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SRPT / Sarepta Therapeutics shares fall as report says FDA almost rejected its gene therapy

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares took a beating Thursday as Stat News reported that reviewers at the US Food and Drug Administration (FDA) were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by the company. The “non-binding conclusion" prompted FDA official Peter Marks to intervene earlier this year and schedule an advisory meeting on May 12, Stat said citing three people with direct knowledge of the agency deliberations. Read More

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Posted: Apr 13 2023, 10:26

Author Name: Proactive Investors

SRPT News

By Investors Business Daily
October 31, 2023

Sarepta Crashes 39% After Its Gene Therapy Flops Its Biggest-Ever Test

Sarepta Therapeutics' gene therapy, Elevidys, faces an uphill regulatory journey, analysts said Tuesday on mixed test results.

By Barrons
October 31, 2023

Sarepta Stock Sinks on Mixed Gene Therapy Results

In a gene therapy study for patients with Duchenne muscular dystrophy, the primary endpoint was not met.

By Investors Business Daily
October 30, 2023

Sarepta Therapeutics Stock Halted After Unveiling Mixed Results For Its First Gene Therapy

Sarepta unveiled mixed results late Monday for a gene therapy that targets a muscle-wasting disease in boys. SRPT stock was halted.

By Reuters
October 30, 2023

Sarepta's gene therapy fails to meet primary goal in rare muscular dystrophy trial

Sarepta Therapeutics' gene therapy to treat Duchenne muscular dystrophy failed to reach statistical significance in a late-stage trial, the company re

By The Motley Fool
August 23, 2023

Is Sarepta Therapeutics Stock a Top Growth Vehicle?

Wall Street is expecting big things from the rare disease specialist Sarepta Therapeutics in 2023 and beyond. However, the company does face some impo

By Seeking Alpha
August 2, 2023

Sarepta Therapeutics, Inc. (SRPT) Q2 2023 Earnings Call Transcript

Sarepta Therapeutics, Inc. (NASDAQ:SRPT ) Q2 2023 Earnings Conference Call August 2, 2023 4:30 PM ET Company Participants Francesca Nolan - IR Directo

By Zacks Investment Research
August 2, 2023

Sarepta Therapeutics (SRPT) Reports Q2 Loss, Misses Revenue Estimates

Sarepta Therapeutics (SRPT) came out with a quarterly loss of $0.27 per share versus the Zacks Consensus Estimate of a loss of $1.89. This compares to

By Zacks Investment Research
July 25, 2023

Sarepta Therapeutics (SRPT) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release

Sarepta Therapeutics (SRPT) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared

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