Vaxxinity Gets Fast Track designation from FDA For Alzheimer's disease Candidate UB-311

Vaxxinity, Inc. VAXX announced that UB-311 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease.

UB-311 has been well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo in the Phase 2a clinical trials

Mei Mei Hu, Chief Executive Officer of Vaxxinity. Said, ”We are on an encouraging clinical path for UB-311 and look forward to collaborating with the FDA and other global regulatory agencies to bring UB-311 expeditiously to the global market. Because our vaccine approach allows for more convenient administration and broad access, UB-311 is positioned to potentially lead a paradigm shift in the treatment, and even prevention, of Alzheimer’s disease."

Vaxxinity is planning to initiate Phase 2b trial evaluating UB-311 in late 2022.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Vaxxinity is trading down 15 percent at $5.91