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Acer Therapeutics Shares Plunge On FDA Complete Response Letter

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Acer Therapeutics Shares Plunge On FDA Complete Response Letter

Acer Therapeutics Inc (NASDAQ: ACER) shares were trading down more than 75% Tuesday after it received a letter from the Food and Drug Administration regarding its drug application for Edsivo in the treatment of vascular Ehlers-Danlos syndrome.

The FDA said it is necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.

The rare disorder is caused by a gene mutation affecting a major protein, which causes weakness in vessel walls and hollow organs.

Acer Therapeutics plans to request a meeting to discuss the FDA’s response.

“We remain committed to working closely with the FDA to fully understand its response,” CEO Chris Schelling said in a statement. “We expect to respond to the FDA in the third quarter of this year." 

Acer Therapeutics shares were down 77.36% at $4.36 at the time of publication. 

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