drug
omaveloxolone
Marketedupdated 3mo agoby Reata Pharmaceuticals Inc
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 2all catalysts(0)
nothing on the calendar yet
Trials studying omaveloxolone
- —A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
- phase3A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia
- phase1A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55
- phase2A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
- phase1A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
- phase1A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
- phase1A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55
- phase2RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 20, 2027
~1.4 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (7)
- Apr 24, 2033compositionUS 8993640
- Apr 24, 2033compositionUS 9701709
- Dec 3, 2029compositionUS 81247993.3y
- Apr 20, 2029method-of-use (U-3552)US 110914302.7y
- Apr 20, 2029method-of-use (U-3863)US 119198382.7y
- Apr 20, 2029formulationUS 84408542.7y
- Apr 20, 2029compositionUS 96701472.7y
FDA exclusivities (3)
- Feb 28, 2030ODE-427Orphan Drug (7y)3.6y
- Feb 28, 2028NCENew Chemical Entity (5y)1.5y
- Dec 20, 2027M-270Method (3y)1.4y
News(2)
- 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 · 13d ago
- Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlookInvestors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.biopharma_dive · 3mo ago
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