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

RTTNews | 1135 दिनों पहले

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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टैग: 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 | 286 दिनों पहले

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.

RTTNews | 465 दिनों पहले

KOSPI May Break Through 3,200-Point Level

KOSPI May Break Through 3,200-Point Level

The South Korea stock market has climbed higher in two straight sessions, advancing almost 20 points or 0.6 percent in that span. The KOSPI now sits just shy of the 3,200-point plateau and it may open to the upside again on Friday.

RTTNews | 17 मिनटों पहले

Japan Data On Tap For Friday

Japan Data On Tap For Friday

Japan is scheduled to release a batch of data on Friday, headlining a busy day for Asia-Pacific economic activity. On tap are July figures for unemployment, industrial production, retail sales, housing starts and construction orders, as well as August data for household confidence and Tokyo inflation.

RTTNews | 1घंटे 17 मिनट पहले

Euro Climbs Against Majors

Euro Climbs Against Majors

The euro firmed against its major counterparts in the New York session on Thursday.

RTTNews | 1घंटे 48 मिनट पहले

Swiss Market Ends Marginally Up

Swiss Market Ends Marginally Up

The Switzerland market ended marginally up on Thursday after a choppy ride as stocks swung between gains and losses right through the day's trading session.

RTTNews | 5घंटे 26 मिनट पहले

European Stocks Close Weak

European Stocks Close Weak

European stocks closed lower on Thursday as the mood remained largely cautious with investors closely following geopolitical news, digesting tech giant Nvidia's earnings, and some crucial economic data from the U.S.

RTTNews | 5घंटे 46 मिनट पहले

Canadian Stocks Turning In Mixed Performance; TSX Down Marginally

Canadian Stocks Turning In Mixed Performance; TSX Down Marginally

After a positive start and a subsequent drop early on in the session, the Canadian market remains weak around early afternoon on Thursday, weighed down by losses in consumer staples, industrials and communications sectors.

RTTNews | 6घंटे 20 मिनट पहले

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