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

RTTNews | Před 358 dny
Stocktwits
PTC Therapeutics Says European Commission Returns Translarna Opinion To CHMP For Re-evaluation

(RTTNews) - 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.

As a result, Translarna remains on the market and available for patients in Europe consistent with its current marketing authorization. The EC has asked the CHMP to further consider the totality of evidence, including data from patient registries and real-world evidence, in a revised opinion.

In addition, the European Medicines Agency (EMA) has informed PTC that the decision has been taken to consider the Scientific Advisory Group (SAG) meeting for Translarna held on September 5, 2023, and all the procedural steps that followed, as invalid.

Furthermore, the input from the SAG meeting held in September 2023 as well as the meeting held in January 2024 will not be considered by the CHMP in any future evaluation of Translarna.

Given the inability to accurately forecast the upside impact of the continued authorization of Translarna in Europe on 2024 revenue, PTC will pause 2024 total revenue guidance at this time.

Značky : PTCT
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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.
RTTNews | Před 180 dny
PTC Therapeutics Granted Marketing Authorization By EU For Upstaza To Treat AADC Deficiency

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

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.
RTTNews | Před 1028 dny
China Bourse Tipped To Open In The Green

China Bourse Tipped To Open In The Green

The China stock market has moved higher in consecutive trading days, improving almost 35 points or 1 percent along the way. The Shanghai Composite Index now rests just beneath the 3,375-point plateau and it's looking at a higher open again on Wednesday.
RTTNews | Před 2 minutami
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.
RTTNews | Před 32 minutami
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.
RTTNews | Před 37 minutami
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.
RTTNews | Před 1 h 2 min
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 | Před 1 h 32 min
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 | Před 1 h 47 min
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