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Acer Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding the NDA for ACER-001 (sodium phenylbutyrate) for treating urea cycle disorders (UCDs). The FDA stated that an inspection cannot proceed due to a third-party packaging manufacturer not being ready. Importantly, no concerns were raised regarding the drug's efficacy, safety, or pharmacokinetics. Acer plans to address the FDA's comments and intends to resubmit the NDA by early-to-mid Q3 2022.
Acer Therapeutics Inc. (Nasdaq: ACER) announced on June 7, 2022, that it has not yet received a decision from the FDA regarding its 505(b)(2) New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) aimed at treating urea cycle disorders (UCDs). The NDA was accepted for review on October 5, 2021, with a target action date of June 5, 2022. However, the FDA has communicated that the review is still ongoing and no new target date has been established. Acer plans to issue a press release following the FDA's decision.
Acer Therapeutics Inc. (Nasdaq: ACER) reported Q1 2022 financial results, ending March 31, with a net loss of $9.2 million or $0.64 per share, compared to a $4.6 million loss or $0.33 per share in Q1 2021. The company ended the quarter with $20.8 million in cash. Significant milestones ahead include an FDA decision on ACER-001's NDA by June 5, 2022, and the initiation of a Phase 3 trial for EDSIVO™ by the end of Q2 2022. R&D expenses increased to $3.2 million due to higher contract manufacturing and clinical costs.
Acer Therapeutics Inc. (Nasdaq: ACER) is advancing its pivotal Phase 3 DiSCOVER clinical trial of EDSIVO™ (celiprolol) for treating COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS). The company has reached a Special Protocol Assessment agreement with the FDA, confirming the trial design's adequacy. The trial aims to enroll approximately 150 patients to assess EDSIVO™'s efficacy in reducing serious clinical events. Following a Breakthrough Therapy designation from the FDA in April 2022, the trial is set to begin by the end of Q2 2022, with results expected in about 3.5 years.
Acer Therapeutics (Nasdaq: ACER) and Relief Therapeutics presented data on ACER-001 at the GMDI Conference on May 5, 2022. ACER-001, a sodium phenylbutyrate formulation, showed bioequivalence to BUPHENYL® powder under both fed and fasting conditions. The studies also reported similar safety profiles. The FDA's PDUFA target action date for ACER-001 is June 5, 2022, with plans for a EU marketing application submission if approved. The findings underscore the potential of ACER-001 as a new therapeutic option for Urea Cycle Disorders (UCDs).
Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, RLFTY) presented data on ACER-001 (sodium phenylbutyrate) at the GMDI Conference on May 5, 2022. The studies demonstrated that ACER-001 is bioequivalent to BUPHENYL under fasting and fed conditions, with no major safety concerns. The companies anticipate a decision from the FDA regarding the new drug application on June 5, 2022, and plan to submit a marketing application in the EU later this year. ACER-001 aims to address unmet needs in Urea Cycle Disorders.
Acer Therapeutics Inc. (Nasdaq: ACER) announced its participation in the H.C. Wainwright Global Investment Conference from May 24-26, 2022. The event will feature an on-demand recorded presentation and one-on-one virtual meetings starting at 7:00 am ET on May 24. Acer focuses on therapies for serious, rare diseases with unmet medical needs, including programs like ACER-001 for metabolic disorders and ACER-801 for induced vasomotor symptoms. The company aims to develop treatments with favorable safety profiles and accelerated regulatory paths.
Acer Therapeutics Inc. (Nasdaq: ACER) and Relief Therapeutics presented new data on their sodium phenylbutyrate product, ACER-001, at the Society for Inherited Metabolic Disorders Annual Meeting. The studies showed that ACER-001 is bioequivalent to BUPHENYL® powder under both fasting and fed conditions, with no major safety issues reported. These findings support ACER-001 as a potential alternative for Urea Cycle Disorder (UCD) patients. The FDA's target action date for ACER-001's new drug application is June 5, 2022.
Acer Therapeutics (NASDAQ:ACER) and Relief Therapeutics (SIX:RLF, OTCQB:RLFTF, RLFTY) presented data on ACER-001 at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting held from April 10-13, 2022. The studies demonstrated that taste-masked sodium phenylbutyrate (ACER-001) is bioequivalent to BUPHENYL® under both fasting and fed conditions, with similar safety profiles. The FDA's PDUFA date for ACER-001 is set for June 5, 2022, with potential benefits for patients with urea cycle disorders (UCDs). The findings highlight ACER-001 as a promising alternative therapy.
Acer Therapeutics Inc. (Nasdaq: ACER) announced that the FDA has granted Breakthrough Therapy designation for celiprolol to treat patients with COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS). This designation aims to expedite drug development for serious conditions. The company is seeking agreement on the proposed Phase 3 DiSCOVER trial, which aims to enroll approximately 150 patients in the U.S. The trial is expected to take about 3.5 years to complete. EDSIVO™ is currently investigational and not FDA-approved.
