WASHINGTON (AP) -- Shares of Delcath Systems Inc. jumped in afterhours trading Tuesday after the medical device and drugmaker said it received preferential regulatory status for its experimental treatment for liver cancer.
THE SPARK: The company said after market's close that the Food and Drug Administration granted "orphan drug" status to its melphalan chemotherapy for primary liver cancer. Drugs granted the designation, which is reserved for rare diseases and conditions, are entitled to seven years of competition-free marketing, as well as tax credits for research and development costs. The designation typically makes it easier for companies to recoup investments on drugs for small patient populations.
THE BIG PICTURE: Delcath is a specialty-drug and medical-device company focused on cancer treatments. It makes a catheter system that treats cancer by delivering high doses of chemotherapy drugs directly to the liver while controlling exposure to the rest of the body.
The FDA is reviewing several uses of the technology, including treatment of inoperable ocular melanoma, a cancer of the eye that can spread to the liver. The system is available in Europe for that use under the name Chemosat.
SHARE ACTION: Delcath Systems Inc. shares rose 9 cents, or 30 percent, to 40 cents in afterhours trading Tuesday.
Aber die Bude existiert noch. Heute Präsentation bei der Needham Healthcare Conference und ein 8-K Filing am 14.04.15. Die Konferenz scheint akzeptabel zu laufen, die Aktie von 1,01 auf 1,09. Das ist auch mein Kaufkurs heute an der Nasdaq.
Delcath ist schon ein echt übler Underperformer, abgestürzt von 250 Dollar im High 2010 auf 0,92 Dollar dieses Jahr, der Ruin jedes Depots wer da nicht irgendwann die Reissleine zog. Warum der Neueinstieg? Das Volumen hat mich angesprochen, plötzlich wurden gestern statt der üblichen 60000 Shares plötzlich 300000 Shares gehandelt. Ausserdem lebt die Firma tatsächlich noch und ist ein gefundenes Fressen für Kursmanipulationen bei einer Marktkapitalisierung von nur 13 Millionen Dollar.
Viel wird bei uns in Deutschland geforscht, 20% Tagesplus.
Delcath's European Key Opinion Leader Forum On CHEMOSAT Therapy Affirms Benefits To Liver Cancer Patients PR Newswire Delcath Systems, Inc. 2 hours ago
NEW YORK, May 27, 2015 /PRNewswire/ -- Delcath Systems, Inc. (DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces findings from its recent three-day Key Opinion Leader Forum that focused on CHEMOSAT®, the Company's percutaneous hepatic perfusion (PHP) therapy for the treatment of liver cancers. The Forum took place near Paris and included more than 20 medical specialists in oncology, surgical oncology, anesthesiology and interventional radiology from across Europe where CHEMOSAT is commercially available. CHEMOSAT is not commercially available in the US.
The Forum featured a discussion of hands-on commercial experiences with CHEMOSAT. Key findings from the Forum were:
Clinicians continue to produce positive, life-extending results treating liver cancer patients with CHEMOSAT in multiple tumor types CHEMOSAT is well tolerated and is an easy-to-learn procedure for an experienced treatment team Multiple treatment courses of at least four procedures have been shown to be safe and well tolerated while continuing to provide clinical benefit and good quality of life Reimbursement continues to be covered through individual funding requests Clinicians are encouraged by the potential for CHEMOSAT to treat many tumor types and support the generation of additional data in these potential indications
"This 3-day forum on CHEMOSAT provided a unique opportunity for us to share our patient experiences from multiple treatment centers in Europe using CHEMOSAT to treat liver cancer patients. The exchange of ideas and practices among a diverse field of leading clinicians in the various medical specialties that implement CHEMOSAT therapy was illuminating and compelling, especially given the meaningful clinical benefits it brings to patients. The discussions were very valuable and have given me new perspectives on the implementation of CHEMOSAT for my liver cancer patients," noted Prof. Arndt Vogel, M.D., Clinic of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
Alex Vahrmeijer, M.D., Ph.D., a surgical oncologist at Leiden University Medical Centre, the Netherlands, commented, "Delcath's CHEMOSAT is an effective new therapy for metastases confined to the liver for patients with very limited treatment options. We have demonstrated the ability to perform repeat PHP procedures with CHEMOSAT that showed continued tolerability and significant clinical benefit for patients in this life-limiting cancer indication. We believe this procedure has strong potential to treat a number of other tumor types and is worthy of further clinical investigation in those indications."
"We were delighted to convene this Forum as it brought together clinicians from across Europe who are commercially using CHEMOSAT to share their treatment center's patient experiences and to exchange ideas on optimizing the procedure and expanding the clinical benefits of CHEMOSAT in other tumor types," stated Jennifer Simpson, Ph.D., President and Chief Executive Officer of Delcath. "This Forum produced valuable data both for the commercialization of CHEMOSAT and for its expanded clinical development. European clinicians who participated in the Forum are in the process of developing a white paper on their findings and recommendations. We look forward to the publication of their report and expect it will further the awareness and understanding of the benefits of CHEMOSAT to treat liver cancers, while supporting continued adoption in key European markets."