Catalyst Biosciences

Biotech

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 3 drugs with upcoming expirations

Activity

Key Events

Oct 26, 2023FDAAgamree — AGAMREE

May 17, 2021TrialStudy of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders

May 4, 2021TrialStudy of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

Sep 24, 2019TrialStudy of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

Jun 18, 2019TrialStudy of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B

Nov 28, 2018FDAFirdapse — FIRDAPSE

Dec 18, 2017TrialStudy of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B

Details

Company Info

Company Overview

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Mkt Cap

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Revenue

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Cash

Patent Expirations

7 patent groups across drugs · Source: FDA Orange Book

DrugExpires

FycompaJul 1, 2026 Agamree3 patentsMay 28, 2029 Firdapse4 patentsJun 29, 2032 AgamreeMar 7, 2033 FirdapseMay 26, 2034 FirdapseFeb 25, 2037 Agamree3 patentsMar 17, 2040

Regulatory

Regulatory Timeline

20121 event

FDAOct 22

Fycompa — FYCOMPA

Application NDA202834 (NDA)

20161 event

FDAApr 29

Fycompa — FYCOMPA

Application NDA208277 (NDA)

20181 event

FDANov 28

Firdapse — FIRDAPSE

Application NDA208078 (NDA)

20231 event

FDAOct 26

Agamree — AGAMREE

Application NDA215239 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)