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Amryt Pharma given go-ahead to continue Phase III EASE trial

Fri, 04th Jan 2019 14:41

(Sharecast News) - Revenue-generating orphan drug company Amryt Pharma announced the results of an unblinded interim efficacy analysis on its pivotal Phase III EASE trial for AP101 as a potential treatment for Epidermolysis Bullosa (EB) on Friday.The London-listed firm said the analysis was conducted by an independent data monitoring committee, which recommended that the trial should continue with an increase of 48 patients in the study to a total of 230 evaluable patients, in order to achieve 80% statistical power.It said the analysis was conducted using unblinded efficacy data received by the IDMC for the primary endpoint from the first half of the study.Amryt said it would begin the recruitment process for the additional patients required, and now expected a readout of the top line data from the EASE study in the second half of 2019.Following the announcement, Amryt said it was now in a position to draw down the remaining €5m of its European Investment Bank facility."The IDMC's recommendation is good news for Amryt as it allows us to continue the trial with only a modest increase in the size of the study," said chief executive officer Joe Wiley."This brings us closer to potentially delivering a treatment for patients with EB."Wiley thanked the patients, families and clinical investigators involved in the EASE trial to date."Today's news is a significant milestone for Amryt and our shareholders in building towards our vision of becoming a global leader in rare and orphan diseases."
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8 May 2018 13:13

Former Amryt Pharma Non-Executive Friel Sells 8.4 Million Shares (ALLISS)

LONDON (Alliance News) - Amryt Pharma PLC on Tuesday said on Tuesday a company owned by a former non-executive director has sold 8.4 million shares in the company.Raglan Road Capital Ltd is

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15 Mar 2018 14:15

Amryt 2017 Revenue Soars On Lojuxta Sales As New In-Licence Sealed

LONDON (Alliance News) - Amryt Pharma PLC said Thursday it has signed an in-licence agreement for a gene therapy platform, with the company making a "very start in for to

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15 Mar 2018 05:25

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6 Feb 2017 09:23

Amryt Pharma Gets Positive Study Results For Possible Acromegaly Drug

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2 Dec 2016 08:07

Amryt Pharma secures €20m loan from European Investment Bank

(ShareCast News) - AIM-listed Amryt Pharma has secured a €20m loan from the European Investment Bank to secure its near and mid-term funding for its gel product and a development for a drug compound compound. The loan secures funding for its product Episalvan, which treats skin disorder Epidermolysi

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7 Nov 2016 12:19

Amryt Pharma's drug compound gains FDA approval

(ShareCast News) - The US Food and Drug Administration (FDA) has granted orphan drug designation to AIM-listed Amryt Pharma's drug compound which has the potential to treat acromegaly. The drug compound, AP102, now qualifies for tax credits for qualified clinical trials and market exclusivity on reg

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13 Sep 2016 16:10

Amryt Pharma positive about drug developments

(ShareCast News) - Clinical stage specialty pharma company focused on best in class treatments for orphan diseases, Amryt Pharma, posted its interim financial statements for the six months to 30 June on Tuesday. The AIM-traded firm was admitted to trading on AIM and the ESM market of the Irish Stock

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9 Jun 2016 09:55

Amryt Pharma Plans Trials Of Episalvan Product By End Of 2016

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19 Apr 2016 12:05

Amryt Pharma reverses onto AIM to advance orphan drug strategy

(ShareCast News) - Speciality drug developer Amryt Pharma has completed its flotation via the reverse takeover of AIM-listed Fastnet, raising £10m of new cash in the process and acquiring two operating companies. As part of the float, Amryt acquired drug German drug development and manufacturing com

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19 Apr 2016 08:52

Amryt Pharma Starts Trading After Fastnet Reverse Takeover (ALLIPO)

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