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Aridis Pharmaceuticals, Inc. (NASDAQ: ARDS) is a biopharmaceutical company based in Los Gatos, California, focused on developing innovative anti-infective therapies for life-threatening infections. The company leverages its proprietary ʎPEX™ and MabIgX® technology platforms to identify potent B-cells from patients who have successfully overcome infections and rapidly manufacture monoclonal antibodies (mAbs) for therapeutic use. These mAbs are already of human origin and do not require further engineering optimization to achieve full functionality.
Aridis is advancing multiple clinical-stage mAbs targeting bacteria and viruses that cause severe infections such as ventilator-associated pneumonia (VAP) and hospital-acquired pneumonia (HAP). The company’s novel approach addresses the limitations of current broad-spectrum antibiotics, such as increasing drug resistance, short duration of efficacy, and disruption of the human microbiome.
Highlighted in Aridis' pipeline are seven key products:
- AR-301 (VAP/HAP/CAP): A fully human IgG1 mAb targeting Staphylococcus aureus alpha-toxin, currently in Phase 3 clinical development.
- AR-320 (VAP): A fully human mAb for the prevention of VAP caused by S. aureus, in Phase 3 clinical development.
- AR-501 (Cystic Fibrosis): An inhaled formulation of gallium citrate to treat chronic lung infections in cystic fibrosis patients, in Phase 2a clinical study.
- AR-701 (COVID-19): A cocktail of fully human mAbs targeting SARS-CoV-2 spike proteins.
- AR-101 (HAP): A fully human IgM mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa liposaccharides serotype O11.
- AR-201 (RSV Infection): A fully human IgG1 mAb directed against the F-protein of respiratory syncytial virus (RSV), licensed to the Serum Institute of India.
- AR-401 (Blood Stream Infections): A preclinical mAb program targeting gram-negative Acinetobacter baumannii.
Aridis has recently achieved significant milestones including positive Phase 2a results for AR-501, FDA and EMA agreement on AR-301 Phase 3 study design, and multiple grants from the National Institute of Allergy and Infectious Diseases (NIAID). The company continues to explore strategic partnerships to advance its clinical programs and maximize value for shareholders.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) received a notice from Nasdaq on April 19, 2023, regarding its non-compliance with Listing Rules due to the late filing of its Form 10-K for the year ended December 31, 2022. The Due Date for this filing was April 17, 2023. While this notice doesn't immediately affect ARDS's securities listing, the company must appeal to a Hearings Panel within seven days to avoid suspension. Aridis is already under review for failing to meet the $35 million minimum market value requirement. The company is working diligently to complete and submit the Form 10-K as soon as possible, emphasizing its commitment to compliance.
Aridis Pharmaceuticals (Nasdaq: ARDS) announced a corporate update, highlighting a significant development regarding its candidate AR-320. MedImmune Limited has terminated their license for AR-320 due to payment issues, placing its Phase 3 study on hold. The company seeks resolution while emphasizing commitment to its pipeline, including AR-301 and AR-501, which show positive clinical data. Operating expenses have decreased due to the trial pause, and employee headcount is now at 26. Feedback from FDA and EMA on AR-301’s study design is expected by the end of April 2023.
Aridis Pharmaceuticals (Nasdaq: ARDS) has announced a registered direct offering of 6 million shares of common stock at $0.38 per share, expected to close around March 16, 2023. The offering aims to raise approximately $2.28 million before expenses, with proceeds designated for working capital and general corporate purposes. H.C. Wainwright & Co. is the exclusive placement agent. This transaction utilizes a previously filed shelf registration statement with the SEC. The company develops innovative anti-infectives and has multiple monoclonal antibody candidates in various stages of clinical development.
Aridis Pharmaceuticals (Nasdaq: ARDS) announced promising preliminary results from its Phase 2a study of AR-501, aimed at treating cystic fibrosis patients with Pseudomonas aeruginosa infections. Key findings include that AR-501 demonstrated safety and met pharmacokinetic endpoints, with no serious adverse events reported. Patients received three inhaled doses, achieving over 50-fold higher sputum concentrations than needed to inhibit the bacteria. The study showed better respiratory uptake compared to previous intravenous formulations, setting a foundation for further efficacy studies. Aridis plans to engage regulatory bodies to discuss next steps.
RedChip Companies announced that interviews featuring Rail Vision Ltd. (RVSN), Aridis Pharmaceuticals, Inc. (ARDS), and Digital Ally, Inc. (DGLY) will be aired on The RedChip Money Report on Bloomberg TV on February 18, 2023, at 7 p.m. ET. This program reaches approximately 73 million homes across the U.S., offering significant exposure for the companies involved. Rail Vision aims to enhance railway safety and efficiency through AI technology, while Aridis focuses on developing innovative anti-infectives. Digital Ally engages in video solutions and health protection products, expanding its business through strategic acquisitions.
Aridis Pharmaceuticals (Nasdaq: ARDS) announced top-line results from the AR-301-002 Phase 3 study, assessing the efficacy of the monoclonal antibody AR-301 in treating ventilator-associated pneumonia (VAP) caused by S. aureus. The study enrolled 174 ICU patients but fell short of its target of 240 due to pandemic-related disruptions. Results showed a clinical cure rate of 68.9% for AR-301 plus standard care, compared to 57.6% for standard care alone, although statistical significance was not achieved (p=0.23). Notably, older patients showed a 34% improvement in clinical cure at Day 21 (p=0.057). Plans for a second Phase 3 study are underway to further investigate AR-301's potential.
Aridis Pharmaceuticals (NASDAQ: ARDS) announced participation in a Key Opinion Leader (KOL) event on January 24, 2023, focusing on anti-infective treatments for cystic fibrosis (CF) patients. This event highlights the company's Phase 2a trial of AR-501, an inhaled formulation of gallium citrate aimed at treating chronic lung infections in CF patients. Experts, including Dr. Jane E. Gross and Dr. Noah Lechtzin, will discuss the treatment landscape, with Aridis' CEO and Chief Medical Officer also participating. The event underscores the potential of AR-501 in addressing unmet medical needs in CF.
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