Will Biohaven announce topline results from the RISE3 trial of opakalim in focal epilepsy by December 31, 2026?
deadline 2026-12-31
confidence medium
tier 4 evidence
68%PolySignal estimate
Resolution criterion
Yes if, no later than December 31, 2026, Biohaven publicly reports the topline results of the RISE3 trial of opakalim (the outcome on the primary endpoint, positive or negative) in a press release or SEC filing. The deadline is the last day of the period the company gave in its filing ("2H 2026"). An announcement of a delay or of a new timeline, enrollment or interim data that do not report the primary-endpoint outcome, or the absence of any announcement by that date, resolves NO.
Verified starting state
As of October 11, 2026: according to the Biohaven filing of August 26, 2026, the company expects topline results in the period "2H 2026". Source: https://www.sec.gov/Archives/edgar/data/1935979/000193597926000072/exhibit991-biohavenandskbi.htm
What pushes it up
- The Aug 26 2026 SEC filing explicitly states Biohaven expects topline results in 2H 2026 (tier 1).
- Enrollment in the RISE3 trial was completed by end‑June 2026, putting data collection on schedule (tier 4).
What pushes it down
- The only trial‑status reports are tier 4 press items; no tier 2 or tier 1 confirmation of an imminent data read‑out.
- Potential delays in data analysis, regulatory review, or unexpected safety/efficacy findings could push reporting past Dec 31 2026.
What would move this number most
Whether any unforeseen data‑analysis or regulatory issues will delay the read‑out beyond the 2H 2026 window.
How this number is built
| Deadline | 2026-12-31 |
| Base rate | 65% |
| Best evidence | tier 4 · 2 article(s) used |
| Independent runs | 68 · 68 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-12 16:34 |
| Model | openai/gpt-oss-120b (Groq) |
Sources consulted