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Amryt Pharma positive about drug developments

Tue, 13th Sep 2016 16:10

(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 Exchange on 19 April following the reverse takeover of Fastnet Equity.During the period Amryt completed a placing, at 24p per share, raising gross proceeds of £10m through the issue of 41,673,402 new ordinary shares.It said its H1 2016 financial expenditure was in line with management expectations, and it had an €11.7m cash balance at 30 June 2016, with €10.7m at 31 August 2016Post-reverse takeover EBITDA, excluding one-off reverse takeover-related costs, were €1.29m."The first six months of 2016 have been transformational for the company," said non-executive chairman Harry Stratford."On 18 April, 2016 we successfully concluded our first two acquisitions of Birken and Som and at the same time completed the reverse takeover of Fastnet Equity and a share placing which raised £10 million gross."These events were important strategic milestones in realising the company's vision of becoming a significant player in the underserved orphan disease market."Stratford said Amryt is particularly excited by the prospects of its lead product Episalvan, a potential treatment for a rare and distressing hereditary skin disorder called Epidermolysis Bullosa or EB."In the short period since the formation of the company, we have finalised our protocol design for our proposed pivotal phase 3 study in EB and have submitted it to the European Medicines Agency for approval," he explained."We have also been granted a meeting with the FDA in early Q4, 2016.Stratford said the board anticipates that this phase 3 study will, subject to regulatory sign-off, enrol its first patient in Q1, 2017."Given the unique characteristics of our EB product and the lack of any available treatment options currently, we believe this market offers a significant commercial opportunity for us."
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30 Mar 2021 12:11

Amryt releases data from Italy lomitapide study

(Sharecast News) - Commercial-stage biopharmaceutical company Amryt Pharma released efficacy and safety data from the 'Lochnes' investigator-sponsored study of lomitapide in familial chylomicronemia syndrome (FCS) on Tuesday, which was conducted by expert lipidologists in Italy.

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29 Mar 2021 09:15

European approval for Amryt's Oleogel-S10 moves closer

(Sharecast News) - Commercial-stage biopharmaceutical company Amryt Pharma announced the validation of its marketing authorisation application for 'Oleogel-S10' by the European Medicines Agency on Monday, for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa.

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23 Mar 2021 19:03

IN BRIEF: Amryt gets positive feedback on Myalept from US regulator

IN BRIEF: Amryt gets positive feedback on Myalept from US regulator

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23 Mar 2021 09:34

Amryt upbeat on positive FDA feedback

(Sharecast News) - Commercial-stage biopharmaceuticals company Amryt Pharma has received further feedback from the United States Food and Drug Administration (FDA) on Myalept, it said on Tuesday, and its proposed development plan and study design to support an indication for patients with partial lipodystrophy (PL).

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22 Mar 2021 19:07

IN BRIEF: Amryt's Myalepta secures reimbursement approval in France

IN BRIEF: Amryt's Myalepta secures reimbursement approval in France

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22 Mar 2021 09:04

Amryt's Myalepta gets reimbursement approval in France

(Sharecast News) - Commercial-stage biopharmaceuticals company Amryt Pharma announced on Monday that the French Ministry of Social Affairs and Health has approved 'Myalepta', or metreleptin, for reimbursement in the country as an adjunct to diet as replacement therapy.

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15 Mar 2021 16:38

Director dealings: Amryt Pharma chairman makes share purchase

(Sharecast News) - Amryt Pharma revealed on Monday that chairman Ram Stafford had acquired 300,100 ordinary shares in the AIM-listed commercial-stage biopharmaceutical company.

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9 Mar 2021 06:55

IN BRIEF: Amryt, Medison sign distribution deal for Myalepta in Canada

IN BRIEF: Amryt, Medison sign distribution deal for Myalepta in Canada

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8 Mar 2021 12:19

Amryt Pharma signs another distribution deal with Medison

(Sharecast News) - Commercial-stage biopharmaceutical company Amryt Pharma announced the signing of a distribution agreement with Medison Pharma to distribute 'Myalepta' in Canada on Monday.

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4 Mar 2021 12:46

TRADING UPDATES: Origin Enterprises loss slims; Amryt issues guidance

TRADING UPDATES: Origin Enterprises loss slims; Amryt issues guidance

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4 Feb 2021 14:18

Amryt signs multi-regional distribution deals with Medison

(Sharecast News) - Commercial-stage biopharmaceuticals company Amryt Pharma announced the signing of multi-regional distribution agreements with Medison Pharma on Thursday.

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4 Feb 2021 12:14

Amryt Pharma Signs Drug Distribution Agreements With Medison Pharma

Amryt Pharma Signs Drug Distribution Agreements With Medison Pharma

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20 Jan 2021 21:32

IN BRIEF: Amryt Receives Reimbursement Approval For Myalepta

IN BRIEF: Amryt Receives Reimbursement Approval For Myalepta

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23 Dec 2020 19:50

UK TRADING UPDATE SUMMARY: Polarean And Amryt Get US FDA Boost

UK TRADING UPDATE SUMMARY: Polarean And Amryt Get US FDA Boost

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17 Dec 2020 13:38

Amryt gets reimbursement approval for 'Lojuxta' in Saudi Arabia

(Sharecast News) - Biopharmaceutical company Amryt announced on Thursday that Ministry of Health reimbursement approval has been granted for 'Lojuxta', or lomitapide, in Saudi Arabia.

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