Welcome to our dedicated page for Acer Therapeutics news (Ticker: ACER), a resource for investors and traders seeking the latest updates and insights on Acer Therapeutics stock.
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) has announced that it has regained compliance with Nasdaq's minimum market value of listed securities standard, as confirmed by Nasdaq on March 30, 2022. The company had previously been notified on December 29, 2021, that it failed to meet the $35 million requirement for 30 consecutive business days. Following this notification, Acer's market value exceeded the threshold for 10 consecutive business days from March 16 to March 29, 2022, leading to the closure of the compliance matter.
Acer Therapeutics Inc. (Nasdaq: ACER) announced the enrollment of its first patient in a Phase 2a trial for ACER-801 (osanetant), aimed at treating moderate to severe Vasomotor Symptoms (VMS) linked to menopause.
The randomized, double-blind trial will assess varying doses of ACER-801 versus placebo in approximately 56 post-menopausal women over 14 days, followed by a safety evaluation. Results could provide essential proof of concept for ACER-801’s effectiveness, guiding further development for induced VMS treatments.
SWK Holdings Corporation (Nasdaq: SWKH) reported its fourth-quarter 2021 financial results, highlighting a total revenue of $15.0 million, representing a 38% increase from the prior year. The company closed four transactions between December 2021 and March 2022, deploying $38.5 million. Notably, Enteris received a $5.0 million milestone payment from Cara Therapeutics. Despite a 10.7% decrease in total investment assets to $189.7 million, non-GAAP adjusted net income rose to $9.5 million, a increase from $7.5 million year-over-year.
Acer Therapeutics Inc. (Nasdaq: ACER) announced the execution of convertible note and loan financing facilities totaling up to $48.5 million with Marathon Asset Management and SWK Holdings. The funds will be utilized to advance its pipeline, including ACER-001, pending FDA approval by June 5, 2022. Key financing details include a $6 million secured convertible note from Marathon and a $6.5 million secured loan from SWK, both maturing in 2025. The financing extends Acer's cash runway and supports ongoing clinical trials, addressing significant unmet medical needs in rare diseases.
Acer Therapeutics Inc. (Nasdaq: ACER) reported its financial results for Q4 and full year 2021, highlighting significant progress in its pipeline. The company filed a New Drug Application for ACER-001 and received patent approvals, with a PDUFA action date set for June 5, 2022. The cash position as of December 31, 2021, stood at $12.7 million, expected to fund operations into mid-2022. Despite a decreased net loss of $4.4 million in Q4, total annual losses were $15.4 million, reflecting ongoing investment in clinical trials and developments.
Acer Therapeutics has appointed Dr. Adrian Quartel as its new Chief Medical Officer, bringing over 20 years of drug development experience. His role will include overseeing clinical development and medical affairs. Dr. Quartel's background includes leadership positions at Adamas Pharmaceuticals and BioMarin Pharmaceuticals, where he launched six treatments for rare diseases. As part of his employment, he has been granted an option to purchase 200,000 shares of Acer’s stock. This strategic appointment aims to enhance Acer’s product pipeline and further its commitment to patients with serious rare diseases.
Acer Therapeutics Inc. (Nasdaq: ACER) announced its participation in the BIO CEO & Investor Conference from February 14-17, 2022. The event will feature an on-demand recorded corporate presentation and virtual one-on-one meetings. Acer focuses on developing therapies for rare, life-threatening diseases with unmet medical needs. Its product pipeline includes ACER-001 for metabolic disorders, ACER-801 for induced vasomotor symptoms, EDSIVO™ for vascular Ehlers-Danlos syndrome, and ACER-2820 targeting infectious diseases like COVID-19.
Acer Therapeutics and RELIEF THERAPEUTICS announced the acceptance of four abstracts for ACER-001 presentations at upcoming conferences, indicating strong potential for this treatment for urea cycle disorders (UCDs). The ACER-001 New Drug Application (NDA) is under FDA review with a target action date of June 5, 2022. CEO Chris Schelling expressed hope for ACER-001 as an alternative to existing therapies, addressing patient compliance issues. Presentations will occur at the Society for Inherited Metabolic Disorders Annual Meeting and the Genetic Metabolic Dieticians International Conference.
Acer Therapeutics Inc. (Nasdaq: ACER) announced participation in the upcoming 11th Annual LifeSci Partners Corporate Access virtual event and the H.C. Wainwright Global BioConnect Virtual Conference. The LifeSci event will feature one-on-one virtual meetings from January 5-7, 2022, while the H.C. Wainwright conference will present on-demand recordings on January 10, 2022. Acer focuses on developing therapies for serious rare diseases, with a diverse pipeline including ACER-001 for metabolic disorders and ACER-801 for induced vasomotor symptoms.
Acer Therapeutics Inc. (Nasdaq: ACER) has announced the FDA's clearance of its IND application for ACER-801, a selective non-peptide neurokinin 3 receptor antagonist, aimed at treating induced Vasomotor Symptoms (iVMS). A Phase 2a clinical trial is slated to begin in Q1 2022, contingent upon securing additional funding. This trial will assess the drug's safety, pharmacokinetics, and efficacy in alleviating menopause-related symptoms. Previous studies involving over 1,200 participants indicate a favorable safety profile for ACER-801.
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Has Acer regained rights to OLPRUVA™?
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