PHARMA MAR (PHM.MC) -- ehemals Zeltia (Seite 51)
eröffnet am 07.11.04 11:23:23 von
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ISIN: ES0169501022 · WKN: A2P9YT · Symbol: PMRA
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| 17,440 | +44,61 | |
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FeedbackATLANTIS study has reached the goal of patient recruitment
ATLANTIS study, in small-cell lung cancer with lurbinectedin,recruited 600 patients in a total of 160 hospital centers in 20 countries
Top line data is expected to readout around the end of 2019
The primary endpoint is overall survival
https://www.cnmv.es/Portal/HR/verDoc.axd?t={a6215d32-273c-46…
PharmaMar announced today the signing of an agreement with Impilo Pharma
PHM has announced today the signing of an agreement with Impilo Pharma,a part of Immedica Group, for the exclusive promotion and distribution
of its antitumour compound, Yondelis, throughout the Nordic countries and Eastern Europe.
This agreement will come into effect in six months.
According to the terms of the agreement, PharmaMar will receive an up-front payment of 2 million euros.
Impilo Pharma will be responsible for the promotion and the distribution of Yondelis throughout the
above mentioned territories, and PharmaMar will be the manufacturer of the product.
https://www.finanznachrichten.de/nachrichten-2018-07/4439235…
Geschäftszahlen 1. Halbjahr 2018
PharmaMar hat heute die Halbjahresgeschäftszahlen 1H/18 veröffentlicht:https://www.pharmamar.com/wp-content/uploads/2018/07/PR_Resu…
Auf erste Sicht hören sich die Zahlen gut an. Bei genauerer Analyse sieht man aber, dass es auf der Einnahmenseite einige Einmaleffekte gegeben hat und - neben Yondelis - dringend ein weiteres markteingeführtes Medikament benötigt wird. Außerdem fallen weiterhin hohe Kosten für Forschung und Entwicklung an (das ist auch gut so und PHM kann diese Kosten auch stemmen).
Unabhängig davon habe ich weiterhin eine positive Sicht auf das Unternehmen. Frühere hohe Aktienkurse werden wir aber vorerst kaum zu sehen bekommen. Gefragt ist Geduld.
Kurssprung?
Hat irgend jemand im Forum eine Info, warum der Kurs heute so anspringt? Bei mir wird auf verschiedenen Portalen unterschiedlich ein aktuelles Kursplus von ca. 9 - max. 17 % angezeigt, bei der Börse Madrid gerade rd. 13 %.Hat PHM evtl. einen neuen Partnervertrag abgeschlossen? Eine PM o.Ä. finde ich nicht, vermute aber, einige Insider könnten mal wieder mehr wissen und kaufen...
SCLC
Expert Provides Insight on Shifting SCLC Treatment Landscapehttps://www.targetedonc.com/news/expert-provides-insight-on-…
Lurbinectedin is another agent that has a number of different mechanisms,
including DNA double-strand breaks, which effects the tumor microenvironment.
That in combination with doxorubicin had a very nice response rate in the second-line setting.
The single-agent trial is ongoing. That is something to look out for.
Trading Spotlight
€3,000,000 from Chugai
PharmaMar regains all its rights for Zepsyre® in Japan with immediate effect and receives a payment of €3,000,000 from Chugai
PharmaMar progresses in the clinical development of Zepsyre® in Japan
while its ATLANTIS global registration trial in small-cell lung cancer continues
ATLANTIS trial has successfully passed two safety analyses by the IDMC
after inclusion of 150 and 500 patients, respectively
PharmaMar continues with the clinical development of Zepsyre® in Japan,
while its global registration trial in small-cell lung cancer (ATLANTIS; n=600)
is about to finalize recruitment in July 2018.
PharmaMar has begun discussions with new potential licensees for Japan
during the recent annual meeting of ASCO (American Society of Clinical Oncology) in June,
where the company has presented encouraging clinical data on the use of Zepsyre®
in small- cell lung cancer as a single agent, including an overall survival benefit of 11.8 months.
https://www.prnewswire.com/news-releases/pharmamar-and-chuga…
Antwort auf Beitrag Nr.: 57.908.001 von bonDiacomova am 05.06.18 06:41:12PharmaMar requests the modification from primary endpoint to OS for the ATLANTIS trial
Madrid, 12th of June 2018.- PharmaMar (MSE:PHM) announced today that based on recent receipt of OS (overall survival) data from lurbinectedin Phase II small-cell lung cancer studies, including the monotherapy trial presented at ASCO on June 3rd that saw an OS of 11.8 months, a protocol amendment was submitted to FDA and other competent authorities to change the primary endpoint of the ATLANTIS Phase III trial from PFS (progression free survival) to OS. The changes will begin when the competent authorities with responsibility for review and approval of the study approve of the changes, which in the US we expect to happen in the next few weeks. The safety of the patients and the integrity of this study are not compromised by these changes. PharmaMar remains blinded to the data, and continues to expect completion of recruitment in the third quarter of 2018. This means PharmaMar expects the top line data, which is event driven, to readout in the second half of 2019.
According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we feel that this change in endpoint to OS given what we have seen in the recent data, including those presented at ASCO, offers us a better chance for success, especially as we know regulators prefer OS data over a surrogate endpoint subject to interpretation in this type of disease setting."
https://www.pharmamar.com/wp-content/uploads/2018/06/PR_ATLA…
Madrid, 12th of June 2018.- PharmaMar (MSE:PHM) announced today that based on recent receipt of OS (overall survival) data from lurbinectedin Phase II small-cell lung cancer studies, including the monotherapy trial presented at ASCO on June 3rd that saw an OS of 11.8 months, a protocol amendment was submitted to FDA and other competent authorities to change the primary endpoint of the ATLANTIS Phase III trial from PFS (progression free survival) to OS. The changes will begin when the competent authorities with responsibility for review and approval of the study approve of the changes, which in the US we expect to happen in the next few weeks. The safety of the patients and the integrity of this study are not compromised by these changes. PharmaMar remains blinded to the data, and continues to expect completion of recruitment in the third quarter of 2018. This means PharmaMar expects the top line data, which is event driven, to readout in the second half of 2019.
According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we feel that this change in endpoint to OS given what we have seen in the recent data, including those presented at ASCO, offers us a better chance for success, especially as we know regulators prefer OS data over a surrogate endpoint subject to interpretation in this type of disease setting."
https://www.pharmamar.com/wp-content/uploads/2018/06/PR_ATLA…
Antwort auf Beitrag Nr.: 57.958.650 von ODI01 am 11.06.18 15:59:41Endlich mal wieder gute Nachrichten, auf die dann heute auch der Kurs richtig angesprungen ist.
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