Long COVID Phase 2 Misses Overall Endpoint but Hits Key Subgroups
BIVI sits 59% above its 52-week low of $0.82 on light trading volume (0.1× avg).
Summary
BioVie's Phase 2 ADDRESS-LC trial in Long COVID missed statistical significance in the overall intent-to-treat population, but pre-specified subgroups with higher baseline fatigue, post-exertional malaise, or cognitive impairment showed significant improvements versus placebo. The fatigue subgroup hit p=0.02 on the PROMIS Fatigue scale, and objective cognitive gains appeared in the high-PEM group, with safety comparable to placebo. The mixed readout supports an enriched Phase 3 design rather than a near-term regulatory path, and a $13.13M Department of Defense grant provides non-dilutive funding for the Long COVID program. This is the company's second clinical data point in recent months, following the positive Phase 2 SUNRISE-PD results in early Parkinson's disclosed in the August 6 8-K. The company remains under a going concern warning with roughly $9M in cash and a $6.5M at-the-market program in place, so any program funding matters.
At the time of this announcement, BIVI was trading at $1.30 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $10.2M. The 52-week trading range was $0.82 to $3.79. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.