Video Guide
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.
Ticker
Drug | Disease (links)
Stage (next event)
Catalyst Date
BMY
PDUFA
Opdivo® (nivolumab) + Yervoy (ipilimumab)
Hepatocellular Carcinoma
April 21, 2025
CheckMate -9DW trial. 3/20/24- Reported Ph3 data, met primary endpoint w/ data at ASCO'24. 7/19/24- Received EMA validation, initiating procedural review. 8/21/24- sBLA acceptance. PDUFA date April 21, 2025. 1/31/25- Received positive CHMP opinion. 3/7/25- Received EC approval.
Approval decision
ABEO
PDUFA
Pz-cel (prademagene zamikeracel) EB-101 (COL7A1)
Recessive Dystrophic Epidermolysis Bullosa (RDEB)
April 29, 2025
VIITAL study. 11/27/23- Priority Review w/ PDUFA date May 25, 2024. 4/22/24- FDA CRL. Complete & submit requested CMC info in Q3 2024. 10/29/24- BLA resubmission. 11/12/24- BLA resubmission accepted with PDUFA date April 29, 2025.
Approval decision
MBRX
Phase 1b/2
Annamycin
STS (Soft Tissue Sarcoma) Lung Metastases
April 2025
MB-107 trial. 11/13/23- Positive interim data. Final data read-out in Q3 2024 & initiate 1st line STS study in Q3 '24. 3/21/25- CSR finalized but not yet submitted. Final data to be presented by the end of April 2025.
Data readout
ARQT
PDUFA
ARQ-154 topical roflumilast foam 0.3%
Scalp and body psoriasis
May 22, 2025
ARRECTOR trial. 10/13/23- Presentation at EADV Congress. 7/23/24- Submitted sNDA. 9/24/24- FDA accepted sNDA with PDUFA target action date of May 22, 2025. 3/7/25- Study results via poster presentation at AAD'25 on March 7-11, 2025.
Approval decision
LQDA
PDUFA
YUTREPIA (Treprostinil) (LIQ861)
PAH (Pulmonary Arterial Hypertension), PH-ILD (Pulmonary hypertension associated with interstitial lung disease)
May 23, 2025
9/25/23- Accepted submission to add PH-ILD, PDUFA set for 1/24/2024. 1/25/24- FDA would not make decision by initial target date. 4/1/24- Favorable legal & regulatory outcomes. 8/19/24- Tentative approval, final approval after expiration of 3-year regulatory exclusivity on May 23, 2025. 8/22/24 Files Litigation to Challenge Regulatory Exclusivity. 9/30/24 Presentation at CHEST 2024.
Approval decision
Amp Volatility is calculated based off of options pricing with expiration after event.
Last Calculated: 03/13/20
