Biogen Advances BIIB115 in Post–Gene Therapy SMA: Early Signals for Long‑Term Growth
Biogen Inc. (BIIB) announced an update on their ongoing clinical study.
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Biogen Readies New SMA Study After Gene Therapy: What Investors Should Know
The phase 3 study “A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants With Genetically Diagnosed Spinal Muscular Atrophy” will test Biogen’s next SMA drug in babies who already received gene therapy. The goal is to see if follow‑on treatment can improve safety and long‑term outcomes, a key question for the SMA care market.
The trial tests salanersen (BIIB115), an injectable drug given into the fluid around the spine, and a sham procedure. Salanersen is designed to boost production of a key protein linked to muscle function in SMA, with the aim of reducing disease severity after initial gene therapy.
This is an interventional, randomized phase 3 trial with two parallel groups: one gets salanersen, the other a sham procedure in the first year. The study is “double‑blind,” meaning families, doctors, and assessors do not know who gets the active drug, and the main purpose is to test treatment benefit and safety.
The study was first submitted on 26 Feb 2026, marking Biogen’s formal move to late‑stage testing of BIIB115 in this setting. The last update was filed on 4 Jun 2026, confirming details before sites begin enrollment, while primary and final completion dates will guide when investors can expect key data and potential readouts.
For Biogen (BIIB), this trial expands its SMA pipeline beyond current therapies and could extend its role in a niche but strategic rare‑disease market. Success would support a “layered” treatment model after gene therapy, potentially strengthening BIIB’s growth story and challenging rivals in SMA and gene therapy, though near‑term revenue impact is limited until data arrive.
The study is not yet recruiting but is now formally updated and ongoing in the registry, with further details available on the ClinicalTrials portal.
To learn more about BIIB’s potential, visit the Biogen Inc. drug pipeline page.
