Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of its blockbuster spinal muscular atrophy (SMA) drug Spinraza.

This new proposed dosing regimen simplifies administration by offering two initial 50 mg doses spaced 14 days apart, followed by a 28 mg maintenance dose every four months. This approach reduces the dosing frequency compared to the current regimen, which requires four loading doses of 12mg administered at an interval of 14 days, followed by a 12 mg maintenance dose every four months.

Biogen’s regulatory filings are supported by data from the phase II/III DEVOTE study, which achieved its primary endpoint of statistically significant improvement in motor function in infants with SMA treated with a higher dose of Spinraza.

Per management, a higher dose regimen of the drug has the potential to slow neurodegeneration faster through greater reductions in neurofilament as early as day 64 relative to the currently approved dose. It believes that the maintenance of a higher drug dose over time could lead to meaningful clinical benefit in infants with symptomatic SMA.

BIIB’s Stock Performance

Shares of Biogen have lost nearly 42% in the past year compared with the industry’s 12% decline.

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Spinraza: A Key Revenue Driver for Biogen

Spinraza was discovered and developed jointly by Biogen and Ionis Pharmaceuticals IONS. Post approval for the SMA indication, Biogen in-licensed the drug’s worldwide rights from Ionis and assumed responsibility for its future development, manufacturing and commercialization.

However, Biogen’s Spinraza faces competition from Novartis’ NVS gene therapy Zolgensma and Roche RHHBY/PTC Therapeutics’ Evrysdi, both of which are approved in SMA indication.

Competition from both the NVS and RHHBY therapies has shifted market dynamics, negatively impacting Spinraza’s sales in the United States. Due to increased competitive pressure, sales of the Biogen drug have declined almost 3% year over year in 2023 and over 13% in the first nine months of 2024.

BIIB’s Other Ongoing Collaborations With IONS

Both Biogen and Ionis have a collaboration agreement for another marketed drug, Qalsody (tofersen), which was initially developed by Ionis. In April 2023, the FDA granted accelerated approval to this drug to treat adult patients with superoxide dismutase 1 amyotrophic lateral sclerosis (SOD1-ALS). Qalsody was also approved for a similar indication in the EU last year. Biogen enjoys worldwide commercial rights for this drug.

BIIB is also collaborating with Ionis to develop new therapies for a broad range of neurological diseases. Some candidates that both companies are jointly developing include BIIB094 for Parkinson’s disease and BIIB080 for Alzheimer’s disease, which are being evaluated in early to mid-stage studies.

Biogen Inc. Price

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BIIB’s Zacks Rank

Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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