Catalyst Database

STARGLO study. Ph3 data in 2024. 6/15/24 - Met primary endpoint of overall survival and secondary endpoints. Presented data at EHA '24. 12/4/24- sBLA accepted with PDUFA date July 20, 2025.

IGNYTE/IGNYTE-3 study. 9/9/24- Pre-BLA Meeting. 9/15/24- Primary analysis data at ESMO '24. 11/9/24- Primary analysis data at SITC '24. 11/21/24- Received BTD and submitted BLA to FDA. 1/21/25- BLA accepted. PDUFA action date of July 22, 2025, with priority review.

ESMO 2025 Abstract release dates: July 25, 2025 for regular abstracts; September 20, 2025 for late-breaking abstracts.

AAIC meeting dates: July 27-31, 2025. See more about conference on their website: https://aaic.alz.org/

AAIC abstracts release (and embargo lifts) on date of conference presentation. See more about the embargo policy: https://aaic.alz.org/press/pressroom.asp#embargo

foresiGHt trial. Presentation at ECE & ESPE 2023. 12/19/23 Positive top-line data. Submit sBLA in Q3 2024. Presentation at ENDO '24. 9/30/24- Submitted sBLA. 12/12/24- Accepted sBLA w/ PDUFA goal date of July 27, 2025.

APHENITY Ph3 trial. Results and primary endpoint achieved. 3/28/24- Submitted MAA at EMA. Regulatory submissions in Japan & Brazil in 2024. 5/28/24- European MAA validation. 7/30/24- Submitted NDA to FDA. 10/1/24- FDA accepted NDA. 10/14/24 PDUFA action date set for 7/29/25.

OLYMPIA-1, ELM-1 and ELM-2 trials. 8/17/23- EMA accepts MAA. 12/10/23 Updated data at ASH '23. 9/29/23- Accepted BLA w/ PDUFA date 3/31/2024. 3/25/24- Received CRL. 6/28/24- Recommended for EU approval by the CHMP. 8/26/24 EU approval. 2/26/25- BLA accepted. PDUFA target action date July 30, 2025.

ASRS 2025 meeting dates: July 30 - August 2, 2025. Embargoes on abstracts will lift after the corresponding live meeting presentations.

Abstract release dates: July 30 - August 2, 2025. Embargoes on abstracts will lift after the corresponding live meeting presentations.