Biogen has secured a regulatory milestone for its spinal muscular atrophy (SMA) treatment Spinraza, with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepting supplemental applications for a higher-dose regimen. This development arrives amid organizational changes as the company restructures its research operations.
The supplemental new drug application is based on data from the DEVOTE Phase II/III trial, which evaluated an increased dosing regimen of 50/28 mg in both children and adults who had previously received the standard 12 mg dose of Spinraza (nusinersen).
"Results from the DEVOTE study have shown us that the higher dose regimen of nusinersen can enable meaningful clinical benefits while maintaining a safety profile broadly consistent with the approved 12 mg regimen," stated Dr. Thomas Crawford, co-director of the Muscular Dystrophy Association Clinic at Johns Hopkins Medicine.
Research Operations Restructuring
Concurrent with this regulatory progress, Biogen is implementing significant changes to its research division. The company confirmed plans to reduce its research workforce as part of a broader initiative to enhance its drug development capabilities. This restructuring falls under the leadership of Jane Grogan, who assumed the role of research head in October 2023.
In a communication to her team, Grogan emphasized the necessity to "accelerate timelines from drug discovery to proof of concept." The workforce reduction follows what she described as an "extensive assessment" conducted over recent months, aiming to create a more agile and efficient research organization.
Strategic Context and Financial Implications
These organizational changes are part of a larger cost-optimization strategy announced in July 2023, targeting $1 billion in operating expense reductions. The initiative previously outlined plans to eliminate approximately 1,000 positions, representing about 11% of Biogen's workforce.
The restructuring comes at a challenging time for Biogen, with its stock trading at a five-year low of around $140 per share. The company faces additional pressure from the underperformance of Leqembi, its Alzheimer's disease therapy. Eisai, Biogen's development and commercialization partner, recently reduced its fiscal year 2024 forecast for Leqembi to approximately $280 million, down from an initial projection of $370 million.
Business Development Activities
Despite market pressures, Biogen maintains a measured approach to business development. The company recently proposed acquiring development partner Sage Therapeutics for approximately $469 million, though this unsolicited offer has led to legal complications, with Sage filing a lawsuit in Delaware court.
Priya Singhal, Biogen's head of development, addressed investor concerns at the 2025 J.P. Morgan Healthcare Conference, stating, "We're always looking at internal and external innovation. But do we believe that a deal at any cost is critical to drive Biogen growth? That's not the case, because we believe that we are really positioned very well."
