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  1. pharmadog
  2. ›drugs
  3. ›Spinraza
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nusinersen

Marketedupdated 5mo ago
by $BIIB BIOGEN INC.
Approved
annual revenue · 2024–2024peak $1.6B
2024: $1.6B2024$1.6B
community read0 votes

🐶 often sniffed alongside

top 1
  • tagApproval48 co-mentions · 12 sources

all catalysts(0)

nothing on the calendar yet

Trials studying nusinersen

  • phase1A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)recruitingn=78
  • —Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)active not recruitingn=74
  • phase2A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophyrecruitingn=52
  • phase3A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)active not recruitingn=115
  • phase2A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophycompletedn=25
  • phase4A Study to Learn About the Effect of Nusinersen (BIIB058) Given as Injections to Children With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (RESPOND)completedn=46
  • phase3Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophycompletedn=145
  • —Adult SMA Research and Clinical Hubrecruitingn=600

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 11, 2027
280 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (7)

  • Mar 4, 2036method-of-use (U-2094)US 12013403
  • Sep 11, 2035method-of-use (U-1942)US 10436802
  • Jan 9, 2034method-of-use (U-1943)US 9926559
  • Dec 23, 2030compositionUS 83619774.2y
  • Nov 24, 2030method-of-use (U-1941)US 89808534.1y
  • Jun 17, 2030method-of-use (U-1943)US 97177503.7y
  • Jul 11, 2027compositionUS 7838657280d

News(7)

  • Boehringer, Envisagenics sign $1B multi-target oncology collaboration
    Boehringer Ingelheim and AI drug discovery company Envisagenics have agreed to a potential $1 billion multi-year pact that will task Boehringer with validating tumor-specific targets.
    fiercebiotech · 12d ago
  • Scholar Rock secures first FDA approval for muscle-targeting rare disease drug
    Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.
    biospace · 19d ago
  • Ionis’ ‘breakthrough’ Alexander disease approval establishes pillar of rare disease pipeline
    After Jenny Pearson’s daughter Elise first had a seizure at 16 months old, an MRI came back clean—her brain “looked beautiful,” Pearson recalled to Fierce. But a follow-up scan a year later, just d…
    fiercebiotech · 29d ago
  • FDA approves Ionis’ antisense drug as first targeted therapy for Alexander disease
    Zanvastro, an antisense oligonucleotide therapy, represents the first independent neurology launch for Ionis Pharmaceuticals, which intends to leverage the foothold for more approvals in rare neuro…
    biospace · 1mo ago
  • Biogen’s targeted ALS treatment is reversing decline in some patients. Can more be helped?
    Three years after Qalsody was approved by the FDA as the first drug to target a genetic cause of ALS, some patients are reporting not only disease stabilization but also improvement of symptoms.
    biospace · 1mo ago
  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    biopharma_dive · 2mo ago
  • ‘We have what we need to grow:’ Biogen CEO happy to ease off the M&A for a while
    Biogen's business development team may have been busy in recent years, but CEO Christopher Viehbacher is easing off the acquisitions for a while.
    fiercebiotech · 2mo ago
brand
Spinraza
generic
nusinersen
indication
Spinal Muscular Atrophy (SMA)
phase
marketed
approved
2016-12-23
Data sources
openFDA · ClinicalTrials.gov
last refreshed 2h ago
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