Acer Therapeutics Inc 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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