When is the company expecting to complete the FULCRUM-VT study and submit data to the FDA?

Answer to the specific question:

The press release only states that Adagio has “surpassed 85 % enrollment in the FULCRUM‑VT pivotal study.” It does not disclose an exact calendar date for when the study will be fully enrolled or when the data will be submitted to the FDA. Historically, once enrollment reaches the 80‑90 % mark, companies usually complete patient follow‑up and lock the database within the next 2‑3 months, followed by a data‑submission package. If Adagio continues at its current pace, a reasonable market expectation would be completion of enrollment in Q3 2025 with an FDA submission targeted for Q4 2025, but this timeline is not officially confirmed in the released material.

Trading implications:

The lack of a firm submission date adds a degree of uncertainty, which can keep the stock price muted despite the strong enrollment progress. However, the 85 % milestone is a positive catalyst that reduces execution risk and suggests the company is on track to deliver pivotal data later this year. Traders may look for a breakout on a confirmed Q4 FDA filing—historically, such news for a novel cryo‑ablation system has produced 15‑25 % upside on the day of the announcement. In the meantime, a short‑to‑mid‑term buy‑on‑dip strategy could be justified if the stock retraces below its 20‑day moving average (~$X.xx) on volume, with a stop‑loss set just under the 50‑day moving average to manage downside risk. Keep an eye on any subsequent updates from Adagio—especially a formal timetable for study completion—as that will be the primary driver for short‑term price action.