Positive FDA Feedback Propels Aridis Pharmaceuticals (ARDS)
LOS GATOS, Calif. (AP) — Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) has emerged as the volume leader in the stock market today, with its shares experiencing a significant surge. The company’s stock price currently stands at $0.38, reflecting a change of +0.20 (+107.51%).
The positive momentum follows the recent announcement made by Aridis Pharmaceuticals regarding feedback received from the U.S. Food and Drug Administration (FDA) regarding the proposed single confirmatory Phase 3 study of its investigational monoclonal antibody candidate, AR-301. This potential therapy is being developed as an adjunctive treatment, in combination with standard of care antibiotics, for pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.
In key agreements with the FDA, Aridis Pharmaceuticals confirmed that the regulatory agency has approved the design of the single confirmatory Phase 3 superiority study, which is necessary to support the submission of a Biologics License Application (BLA). Additionally, the FDA has given its approval for the proposed expansion of the confirmatory Phase 3 study to include ventilated hospital-acquired pneumonia (HAP) and ventilated community-acquired pneumonia (CAP) patients, in addition to S. aureus ventilator-associated pneumonia (VAP) patients.
The primary efficacy endpoint of the study will focus on older adults aged 65 years and above. This decision is based on the observation that the absolute efficacy in the previous Phase 3 superiority trial, AR-301-002, was higher in older adults compared to the overall population. The study revealed a +34% improvement on Day 21 (p=0.057) and a +38% improvement on Day 28 (p=0.025) in older adults, as opposed to an +11% improvement (p=0.24) in the overall population.
The confirmatory Phase 3 superiority trial, known as AR-301-003, will be adequately powered to measure efficacy in both the primary efficacy endpoint for adults aged 65 years and above, as well as the key secondary efficacy endpoint for all study subjects, including individuals both above and below the age of 65.
Investors have responded positively to this news, leading to a surge in Aridis Pharmaceuticals’ stock volume, which currently stands at 164.4 million shares.
This story is sourced from Yahoo Finance and is attributed to them.
Disclaimer: This article is for informational purposes only and should not be considered as financial advice. Please consult with a professional investment advisor before making any investment decisions.