Wedbush's meetings with Acer Therapeutics Inc (NASDAQ: ACER) in the wake of last week's 14-percent decline in the stock suggest that the review of ast week’s 14 percent decline in the company’s share price, suggest the review of the company's Edsivo product is on track, the sell-side firm said Monday.
The PDUFA date for a potential FDA approval of Edsivo for the treatment of Vascular Ehlers-Danlos Syndrome (vEDS) patients is scheduled for June 25, Chico said in the note. (See her track record here.)
Recent data presentations offer “further support” for Acer Therapeutics’ estimates of vEDS’ addressable market size and Edsivo's differentiation from other agents, the analyst said.
Regarding investor concern around whether the data supporting Edsivo’s filing was too limited for an FDA approval, Chico said that it is consistent with the filings of recently approved orphan indications.
Acer has not indicated any requests from the FDA for additional studies, and the drug’s safety profile is well-understood, since it has been available in Europe for several years, she said.
Some investors are also concerned about the Edsivo data not being robust enough to warrant FDA approval, the analyst said.
The filing data was supported by another recent data set from a patient registry study that also demonstrated a survival benefit with celiprolol treatment, Chico said.
“Bottom line, we continue to think the data is sufficient to warrant an approval, particularly given the morbidity and mortality associated with vEDS."
Acer Therapeutics shares were down 2.74 percent at $15.95 at the time of publication Monday.
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Latest Ratings for ACER
|May 2019||Initiates Coverage On||Outperform|
|Dec 2018||Initiates Coverage On||Buy|
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