Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

RTTNews | vor 1142 Tagen
Stocktwits
Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

(RTTNews) - Biopharmaceutical company Amryt Pharma plc (AMYT) announced the European Commission (EC) approval of Filsuvez in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.

EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market.

The centralized marketing authorization will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.

The EC approval of Filsuvez is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

Tags: AMYT
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Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Biopharmaceutical company Amryt Pharma plc (AMYT) announced Friday that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company's New Drug Application (NDA) for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).
RTTNews | vor 1141 Tagen
Positive Start Seen For Canadian Stocks

Positive Start Seen For Canadian Stocks

Canadian stocks may edge up a bit in early trades Friday morning with some encouraging earnings announcements and firm commodity prices aiding sentiment. Investors will also be reacting to the data showing a 41,000 jobs drop in Canadian employment in the month of July. Data from Statistics Canada also showed that the unemployment rate in Canada came in unchanged at 6.9%.
RTTNews | vor 2Std 21 Minuten
UK Market Roughly Flat; Mining Stocks Move Higher

UK Market Roughly Flat; Mining Stocks Move Higher

Amid a lack of economic and earnings data, U.K. stocks are moving in a tight range in somewhat lackluster trade on Friday. Investors are assessing the potential impact of the Trump administration's reciprocal tariffs on global economic growth. Optimism about a rate cut by the Fed next month is aiding sentiment a bit.
RTTNews | vor 4Std 15 Minuten
CAC 40 Climbs Higher For 3rd Straight Day

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French stocks are modestly higher on Friday, extending gains to a third straight session, with mostly encouraging corporate earnings announcements aiding sentiment. Concerns about the potential impact of Trump's reciprocal tariffs limit market's upside a bit.
RTTNews | vor 4Std 34 Minuten
DAX Modestly Lower After Four-day Winning Streak

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German stocks are down in negative territory on Friday, drifting lower after four successive days of gains, as some disappointing earnings announcements, and concerns about the impact of tariffs imposed by U.S. President Donald Trump weigh on sentiment.
RTTNews | vor 5Std 38 Minuten
European Shares Mixed As Investors Weigh Trump Tariff Impact

European Shares Mixed As Investors Weigh Trump Tariff Impact

European stocks were mixed on Friday after the Trump administration's higher tariff rates on trading partners took effect from midnight and Moscow confirmed Russian President Vladimir Putin and U.S. President Donald Trump are preparing to meet in the coming days, raising hopes of a ceasefire in the Ukraine war.
RTTNews | vor 6Std 9 Minuten
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