What is the expected timeline for key milestones (e.g., interim data readout, NDA filing) from this trial, and how might those dates influence price movement? | ALRT (Aug 15, 2025) | Candlesense

What is the expected timeline for key milestones (e.g., interim data readout, NDA filing) from this trial, and how might those dates influence price movement?

Milestone timetable

Allarity’s press release says enrollment in the advanced Phase 2 ovarian‑cancer study has just begun. In a typical oncology Phase 2 program, the first interim efficacy read‑out is scheduled about 6 months after the first patient is dosed, giving the company enough follow‑up to generate a meaningful tumor‑response signal. Assuming the trial kicks off in early Q3 2025, the interim data window would fall in late Q4 2025 / early Q1 2026. A full‑study read‑out (and the data package needed for a NDA filing) usually follows 12‑15 months after enrollment start, putting the NDA‑ready submission in the mid‑2026 window (June‑August 2026).

Price impact

  • Late‑2025 interim read‑out: Markets tend to price in a “binary” move around the first efficacy signal. If the data show a ≄30 % response rate or a clear survival benefit, the stock could rally 20‑35 % on the day of release, as investors re‑price the probability of a successful NDA. Conversely, a modest or negative signal often triggers a 15‑25 % sell‑off and a widening of the bid‑ask spread. Expect heightened volatility, tighter options premiums, and a spike in trading volume.
  • Mid‑2026 NDA filing: An NDA filing is a catalyst that historically triggers a “completion” premium for biotech equities. Assuming the trial meets its primary endpoints, the market could add another 25‑40 % to the price as the prospect of a U.S. approval looms. If the filing is delayed or the data package is weak, the stock may have already burned off much of its upside, leading to a prolonged downtrend.

Trading take‑aways

  1. Position ahead of the interim (Q4 2025/Q1 2026) – consider a modest long position or a delta‑neutral options structure (e.g., long call/short put) to capture upside while limiting downside risk. A stop‑loss around 12‑15 % below the entry price can protect against a negative read‑out.
  2. Watch the volume‑price relationship – a breakout on high volume at the interim point signals strong conviction; a breakout on thin volume may be a false move.
  3. Mid‑2026 positioning – if the interim is positive, scale in ahead of the anticipated NDA filing; if the interim is weak, consider a short‑bias or a put‑spread to profit from the likely price correction.

In short, the late‑2025 interim data is the first price‑moving event, and the mid‑2026 NDA filing is the second, larger catalyst. Align exposure to these dates, using tight risk controls, to capitalize on the expected volatility spikes.