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Acer Therapeutics reports Q3 EPS (31c), consensus (68c)
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Acer Therapeutics reports Q3 EPS (31c), consensus (68c)

"I am pleased with our team’s progress in the third quarter, highlighted by the timely resubmission of our New Drug Application following the Complete Response Letter issued by the US Food and Drug Administration in response to ACER-001’s NDA submission," stated Chris Schelling, CEO. "As the FDA continues its review of our resubmitted NDA for UCDs, we remain focused on advancing ACER-001 for the treatment of Maple Syrup Urine Disease, having submitted our IND application to the FDA for a Phase 2a trial and receiving Orphan Drug Designation from the European Commission. In addition to the advancement of ACER-001, we made significant progress with the continued development of our other pipeline programs, including the initiation of our pivotal, Phase 3 DiSCOVER trial of EDSIVO for the treatment of COL3A1-positive vascular Ehlers-Danlos Syndrome patients — the only ongoing clinical trial in this patient population, to our knowledge — and expansion of our ACER-801 program into treatment and prevention of Post-traumatic Stress Disorder through an investigator-sponsored trial to be conducted by the University of North Carolina. And early next year, we look forward to reporting topline results from our ongoing Phase 2a clinical trial of ACER-801 for the treatment of moderate to severe Vasomotor Symptoms in post-menopausal women."

Published first on TheFly

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