Catalyst Database

11/5/24- Successful meeting w/ FDA. 12/19/24- BLA submitted. 2/5/25- New positive data & presentation at WORLDSymposium '25. 2/18/25- BLA accepted & priority review with PDUFA date August 18, 2025.

MOVE-FA Ph3 trial. Data read out on 5/23/23, primary endpoints not met. In Q1 '24, held type C meeting w/ FDA, path for NDA submission based on Ph3 & ongoing OLE data. Coordinating w/ EMA for marketing in EEA w/ outcome in Q1 2024. 12/19/24- NDA submitted. 2/19/25- NDA accepted, granted priority review. PDUFA target action date August 19, 2025.

Ph3 OASIS-HAE study. 1/22/24 Positive Top-line data. 5/31/24- Presented results. Submit NDA to FDA and MAA at EMA in 2024. 10/3/24- Present new data at ACAAI '24. 11/4/24 Accepts NDA, PDUFA date for 8/21/25. Presentation at AAAAI / WAO '25.

01/2023- Enrollment completed. 01/16/24- Received EC ODD. 8/14/24- Initiated confirmatory trial enrollment. 12/2024- Submitted BLA. 2/25/25- FDA granted priority review for BLA with PDUFA date August 27, 2025.

1/13/25- FDA accepted sNDA w/ PDUFA target action date of August 28, 2025.

Collab w/ Eisai. SC formulation. 5/15/24- Initiates Rolling BLA. 10/31/24- Completes rolling submission to FDA. 11/15/24- Receives positive opinion from CHMP. 1/13/25- BLA accepted with PDUFA action date set for August 31, 2025.

AERIFY-1 & AERIFY-2. w/ Sanofi. Complete Ph3 enrollment in H2 '24. Data in 2025.

HOPE-2/HOPE-3 trials. 1/2/25- Completed BLA submission. 3/4/25- BLA accepted and priority review. PDUFA target action date August 31, 2025. 3/17/25- Long-term data from ongoing HOPE-2 OLE trial presented at MDA 2025.

RECON study. 5/16/24- Initiated BLA rolling submission. 9/6/24- Completed BLA submission. 11/1/24- BLA accepted with PDUFA goal date of September 5th, 2025. FDA does not currently plan to hold an Adcom.

WCLC meeting dates: September 6-9, 2025. See more info on the website : https://wclc.iaslc.org/