Report
Jacob Mekhael

Hyloris FDA approval for Tranexamic Acid Intravenous Premix RTU

Hyloris announced that its partner Avenacy received FDA approval for its ANDA (generic NDA) of Tranexamic Acid Intravenous Premix Ready-to-Use (RTU), with launch planned for 2H25. This product, approved through the generic ANDA pathway, is non-core for the company, as Hyloris' main focus is on the more valuable reformulation and repurposing 505(b)(2) pathway. Sales of intravenous tranexamic acid reached $ 29.1m in the 12 months up to March 2025, and we estimate Hyloris could receive approx. $ 2m in income from the RTU presentation at peak based on the profit sharing agreement with Avenacy in the US. Given this is a non-core asset with a small contribution, we reiterate our € 5 TP and Hold rating.
Underlying
Hyloris Pharmaceuticals

Provider
KBC Securities
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Analysts
Jacob Mekhael

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