24 - Beat
DCTH
Sec Filings
- 11/15/24 - Form SC
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- DCTH's page on the SEC website