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Acer Therapeutics Inc. (Nasdaq: ACER), based in Cambridge, MA, is a pioneering biotechnology company focused on developing repurposed and reformulated medicines to address ultra-orphan diseases with significant unmet medical needs. Acer's flagship product, OLPRUVA™ (sodium phenylbutyrate), was approved by the FDA in December 2022 and targets urea cycle disorders (UCDs), conditions that prevent the body from removing waste nitrogen, leading to serious health issues. OLPRUVA™ is now available in all dosage strengths and is supported by a dedicated patient support team through Navigator by Acer Therapeutics to ensure seamless prescription management and patient care.
In addition to OLPRUVA™, Acer is also developing EDSIVO™ (celiprolol) for vascular Ehlers-Danlos syndrome (vEDS) and has paused the development of ACER-801 (osanetant) for Vasomotor Symptoms (VMS) and other conditions. The company is actively engaged in discussions with major pharmacy benefits managers and government payers to secure insurance coverage for OLPRUVA™, which is expected to be included in commercial insurance plans by the second half of 2023 and Medicaid programs by the third quarter of 2023.
Acer has recently regained worldwide rights to OLPRUVA™ (excluding Geographical Europe) from Relief Therapeutics, allowing the company to reinvest more capital into potential lifecycle expansion opportunities. This move aims to maximize the global commercialization of OLPRUVA™, ensuring it reaches as many patients in need as possible.
The company's strategic focus on rare diseases underscores its commitment to transforming the lives of patients with limited treatment options, leveraging innovative solutions like OLPRUVA™ to address critical health challenges globally.
Acer Therapeutics Inc. (Nasdaq: ACER) reported financial results for Q4 and the full year ended December 31, 2022. The company achieved its first FDA product approval for OLPRUVA™ (sodium phenylbutyrate), a treatment for urea cycle disorders. As of Q4 2022, Acer had $2.3 million in cash. Research and development expenses increased to $11.9 million for the year, up from $6.5 million in 2021. The net loss for 2022 was $26.2 million, or $1.66 per share, compared to $15.4 million in 2021. Upcoming milestones include the U.S. launch of OLPRUVA™ expected in July 2023, pending available capital.
Acer Therapeutics Inc. (Nasdaq: ACER) released survey findings indicating that taste and odor significantly influence Urea Cycle Disorder (UCD) treatment adherence. Presented at the SIMD Annual Meeting, the survey revealed that healthcare providers rated their satisfaction with current options as low (mean rating 5.4/9). These findings underscore the need for improved treatment formulations, with Acer's OLPRUVA™ showcasing an innovative approach to enhance palatability. The company remains dedicated to addressing unmet medical needs in UCDs while advancing its clinical pipeline for various conditions.
Acer Therapeutics has announced a definitive agreement to sell 2,920,306 shares of its common stock at a price of $0.916 per share in a registered direct offering. The concurrent private placement will issue warrants for the same number of shares, with an exercise price of $0.791. The offering, expected to close around March 24, 2023, is projected to generate gross proceeds of approximately $2.675 million, which will be used for general corporate purposes and working capital. H.C. Wainwright & Co. is the exclusive placement agent for this offering.
Acer Therapeutics Inc. (Nasdaq: ACER) announced that its Phase 2a trial for ACER-801 showed it was safe but did not achieve statistical significance in reducing hot flash frequency or severity in postmenopausal women. As a result, the program will be paused for a detailed data review. The company continues to prepare for the commercial launch of OLPRUVA™ for urea cycle disorders and is advancing the Phase 3 trial of EDSIVO™ for vascular Ehlers-Danlos syndrome. Acer's CEO expressed disappointment about the trial's outcome and emphasized the importance of conducting a thorough analysis of the data.
Acer Therapeutics Inc. (ACER) announced the upcoming presentation of survey data on treatment preferences for Urea Cycle Disorders (UCDs) at the SIMD Annual Meeting from March 18-21, 2023. Preliminary launch activities for OLPRUVA™, a new treatment for UCDs using sodium phenylbutyrate, are advancing, with expectations for drug availability in early July 2023. The commercialization strategy includes establishing a patient support service, OLPRUVA™ Navigator, aimed at enhancing patient adherence. Acer plans to competitively price OLPRUVA™ below current alternatives, focusing on accessibility for patients while investing revenue into improving patient outcomes.
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