Acer Therapeutics Inc. Stock Price, News & Analysis

Acer Therapeutics Inc. (Nasdaq: ACER) recently announced that its management will participate in two significant upcoming conferences: the Gilmartin Group Emerging Growth Company Showcase and the H.C. Wainwright 24th Annual Global Investment Conference. The recorded presentation for the Gilmartin conference will be available on August 31, 2022, at 10:30 am ET, while the H.C. Wainwright presentation will go live on September 12, 2022, at 7 am ET. These presentations will focus on Acer's commitment to developing therapies for serious, rare diseases.

Acer Therapeutics Inc. (Nasdaq: ACER) reported its Q2 2022 results with a net loss of $2.7 million, or $0.17 per share, improved from a loss of $3.1 million in Q2 2021. As of June 30, 2022, cash and equivalents stood at $14.5 million. The FDA accepted the NDA resubmission for ACER-001 for urea cycle disorders, with a PDUFA date of January 15, 2023. Additionally, Acer initiated a pivotal Phase 3 trial for EDSIVO™ for vascular Ehlers-Danlos Syndrome and plans to report Phase 2a results for ACER-801 in Q4 2022.

Acer Therapeutics has received orphan medicinal product designation from the European Commission for ACER-001 (sodium phenylbutyrate), targeting treatment for Maple Syrup Urine Disease (MSUD). This designation, following a similar one from the FDA in 2014, indicates the potential for up to 10 years of market exclusivity in the EU. The ongoing clinical trials suggest that ACER-001 may effectively reduce harmful branched-chain amino acids in patients with MSUD. Currently, the only treatment option is a restrictive diet, underscoring the urgent need for an approved therapy.

Acer Therapeutics (Nasdaq: ACER) and RELIEF THERAPEUTICS announced the submission of an Investigational New Drug (IND) application to the FDA for ACER-001 (sodium phenylbutyrate) targeting Maple Syrup Urine Disease (MSUD). This rare metabolic disorder, if untreated, can cause severe neurological issues. The upcoming Phase 2a trial aims to assess ACER-001's effect on blood leucine and branched-chain amino acids in MSUD patients. The drug is already designated as an orphan drug by the FDA for MSUD and is also part of Acer's broader development pipeline.

Acer Therapeutics announced the acceptance of its resubmitted New Drug Application (NDA) for ACER-001 by the FDA. This follows a Complete Response Letter where additional inspections were needed. The PDUFA target date for FDA action is January 15, 2023. Acer is optimistic about the review process as it has stated that its contract manufacturer is ready for inspection. If approved, ACER-001 will provide a new treatment option for patients with urea cycle disorders (UCDs), marking a key commitment to addressing rare diseases.

Acer Therapeutics Inc. has resubmitted its New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) to the FDA for treating urea cycle disorders (UCDs). This resubmission addresses all requested items from the FDA's previous Complete Response Letter (CRL). The company confirmed that its third-party contract manufacturer is ready for inspection, which is a crucial requirement for NDA approval. The FDA's response regarding this resubmission is expected within 14 days. ACER-001 has not yet received regulatory approval.

Acer Therapeutics Inc. announced the issuance of a key patent for its drug ACER-001 in China, valid until August 2031. The patent covers a polymer-coated formulation of sodium phenylbutyrate, aimed at treating urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD). This milestone strengthens Acer's intellectual property portfolio and supports its plans for potential commercialization in China. ACER-001 is currently under investigation and has not yet received regulatory approval.

Acer Therapeutics Inc. (NASDAQ: ACER) has initiated patient screening for its Phase 3 DiSCOVER trial of EDSIVO™ (celiprolol), targeting COL3A1-positive vascular Ehlers-Danlos Syndrome (vEDS). This trial aims to establish EDSIVO™ as the first approved treatment for this life-threatening condition. The trial will involve approximately 150 patients in a randomized, placebo-controlled design, assessing clinical event reduction. Completion is projected within 3.5 years, necessitating additional funding. EDSIVO™ has not yet received FDA approval, and its market potential is significant as there are currently no approved therapies for vEDS.

Acer Therapeutics Inc. (ACER) has promoted Tanya Hayden to Chief Operating Officer, enhancing the company's operational and commercial strategy. Previously serving as Vice President, Hayden has been pivotal in advancing investigational programs, particularly for ACER-001, aimed at treating urea cycle disorders. Harry S. Palmin remains as Chief Financial Officer, a role he held alongside COO. This leadership change is expected to drive growth and streamline operations as the company approaches key milestones in its product pipeline.