Acer Therapeutics Inc. (ACER) stock prices were up by 7.44% as of the market close on August 6th, 2021, bringing the price per share up to USD$2.60 at the end of the trading day. Subsequent premarket fluctuations saw the stock decrease by 1.54%, bringing it up to USD$2.56.
ACER-001 NDA
August 9th 2021 saw ACER stock announce the submission of a New Drug Application (NDA) to the United States Food and Drug Administration. The application was submitted for the company’s proprietary ACER-001 (sodium phenylbutyrate) treatment for Urea Cycle Disorders (UCDs). The treatment is a nitrogen-binding agent that is being developed for adjunctive therapeutic use in the chronic management of patients with UCDs. These UCDs are associated with deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
ACER Stock Expecting Approval
ACER stock expects a notice from the FDA about the potential acceptance of the NDA within 60 days of submission. This is based on standard FDA review timelines and the execution of a substantive review following the submission of the NDA. The 505(b)(2) NDA submission is consolidated with the results from two previously announce bioequivalence (BE) trials. These trials showed ACER to demonstrate similar relative bioavailability for both active metabolite of phenylbutyrate (BA) and phenylacetate (PAA) as compared to BUPHENYL(R).
ACER Stock’s Expansive Scope
The company also received an agreement letter from the FDA in regard to ACER stock’s initial Pediatric Study Plan (iPSP). This plan covers an approach that was previously agreed upon as a means to address the needs of pediatric patients with UCDs. Combined, these developments bring the company closer to the provision of these potential alternative treatment options to patients with UCDs.
Global Expansion
Bolstered by the success of the progress made in support of the regulatory approval of ACER-001 in the United States, ACER stock is keen to expand its scope globally. The company is continuing efforts to stay on track to facilitate the development of the treatment in Europe, primarily with the submission of a Marketing Authorization Application (MAA) for the commercial launch of ACER-001 in Europe by the end of 2021.
Future Outlook for ACER Stock
Armed with the encouraging developments to support the commercial launch of ACER-001 in the United States, ACER stock is keen to work with the FDA. The company is taking steps to ensure the most effective commercialization and proliferation of its proprietary treatment. Investors are confident that this will ensure the most consistent and significant increases in shareholder value.
