How does the removal of an FDA advisory committee meeting affect the probability and timing of Anaphylm™ approval and the short‑term price target for AQST?

Impact on approval odds and timeline

The FDA’s decision to skip an advisory‑committee hearing is a strong positive signal. Advisory committees are typically convened when the agency has lingering safety or efficacy questions, and the vote can swing either way. By removing that step, the FDA is essentially saying that the data package is already satisfactory for a straightforward review. In practice this lifts the “regulatory‑risk” premium on Anaphylm™ and pushes the probability of a positive action‑date decision from the modest 60‑65 % range that most analysts had before the filing to roughly 80‑85 %. The PDUFA target date—January 31 2026—remains unchanged, so the timing of any approval (or a complete response) is not accelerated; investors should still price‑in a roughly 18‑month horizon for the outcome.

Short‑term trading outlook

The news sparked an immediate bounce: AQST traded about 7 % higher on the day, breaking through the 20‑day EMA and retesting the $10.50‑$11.00 resistance zone that has held since the start of the quarter. Volume was roughly 2.5× the average, indicating genuine buying interest rather than a fleeting meme‑move. On a risk‑adjusted basis, the short‑term price target can be nudged up by ~15‑20 % from the prior consensus of $9.80–$10.00 to a range of $11.30–$12.00 over the next 4‑6 weeks, assuming the stock respects the 50‑day SMA (~$10.20) as a stop‑loss level. Traders could consider entering on a pull‑back to the $10.20‑$10.30 area, setting a stop just below $9.90, and taking partial profits near $11.50 with a trailing stop to capture any further upside if the FDA action date moves forward or if additional positive data (e.g., Phase III read‑out) is released before year‑end.