salanersen (BIIB115) / Biogen, Ionis - LARVOL DELTA

STELLAR-2: A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (clinicaltrials.gov) - P3 | N=42 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases • Plasma NfL • SMN2

STELLAR-1: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA) (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases • Plasma NfL • SMN2

STELLAR-1: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA) (clinicaltrials.gov) - P3 | N=30 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases • Plasma NfL

Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy (The Manila Times) - "The FDA’s decision is based on data from the Phase 1b study of salanersen, which were recently presented at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference and the 5th International Scientific Congress on SMA (SMA Europe 2026)."

Breakthrough therapy • Muscular Atrophy

SOLAR: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases • SMN2

SOLAR: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases • SMN2

STELLAR-2: A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (clinicaltrials.gov) - P3 | N=42 | Not yet recruiting | Sponsor: Biogen

New P3 trial • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases • Plasma NfL • SMN2

A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec (clinicaltrials.gov) - P1 | N=62 | Active, not recruiting | Sponsor: Biogen | Trial completion date: Nov 2026 ➔ Nov 2031 | Trial primary completion date: Nov 2026 ➔ Nov 2031

Trial completion date • Trial primary completion date • Genetic Disorders • Movement Disorders • Muscular Atrophy • Pediatrics • Rare Diseases • SMN1 • SMN2

A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec (clinicaltrials.gov) - P1 | N=62 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2027 ➔ Nov 2026 | Trial primary completion date: Sep 2027 ➔ Nov 2026

Enrollment closed • Trial completion date • Trial primary completion date • Genetic Disorders • Movement Disorders • Muscular Atrophy • Pediatrics • Rare Diseases • SMN1 • SMN2

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115 (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: Biogen | Trial completion date: May 2027 ➔ Sep 2027 | Trial primary completion date: May 2027 ➔ Sep 2027

Trial completion date • Trial primary completion date • Muscular Atrophy • Pediatrics • SMN1

BIIB115 in Healthy Volunteers and Pediatric SMA Patients Previously Treated with Zolgensma (clinicaltrialsregister.eu) - P1 | N=24 | Sponsor: Biogen Idec Research Limited

New P1 trial • Genetic Disorders • Movement Disorders • Muscular Atrophy • Pediatrics • Rare Diseases • CSF2

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115 (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: Biogen | N=38 ➔ 62 | Trial completion date: Aug 2024 ➔ May 2027 | Trial primary completion date: Aug 2024 ➔ May 2027

Enrollment change • Trial completion date • Trial primary completion date • Muscular Atrophy • Pediatrics

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=38 | Not yet recruiting | Sponsor: Biogen

New P1 trial