HCW Biologics, Inc. ( HCWB ) shares are trading higher on Monday after the company announced clearance from the Food and Drug Administration (FDA) for its Phase 1 trial of HCW9302.

The Details: The company’s HCW9302 is a potential treatment for moderate-to-severe alopecia areata, which is an autoimmune disease. Currently, there are no curative FDA-approved treatments for the disease.

The Phase 1 trial aims to establish a safe and effective dose of HCW9302. If successful, the company will proceed with Phase 2 studies to test the drug in other autoimmune diseases and inflammatory conditions, including dermatological disorders and diabetes.

Alopecia areata causes sudden hair loss and can have a significant negative impact on a patient’s quality of life and psychological health.

“The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative immunotherapeutic treatment of autoimmune diseases. This trial is a milestone for our Company, and the beginning of clinical development of treatments for quality-of-life indications,” said Dr. Hing C. Wong, Founder and CEO of HCW.

HCW stock is trading on higher than normal session volume at 311.50 million shares. The company’s average session volume over the past 100 days is 9.61 million shares, according to data from Benzinga Pro.

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HWCB Price Action: At the time of writing HCW stock is trading 138.7% higher at 66 cents, per data from Benzinga Pro.

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