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Acer Therapeutics Inc. (Nasdaq: ACER) reported its Q3 2021 financial results, highlighting significant corporate developments. The FDA accepted its NDA for ACER-001, targeting a PDUFA date of June 5, 2022. Additionally, the company received a formulation patent for ACER-001, extending its proprietary position until 2036. Cash and equivalents stood at $14.2 million, sufficient to sustain operations through mid-2022. The net loss for Q3 2021 narrowed to $3.3 million ($0.23 per share), compared to $5.9 million ($0.51 per share) in Q3 2020.
Acer Therapeutics announced the issuance of a new U.S. patent for its formulation of ACER-001 (sodium phenylbutyrate), enhancing its intellectual property protection until 2036. The patent covers a taste-masked, multi-particulate dosage for oral administration, vital for treating Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD). Management expressed confidence in advancing ACER-001 towards commercialization, with a planned submission to the FDA for the Orange Book listing, contingent on receiving marketing approval.
Acer Therapeutics Inc. and its partner RELIEF THERAPEUTICS announced the issuance of a Notice of Allowance for ACER-001's formulation patent by the USPTO, strengthening its proprietary position in the U.S. until 2036. The patent covers taste-masked, multi-particulate oral dosage forms aimed at treating Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD). If approved, Acer plans to submit the patent for FDA listing. Additionally, both companies are pursuing similar claims in Europe for ACER-001, with a Marketing Authorization Application anticipated in Q2/Q3 2022.
Acer Therapeutics Inc. announced that the FDA has accepted the New Drug Application (NDA) for ACER-001 for treating Urea Cycle Disorders (UCDs), with a target action date set for June 5, 2022. This NDA is backed by two bioequivalence trials, indicating ACER-001's effectiveness compared to the reference drug, BUPHENYL. CEO Chris Schelling expressed optimism about the review process. Additionally, Relief Therapeutics, its collaboration partner, plans to submit a Marketing Authorization Application (MAA) in Europe in Q2/Q3 2022.
Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on therapies for rare and life-threatening diseases, will present at the H.C. Wainwright Global Investment Conference from September 13-15, 2021. The presentation will be available on demand starting September 13 at 7 AM ET, along with one-on-one investor meetings. Acer’s pipeline includes ACER-001 for inborn errors of metabolism, ACER-801 for vasomotor symptoms, EDSIVO™ for vascular Ehlers-Danlos syndrome, and ACER-2820 for infectious diseases. More details can be found on their website.
Acer Therapeutics Inc. (Nasdaq: ACER) reported Q2 2021 financial results, highlighting significant progress in its product pipeline. The company submitted an NDA for ACER-001 for Urea Cycle Disorders and plans to initiate two IND submissions by Q4 2021. The cash position increased to $22.1 million, aiding operations into mid-2022. Net loss was $3.2 million, a reduction from $5.8 million compared to the same quarter last year. Recent corporate developments include key management hires to strengthen the team.
Acer Therapeutics Inc. (Nasdaq: ACER) has submitted a New Drug Application (NDA) to the FDA for ACER-001, a treatment for Urea Cycle Disorders (UCDs). This submission follows successful bioequivalence trials confirming ACER-001's efficacy compared to existing treatments. The FDA is expected to notify Acer regarding the NDA's acceptance within 60 days. The drug aims to provide an alternative solution for UCD patients, particularly addressing adherence issues with current therapies. ACER-001 is still investigational and has not received FDA approval.
Acer Therapeutics Inc. (NASDAQ: ACER) and Relief Therapeutics have submitted a New Drug Application (NDA) to the FDA for ACER-001 (sodium phenylbutyrate) aimed at treating Urea Cycle Disorders (UCDs). This nitrogen-binding agent supports chronic management of UCDs and is based on favorable bioequivalence study results. FDA notification on NDA acceptance is expected within 60 days. Acer is also preparing for a potential launch while working towards a European Marketing Authorization Application.
Acer Therapeutics (Nasdaq: ACER) announced plans to initiate a pivotal Phase 3 clinical trial for EDSIVO™ (celiprolol) in patients with COL3A1+ vascular Ehlers-Danlos Syndrome (vEDS). Following a Type B meeting with the FDA, Acer received positive feedback on the trial design, including plans for a decentralized approach and the use of an independent adjudication committee. The trial aims to enroll approximately 200 patients over an estimated 3.5 years. Funding of up to $10 million is necessary to proceed, with potential sources including cash reserves and partnerships. EDSIVO™ is not currently FDA approved.
Acer Therapeutics and Relief Therapeutics have reported a positive outcome from their pre-New Drug Application (NDA) meeting with the FDA regarding ACER-001, a treatment for Urea Cycle Disorders (UCDs). The FDA feedback indicates that the planned data package is likely sufficient for the NDA submission under Section 505(b)(2). The companies aim to complete the NDA submission by Q3 2021, pending agreement on the initial pediatric study plan. ACER-001, an investigational sodium phenylbutyrate formulation, is designed to address the unmet needs in UCD treatment.
