Why Aridis Pharmaceuticals Shares Are Soaring Today

Aridis Pharmaceuticals Inc. ARDS shares popped over 100% Wednesday afternoon after the company announced it received an agreement from the FDA on a single confirmatory Phase 3 study of AR-301.

What To Know: AR-301, an investigational monoclonal antibody candidate, is being developed as an adjunctive therapy in combination with standard of care antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus in mechanically ventilated hospitalized patients.

The FDA agreed on the design of the single confirmatory Phase 3 superiority study required to support the submission of a Biologics License Application, as well as a proposed expansion of the trial and clinical efficacy endpoints.

"We are particularly gratified to reach concurrence with the FDA on the overall study design, endpoints, and patient populations," said Aridis CEO Vu Truong. "This provides a clear clinical and regulatory pathway to bring AR-301 to patients with high unmet medical needs and enhances the opportunity for potential pharma partners."

Related Link: Why Is Ambarella (AMBA) Stock Trading Down Today?

ARDS Price Action: Shares of ARDS were up 140.5% at 45 cents at publication time, according to Benzinga Pro.

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