How does the FDA feedback received impact the timeline and likelihood of trial success?

The FDA’s recent feedback—delivered alongside Health Canada’s No‑Objection Letter—allowed Taysha to move forward with site activation for the REVEAL pivotal trial. Because the agency did not request any substantive protocol changes, the company can keep its original enrollment window of Q4 2025, meaning the trial timeline remains essentially on‑track. In regulatory terms, this alignment signals that the FDA views the trial design as acceptable and that the data package will likely satisfy the agency’s evidentiary standards, which historically translates into a higher probability of a successful read‑out.

From a market perspective, the removal of a major regulatory hurdle reduces downside risk and narrows the “regulatory‑delay” discount that many investors still price in. Assuming the trial proceeds without further interruptions, the stock could capture upside on any positive interim data or a favorable final outcome. Traders should therefore consider a long‑biased stance on TSHA with a modest risk‑managed exposure, while still monitoring for any subsequent FDA correspondence that could alter the enrollment schedule or trial endpoints. A breakout above current resistance levels would validate the market’s belief in an accelerated path to potential approval, whereas a breach of support could indicate lingering concerns about execution or data quality.