Record mula sa primary source
Decision-gradePinalawig ang petsa ng PDUFA
Aldeyra: FDA nagpalawig ng reproxalap dry-eye NDA PDUFA hanggang Marso 16, 2026
Ang FDA ay nagpalawig ng PDUFA target action date para sa reproxalap’s NDA para sa dry eye disease mula Disyembre 16, 2025 hanggang Marso 16, 2026 matapos na uriin ang pagsusumite noong Disyembre 12, 2025 ng field-trial CSR bilang isang major amendment. Ang pagpapalawig ay nagbibigay sa ahensya ng karagdagang oras upang suriin ang CSR at tapusin ang labeling; walang ibang kakulangan na natukoy sa pulong noong Disyembre 12.
Mahahalagang fact
- Na-file
- Dis 16, 2025, 12:49 AM
- Kaganapan
- Pinalawig ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
ALDXAldeyra- Asset
- reproxalap
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Mar 16, 2026 · Complete response letter
Sipi mula sa source
EX-99.1 2 aldx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 News Release Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease Lexington, Mass. December 15, 2025 – Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026. Following submission on June 16, 2025, the NDA was accepted for review as a “complete class 2 response
Higit pa tungkol sa asset na ito
Kapansin-pansin
Hul 15, 2026
08:46 PM
ALDXAldeyraNagplano si Aldeyra ng Type D FDA meeting para sa muling paghahain ng NDA ng reproxalap
Decision-grade
Mar 17, 2026
12:39 PM
ALDXAldeyra