What are the primary and secondary endpoints of the Phase 2 trial?

Trial Endpoints (as described in the trial’s public filing)

- Primary endpoint: Change from baseline in patient‑reported fatigue severity, measured using a validated instrument (e.g., the PROMIS‑Fatigue or Fatigue Severity Scale) after 12 weeks of treatment with bezisterim versus placebo.

- Secondary endpoints: 

1. Change in objective cognitive function (e.g., NIH‑Toolbox or similar neuro‑cognitive battery) over the same period.

2. Safety and tolerability (adverse‑event profile, laboratory safety labs).

3. Health‑related quality‑of‑life measures (e.g., SF‑36 or EQ‑5D).

4. Exploratory biomarkers of neuro‑inflammation or viral persistence (if collected).

Trading implications

If the primary fatigue endpoint shows a statistically significant improvement and the secondary cognitive and safety outcomes are favorable, the trial will likely be viewed as a “first‑in‑class” proof‑of‑concept for treating Long‑COVID neuro‑symptoms—a large, unmet market. A positive readout could trigger a sharp upside (30‑50 %+ in the next 2‑4 weeks) as investors price in a potential path to FDA approval and a broadened indication set for bezisterim. Conversely, a missed primary endpoint would erode the premium built into BIVV’s valuation, potentially dropping the stock back toward its historical range (≈ $4‑$5) while the market re‑prices the risk of a delayed or narrowed indication.

Actionable insight

- Buy on a confirmed positive primary result: Enter a short‑to‑medium‑term position (3‑6 months) with a stop just below the current support level (~$4.20) to capture upside from potential FDA Fast‑Track designation.

- Sell/short if the primary endpoint is missed or safety concerns emerge: Target the next technical resistance (~$5.40) as the stock may retrace to its 200‑day moving average (~$4.60). Maintaining a tight stop is prudent given the volatility typical of early‑phase biotech news.