Acer Shares Down On FDA's CRL For Genetic Disorder Treatment
Zacks Investment Research | Jun 26, 2019 08:32AM ET
Shares of Acer Therapeutics Inc. (NASDAQ:ACER) slumped more than 75% after it received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for Edsivo (celiprolol) for the treatment of vascular Ehlers-Danlos Syndrome (vEDS). Ehlers-Danlos Syndrome (“EDS”) is an inherited disorder caused by mutations in the genes responsible for the structure, production, or processing of collagen.
In the CRL, the FDA has asked the company to conduct an adequate and well-controlled study to determine whether Edsivo reduces the risk of clinical events in patients with vEDS. Acer plans to request a meeting with the FDA to discuss its response. The company expects to respond to the FDA in the third quarter of 2019. The CRL implies a delay in the approval of Edsivo.
Edsivois a selective adrenergic modulator and is currently approved in the European Union for the treatment of hypertension and angina.
Edsivo has an Orphan Drug exclusivity designation in the United States for the vEDS indication.
The company also has other candidates in its pipeline. Its ACER-001 is a fully taste-masked, immediate release formulation of sodium phenylbutyrate for the treatment of various inborn errors of metabolism, including urea cycle disorders (“UCD”) and Maple Syrup Urine Disease (“MSUD”). The company expects to submit an NDA for ACER-001 in UCD in the fourth quarter of 2019. The company also has osanetant in its pipeline, which is being evaluated for the treatment of various neuroendocrine disorders. An investigational new drug (“IND”) application for the drug is anticipated in the second half of 2019.
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