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

RTTNews | 1137 days ago
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
Stocktwits
read more
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 | 1136 days ago
Thai Stock Market Expected To Open In The Red Again On Monday

Thai Stock Market Expected To Open In The Red Again On Monday

The Thai stock market has moved lower in consecutive trading days, falling more than 25 points or 2 percent along the way. The Stock Exchange of Thailand now sits just beneath the 1,220-point plateau and it's likely in for a rough ride again on Monday.
RTTNews | 51 minutes ago
Indonesia Bourse May Turn Lower Again On Monday

Indonesia Bourse May Turn Lower Again On Monday

The Indonesia stock market on Friday halted the two-day slide in which it had dropped almost 140 points or 1.9 percent. The Jakarta Composite Index now sits just shy of the 7,540-point plateau although it's likely to head south again on Monday.
RTTNews | 1h 21min ago
Japanese Market Sharply Lower; Down 2%

Japanese Market Sharply Lower; Down 2%

The Japanese stock market is trading sharply lower on Monday, extending the losses in the previous session, following the broadly negative cues from Wall Street on Friday, with the Nikkei 225 tumbling more than 2 percent to well below the 39,950 level, with weakness across all sectors led by exporters, automakers and financial stocks.
RTTNews | 1h 21min ago
No Help Yet For Hong Kong Stock Market

No Help Yet For Hong Kong Stock Market

The Hong Kong stock market has tracked lower in four straight sessions, dropping more than 1,050 points or 4 percent along the way. The Hang Seng Index now rests just above the 24,500-point plateau and it's expected to open in the red again on Monday.
RTTNews | 1h 36min ago
Lower Open Predicted For China Stock Market

Lower Open Predicted For China Stock Market

The China stock market has finished lower in consecutive trading days, sinking more than 55 points or 1.7 percent along the way. The Shanghai Composite Index now sits just shy of the 3,560-point plateau and the losses may accelerate on Monday.
RTTNews | 1h 51min ago
Australian Market Slightly Lower

Australian Market Slightly Lower

The Australian stock market is slightly lower on Monday, extending the losses in the previous two sessions, following the broadly negative cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is staying just above the 8,650.00 level, with weakness in energy, financial and technology stocks partially offset by strong gains in mining stocks.
RTTNews | 1h 51min ago
Tools
Kalender Ekonomi
Jam pasar
Suku bunga
Kalender hari libur
Pasar Valas
Forex Volatility
Forex Correlation
Berita Forex
forex analysis
COT Data
Likuiditas
Kalkulator Forex
Forex Heat Map
Heatmap indikator
Komunitas
Komunitas
Sistems
Most Popular Systems
Strategies
Kontes
Forex Charts
Forex Sentiment
Sentiment Indicator
Reviu
Pialang
Prop Trading Firms
VPS Services
Signal Providers
EA Programming Services
Affiliate Programs
PAMM Broker Services
Rebate Program Services
Trading Platforms
Expert Advisors
Crypto Exchanges
Kursus trading
Pialang
Forex Spreads
Forex Broker Quotes
Forex Broker Swaps
Forex Broker Volume
Forex Broker Promotions Siaran Pers
Platform
Widgets
Features
API
RSS
Stock Portfolio
Affiliate Software
Advanced Charts
Support
FAQ
Help
Contact Us
Report a Bug!
About
Blog
© 2025 Myfxbook Ltd. All Rights Reserved.
HIGH RISK WARNING: Foreign exchange trading carries a high level of risk that may not be suitable for all investors. Leverage creates additional risk and loss exposure. Before you decide to trade foreign exchange, carefully consider your investment objectives, experience level, and risk tolerance. You could lose some or all of your initial investment. Do not invest money that you cannot afford to lose. Educate yourself on the risks associated with foreign exchange trading, and seek advice from an independent financial or tax advisor if you have any questions. Any data and information is provided 'as is' solely for informational purposes, and is not intended for trading purposes or advice. Past performance is not indicative of future results.