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FDA Grants Tentative Approval for AFT's Scomara with US Launch Delayed Until 2029
8:40am on Tuesday 21st of July, 2026 AEST
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Pharmaceuticals
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FDA Grants Tentative Approval for AFT's Scomara with US Launch Delayed Until 2029
8:40am on Tuesday 21st of July, 2026 AEST
Key Points
FDA issues tentative approval for Scomara cream
US launch delayed until March 2029 due to orphan exclusivity
Treatment targets Facial Angiofibromas in Tuberous Sclerosis
Competitive edge in markets outside US with once-daily dosing
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AFT Pharmaceuticals (NZX:AFT)
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