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Taldefgrobep alfa

Alternative Names: Taldefgrobep alfa, tadefgrobep alfa, rg-6206, rg 6206, rg6206, bms-986089, bms986089, bms 986089, ro-7239361, ro 7239361, ro7239361, BHV-2000, BHV2000, BHV 2000
Clinical Status: Active
Latest Update: 2025-01-30
Latest Update Note: Clinical Trial Update

Product Description

For Duchenne Muscular Dystrophy; (Sourced from: https://www.chugai-pharm.co.jp/english/profile/media/conference/files/181024ePresentation.pdf)

Mechanisms of Action: GDF8 Inhibitor

Novel Mechanism: Yes

Modality: Peptide/Protein

Route of Administration: Subcutaneous

FDA Designation: Fast Track - Muscular Atrophy, Spinal|Muscular Atrophy
Orphan Drug - Muscular Atrophy, Spinal|Muscular Atrophy *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: Bristol-Myers Squibb

Clinical Description

Map of Global Clinical Trials for Taldefgrobep alfa

Countries in Clinic: Belgium, Czech Republic, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States

Active Clinical Trial Count: 3

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Muscular Atrophy, Spinal|Spinal Diseases

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated
RESILIENT

P3

Active, not recruiting

Spinal Diseases|Muscular Atrophy, Spinal

2025-01-01

45%

2023-10-06

Patient Enrollment|Primary Endpoints|Treatments|Trial Status
RESILIENT

P3

Active, not recruiting

Muscular Atrophy, Spinal

2025-11-02

2025-05-23

Treatments
BHV2000-301

P3

Active, not recruiting

Muscular Atrophy, Spinal

2025-10-08

2025-05-02

Treatments

Recent News Events

Date

Type

Title

01/13/2025

News Article

 Biohaven Highlights Portfolio Progress, Innovation, and Anticipated Milestones at the 43rd Annual J.P. Morgan Healthcare Conference; Reports Positive Degrader Data with Rapid, Deep, and Selective Lowering of Galactose-Deficient IgA1 with Next Generation Potential Therapy for IgA Nephropathy

05/29/2024

News Article

 Biohaven Showcases Broad Innovative Portfolio and Pipeline Updates Across Multiple Therapeutic Areas including Immunology, Neuroscience, Metabolic Disorders and Oncology at Annual Investor R&D Day

02/01/2024

PubMed

 The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy.

01/08/2024

News Article

 Biohaven Highlights Progress Across Innovative Portfolio and Outlines 2024 Anticipated Milestones at the 42nd Annual J.P. Morgan Healthcare Conference; Established Extensive Portfolio Across 20 Therapeutic Indications in Neuroscience, Immunology and Oncology

01/01/2024

PubMed

 Stride Velocity 95th Centile Detects Decline in Ambulatory Function Over Shorter Intervals than the 6-Minute Walk Test or North Star Ambulatory Assessment in Duchenne Muscular Dystrophy.

11/14/2023

News Article

 Biohaven Reports Third Quarter 2023 Financial Results and Recent Business Developments

08/01/2020

PubMed

 Immunotherapy in Hodgkin and non-Hodgkin lymphoma: Innate, adaptive and targeted immunological strategies.

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