Wednesday, November 16, 2016 2:56:52 PM
a $4m Cap Co. among Johnson & Johnson ( $JNJ), Merck & Co., Inc ( $MRK), Pfizer Inc. ( $PFE), Novartis AG ( $AGS)
FDA approval +CE Mark too."The FDA has granted us six orphan drug designations, including three orphan designations for the use of the drug melphalan for the treatment of patients with mOM, HCC and ICC. Melphalan/HDS has not been approved for sale in the United States".
http://finance.yahoo.com/news/world-bile-duct-cancer-cholangiocarcinoma-150500717.html
Folks are usually focusing U.S. market only but DCTH is a major P2/P3 World player for Duct Cancer and deep in EU market:
CHEMOSAT Available At Major Cancer Centers Throughout European Region:
1. CE Marked as Class IIb Medical Device with broad indication
2. >300 commercial procedures performed
3. Broad range of tumor types treated
4. Expansion into Turkey March 2016
5. National reimbursement established in Germany for 2016 after <3 years of commercial activity
2H2016:
• German ZE Reimbursement Level Defined
• P2 ICC Cohort Enrollment Completed
• EU Registry Data Readout #2
$32.2 million aggregate proceeds to fund clinical development programs, commercial activities & ongoing operations.
My posts are my opinion and should not be used as investment advice. Make your own decisions in your stock trades.
Recent DCTH News
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/18/2024 09:10:58 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/18/2024 09:07:27 PM
- Delcath Systems Announces New Data Presented at ESMO 2024 Demonstrating Efficacy of HEPZATO KIT™ in Metastatic Uveal Melanoma Subgroups • Business Wire • 09/16/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/29/2024 12:00:53 PM
- Delcath Systems, Inc. Announces Positive Results from Independent Study on Liver-Directed Therapy for Uveal Melanoma Patients • Business Wire • 08/28/2024 08:01:00 PM
- Delcath Systems to Participate at the H.C. Wainwright 26th Annual Global Investment Conference • Business Wire • 08/28/2024 08:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/28/2024 12:33:53 PM
- Delcath Systems, Inc. Announces Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients • Business Wire • 08/27/2024 12:30:00 PM
- Delcath Systems, Inc. Announces Promising Results from Independent Study on Repeated Hepatic Chemosaturation for Liver Tumors • Business Wire • 08/26/2024 08:01:00 PM
- Delcath Systems Announces Poster Presentation at the 2024 ESMO Congress • Business Wire • 08/20/2024 12:30:00 PM
- Delcath Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 08/12/2024 08:01:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/06/2024 04:15:07 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/05/2024 08:36:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/05/2024 08:12:28 PM
- Delcath Systems Reports Second Quarter 2024 Results and Business Highlights • Business Wire • 08/05/2024 08:01:00 PM
- Delcath Systems Announces CMS Approval for NTAP for HEPZATO KIT™ • Business Wire • 08/05/2024 12:30:00 PM
- Delcath Systems to Participate in Upcoming Investor Conferences • Business Wire • 07/30/2024 08:01:00 PM
- Delcath Systems to Host Second Quarter 2024 Earnings Call • Business Wire • 07/22/2024 08:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/19/2024 08:06:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/09/2024 03:13:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 01:01:01 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/29/2024 08:06:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:32:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:31:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:30:44 PM
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