What are the key milestones (clinical trial read‑outs, FDA submissions, approvals) required before the revenue forecast can be realized?

Key milestones that must be hit before Tevogen’s $1 bn launch‑year revenue can be materialised

Trading implications

• Near‑term risk: Until the IND and Phase 1 read‑out, the $1 bn forecast is highly speculative. Any safety signal or delay in filing will compress the timeline and depress the stock. Expect heightened volatility around the first Phase 1 data (likely Q4 2025).
  
• Mid‑term catalyst: A robust Phase 2 read‑out (e.g., ≥ 30 % overall response in the infectious‑disease cohort) would de‑risk the BLA and could trigger a “buy‑on‑breakout” rally, as the market prices in the probability of a 2028 launch.
  
• Long‑term upside: If the company secures priority‑review status and hits the 2028 FDA decision window, the upside to the current price could be 150‑200 % given the $1 bn launch‑year revenue versus the current market cap. Conversely, a missed PDUFA or a negative advisory‑committee vote would likely trigger a 50‑70 % sell‑off.
  

Bottom line: The $1 bn launch‑year revenue is contingent on a sequential chain of regulatory milestones—IND → early‑phase read‑outs → pivotal data → BLA → FDA approval → commercial launch. Each step adds a discrete probability filter; traders should monitor the timing and data quality of the Phase 1/2 read‑outs most closely, as they set the odds for the downstream BLA and approval that ultimately unlock the revenue forecast. A disciplined, milestone‑driven position‑sizing approach—light exposure pre‑IND, scaling up after a positive Phase 2 read‑out, and full conviction post‑FDA approval—will best capture upside while managing the high regulatory risk inherent in Tevogen’s model.