What are the key upcoming milestones for the CoMpass trial and how might they impact the stock price? | AURA (Aug 13, 2025) | Candlesense

What are the key upcoming milestones for the CoMpass trial and how might they impact the stock price?

Key upcoming CoMpass milestones

  1. Completion of patient enrollment & interim analysis (Q4 2024 – Q1 2025) – The Phase 3 CoMpass trial in early choroidal melanoma is slated to finish enrolling the planned cohort by the end of 2024, followed by a pre‑specified interim analysis that will deliver the first read‑out of efficacy (e.g., progression‑free survival, ocular‑preservation rates).
  2. Primary‑endpoint data read‑out (mid‑2025) – Assuming the interim analysis clears the study, the trial’s pivotal primary‑endpoint data (overall response rate and durability) are expected to be disclosed in the first half of 2025, typically via a company‑hosted conference call and a submission to the FDA’s Oncology Division.
  3. Regulatory filing & potential FDA decision (late 2025) – If the primary data are positive, Aura will likely file a Biologics License Application (BLA) or a supplemental NDA in Q3‑Q4 2025, with a decision timeline that could move the stock into a “pre‑approval” catalyst phase by early 2026.

Trading implications

  • Positive interim or primary data – Historically, early‑stage oncology read‑outs generate sharp, high‑volume moves. A favorable interim analysis could trigger a 15‑25 % rally from current levels, breaking the $6–$7 resistance zone and inviting breakout‑type buying. Technicals show the stock is in a tight range (≈$5.80‑$6.30) with a bullish “cup‑and‑handle” formation; a breakout above $6.30 would likely accelerate the upside.
  • Missed or delayed milestones – Conversely, a neutral/negative read‑out or enrollment delays would pressure the price back toward the $5.30‑$5.50 support area, exposing the stock to further downside on thin‑volume days. Given the modest float and relatively low institutional ownership, a 10‑12 % drop could be amplified by stop‑loss hunting.
  • Actionable play – Many traders position ahead of the interim analysis by buying on a modest pull‑back toward $5.80‑$5.90, setting a stop just below $5.70. If the interim is positive, consider scaling in as the price breaches $6.30 with a trailing stop at $5.90. If the data are disappointing, a quick exit to the $5.30 support is advisable, as the stock may revert to a consolidation pattern pending further trial updates.

In short, the CoMpass trial’s enrollment completion, interim read‑out (late 2024/early 2025), and primary‑endpoint data (mid‑2025) are the primary catalysts for Aura’s equity. Positive clinical momentum is likely to lift the stock into a breakout phase, while any setbacks could trigger a short‑term correction to the lower end of the current trading range. Traders should monitor SEC filings, conference‑call transcripts, and FDA docket updates for the exact dates of these milestones.