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
Allarityâs press release says enrollment in the advanced PhaseâŻ2 ovarianâcancer study has just begun. In a typical oncology PhaseâŻ2 program, the first interim efficacy readâout is scheduled aboutâŻ6âŻmonths after the first patient is dosed, giving the company enough followâup to generate a meaningful tumorâresponse signal. Assuming the trial kicks off in early Q3âŻ2025, the interim data window would fall in late Q4âŻ2025âŻ/âŻearly Q1âŻ2026. A fullâstudy readâout (and the data package needed for a NDA filing) usually follows 12â15âŻmonths after enrollment start, putting the NDAâready submission in the midâ2026 window (JuneâAugustâŻ2026).
Price impact
- Lateâ2025 interim readâout: Markets tend to price in a âbinaryâ move around the first efficacy signal. If the data show a â„30âŻ% response rate or a clear survival benefit, the stock could rally 20â35âŻ% on the day of release, as investors reâprice the probability of a successful NDA. Conversely, a modest or negative signal often triggers a 15â25âŻ% sellâoff and a widening of the bidâask spread. Expect heightened volatility, tighter options premiums, and a spike in trading volume.
- Midâ2026 NDA filing: An NDA filing is a catalyst that historically triggers a âcompletionâ premium for biotech equities. Assuming the trial meets its primary endpoints, the market could add another 25â40âŻ% 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 takeâaways
- Position ahead of the interim (Q4âŻ2025/Q1âŻ2026) â consider a modest long position or a deltaâneutral options structure (e.g., long call/short put) to capture upside while limiting downside risk. A stopâloss around 12â15âŻ% below the entry price can protect against a negative readâout.
- Watch the volumeâprice relationship â a breakout on high volume at the interim point signals strong conviction; a breakout on thin volume may be a false move.
- Midâ2026 positioning â if the interim is positive, scale in ahead of the anticipated NDA filing; if the interim is weak, consider a shortâbias or a putâspread to profit from the likely price correction.
In short, the lateâ2025 interim data is the first priceâmoving event, and the midâ2026 NDA filing is the second, larger catalyst. Align exposure to these dates, using tight risk controls, to capitalize on the expected volatility spikes.