Epigenomics AG / Key word(s): Regulatory Admission
04.11.2015 20:19
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
FDA requests further data for approval of Epigenomics' blood-based
colorectal cancer screening test
Berlin, Germany, November 4, 2015 - Epigenomics AG, Berlin, Germany,
(Frankfurt Prime Standard: ECX, ISIN: DE000A11QW50), announces 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(R).
In its letter, the FDA provided guidance and recommendations on how to
amend the PMA to make it approvable. The agency requested additional data
demonstrating that the blood-based Epi proColon(R) test will increase
compliance to CRC screening in the intended use population, i.e. in those
patients with a history of noncompliance to recommended CRC screening
programs.
The management of Epigenomics is taking immediate steps to address the
FDA's requests. This includes a meeting with the FDA in the near-term in
order to discuss how to best address the outstanding questions. It is
expected that an additional study to demonstrate increased compliance and
adherence of patients to blood-based CRC testing will be needed. Details of
the study will be determined in dialogue with the FDA. As in the past,
Epigenomics is committed to provide information about the regulatory way
forward to its shareholders and to the public in a timely and comprehensive
manner.
Together with its strategic commercialization partner Polymedco,
Epigenomics will continue to diligently prepare for commercializing Epi
proColon(R) in the United States.
In the previous ADMIT (Adherence to Minimally Invasive Testing) study,
Epigenomics aimed to demonstrate that Epi proColon(R) will increase CRC
participation in patients being offered this convenient blood-based test as
compared to those being offered a fecal immunochemical test (FIT). While
the adherence to Epi proColon(R) was nearly 100%, the participation rate to
the FIT-test of 88% by far exceeded the levels seen in many studies. The
FDA's request for additional data suggests that the studied population in
the ADMIT trial was not fully suitable for Epi proColon(R).
- End of Ad hoc -
Contact Epigenomics AG
Peter Vogt, Investor & Public Relations
Epigenomics AG
Geneststraße 5
10829 Berlin
Phone +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
Epigenomics legal disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Epigenomics AG and its business. Such statements
involve certain known and unknown risks, uncertainties and other factors
which could cause the actual results, financial condition, performance or
achievements of Epigenomics AG to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Epigenomics AG is providing this communication
as of this date and does not undertake to update any forward-looking
statements contained herein as a result of new information, future events
or otherwise.
The information contained in this communication does not constitute nor
imply an offer to sell or transfer any product, and no product based on
this technology is currently available for sale by Epigenomics in the
United States or Canada. The analytical and clinical performance
characteristics of any Epigenomics product based on this technology which
may be sold at some future time in the U.S. have not been established.
04.11.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Epigenomics AG
Geneststraße 5
10829 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir@epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A11QW50
WKN: A11QW5
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Archives
04. November 2015
Epigenomics AG: FDA requests further data for approval of Epigenomics’ blood-based colorectal cancer screening test
02. November 2015
Epigenomics AG: Epigenomics AG to provide an update on blood-based epigenetic tests at the Association of Molecular Pathology (AMP) 2015 Annual Meeting
|
DGAP-News: Epigenomics AG / Key word(s): Conference 2015-11-02 / 14:00 Press release Epigenomics AG to provide an update on blood-based epigenetic tests at the Association of Molecular Pathology (AMP) 2015 Annual Meeting Berlin (Germany) and Germantown, MD (U.S.A.), November 2, 2015 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced today that it will host a corporate workshop at the Association for Molecular Pathology (AMP) 2015 Annual Meeting. Attendees of AMP, analysts, investors and media representatives are cordially invited to join this event on November 4, 2015, at 4pm CDT in room 17A at the Austin Convention Center, Austin, TX. The workshop will provide an update on Epigenomics’ colorectal and lung cancer programs. First, the Company will present trials demonstrating patient willingness to accept Septin9 plasma screening for colorectal cancer. Subsequently, an update on the deployment of the Septin9 test into the clinical laboratory setting will be provided. Finally, data on the performance of the company’s liquid biopsy marker panel using Real-Time PCR methylation detection for lung cancer detection will be presented. Following the workshop, there will be an opportunity for discussion of the studies and applications for epigenetic biomarkers in oncology with Epigenomics’ technology group. The workshop will be hosted by Dr. Thomas Taapken, CEO/CFO of Epigenomics AG, and Noel Doheny, CEO of Epigenomics’ US subsidiary. Presentations will be held by:
“Will the Availability of a Blood Test Increase CRC Screening Participation in the Non-Adherent Population?”
“Cancer Screening: Bringing Blood-based Epigenetic Cancer Testing into the Clinical Laboratory”
“An Emerging Tool for Lung Cancer Management” “We are highly committed to drive innovation in the field of blood-based cancer detection using our epigenetic tests,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. “In this respect, AMP 2015 represents an important opportunity to share new data from our colorectal and lung cancer programs with the medical and laboratory community.” About Epigenomics Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The Company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon(R), is a blood-based screening test for the early detection of colorectal cancer and is currently marketed in Europe and China. For more information, visit www.epigenomics.com. Contact Epigenomics AG Peter Vogt For U.S. press inquiries: Epigenomics, Inc. Epigenomics legal disclaimer The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.
2015-11-02 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English | |
| Company: | Epigenomics AG | |
| Geneststraße 5 | ||
| 10829 Berlin | ||
| Germany | ||
| Phone: | +49 30 24345-0 | |
| Fax: | +49 30 24345-555 | |
| E-mail: | ir@epigenomics.com | |
| Internet: | www.epigenomics.com | |
| ISIN: | DE000A11QW50 | |
| WKN: | A11QW5 | |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart | |
| End of News | DGAP News Service |
|
|
| 407675 2015-11-02 |
30. October 2015
Epigenomics AG: Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG mit dem Ziel der europaweiten Verbreitung
Epigenomics AG / Veröffentlichung der Gesamtzahl der Stimmrechte
30.10.2015 18:15
Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG, übermittelt durch DGAP - ein Service der EQS Group AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
---------------------------------------------------------------------------
Hiermit teilt die Epigenomics AG mit, dass die Gesamtzahl der Stimmrechte
am Ende des Monats Oktober 2015 insgesamt 18088384 Stimmrechte beträgt.
30.10.2015 Die DGAP Distributionsservices umfassen gesetzliche
Meldepflichten, Corporate News/Finanznachrichten und Pressemitteilungen.
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de
---------------------------------------------------------------------------
Sprache: Deutsch
Unternehmen: Epigenomics AG
Geneststraße 5
10829 Berlin
Deutschland
Internet: www.epigenomics.com
Ende der Mitteilung DGAP News-Service
---------------------------------------------------------------------------
09. September 2015
Epigenomics AG: Release of Voting Rights Notifications (§ 21 para. 1 WpHG)
Epigenomics AG
09.09.2015 17:02
Dissemination of a Voting Rights Announcement, transmitted by
DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Voting Rights: Release of Voting Rights Notifications (§ 21 para. 1 WpHG)
in Accordance with § 26 para. 1 WpHG (German Securities Trading Act) with
the Aim of an Europe-wide Distribution
Issuer:
Epigenomics AG
- ISIN DE000A11QW50 -
Geneststr. 5
10829 Berlin
Deutschland
Voting Rights Notifications:
1. On 7 September 2015, the company Morgan Stanley, Wilmington, Delaware,
USA, notified Epigenomics AG of voting rights in Epigenomics AG
pursuant to sec. 21 para. 1 WpHG as follows:
On 1 September 2015, as a consequence of the disposal of shares to which
voting rights are attached, the share of Morgan Stanley in the voting
rights of Epigenomics AG fell below the 3 per cent threshold of sec. 21
para. 1 WpHG and amounted, as at this date, to 0.01 per cent of the voting
rights (2,500 voting rights) in Epigenomics AG.
All 0.01 per cent of the voting rights (2,500 voting rights) are attributed
to Morgan Stanley pursuant to sec. 22 para. 1 sent. 1 no. 1 WpHG.
2. Furthermore, on 7 September 2015, Morgan Stanley Capital Management,
LLC, Wilmington, Delaware, USA, notified Epigenomics AG of voting
rights in Epigenomics AG pursuant to sec. 21 para. 1 WpHG as follows:
On 1 September 2015, as a consequence of the disposal of shares to which
voting rights are attached, the share of Morgan Stanley Capital Management,
LLC in the voting rights of Epigenomics AG fell below the 3 per cent
threshold of sec. 21 para. 1 WpHG and amounted, as at this date, to 0.01
per cent of the voting rights (2,500 voting rights) in Epigenomics AG.
All 0.01 per cent of the voting rights (2,500 voting rights) are attributed
to Morgan Stanley Capital Management, LLC pursuant to sec. 22 para. 1 sent.
1 no. 1 WpHG.
3. Furthermore, on 7 September 2015, Morgan Stanley Domestic Holdings,
Inc., Wilmington, Delaware, USA, notified Epigenomics AG of voting
rights in Epigenomics AG pursuant to sec. 21 para. 1 WpHG as follows:
On 1 September 2015, as a consequence of the disposal of shares to which
voting rights are attached, the share of Morgan Stanley Domestic Holdings,
Inc. in the voting rights of Epigenomics AG fell below the 3 per cent
threshold of sec. 21 para. 1 WpHG and amounted, as at this date, to 0.01
per cent of the voting rights (2,500 voting rights) in Epigenomics AG.
All 0.01 per cent of the voting rights (2,500 voting rights) are attributed
to Morgan Stanley Domestic Holdings, Inc. pursuant to sec. 22 para. 1 sent.
1 no. 1 WpHG.
4. Furthermore, on 7 September 2015, Morgan Stanley & Co. LLC, Wilmington,
Delaware, USA, notified Epigenomics AG of voting rights in Epigenomics
AG pursuant to sec. 21 para. 1 WpHG as follows:
On 1 September 2015, as a consequence of the disposal of shares to which
voting rights are attached, the share of Morgan Stanley & Co. LLC in the
voting rights of Epigenomics AG fell below the 3 per cent threshold of sec.
21 para. 1 WpHG and amounted, as at this date, to 0.00 per cent of the
voting rights (0 voting rights) in Epigenomics AG.
Date of release: 9 September 2015
Epigenomics AG
The Executive Board
Contact:
Epigenomics AG
Antje Zeise
Manager Investor Relations
Tel.: +49 (0)30 24345 386
Fax: +49 (0)30 24345 555
Email: antje.zeise@epigenomics.com
09.09.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Epigenomics AG
Geneststraße 5
10829 Berlin
Germany
Internet: www.epigenomics.com
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
04. September 2015
Epigenomics AG: Release according to Article 26, Section 1 of the WpHG [the German Securities Trading Act] with the objective of Europe-wide distribution
Epigenomics AG
04.09.2015 21:40
Dissemination of a Voting Rights Announcement, transmitted by
DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Voting Rights: Release of Voting Rights Notifications (§ 21 para. 1 WpHG)
in Accordance with § 26 para. 1 WpHG (German Securities Trading Act) with
the Aim of an Europe-wide Distribution
Issuer:
Epigenomics AG
- ISIN DE000A11QW50 -
Geneststr. 5
10829 Berlin
Deutschland
Voting Rights Notifications:
1. On 4 September 2015, the company Morgan Stanley, Wilmington, Delaware,
USA, notified Epigenomics AG of voting rights in Epigenomics AG
pursuant to sec. 21 para. 1 WpHG as follows:
On 31 August 2015, as a consequence of the acquisition of shares to which
voting rights are attached, the share of Morgan Stanley in the voting
rights of Epigenomics AG exceeded the 3 per cent threshold of sec. 21 para.
1 WpHG and amounted, as at this date, to 4.83 per cent of the voting rights
(864,419 voting rights) in Epigenomics AG.
All 4.83 per cent of the voting rights (864,419 voting rights) are
attributed to Morgan Stanley pursuant to sec. 22 para. 1 sent. 1 no. 1 WpHG
through the following entities controlled by Morgan Stanley and holding 3
per cent or more of the voting rights in Epigenomics AG:
- Morgan Stanley Capital Management, LLC
- Morgan Stanley Domestic Holdings, Inc.
- Morgan Stanley & Co. LLC
2. Furthermore, on 4 September 2015, Morgan Stanley Capital Management,
LLC, Wilmington, Delaware, USA, notified Epigenomics AG of voting
rights in Epigenomics AG pursuant to sec. 21 para. 1 WpHG as follows:
On 31 August 2015, as a consequence of the acquisition of shares to which
voting rights are attached, the share of Morgan Stanley Capital Management,
LLC in the voting rights of Epigenomics AG exceeded the 3 per cent
threshold of sec. 21 para. 1 WpHG and amounted, as at this date, to 4.83
per cent of the voting rights (864,419 voting rights) in Epigenomics AG.
All 4.83 per cent of the voting rights (864,419 voting rights) are
attributed to Morgan Stanley Capital Management, LLC pursuant to sec. 22
para. 1 sent. 1 no. 1 WpHG through the following entities controlled by
Morgan Stanley Capital Management, LLC and holding 3 per cent or more of
the voting rights in Epigenomics AG:
- Morgan Stanley Domestic Holdings, Inc.
- Morgan Stanley & Co. LLC
3. Furthermore, on 4 September 2015, Morgan Stanley Domestic Holdings,
Inc., Wilmington, Delaware, USA, notified Epigenomics AG of voting
rights in Epigenomics AG pursuant to sec. 21 para. 1 WpHG as follows:
On 31 August 2015, as a consequence of the acquisition of shares to which
voting rights are attached, the share of Morgan Stanley Domestic Holdings,
Inc. in the voting rights of Epigenomics AG exceeded the 3 per cent
threshold of sec. 21 para. 1 WpHG and amounted, as at this date, to 4.83
per cent of the voting rights (864,419 voting rights) in Epigenomics AG.
All 4.83 per cent of the voting rights (864,419 voting rights) are
attributed to Morgan Stanley Domestic Holdings, Inc. pursuant to sec. 22
para. 1 sent. 1 no. 1 WpHG through the following entity controlled by
Morgan Stanley Domestic Holdings, Inc. and holding 3 per cent or more of
the voting rights in Epigenomics AG:
- Morgan Stanley & Co. LLC
4. Furthermore, on 4 September 2015, Morgan Stanley & Co. LLC,
Wilmington,
Delaware, USA, notified Epigenomics AG of voting rights in Epigenomics
AG pursuant to sec. 21 para. 1 WpHG as follows:
On 31 August 2015, as a consequence of the acquisition of shares to which
voting rights are attached, the share of Morgan Stanley & Co. LLC in the
voting rights of Epigenomics AG exceeded the 3 per cent threshold of sec.
21 para. 1 WpHG and amounted, as at this date, to 4.83 per cent of the
voting rights (864,419 voting rights) in Epigenomics AG.
Date of release: 4 September 2015
Epigenomics AG
The Executive Board
Contact:
Epigenomics AG
Antje Zeise
Manager Investor Relations
Tel.: +49 (0)30 24345 386
Fax: +49 (0)30 24345 555
Email: antje.zeise@epigenomics.com
04.09.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Epigenomics AG
Geneststraße 5
10829 Berlin
Germany
Internet: www.epigenomics.com
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
31. August 2015
Epigenomics AG: Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG mit dem Ziel der europaweiten Verbreitung
Epigenomics AG / Veröffentlichung der Gesamtzahl der Stimmrechte
31.08.2015 09:18
Veröffentlichung der Gesamtzahl der Stimmrechte nach § 26a WpHG, übermittelt durch DGAP - ein Service der EQS Group AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
---------------------------------------------------------------------------
Hiermit teilt die Epigenomics AG mit, dass die Gesamtzahl der Stimmrechte
am Ende des Monats August 2015 insgesamt 17884459 Stimmrechte beträgt.
31.08.2015 Die DGAP Distributionsservices umfassen gesetzliche
Meldepflichten, Corporate News/Finanznachrichten und Pressemitteilungen.
DGAP-Medienarchive unter www.dgap-medientreff.de und www.dgap.de
---------------------------------------------------------------------------
Sprache: Deutsch
Unternehmen: Epigenomics AG
Geneststraße 5
10829 Berlin
Deutschland
Internet: www.epigenomics.com
Ende der Mitteilung DGAP News-Service
---------------------------------------------------------------------------