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PTC Therapeutics Granted Marketing Authorization By EU For Upstaza To Treat AADC Deficiency

RTTNews | 1028 hari yang lalu

PTC Therapeutics Granted Marketing Authorization By EU For Upstaza To Treat AADC Deficiency

(RTTNews) - PTC Therapeutics, Inc. (PTCT) announced Wednesday that Upstaza (eladocagene exuparvovec) was granted marketing authorization by the European Commission. Upstaza is the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and the first marketed gene therapy directly infused into the brain. It is approved for patients 18 months and older.

Upstaza is a one-time gene replacement therapy indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of AADC deficiency with a severe phenotype.

The marketing authorization is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.

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FDA Approves PTC's Kebilidi As First Gene Therapy To Treat AADC Deficiency

FDA Approves PTC's Kebilidi As First Gene Therapy To Treat AADC Deficiency

The U.S. Food and Drug Administration approved PTC Therapeutics, Inc.'s Kebilidi (eladocagene exuparvovec-tneq) gene therapy for the treatment of aromatic L-amino acid decarboxylase or AADC deficiency. Kebilidi is the first FDA-approved gene therapy for the deficiency. PTC shares gained around 8.5 percent in the extended trading on the Nasdaq on Thursday.

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PTC Therapeutics Says European Commission Returns Translarna Opinion To CHMP For Re-evaluation

PTC Therapeutics Says European Commission Returns Translarna Opinion To CHMP For Re-evaluation

PTC Therapeutics, Inc. (PTCT) announced Monday that the European Commission (EC) has decided not to adopt the CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation.

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Tech Shares May Boost Taiwan Stock Market

Tech Shares May Boost Taiwan Stock Market

The Taiwan stock market has moved higher in three straight sessions, collecting almost 800 points or 4 percent in that span. The Taiwan Stock Exchange now sits just above the 21,330-point plateau and it's likely to open to the upside again on Wednesday.

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Japan Producer Prices Rise 0.2% In April

Japan Producer Prices Rise 0.2% In April

Producer prices in Japan were up 0.2 percent on month in April, the Bank of Japan said on Wednesday - slowing from 0.4 percent in March.

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Singapore Bourse May Crack Resistance At 3,900 Points

Singapore Bourse May Crack Resistance At 3,900 Points

The Singapore stock market has tracked higher in back-to-back sessions, gathering more than 30 points or 0.8 percent along the way. The Straits Times Index now sits just above the 3,880-point plateau and it may see additional support on Wednesday.

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Malaysia Shares Expected To Open To The Upside On Wednesday

Malaysia Shares Expected To Open To The Upside On Wednesday

The Malaysia stock market has moved higher in two straight sessions, advancing almost 40 points or 2.7 percent in that span. The Kuala Lumpur Composite Index now sits just above the 1,580-point plateau and it may extend its gains again on Wednesday.

RTTNews | 1j 27min yang lalu

Japan Bourse May Add To Its Winnings On Wednesday

Japan Bourse May Add To Its Winnings On Wednesday

The Japanese stock market has moved higher in four straight sessions, rallying more than 1,400 points or 3.7 percent along the way. The Nikkei 225 now sits just above the 39,180-point plateau and it may open in the green again on Wednesday.

RTTNews | 1j 42min yang lalu

South Korea Shares May Extend Winning Streak

South Korea Shares May Extend Winning Streak

The South Korea stock market has finished higher in back-to-back sessions, collecting almost 30 points or 1.2 percent in that span. The KOSPI now sits just shy of the 2,610-point plateau and it's tipped to open to the upside again on Wednesday.

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