Filter by Year
Acer Therapeutics Compliant with All Nasdaq Listing Criteria
NEWTON, MA – Dec. 29, 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 The Nasdaq Stock Market LLC has formally notified Acer that the company has regained compliance with the […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce U.S. FDA Approval of OLPRUVA™for Patients with Urea Cycle Disorders
New FDA-approved formulation for patients living with urea cycle disorders
$42.5 million of non-dilutive debt funding available to Acer that, if drawn, would extend cash runway into H2 2023
NEWTON, MASS. and GENEVA – Dec. 27, 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 U.S. Food and Drug Administration (FDA) has approved OLPRUVA™ (sodium phenylbutyrate) for oral suspension in the U.S. for the treatment of certain […]
Read MoreAcer Therapeutics Announces $1.5M Private Placement
NEWTON, MA – November 30, 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 entered into definitive agreements with its CEO as well as its Chairman for a private […]
Read MoreAcer Therapeutics Reports Q3 2022 Financial Results and Provides Corporate Update
NEWTON, MA – November 14, 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 reported financial results for the third quarter ended September 30, 2022 and provided an update on Acer’s recent corporate […]
Read MoreAcer Therapeutics Receives Notice of Allowance of Key US Patent Application Covering EDSIVO™ (celiprolol)
Notice of allowance of celiprolol method of treatment of vEDS patent application strengthens proprietary position in U.S. until 2038
NEWTON, MA – Oct. 26, 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 that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Acer’s […]
Read MoreAcer Therapeutics Announces University of North Carolina Receives Department of Defense Grant to Support the Proposed Investigator Sponsored OASIS Trial of ACER-801 (Osanetant) to Reduce the Frequency and Severity of Post-Traumatic Stress Disorder
$3 million awarded to University of North Carolina (UNC) to support a proposed 180-patient, randomized, placebo-controlled trial in trauma patients
Proposed investigator-sponsored trial to evaluate the potential for ACER-801 to reduce the frequency and severity of acute stress disorder and post-traumatic stress disorder (PTSD)
Up to 20% of people who have experienced a traumatic event will develop PTSD1 leading to over 12 million adults in the US suffering from PTSD during a given year2
NEWTON, MA — October 6, 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 that the University of North Carolina (UNC) Institute for Trauma Recovery has been awarded a $3 million […]
Read MoreAcer Therapeutics Announces Expansion of ACER-801 (osanetant) Development Indications to Include Post-Traumatic Stress Disorder
Licensed exclusive worldwide rights from Emory University to patents and patent applications for certain methods of treating or preventing post-traumatic stress disorder (PTSD) with osanetant
Osanetant targets a distinct group of brain cells in a region of the brain that controls the formation and consolidation of fear memories, which may aid in preventing PTSD1
Up to 20% of people who have experienced a traumatic event will develop PTSD2 leading to over 12 million adults in the US suffering from PTSD during a given year3
NEWTON, MA – October 5, 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 expansion of ACER-801 (osanetant) into a new indication, for the reduction of the frequency and severity of […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce Receipt of Notice of Allowance of US Patent Application Covering a Kit Comprising Phenylbutyrate and Sodium Benzoate
Notice of allowance covering these claims further strengthens ACER-001 proprietary position in US; patent expected to be issued in Q4 2022 and expire in 2038
NEWTON, MA and GENEVA, SWITZERLAND – October 3, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief) today announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Acer for US patent application No. 16/624,834 for claims related to […]
Read MoreAcer Therapeutics to Participate in August and September 2022 Investor Conferences
NEWTON, MA – August 23, 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 Acer’s management team will virtually present at, and participate in, the upcoming Gilmartin Group Emerging Growth Company […]
Read MoreAcer Therapeutics Reports Q2 2022 Financial Results and Provides Corporate Update
NEWTON, MA – August 15, 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 reported financial results for the second quarter ended June 30, 2022, and provided a corporate update. “I am very […]
Read MoreRelief Therapeutics and Acer Therapeutics Announce that the European Commission Has Granted Orphan Drug Designation for ACER-001 in Maple Syrup Urine Disease
Orphan designation provides potential for up to 10-year market exclusivity in the EU upon regulatory approval
GENEVA, SWITZERLAND and NEWTON, MA – August 12, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), and its collaboration partner, 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 […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease
Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital
NEWTON, MA and GENEVA, SWITZERLAND – July 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 submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Review of NDA Resubmission for ACER-001 for Treatment of UCDs
Prescription Drug User Fee Act (PDUFA) target action date set for January 15, 2023
NEWTON, MA and GENEVA, SWITZERLAND – July 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 […]
Read MoreAcer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs
Acer has notified the FDA in the resubmission that the third-party contract packaging manufacturer is ready for inspection
NEWTON, MA – July 18, 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 resubmission of Acer’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 […]
Read MoreAcer 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
Key patent strengthens proprietary position in China until August 2031
NEWTON, MA and GENEVA, SWITZERLAND – July 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 […]
Read MoreAcer Therapeutics Announces Initiation of its Pivotal Phase 3 DiSCOVER Trial of EDSIVO™ (celiprolol) for the Treatment of Vascular Ehlers-Danlos Syndrome
NEWTON, MA – June 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 DiSCOVER (Decentralized Study of Celiprolol on vEDS-related […]
Read MoreAcer Therapeutics Announces Promotion of Tanya Hayden to Chief Operating Officer
NEWTON, MA – June 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). Harry S. Palmin, who had been serving as […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce Update on U.S. FDA Review of New Drug Application (NDA) for ACER-001
Citing the need to inspect a third-party contract packaging manufacturer, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)
The FDA has not raised any approvability concerns related to the efficacy, safety or pharmacokinetics of ACER-001
NEWTON, MA and GENEVA, SWITZERLAND – June 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 […]
Read MoreAcer Therapeutics Issues Statement Regarding PDUFA Target Action Date for ACER-001
NEWTON, MA – June 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 […]
Read MoreAcer Therapeutics Reports Q1 2022 Financial Results and Provides Corporate Update
NEWTON, MA –May 16, 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 reported financial results for the first quarter ended March 31, 2022 and provided an update on the Company’s recent corporate […]
Read MoreAcer Therapeutics Announces Agreement with FDA on Special Protocol Assessment for its Phase 3 EDSIVO™ (celiprolol) Trial in Vascular Ehlers-Danlos Syndrome Patients
Phase 3 DiSCOVER clinical trial initiation expected by end of Q2 2022
NEWTON, MA – May 09, 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 it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce Presentation of ACER-001 Data at the Genetic Metabolic Dieticians International Conference
NEWTON, MA and GENEVA, SWITZERLAND – May 6, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), today announced the presentation of data evaluating the bioavailability, bioequivalence and taste attributes of ACER-001 (sodium phenylbutyrate) compared to sodium phenylbutyrate (BUPHENYL®) powder during poster […]
Read MoreAcer Therapeutics to Participate in H.C. Wainwright Global Investment Conference
NEWTON, MA –May 5, 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 Acer’s management team will virtually present at, and participate in, the H.C. Wainwright Global Investment Conference May 24-26, […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce Presentation of ACER-001 Data at the Society for Inherited Metabolic Disorders Annual Meeting
NEWTON, MA and GENEVA, SWITZERLAND – April 12, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), today announced the presentation of data evaluating the bioavailability, bioequivalence and taste attributes of taste-masked sodium phenylbutyrate (ACER-001) compared to sodium phenylbutyrate (BUPHENYL®) powder during […]
Read MoreAcer Therapeutics’ EDSIVO™ (celiprolol) Granted FDA Breakthrough Therapy Designation for Vascular Ehlers-Danlos Syndrome
Discussions ongoing with FDA through special protocol assessment (SPA) seeking agreement on planned pivotal Phase 3 DiSCOVER trial with initiation planned by end of Q2 2022
NEWTON, MA – April 4, 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 U.S. Food and Drug Administration (FDA) has granted celiprolol Breakthrough Therapy designation (BTD) in the U.S. for […]
Read MoreAcer Therapeutics Regains Compliance with Nasdaq Listing Standard
NEWTON, MA – March 31, 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 received notice from The Nasdaq Stock Market (Nasdaq) on March 30, 2022 informing Acer that […]
Read MoreAcer Therapeutics Enrolls First Patient in its Phase 2a Clinical Trial of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause
Results anticipated in H2 2022
NEWTON, MA – March 30, 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 enrollment of the first patient in its Phase 2a randomized, double-blind, placebo-controlled, dose-ranging trial evaluating the efficacy, […]
Read MoreAcer Therapeutics Secures up to $48.5 Million in Convertible Note and Secured Loan Financing Facilities
NEWTON, MA – March 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 entered into convertible note and loan financing facilities for up to $48.5 million with affiliates […]
Read MoreAcer Therapeutics Reports Q4 and Full Year 2021 Financial Results and Provides Corporate Update
NEWTON, MA –March 2, 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 reported financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on the […]
Read MoreAcer Therapeutics Announces Appointment of Adrian Quartel, M.D., FFPM, as Chief Medical Officer
Industry veteran with over 20 years of drug development experience to oversee advancement of Acer’s product pipeline
NEWTON, MA – Feb. 22, 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 appointment of Adrian Quartel, M.D., FFPM, as Chief Medical Officer. Dr. Quartel will oversee Acer’s clinical development, […]
Read MoreAcer Therapeutics to Participate in 2022 BIO CEO & Investor Conference
NEWTON, MA –Feb. 1, 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 Acer’s management team will virtually participate in the BIO CEO & Investor Conference on February 14-17, 2022. Format: On-demand […]
Read MoreAcer Therapeutics and Relief Therapeutics Announce Presentation of Four ACER-001 Posters at the Upcoming SIMD and GMDI Conferences
Data to be presented suggests ACER-001 could represent a potential alternative to sodium and glycerol phenylbutyrate for treatment of UCDs
NEWTON, MA and GENEVA, SWITZERLAND – Jan. 27, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced the acceptance of four ACER-001 abstracts for poster presentations at the upcoming Society for Inherited Metabolic Disorders (SIMD) Annual Meeting on April 10-13, 2022 […]
Read More