What is the potential market size for a therapy addressing Long COVID-related fatigue and cognitive impairment?

Potential market size

Long‑COVID now affects roughly 10–15 % of the >100 million Americans who have been infected with SARS‑CoV‑2, translating to 10–15 million patients in the U.S. alone. Clinical surveys and CDC data show that ≈ 30 % of those patients experience the two hallmark neurological sequelae that the ADDRESS‑LC trial is targeting—persistent fatigue and cognitive “brain‑fog.” That yields a addressable patient pool of roughly 3–4 million individuals in the United States. If a disease‑modifying therapy were priced at the mid‑range of existing chronic‑neurology products (≈ $15,000–$20,000 per patient per year) the U.S. addressable market (SAM) would be $45–$80 billion annually. Adding the EU (≈ 20 % of the U.S. prevalence) pushes the global TAM to $60–$110 billion, with a clear “first‑in‑class” premium for a therapy that improves functional capacity and reduces healthcare utilization (hospitalizations, outpatient visits, and disability claims). The market is further amplified by the projected 5‑7 % CAGR growth in the post‑viral neurology segment, driven by expanding payer recognition of long‑COVID as a chronic condition.

Trading implications

BioVie (BIVV) now has a clear path to a multi‑billion‑dollar market if the Phase 2 data confirm clinically meaningful improvement in fatigue and cognition. From a fundamental view, the company’s valuation currently reflects an early‑stage risk premium (clinical‑trial risk, regulatory uncertainty) and a modest market‑cap relative to the TAM. The technical picture shows BIVV trading near its 50‑day moving average with a modest bullish bias (sentiment = 45). A breakout above the 20‑day moving average, coupled with a rising relative strength index (RSI > 55), would likely trigger a short‑term rally as investors price‑in the TAM upside. Conversely, a miss in the primary endpoint could trigger a rapid decline to support levels around the 200‑day average.

Actionable take‑away: Keep a long‑biased watch on BIVV with a stop‑loss near the 200‑day average (~$1.50 if current price ≈$2.10) and consider a buy‑on‑breakout if the stock crosses $2.30 on volume confirming the breakout. The upside upside potential is large (multiple‑digit % upside) if the trial validates a first‑in‑class efficacy signal, but be mindful of the binary nature of Phase 2 outcomes and the need for a clear regulatory pathway (FDA’s “Post‑Acute Infection” pathway is still being defined). Position size should reflect the high binary risk; a 3‑5 % portfolio allocation is prudent for a speculative‑high‑reward play.