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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

ELVN

Phase 1

ELVN-002 monotherapy

NSCLC & other solid tumors

2025

8/13/24 Ph1 monotherapy data in 2025.

Data readout

TEVA

PDUFA

TVB-009P (denosumab) (Prolia Biosimilar)

Osteoporosis in postmenopausal women

H2 2025

10/8/24- Teva Prolia® biosimilar candidate accepted for review by FDA (BLA) & EU EMA (MAA). Decision by both agencies in H2 2025.

Approval decision

BPTS

Phase 2

Sarconeos (BIO101) (20-hydroxyecdysone)

Obesity

2025

OBA Study: 7/11/24 IND approval. Study start by mid-2024 and preliminary results on the efficacy in 2025

Data readout

REGN

Phase 2/3

Fianlimab + Libtayo® (cemiplimab)

Metastatic melanoma

2025

5/26/23- Data from three independent cohorts. Present at ASCO 2023. 2/2/24 Pivotal initial results from Phase 2/3 study in 2025

Data readout

EXEL

Phase 3

Zanzalintinib + atezolizumab

mCRC (Metastatic colorectal cancer)

H2 2025

STELLAR-303 trial: 8/6/24- Enrollment completed. 1/25/25- Preliminary data in H2 2025 focusing on OS in patients without liver metastases.

Data readout

IONS

Phase 3

Pelacarsen

Cardiovascular Disease Lp(a) CVD

2025

Partnered with Novartis. Phase 3 data & filing in 2025

Data readout

RNA

Phase 3

Delpacibart Etedesiran (Del-desiran) (AOC 1001)

DM1 (Myotonic Dystrophy Type 1)

Q4 2025

MARINA, MARINA-OLE, HARBOR trials: 11/8/23- Presented new data WMS '23. 02/28/24- Present OLE data at MDA clinical & scientific conf. on 03/04/24. 10/3/24- FDA lifted clinical hold. 1/13/25- Additional Ph1/2 data in Q1 '25. Complete enrollment in Ph3 HARBOR trial in mid-2025. OLE data in Q4 '25. NDA submission in 2026.

Data readout

AUTL

Phase 1

AUTO8 (BMCA & CD19)

Multiple Myeloma

2025

MCARTY clinical trial initiated in Q1 2022. 12/9/23- Initial data at ASH 2023. 5/17/24 - enrollment completed. Data update in 2025.

Data readout

INZY

Phase 3

INZ-701 (ENPP1-Fc)

Pediatric patients with ENPP1 Deficiency aged >1 to <13 years

Early 2026

ENERGY 3 trial. Presentation at ICCBH '24. 1/10/25- Enrollment completed; dosing completion in January 2026 w/ topline data in early 2026.

Data readout

INSM

Phase 3

ARIKAYCE (Amikacin Liposome Inhalation Suspension)

Refractory NTM lung disease (Refractory Nontuberculous mycobacterial lung disease), MAC lung disease (Mycobacterium avium complex)

Q1 2026

Sept 2018- approved. Two post marketing confirmatory trials: ARISE (data 9/5/23) and ENCORE. Expect topline data for ENCORE in Q1 2026.

Data readout

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

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