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FDA Grants Orphan Drug Status to Invion’s INV043 for Anal Cancer
8:29pm on Friday 29th of August, 2025 AEST
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Healthcare
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FDA Grants Orphan Drug Status to Invion’s INV043 for Anal Cancer
8:29pm on Friday 29th of August, 2025 AEST
Key Points
FDA grants Orphan Drug Designation to INV043 for anal cancer
Seven-year US market exclusivity and financial incentives awarded
Preclinical studies show ~80% tumor control with immune checkpoint inhibitors
Planned clinical trial collaboration with Peter MacCallum Cancer Centre
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