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Sarepta Therapeutics

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March 29, 2021

Uniqure tries to restore gene therapy calm

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March 16, 2021

Gene therapy data shake Solid

Better-looking safety might not be enough to get Solid back in the Duchenne muscular dystrophy game.

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March 09, 2021

New Nuplazid use in limbo after US knockback

Acadia becomes the latest to fall foul of the US FDA's apparently increasingly strict stance.

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March 01, 2021

US FDA approval tracker February

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February 26, 2021

Sarepta gains credibility, but confirmation is still three years away

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February 23, 2021

Merck & Co makes the accelerated approval pathway its own

Since 2010 14% of US accelerated approvals have been granted to Merck & Co’s Keytruda.

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February 23, 2021

A three way battle beckons in GM1 gangliosidosis

Early data could give clues about whether gene therapies from Sio, Passage Bio or Lysogene will come out on top in this rare inherited disease.

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January 27, 2021

Go or no go? Oncology decisions ahead for the FDA

The US regulator will provide verdicts on cancer projects from TG and Athenex, while Sarepta aims for its third Duchenne approval.

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January 08, 2021

Gene therapy trial fails to rectify Sarepta’s sorry record

Sarepta’s first ever controlled study, of a Duchenne muscular dystrophy gene therapy, brings the markets down to earth.

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December 23, 2020

Voyager hold adds to gene therapy woes

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December 17, 2020

Key upcoming clinical catalysts for biotech

Early 2021 will see rare diseases dominate for biotech, with Sarepta revealing key data on its gene therapy play.

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