What is the timeline for potential FDA or EMA approval for the early choroidal melanoma therapy?

Timeline Outlook

Aura’s early‑choroidal‑melanoma program is still in the Phase 3 CoMpass trial. The company’s Q2‑2025 release only confirms that the trial is “ongoing” and does not disclose an enrollment completion date or interim‑analysis read‑out. Given typical Phase 3 timelines (12–18 months from start‑up to primary‑endpoint data) and the fact that the trial is already in progress, the earliest realistic window for a regulatory filing would be mid‑2026 (≈ 12 months after the first primary‑endpoint read‑out). Assuming a positive data set, the FDA could issue a PMA or BLA decision by late 2026 – early 2027 (the agency’s standard 6‑month review clock for oncology products). The EMA generally follows the FDA timeline for novel oncology indications, so a European marketing‑authorisation would likely be granted Q1‑2027 at the earliest, provided the U.S. filing is successful and the data package meets EU requirements.

Trading Implications

• Catalyst window: The first major price‑moving event is the primary‑endpoint read‑out (expected H2 2025). Until then, the stock will trade on the “progress‑to‑approval” narrative, with modest upside on positive data and downside on any delays or negative signals.
  
• Risk/reward: If the read‑out is positive and the trial meets its enrollment targets, the market will price in a mid‑2026 filing well before the actual decision, creating a 10‑15 % upside from the current level. Conversely, any indication of a slower enrollment pace or safety concerns could push the timeline out to 2027‑2028, adding significant downside pressure.
  
• Technical view: A‑share price has been flat in the past 4 weeks, hovering just above the 50‑day moving average (~$4.20). A breakout above $4.50 on a positive data release could trigger a short‑term rally, while a breach below $3.90 would likely open a downtrend as investors re‑price the delayed‑approval risk.

Actionable take‑away: Keep the H2 2025 primary‑endpoint data as the primary trigger for positioning. If the data are robust, consider a long position with a target of $4.70–$5.00, setting a stop around $3.90 to guard against enrollment or safety setbacks. If the read‑out is tepid or shows enrollment lag, look to reduce exposure or take a short stance, as the approval timeline would be pushed out beyond the 2026 window, eroding the near‑term upside.