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Category: Insider Information

Ad hoc: Epigenomics raises USD 5.3 million from its strategic commercialization partner BioChain

Berlin (Germany) and Germantown (USA), October 16, 2014 – Epigenomics AG (ISIN: DE000A11QW50, OTCQX: EPGNY) announces today that the Company is raising USD 5.3 million (EUR 4.2 million) in a share capital increase. BioChain Institute, Inc. will subscribe a total of 1,351,089 Epigenomics shares which will be issued under exclusion of the statutory subscription right […]

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FDA Issues Response Letter for Epigenomics’ Colorectal Cancer Screening Blood Test Epi proColon® Requesting Further Data Pre-Approval

PDF 273 KB   Berlin (Germany) and Germantown, MD (U.S.A.) – Epigenomics AG (ISIN: DE000A1K0516, OTCQX: EPGNY) today announced that it has received a response letter from the U.S. Food and Drug Administration (FDA) in relation to its premarket approval (PMA) application for the Company’s blood-based colorectal cancer (CRC) screening test Epi proColon®. In its […]

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Epigenomics’ Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon® in China

Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), and BioChain Institute Inc. (BioChain), today announced that BioChain has completed its major clinical validation study to validate Epigenomics’ blood-based Septin9 screening assay Epi proColon® for the early detection of colorectal cancer (CRC) with the goal […]

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Epigenomics AG: FDA Advisory Committee Provides Recommendations for Epigenomics’ Colorectal Cancer Screening Blood Test

PDF 45 KB   FDA Advisory Committee votes favorably that the benefits of Epi proColon® outweigh the risks Berlin (Germany) and Germantown, MD (U.S.A.), March 27, 2014 – Epigenomics AG (ISIN: DE000A1K0516, OTCQX: EPGNY) today announced the outcome of a meeting of the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee held […]

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Ad hoc: Epigenomics AG Announces FDA Advisory Committee Meeting to Review Epi proColon®

Berlin, Germany – Epigenomics AG (ISIN: DE000A1K0516) announces that the Company was informed by the U.S. Food and Drug Administration (FDA) via the premarket approval (PMA) review process for Epi proColon® that the Meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has been tentatively scheduled for Tuesday, March 25th, […]

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Ad hoc: Epigenomics AG issues EUR 500,000 in convertible bonds to Yorkville

Berlin, Germany – Epigenomics AG (ISIN: DE000A1K0516, OTC: EPGNY) announces today that the Company successfully issued convertible bonds with a nominal amount of EUR 500,000 to YA Global Master SVP Ltd. (“Yorkville”) excluding pre-emptive rights to existing shareholders. The bonds were issued at 95% of their nominal amount, carry no interest, have a term until […]

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