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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Australian Market Halves Early Losses In Mid-market

The Australian stock market is halving its early losses in mid-market trading on Monday, snapping an eight-session winning streak, despite the broadly positive cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is falling to near the 8,300.00 level, with weakness in iron ore miners, energy and financial stocks partially offset by gains in gold miners.

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Asian Markets Trade Mostly Lower

Asian stock markets are mostly lower on Monday, following the positive cues from Wall Street on Friday, as traders react to surprise downgrade of the US government's credit rating by one notch to Aa1 by Moody's Ratings, being the last of the three major credit rating agencies to downgrade it. They also react to China announcing anti-dumping duties on plastics from the U.S., EU, Japan and Taiwan.

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Sensex, Nifty Seen Lower On US Debt Concerns

Indian shares look set to open lower on Monday as investors fret about the changing geo-political landscape in India's neighborhood as a new bonhomie between Bangladesh, China and Pakistan takes shape silently.

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Thai Bourse May Reclaim 1,200-Point Plateau

The Thai stock market has alternated between positive and negative finishes through the last eight trading days since the end of the five-day winning streak in which it had advanced more than 50 points or 4.3 percent. The Stock Exchange of Thailand now sits just above the 1,195-point plateau and it's expected to open to the upside again on Monday.

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