Delcath Systems, Inc. DCTH
Delcath Systems, Inc. (Nasdaq: DCTH) is an oncology drug developer. Its lead program, HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), is in Phase 2 for Liver-directed treatment of uveal melanoma with unresectable hepatic metastases. Its next catalyst on record is HEPZATO KIT mCRC Phase 2: Primary endpoint (hPFS) read-out (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: HEPZATO KIT mCRC Phase 2 — Primary endpoint (hPFS) read-out (2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| HEPZATO KIT | Metastatic uveal melanoma (FDA approved 2023-08-14) | device-combination | Approved |
| HEPZATO KIT + trifluridine-tipiracil/bevacizumab | Liver-dominant metastatic colorectal cancer (3rd line) | device-combination | Phase 2 |
| HEPZATO KIT + SOC | Liver-dominant HER2-negative metastatic breast cancer | device-combination | Phase 2 |
Recent results and decisions
- Nov 4, 2025started First patient dosed in August 2025 at City of Hope in the global Phase 2 trial of HEPZATO plus standard of care in liver-dominant mCRC (about 90 patients, 20+ sites).
In August, the first patient was dosed at City of Hope National Medical Center in the global Phase 2 trial of HEPZATO in combination with trifluridine-tipiracil and bevacizumab for liver-dominant metastatic colorectal cancer.
Filing - Nov 4, 2025positive Investigator-initiated Phase 2 CHOPIN trial (presented at ESMO, October 2025) showed a significant improvement in one-year progression-free survival versus CHEMOSAT alone; no figures given.
showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
- Tango Therapeutics, Inc. TNGX
- Tyra Biosciences, Inc. TYRA
- Verastem, Inc. VSTM
- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Unknown Unknown
- Faeth Therapeutics, Inc. FTH
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.