Biogen Stock Slips After FDA Rejects Higher Dose of Spinraza
Regulators issue a Complete Response Letter for the company's spinal muscular atrophy drug, citing the need for more information.
Biogen (BIIB) shares fell in after-hours trading after the U.S. Food and Drug Administration (FDA) declined to approve a higher-dose version of its spinal muscular atrophy (SMA) treatment, nusinersen, which is marketed as Spinraza. The regulatory setback was announced late in the day, causing an immediate reaction from investors.
The biotechnology giant confirmed it received a regarding its supplemental New Drug Application (sNDA). The CRL indicates that the agency cannot approve the application in its present form. Biogen stated the FDA's letter cited the need for additional information, though the specifics were not fully detailed in the initial announcement.
Spinraza, a foundational therapy for SMA, was one of the first breakthrough treatments for the rare and debilitating genetic disorder. The proposed high-dose regimen was intended to offer improved efficacy for patients. This rejection marks a significant hurdle in Biogen’s efforts to strengthen its nusinersen franchise, which faces increasing competition in the SMA market. The stock traded down nearly 1% in the immediate aftermath of the news, reflecting investor disappointment.
According to the company, the FDA did not request further clinical data, and the primary issue appears to be related to the Chemistry, Manufacturing, and Controls (CMC) module of the application. Biogen has stated it is reviewing the CRL and plans to work closely with the FDA to determine the next steps to address the agency's feedback. , which has been focusing on its neurology pipeline.
This regulatory hurdle puts more pressure on Biogen's portfolio, particularly as it navigates a complex market for its Alzheimer's treatments and other neurological drugs. Analysts will be closely watching for a more detailed plan from the company on how it intends to resolve the issues raised by the FDA and the potential timeline for a resubmission. The outcome will be critical for the long-term growth prospects of one of Biogen's key commercial products.