What does the completion of the 26‑week extension enrollment indicate about the trial’s timeline for Phase 2b or potential FDA submission?

What the 26‑week enrollment tells us about the trial clock

Skye’s announcement that the 26‑week extension arm of the Phase 2a CBeyond™ study is now fully enrolled is a log‑istical milestone, not a data‑generation point. With enrollment closed, the company can immediately begin the 52‑week observation period and the 13‑week post‑extension safety follow‑up. In practice this means:

1. Data‑generation window opens now – the first signals on durability, efficacy and safety will start to trickle in over the next 12‑14 months.
   
2. Phase 2b timing is anchored to those read‑outs – assuming the 52‑week dataset meets or exceeds the pre‑specified statistical thresholds, Skye can package the results and file a Phase 2b amendment or a “p‑Series” meeting request with the FDA in the second half of 2025 (roughly 18–24 months from today).
   
3. FDA filing outlook – the 52‑week primary endpoint will likely be the cornerstone of a B‑track submission. If the data are positive, Skye could target a 2026‑early‑2027 B‑track NDA (or a Breakthrough Therapy designation filing) because the regulatory timetable normally adds 3‑6 months after the pivotal data are submitted.

Trading implications

• Short‑term catalyst: The market often rewards the removal of enrollment uncertainty with a modest upside move. Expect a 5‑8 % bump in volume‑weighted price as investors reposition ahead of the first 52‑week read‑outs.
  
• Technical backdrop: Skye is trading near its 20‑day SMA with RSI at ~45 – still room for a bounce without hitting overbought levels. A breach of the 20‑day SMA on higher volume would be a bullish signal; a failure to hold could signal a sell‑off as the stock may have already priced in the “good news” effect.
  
• Positioning: Given the still‑long horizon to meaningful efficacy data, a moderate‑risk, long‑bias position (e.g., 5–10 % of capital in a 6‑12 month horizon) is appropriate. Protect upside with a stop just below the 20‑day SMA (≈ $‑2% from current levels). If the 52‑week interim looks robust, consider scaling into the next wave ahead of a Phase 2b announcement.
  

Bottom line: Completion of the 26‑week enrol­lment clears the path for data generation, nudging the earliest Phase 2b or FDA engagement into the mid‑2025 window and a potential B‑track submission in 2026. The news is a short‑term bullish catalyst, but the real price driver will be the quality of the 52‑week read‑outs that follow. Traders should take the current rally as a entry‑point reset, keep risk modest, and stay primed for a more decisive move once those data emerge.