Delcath (NSDQ:DCTH) said today it inked a securities purchase agreement with an investor for $35 million in senior convertible notes and stock purchase warrants, expecting to bring in $32.2 million to support operations and ongoing clinical trials. Of the $32.2 million in proceeds, Delcath said $3 million will be immediately available, with the remaining $29.2 million […]
Delcath Systems Inc.
Delcath launches Phase III trial for ocular melanoma treatment
Delcath (NSDQ:DCTH) said today it launched a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride designed for the treatment of hepatic dominant ocular melanoma. The newly initiated Focus trial will examine the safety, efficacy and pharmocokinetic profile of its Melphalan and HDS system when compared with the standard of care, the New […]
Delcath inks FDA deal for design of Phase III trial
Delcath (NSDQ:DCTH) said yesterday the company reached a special protocol assessment agreement with the FDA for the design of a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride. The system is designed to treat patients with hepatic dominant ocular melanoma, the New York City-based company said. The company said the agreement acted as a […]
Delcath to settle shareholder suits for $8.5m
Delcath (NSDQ:DCTH) said yesterday that it agreed to pay $8.5 million to settle a clutch of lawsuits filed by shareholders over losses related to its development of the drug-device combination Melblez kit. The lawsuits, filed by shareholders in 2013, sought compensation for losses between April 21, 2010, and May 2, 2013, stemming from 3 separate incidents the plaintiffs claim caused […]
Delcath Systems tanks following reverse stock split
Delcath's cancer-treating system lands U.S., Australian regulatory wins
Medical device company Delcath Systems (NSDQ:DCTH) is on a roll, notching a couple new regulatory milestones this month for its organ-isolating ChemoSat chemotherapy treatment systems.
Cancer: Delcath lands expanded CE Mark for organ-isolating chemo treatment
Delcath Systems (NSDQ:DCTH) won expanded CE Mark approval in the European Union for its ChemoSat organ-isolating cancer treatment system, landing indication for a new drug used to target liver tumors.
FDA accepts Delcath's application for drug-device chemotherapy combo
The FDA agreed to review Delcath Systems’ (NSDQ:DCTH) new drug application, bringing the device maker 1 step closer to launching its organ-isolating chemotherapy system on the U.S. market.
Delcath files new FDA application for chemo drug-device combination
Delcath Systems (NSDQ:DCTH) filed a new FDA application for the latest iteration of its ChemoSat drug-device combination, the Generation 2 device, in treatment of patients with non-operable liver cancer.
Delcath jumps 12% on Euro sales news
Delcath Systems (NSDQ:DCTH) won a lot of Wall Street love today on news that it landed the 1st commercial order for its organ-targeting chemotherapy system, the ChemoSat device.
