Acer Therapeutics Inc.
222 Third Street
Suite 2240
Cambridge
Massachusetts
02142
United States
Website: http://www.acertx.com/
Email: jdavis@acertx.com
92 articles with Acer Therapeutics Inc.
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Acer Therapeutics to Participate in August and September 2022 Investor Conferences
8/23/2022
Acer Therapeutics Inc. (Nasdaq: ACER), today announced that Acer’s management team will virtually present at, and participate in, the upcoming Gilmartin Group Emerging Growth Company Showcase and H.C. Wainwright 24th Annual Global Investment Conference.
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Acer Therapeutics Reports Q2 2022 Financial Results and Provides Corporate Update
8/15/2022
Acer Therapeutics Inc. (Nasdaq: ACER), today reported financial results for the second quarter ended June 30, 2022, and provided a corporate update.
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Relief Therapeutics and Acer Therapeutics Announce that the European Commission Has Granted Orphan Drug Designation for ACER-001 in Maple Syrup Urine Disease
8/12/2022
RELIEF THERAPEUTICS Holding SA and Acer Therapeutics Inc. (Nasdaq: ACER) (Acer), today announced that the European Commission has granted orphan medicinal product designation in the EU to ACER-001 (sodium phenylbutyrate) for the potential treatment of patients with Maple Syrup Urine Disease (MSUD).
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Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDsPrescription Drug User Fee Act (PDUFA) target action date set for January 15, 2023
7/28/2022
Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today announced the U.S. Food and Drug Administration (FDA) has accepted for review Acer’s resubmitted New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs).
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Acer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease
7/28/2022
Acer Therapeutics Inc. and RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety of ACER-001.
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Relief Therapeutics Announces that its Collaboration Partner has Resubmitted the ACER-001 (Sodium Phenylbutyrate) New Drug Application (NDA) to the FDA for the Treatment of Urea Cycle Disorders (UCDs)
7/18/2022
RELIEF THERAPEUTICS Holding SA, announced that its collaboration partner, ACER Therapeutics, Inc., for ACER-001 for oral suspension for the treatment of patients with urea cycle disorders, has resubmitted its New Drug Application for ACER-001 to the U.S. Food and Drug Administration.
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Acer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs
7/18/2022
Acer Therapeutics Inc. today announced the resubmission of Acer’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders.
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Acer Therapeutics and Relief Therapeutics Announce That the China National Intellectual Property Administration (CNIPA) Issued Utility Model Patent 11,202,767 Covering ACER-001 Dosage Form
7/8/2022
Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today announced that the China National Intellectual Property Administration (CNIPA) issued Electronic Patent Certificate ZL202122004991.9 on May 24, 2022, for Utility Model directed to ACER-001 (sodium phenylbutyrate).
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Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer's, Acer's vEDS program hits Phase III and BridgeBio's primary hyperoxaluria type 1 program progresses.
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Acer Therapeutics Announces Initiation of its Pivotal Phase 3 DiSCOVER Trial of EDSIVO™ (celiprolol) for the Treatment of Vascular Ehlers-Danlos Syndrome
6/27/2022
Acer Therapeutics Inc. (Nasdaq: ACER), a clinical stage 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 the initiation of patient screening in its Phase 3 clinical trial of EDSIVO™.
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There were multiple leadership changes in the biopharma industry, with several new chief executive officers tapped to guide companies through their next growth phases.
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Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.
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Acer Therapeutics Announces Promotion of Tanya Hayden to Chief Operating Officer
6/21/2022
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 the promotion of Tanya Hayden to Chief Operating Officer (COO).
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Acer Therapeutics and Relief Therapeutics Announce Update on U.S. FDA Review of New Drug Application (NDA) for ACER-001
6/21/2022
Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs).
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Relief Reports that its Collaboration Partner, Acer Therapeutics, Issued a Statement Regarding the PDUFA Target Action Date for ACER-001
6/8/2022
RELIEF THERAPEUTICS Holding SA reported that its collaboration partner, Acer Therapeutics, Inc., announced that it has not yet received a decision from the U.S. Food and Drug Administration on its 505 New Drug Application for ACER-001, for the treatment of urea cycle disorders.
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Acer Therapeutics Issues Statement Regarding PDUFA Target Action Date for ACER-001
6/7/2022
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 it has not yet received a decision from the U.S. Food and Drug Administration (FDA) on its 505(b)(2) New Drug Application (NDA) for ACER-001.
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June is starting off with a number of important dates for the FDA, including an advisory committee meeting to discuss COVID-19 vaccines in children as young as six months.
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On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
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Acer Therapeutics Reports Q1 2022 Financial Results and Provides Corporate Update
5/16/2022
Acer Therapeutics Inc. reported financial results for the first quarter ended March 31, 2022 and provided an update on the Company’s recent corporate developments.
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Acer Therapeutics Announces Agreement with FDA on Special Protocol Assessment for its Phase 3 EDSIVO™ (celiprolol) Trial in Vascular Ehlers-Danlos Syndrome PatientsPhase 3 DiSCOVER clinical trial initiation expected by end of Q2 2022
5/9/2022
Acer Therapeutics Inc. today announced it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal Phase 3 DiSCOVER.