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

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).

RTTNews | 609 days ago

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.

RTTNews | 677 days ago

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

Genetic medicine maker Sarepta Therapeutics, Inc. (SRPT) announced Thursday that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne muscular dystrophy.

RTTNews | 944 days ago

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.

RTTNews | 967 days ago

Asian Markets Mostly Higher In Holiday Trade

Asian stock markets are mostly higher on Thursday, following the mixed cues from Wall Street overnight, with most major markets in the region closed for Labor Day, including China. Traders booked some profits after the recent upside in markets and a report showing the U.S. economy unexpectedly shrank in the first three months of 2025 generated some optimism about the outlook for interest rates.

RTTNews | 4 minutes ago

Japanese Market Slightly Higher

The Japanese market is trading slightly higher on Thursday, extending the gains in the previous five sessions, following the mixed cues from Wall Street overnight. The Nikkei 225 is moving above the 36,100 level, with a mixed performance across most sectors as traders remain cautious ahead of the Bank of Japan's latest monetary policy decision.

RTTNews | 1h 30min ago

Australian Market Slightly Lower

The Australian market is trading slightly lower on Thursday, snapping a five-session winning streak, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is staying above the 8,100 level, with slight weakness across most sectors led by mining and energy stocks. Some gold stocks were gaining.

RTTNews | 2h 9min ago

Little Movement Seen For Japan Stock Market

The Japanese stock market has finished higher in five straight sessions, rallying almost 1,850 points or 5 percent along the way. The Nikkei 225 now sits just beneath the 36,050-point plateau and it's likely to hold steady in that neighborhood again on Thursday.

RTTNews | 4h 1min ago

EURUSD	1.13184	GBPUSD	1.33159	AUDUSD	0.6419
USDJPY	142.982	USDCAD	1.3785	USDCHF	0.82571

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