Report

Flash note: FDA approves Yondelis in soft tissue sarcoma

The US FDA has approved Zeltia’s Yondelis (trabectedin) for the treatment of soft tissue sarcomas (STS) liposarcoma and leiomyosarcoma. This is positive news for Zeltia and closely follows the approval of Yondelis in all types of STS in Japan late last month. Yondelis will be marketed in the US by Janssen (J&J) and in Japan by Taiho, and the approvals will trigger approx. $20m in milestone payments. The approvals are in line with our expectations and justify the recent strong share price, which is likely to continue to be buoyed by this positive news.
Underlying
Pharma Mar SA

Pharma Mar SA is a Spain-based company engaged in the bio therapeutic drugs manufacture. The Company focuses on research, development and marketing of bio-active principles, primarily from marine origin, for application in human diseases treatment, including antitumour, antiviral and immunomodulation, as well as tropical diseases areas. It manufactures and sells Yondelis, a synthetically modified antitumor agent, which is derived from sea squirts and is implemented in the treatment of soft tissue sarcomas and relapsed ovarian cancer. Furthermore, the Company's products pipeline comprises drug candidates and agents for cancer treatment, such as Aplidin, PM01183 and PM060184. The Company operates through subsidiaries in Italy, Germany, France, and the United States, among others.

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Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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