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Video Guide

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Catalyst Database

Chronological list of catalyst events. Click "See Drug Details" to view detailed info in our AmpCard. Use the Sort options or search box below (e.g. "Phase 2") to filter the catalyst results.

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Drug | Disease (links)

Stage (next event)

Catalyst Date

MRK

PDUFA

WELIREG® (belzutifan)

Advanced pheochromocytoma and paraganglioma (PPGL)

May 26, 2025

Ph2 LITESPARK-015 trial. 1/27/25- sNDA accepted for priority review with PDUFA target action date of May 26, 2025.

Approval decision

ETON

PDUFA

ET-400 (Hydrocortisone Oral Solution)

Adrenocortical Insufficiency

May 28, 2025

4/30/24- Submitted NDA. 7/15/24- FDA accepted NDA. 3/18/25- PDUFA goal date extended to May 28, 2025.

Approval decision

Meeting

Biomedical meeting

American Society of Clinical Oncology (ASCO)

Cancer

May 30- June 3, 2025

ASCO meeting dates: May 30 - June 3, 2025

Meeting dates

Meeting

Biomedical meeting

American Society of Clinical Oncology (ASCO)

Cancer

Late-May 2025

ASCO abstracts releases on Late-May 2025, at 5:00 PM (ET). Late-breaking Abstracts will be released at 7:00 AM CT on their day of presentation at the meeting

Abstract Release

IFRX

Phase 3

Vilobelimab (IFX-1)

PG (Pyoderma gangraenosum)

May 2025

8/10/23- Submitted clinical trial protocol to FDA. 11/6/23 - First patient dosed. 2/28/25- Present data at AAD'25 on March 8, 2025. 3/20/25- Interim analysis by the end of May 2025.

Data readout

Meeting

Biomedical meeting

European Hematology Association (EHA)

Blood cancer

Jun 3, 2025

EHA abstracts release date: May 14, 2025 (15:30 CEST) & June 3, 2025 (15:30 CEST) LBAs

Abstract Release

MRK

PDUFA

Clesrovimab (MK-1654)

Respiratory Syncytial Virus (RSV) Disease

June 10, 2025

MK-1654-004 study. 10/9/24- Ph2b/3 data presented at IDWeek 2024 on October 16-19, 2024. 12/17/24- BLA accepted with PDUFA date of June 10, 2025.

Approval decision

Meeting

Biomedical meeting

European Hematology Association (EHA)

Blood cancer

June 12-15, 2025

EHA meeting dates: June 12-15, 2025

Meeting dates

URGN

PDUFA

UGN-102 (mitomycin)

Low Grade (LG) Non Muscle Invasive Bladder Cancer (NMIBC)

June 13, 2025

ATLAS, ENVISION trials. 7/27/23- Topline data met primary endpoints. 8/14/24- Completed NDA submission. 10/17/24- NDA accepted. PDUFA target date of June 13, 2025. 12/5/24- Long term data reported. 2/14/25- Presented at ASCO GU '25.

Approval decision

KALV

PDUFA

Sebetralstat (KVD900) (film coated)

Hereditary Angioedema

June 17, 2025

KONFIDENT trial. 2/13/24- Topline data, met all endpoints. 6/18/24- Submitted NDA. 8/15/24- EMA validated MAA. 9/3/24- Accepts NDA, PDUFA date June 17, 2025. 9/30/24- Additional MAA submissions. 3/3/25- Interim & pooled data at AAAI/WAO '25. Investor webcast on Mar 25th.

Approval decision

Amp Volatility is calculated based off of options pricing with expiration after event.
Last Calculated: 03/13/20

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