Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy

Quest Diagnostics Says FDA Grants Breakthrough Designation For Adeno-associated Virus Test

Quest Diagnostics (DGX), a diagnostic information services provider, announced Wednesday that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

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FDA OKs Elevidys As First Gene Therapy To Treat Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc. announced Friday that the U.S. Food and Drug Administration or FDA has accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl) for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

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Sarepta Therapeutics Updates Of BLA For Sarepta's Duchenne Muscular Dystrophy Drug Candidate

Sarepta Therapeutics, Inc. (SRPT) on Wednesday provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene.

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Sarepta Therapeutics Says FDA Lifts Clinical Hold On SRP-5051 To Treat Duchenne Muscular Dystrophy

Genetic medicine maker Sarepta Therapeutics, Inc. (SRPT) announced Tuesday that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on SRP-5051 (vesleteplirsen), the Company's investigational, next-generation peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

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Lower Open Called For Thai Stock Market

The Thai stock market has finished higher in two straight sessions, collecting almost 20 points or 1.6 percent along the way. The Stock Exchange of Thailand now sits just above the 1,260-point plateau although it figures to open in the red on Tuesday. The global forecast for the Asian markets is soft, with profit-taking likely on the menu. The European markets were mixed and the U.S. bourses were down and the Asian markets are also expected to open under water.

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Japanese Market Significantly Lower

The Japanese stock market is trading significantly lower on Tuesday, reversing the gains in the previous two sessions, following the broadly negative cues from Wall Street overnight, with the Nikkei 225 falling below the 42,400 level, with weakness across most sectors led by index heavyweights, exporters and financial stocks.

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Indonesia Bourse May Hand Back Monday's Gains

The Indonesia stock market on Monday wrote a finish to the two-day slide in which it had fallen almost 85 points or 1.1 percent. The Jakarta Composite Index now sits just above the 7,925-point plateau although it's looking at a soft start on Tuesday. The global forecast for the Asian markets is soft, with profit-taking likely on the menu. The European markets were mixed and the U.S. bourses were down and the Asian markets are also expected to open under water.

RTTNews | 34 minuter sedan

Hong Kong Shares May Be Stuck In Neutral On Tuesday

The Hong Kong stock market has moved higher in two straight sessions, improving more than 825 points or 3.4 percent along the way. The Hang Seng Index now rests just beneath the 25,830-point plateau although it may open under pressure on Tuesday. The global forecast for the Asian markets is soft, with profit-taking likely on the menu. The European markets were mixed and the U.S. bourses were down and the Asian markets are also expected to open under water.

RTTNews | 49 minuter sedan

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