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March 18, 2020

Acer Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update

OND denies Acer’s appeal but describes possible paths forward for EDSIVO™

 ACER-001 bioequivalence trial complete; New Drug Application submission anticipated early 2021

 Targeting osanetant Phase 1/2 trial initiation by end 2020

NEWTON, MA –March 18, 2020 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on the […]

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Acer Receives Formal Dispute Resolution Request (FDRR) Response from FDA’s Office of New Drugs

Office of New Drugs denies Acer’s appeal but describes possible paths forward for EDSIVO™

NEWTON, MA – March 18, 2020 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has denied Acer’s […]

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February 24, 2020

Acer Therapeutics Announces ACER-001 for Urea Cycle Disorders Trial Shows Bioequivalence to BUPHENYL®

Anticipate submitting New Drug Application in early 2021 assuming successful completion of additional nonclinical work and 12-month long-term stability data

NEWTON, MA – Feb. 24, 2020 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced successful completion and final data from Part B of its pivotal trial evaluating the bioavailability and bioequivalence of […]

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