Acer Therapeutics Inc. Stock Price, News & Analysis

Acer Therapeutics has announced significant developments, including the FDA approval of OLPRUVA™ (sodium phenylbutyrate) for treating urea cycle disorders. CEO Chris Schelling emphasized the importance of this milestone for patients with rare diseases. Acer is also advancing the ACER-801 program for vasomotor symptoms, PTSD, and prostate cancer, with topline results expected in Q1 2023. Furthermore, the ongoing Phase 3 trial of EDSIVO™ for vascular Ehlers-Danlos syndrome is on track. Key milestones for 2023 include various trial results and the expansion of OLPRUVA™ applications.

Acer Therapeutics has launched two investigator-sponsored Phase 2 trials, POSH-MAP and PORT-MAP, to assess the efficacy of ACER-801 (osanetant) in men with prostate cancer. These trials will evaluate osanetant's ability to alleviate hot flashes and suppress testosterone production within 28 days. Each trial involves about 10 participants receiving 200mg of osanetant twice daily. Results will inform the potential of ACER-801 in addressing treatment-related symptoms in men undergoing androgen deprivation therapy (ADT). The company also highlights ongoing evaluations of ACER-801 for other indications.

Acer Therapeutics Inc. (Nasdaq: ACER) has confirmed that it has regained compliance with Nasdaq's $35 million market value requirement for continued listing on the Nasdaq Capital Market. This notification means the previously scheduled hearing before the Nasdaq Hearings Panel has been canceled. Acer focuses on developing therapies for rare and life-threatening diseases, with its product OLPRUVA™ approved for treating urea cycle disorders. The company also has several investigational candidates in its pipeline for various serious conditions.

Acer Therapeutics has announced the FDA's approval of OLPRUVA™ (sodium phenylbutyrate) for treating certain patients with urea cycle disorders (UCDs). This marks the first FDA-approved product for Acer, enhancing treatment options for patients suffering from harmful ammonia accumulation. The approval enables Acer to access $42.5 million in non-dilutive debt funding, extending its cash runway into H2 2023. This innovative formulation is designed to improve patient compliance and management of UCDs, thereby addressing significant unmet medical needs in this rare disease.

Acer Therapeutics Inc. (Nasdaq: ACER) announced a private placement agreement resulting in gross proceeds of $1.5 million. The transaction involves the issuance of 1,229,508 shares of common stock at $1.22 per share, a 5.2% premium over the previous closing price. Investors include CEO Chris Schelling and Chairman Steve Aselage. The funds will primarily support working capital and are expected to cover operational needs through Q4 2022. The placement is set to close on or around December 2, 2022, subject to customary conditions.

Acer Therapeutics Inc. (Nasdaq: ACER) reported its Q3 2022 financial results, ending the quarter with $6.4 million in cash. The quarterly net loss was $5.0 million, or $0.31 per share, compared to a net loss of $3.3 million, or $0.23 per share in Q3 2021. The company resubmitted its New Drug Application (NDA) for ACER-001 to the FDA, with a new PDUFA date of January 15, 2023. Recent developments include initiating a pivotal Phase 3 trial for EDSIVO™ and expanding ACER-801's application for PTSD treatment. The company plans to report topline results from ACER-801's clinical trial in Q1 2023.

Acer Therapeutics Inc. announced a Notice of Allowance from the USPTO for its patent application No. 16/930,208 related to treating vascular Ehlers-Danlos syndrome (vEDS) with celiprolol. This patent strengthens Acer's proprietary position in the U.S. until 2038. The application pertains to treatment methods used in the ongoing Phase 3 DiSCOVER clinical trial of EDSIVO™ (celiprolol) for patients with COL3A1-positive vEDS. The company expects to submit the patent for FDA listing upon marketing approval, which remains contingent on trial outcomes.

Acer Therapeutics announced a $3 million grant awarded to the University of North Carolina for a 180-patient trial aimed at evaluating ACER-801 (osanetant) for acute stress disorder and PTSD. The trial is part of the OASIS initiative, focusing on trauma patients to investigate ACER-801’s potential to reduce symptoms following traumatic events. Enrollment is expected to start in the first half of 2023, pending FDA approval. The trial builds on findings from the AURORA initiative, enhancing research efficiency while addressing a significant unmet need in trauma recovery.

Acer Therapeutics Inc. (Nasdaq: ACER) has announced the expansion of ACER-801 (osanetant) for treating post-traumatic stress disorder (PTSD). The company has licensed worldwide rights from Emory University to patents regarding osanetant's use in reducing PTSD severity. Studies show that osanetant targets specific brain cells involved in fear memory consolidation, potentially decreasing PTSD incidence among trauma victims. With up to 20% of trauma survivors developing PTSD, this could impact over 12 million adults in the US annually. Acer plans to release its clinical development plan for ACER-801 soon.