reports
- Guy Sips
- Jacob Mekhael
- Kristof Samoy
- Wim Hoste
- Mathijs Geerts Danau
Hyloris Positive results for IV Aspirin, NDA will be submitted
Hyloris announced positive topline results from a pivotal study in healthy volunteers for IV aspirin. The trial achieved all its targets, enabling progression towards submission of a New Drug Application (NDA) in 2026 and expected approval in 2027. IV Aspirin is intended to be used in acute coronary syndrome and is part of Hyloris's CV portfolio, for which Hyloris needs to announce a commercial partner in the US. We model € 52m peak sales by 2037. We reiterate our HOLD and € 6 TP.
- Hilde Van Boxstael
- Lynn Hautekeete
- Mathijs Geerts Danau
- Wim Lewi
- Jacob Mekhael
Hyloris Signs agreement with Orion for Tranexamic Acid RTU in Europe
Hyloris announced that it has entered into an exclusive license and supply agreement with Orion for Tranexamic Acid Intravenous Premix RTU (TXA RTU) in major European markets. This follows a previously announced agreement with Avenacy in the US, though we note this product, being a generic, is non-core for the company, as Hyloris' main focus is on reformulation and repurposing via the 505(b)(2) pathway. The company has not disclosed specific figures under the agreement, however it will be eligib...
- Jacob Mekhael
- Michiel Declercq
- Thomas Couvreur
- Jacob Mekhael
Hyloris HY-094 license and distribution agreement in China
Hyloris announced that an exclusive license and distribution agreement has been signed with Grand Life Sciences Group for HY-094 in iron deficiency in China. While specific financial numbers were not disclosed, Hyloris and partner AFT will share the eligible upfront, milestones, and royalties. We view this China deal as a good start, but note that the country represents a small fraction (approx. $ 150m by 2033) of the global iron IV market, expected to reach $ 7.4b by 2033, and look forward to a...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Mathijs Geerts Danau
- Michiel Declercq
- Thomas Couvreur
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Mathijs Geerts Danau
- Michiel Declercq
- Thibault Leneeuw
- Wim Hoste
- Jacob Mekhael
- Mathijs Geerts Danau
Life Sciences Conference 25 Sep 2025
KBC Securities will host its annual life sciences conference on 25 September in Brussels. The event will include 14 exciting companies, both public and private, from the BeNeLux ecosystem and beyond. In this conference note, we provide an overview of the attending companies, as well as an outlook on KBC Securities' life sciences broader coverage.
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Wim Lewi
- Jacob Mekhael
Hyloris XTRAZA license and supply agreement with Huons in South Korea
Hyloris announced that an exclusive license and supply agreement has been signed with Huons for XTRAZA in South Korea. Under the terms, Hyloris will exclusively supply XTRAZA to Huons though further financial terms were not disclosed. This deal follows previously announced agreements in selected APAC regions and Canada with AFT, and in the UK with Colonis Pharma. A phase 3 trial for XTRAZA is ongoing in the US and EU, with data expected by YE25, and we note that a deal for XTRAZA in the larger U...
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Michiel Declercq
- Jacob Mekhael
Hyloris Positive bioavailability study results for Atomoxetine Oral So...
Hyloris announced positive results from a pivotal clinical bioavailability study of its proprietary Atomoxetine Oral Solution, which demonstrated comparable relative bioavailability under fasted conditions to Strattera (atomoxetine) capsules. Following the study results, Hyloris can move ahead with regulatory submission to the FDA in the US. We expect Hyloris to find a partner for US commercialisation, and model peak royalty revenue of € 19m for Atomoxetine Oral Solution in the US. We reiterate ...
- Hilde Van Boxstael
- Jacob Mekhael
- Wim Lewi
- Jacob Mekhael
Hyloris Agreement with Kuvatris could generate a priority review vouch...
Hyloris announced the signing of an R&D funding agreement of $ 2m (plus $ 1.6m equity investment) with Kuvatris to support the development and US approval of intravenous (IV) suramin to treat human African trypanosomiasis (HAT). Given the rare nature of HAT, the value of this program lies in its potential to secure a transferable PRV. Recent examples show PRVs being sold for $160m – Hyloris could get just over 50% of net proceeds, if successful. We see this as a creative deal to boost the compan...
- Guy Sips
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Thomas Vranken
- Wim Lewi
- 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...
- Jacob Mekhael
Hyloris Deal with AFT for XTRAZA in selected APAC regions and Canada
Hyloris announced an exclusive licensing agreement with AFT Pharmaceuticals for XTRAZA (tranexamic acid oral rinse) in Canada, Australia, New Zealand, Singapore and Hong Kong. Under the terms of the agreement Hyloris will receive up to 50% of the gross profits generated. This deal with AFT follows a previously announced agreement for the UK with Colonis Pharma. A phase 3 trial for XTRAZA is ongoing in the US and EU, with data expected by YE25, and we note that a deal for XTRAZA in the larger US...
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Michiel Declercq
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
- Kristof Samoy
- Thibault Leneeuw
- Thomas Couvreur
- Wim Hoste
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