drug
nusinersen
Marketedupdated 5mo agoby $BIIB BIOGEN INC.
Approvedannual revenue · 2024–2024peak $1.6B
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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)
- —Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
- phase2A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
- 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)
- phase2A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
- 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)
- phase3Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
- —Adult SMA Research and Clinical Hub
Patent cliff
source: FDA Orange Bookfirst 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 collaborationBoehringer 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 drugScholar 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 pipelineAfter 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 diseaseZanvastro, 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 pushBetter-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 whileBiogen'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
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