Merrimack Biotech/ Bauchspeicheldrüse
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Merrimack Pharmaceuticals - ist ein relativ kleines Biotechunternehmen aus den USA mit einer guten Forschungspipeline und einem zuglassenen Produkt (nur US) -Onivyde- gegen Bauchspeicheldrüsenkrebs. Die Chance auf eine Zulassung in Europa stehen gut Onivyde also just got the "thumbs up" from The European Medicines Agency's Committee for Medicinal Products for Human Use.
Der Vermarktungspartner außerhalb der USA ist Shire.
Weitere Infos zu Merrimack findet ihr auf der HP des Unternehmens:
http://www.merrimack.com/
Weitere Infos werde ich kurzfristig einstellen.
narbonne
Der (zufällige) 4-Monats-News-Rythmus ist aber leider vorbei..
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Diese P2/3 müsste irgendwann wieder News bringen. Ob/Wann mit Meilenstein weiß ich nicht.
Studienende aber erst Ende 2022. Kann natürlich zwischendurch auch wieder Daten bringen
https://clinicaltrials.gov/ct2/show/...ent+sclc&draw=2&rank=1
“Both Ipsen Pharmaceuticals and Elevation Oncology publicly announced updates during the last three months that indicate that the clinical programs that may result in milestone payments to Merrimack continue to move forward,...”
Zahlen für Q3/21
- Verlust 0,5 Mio. $
- Cash 14,6 Mio. $
- Aktien 13,4 Mio. Stück
“Both Ipsen Pharmaceuticals and Elevation Oncology publicly announced updates during the last three months that indicate that the clinical programs that may result in milestone payments to Merrimack continue to move forward,” said Gary Crocker, CEO and Chairman of Merrimack’s Board of Directors"
https://investors.merrimack.com/news-releases/...21-financial-results
Ipsen´s Phase3 Onivyde Studie (2L SCLC) verfehlt den primären Endpunkt (OS)
https://www.rttnews.com/3301927/...ails-to-meet-primary-endpoint.aspx
https://seekingalpha.com/article/..._alpha&utm_term=28659707.1519
https://seekingalpha.com/article/...g_alpha&utm_term=29543670.845
"MACK has a $225m milestone if its drug Onivyde works in first-line pancreatic cancer (already approved in second-line)..."
https://www.nasdaq.com/market-activity/stocks/mack/real-time
November 3, 2022
https://investors.merrimack.com/news-releases/...22-financial-results
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 3, 2022-- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] today announced its third quarter 2022 financial results for the period ended September 30, 2022.
“During the third quarter we continued to see the benefits of reduced operating expenses,” said Gary Crocker, Chairman of Merrimack's Board of Directors. “We will continue to monitor developments in Ipsen’s Onivyde® (irinotecan liposomal injection) program and Elevation’s seribantumab program.”
Third Quarter 2022 Financial Results
Merrimack reported a net loss of $442 thousand for the third quarter ended September 30, 2022, or $0.03 per basic and diluted share on a fully diluted basis, compared to a net loss of $525 thousand, or $0.04 per basic and diluted share on a fully diluted basis, for the same period in 2021.
General and administrative expenses for the third quarter ended September 30, 2022, were $504 thousand, compared to $619 thousand for the same period in 2021.
As of September 30, 2022, Merrimack had cash and cash equivalents of $13.1 million, compared to $14.6 million as of September 30, 2021.
As of September 30, 2022, Merrimack had 13.4 million shares of common stock outstanding.
Updates on Programs Underlying Potential Milestone Payments
Ipsen
- On August 3, 2022, Ipsen announced results from its Phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer. The announcement indicated that “the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency.” Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.
- On October 27, 2022, Ipsen provided a public update on its sales performance for the first 3 quarters of 2022 and indicated that top line data from its continuing Phase 3 study of ONIVYDE® in first line pancreatic ductal adenocarcinoma were anticipated to be available during the second half of 2022.
Elevation Oncology
- On November 3, 2022 Elevation provided their third quarter investor update and indicated that top line data from its phase 2 CRESTONE Study evaluating the HER3 monoclonal antibody seribantumab in patients with tumors harboring NRG1 fusions are expected in 2024.
About Merrimack
Merrimack Pharmaceuticals, Inc. is a biopharmaceutical company based in Cambridge, Massachusetts that is entitled to receive up to $450.0 million in contingent milestone payments related to its sale of ONIVYDE® to Ipsen S.A. in April 2017. These milestone payments would be payable by Ipsen upon approval by the U.S. Food and Drug Administration (“FDA”) of ONIVYDE for certain additional clinical indications. ONIVYDE® is already approved by the FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. This existing approval is unrelated to any future potential milestone payments. Merrimack’s agreement with Ipsen does not require Ipsen to provide Merrimack with any information on the progress of ONIVYDE clinical trials that is not publicly available. Merrimack is also entitled to receive up to $54.5 million in contingent milestone payments related to its sale of anti-HER3 programs to Elevation Oncology (formerly 14ner Oncology, Inc.) in July 2019.
"Ipsen gibt bekannt, dass die Phase-3-Studie NAPOLI 3 zum Onivyde-Regime eine statistisch signifikante Verbesserung des Gesamtüberlebens bei zuvor unbehandeltem metastasiertem duktalem Adenokarzinom des Pankreas zeigte."
https://www.ipsen.com/press-releases/...reatic-ductal-adenocarcinoma/
Dann sage ich auch hier leise Servus
https://www.businesswire.com/news/home/...Ductal-Adenocarcinoma-mPDAC
"Merrimack Reports Ipsen Announcement of Approval By The US FDA of Onivyde® (Irinotecan Liposome Injection) Plus 5 Fluorouracil/Leucovorin and Oxaliplatin (NALIRIFOX) as a First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
FDA Approval Triggers $225 Million Milestone Payment from Ipsen to Merrimack
Merrimack Expects to Hold Special Meeting of Stockholders to Approve Plan of Dissolution in May 2024
Following Approval of Plan of Dissolution, Merrimack Expects to Issue a Liquidating Dividend Currently Estimated to be Between $14.65 and $15.35 per Share in the Late Spring or Early Summer..."