Reata Lays Commercial Path For Skyclarys With First-Ever Friedreich’s Ataxia Nod
The company forecasts an addressable US patient market that comprises 90% of the total Friedreich’s population of 5,000 based on a broad label covering patients aged 16 and older.
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Reata Puts Hopes On Partner Study To Support Bardoxolone Resubmission
Reata says partner Kyowa Kirin’s outcomes study of bardoxolone in chronic kidney disease may address the questions cited by the FDA in its complete response letter for Alport syndrome.
Sarepta Pressured FDA On Eteplirsen Due To ‘Dire’ Finances, Gave Investors Rosier Picture
Emails reveal company wanted timelines and approval commitments from FDA toward the end of the eteplirsen review, saying it might not be able to continue studies; at the same time, Sarepta was telling investors it had 12 months of cash on hand.
Unity’s UBX1325 Faces Uncertain Path Forward In AMD, But DME Still Looks Promising
The company said the Phase II ENVISION study of the drug in wet age-related macular degeneration did not show non-inferiority to Eylea, leaving it with an uncertain path forward in that indication.