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Epigenomics

Termination of coverage

Update | Pharmaceutical & healthcare | 13 Apr 2017

Edison Investment Research is terminating coverage on Epigenomics (ECX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

Epigenomics

Q316 results and business update

QuickView | Pharmaceutical & healthcare | 11 Nov 2016

Epigenomics continues to execute on the commercial front. The US is now the main market for Epi proColon, the only FDA-approved, blood-based colorectal cancer screening test. Epi proColon US sales account for c 60% of total 9M16 revenues of €0.9m, 83% up y-o-y. The remainder come from Europe and other countries. Epigenomics recently raised c €5m in a private placement. It has five convertible notes, which mature by year-end 2016 and could raise an additional €2.6m, providing funding into 2017.

Epigenomics

Half-year results published

QuickView | Pharmaceutical & healthcare | 09 Nov 2016

Epigenomics has announced H116 results, which highlight the launch ofEpi proColon in the US jointly with Polymedco, the largest distributor ofcolorectal cancer (CRC) screening tests. Epi proColon has been includedin the guidelines of the US Preventive Services Task Force (USPSTF),which underscores the potential of the test as a valid screening method forCRC and recognises the need for additional screening options. The test isalso now commercially available through LabCorp's website. The companyexpects available cash to last into 2017.

Epigenomics

Half year results published

QuickView | Pharmaceutical & healthcare | 11 Aug 2016

Epigenomics has announced H116 results, which highlight the launch of Epi proColon in the US jointly with Polymedco, the largest distributor of colorectal cancer (CRC) screening tests. Epi proColon has been included in the guidelines of the US Preventive Services Task Force (USPSTF), which underscores the potential of the test as a valid screening method for CRC and recognises the need for additional screening options. The test is also now commercially available through LabCorp's website. The company expects available cash to last into 2017.

Epigenomics

Epi proColon gets the FDA's nod

QuickView | Pharmaceutical & healthcare | 15 Apr 2016

Epigenomics has announced that the US FDA has approved Epi proColon, the company's blood-based colorectal cancer (CRC) test. The product, which has become the first FDA-approved test of its kind, will be marketed in the US in co-operation with Polymedco, the largest distributor of CRC screening tests. With launch expected imminently, the US approval opens up a potential commercial opportunity of $2bn. However, we expect that additional investment in commercialisation activities will be needed.

Epigenomics

Epi proColon gets FDA fillip

QuickView | Pharmaceutical & healthcare | 13 Jan 2016

In a surprise move, the FDA has reversed its request for a new behavioural study of Epigenomics' blood-based colorectal cancer (CRC) diagnostic test, Epi proColon. US marketing clearance and launch now look likely over the coming few months. With a current cash reach to H216, a cash call may now be deferred until after a possible US approval, and the consequent increased certainty may prove beneficial to current shareholders.

Epigenomics

New FDA demands delay US launch further

QuickView | Pharmaceutical & healthcare | 10 Nov 2015

Epigenomics announced another delay to the US launch of its blood-based CRC diagnostic test Epi proColon and a moderate downgrade to its FY15 guidance. The FDA demands more evidence of increased compliance in CRC screening using Epi proColon, which is likely to necessitate a further study. With a current cash reach to H216, a cash call is likely before a possible US approval.

Epigenomics

Epi proColon o impending FDA decision

QuickView | Pharmaceutical & healthcare | 09 Nov 2015

The conclusion of the behavioural study (ADMIT) may pave the way for US regulatory approval and launch of Epigenomics' novel Epi proColon bloodbased colorectal cancer (CRC) test in Q415. While ADMIT proved superior compliance using Epi proColon, the abnormally high compliance rate inthe control group may prolong the approval process. Eventual progress towards US approval may however, support a share price recovery.

Epigenomics

ADMIT trial shows exceptional compliance

QuickView | Pharmaceutical & healthcare | 18 May 2015

Epigenomics reported 99.5% compliance of its Epi proColon CRC test in the ADMIT study. Epigenomics believes these data support its FDA application and could lead to US approval in Q315. The exceptional compliance rates in the trial may prolong the approval process, in our view. To cover its funding needs into 2016, it plans to raise up to a further €5m via a rights issue.

Epigenomics

ADMIT trial readout likely in May

QuickView | Pharmaceutical & healthcare | 27 Mar 2015

Epigenomics is soon to conclude a behavioural study that may pave the way for US regulatory approval and launch of its novel Epi proColon blood-based colorectal cancer (CRC) test in H215. A likely exercise of convertible notes should secure sufficient funding in 2015. Commercial sales and thus funding needs beyond 2015 depend on a US approval and reimbursement progress.

Activa Resources

Deutsche Börse Eigenkapitalforum 2014 Research Guide

Sector Commentary: | *Multiple Sectors | 11 Nov 2014

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Epigenomics

ADMIT trial set to start in Q414

QuickView | Pharmaceutical & healthcare | 08 Oct 2014

Epigenomics will shortly initiate a behavioural study that may pave the way for US regulatory approval and launch of its novel Epi proColon blood-based colorectal cancer (CRC) test in 2015. Plans to secure more funding before a US launch are likely with the share price at an attractive entry level.