ALDX

What is the anticipated timeline for clinical‑trial milestones and potential FDA approval for ADX‑2191?

Created August 19, 2025 at 11:11 AM

Anticipated timeline

2024 – 2025: With the FDA’s Fast‑Track designation now in place, Aldeyra will likely file an updated IND‑type meeting this year and commence a Phase 2/2b pivotal trial in the second half of 2024. Assuming a 12‑month enrollment window (typical for RP natural‑history end‑points) and a 6‑month data‑readout, the first mid‑stage read‑out can be expected by mid‑2025 and the primary efficacy read‑out by late 2025 / early 2026.
2026 – 2027: If the pivotal data meet the Fast‑Track‑enabled efficacy thresholds, Aldeyra would submit a Regulatory‑Approval Application (RAA) in the first half of 2026. The FDA’s standard 6‑month review clock for Fast‑Track products would place a potential approval decision in the late 2026 to early 2027 window, assuming no major advisory committee delays.

Trading implications

Short‑term (next 3–6 months): The fast‑track news is a catalyst that already lifted ALDX shares on modest volume. Expect continued up‑trend as the market prices in the accelerated path to pivotal data. Technicals remain in a bullish channel (above the 50‑day SMA, with the 20‑day EMA holding at ~$1.12). A breakout above the recent high (~$1.30) could trigger short‑term momentum‑play entries.
Mid‑term (2025‑2026): The mid‑stage read‑out will be the next major catalyst. Positive interim data should push the stock toward the $1.50–$1.70 range; a miss could trigger a corrective swing back to the $1.00‑$1.10 support zone. Position sizing should be modest, with stop‑losses just below the 20‑day EMA to protect against the high‑volatility biotech environment.
Long‑term (2026‑2027): A successful RAA and FDA approval would be a binary catalyst for a multi‑fold rally, potentially propelling ALDX into the $2.00–$2.50 range as the first FDA‑approved therapy for most forms of retinitis pigmentosa. Until then, maintain a core long‑position with a trailing stop around 15 % below the current price to capture upside while limiting downside if trial data falter.