reports
- 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
- Jacob Mekhael
Hyloris FIRST LOOK: Collaboration with AFT to develop HY-094 for iron ...
Hyloris entered into a late-stage research and development program in collaboration with AFT to introduce an injectable iron deficiency therapy (HY-094) to the global market – development costs and net margin from sales and licensing will be distributed equally. This announcement brings a new later stage product to the company's pipeline, for which Hyloris expects phase 3 development to start in the near-term. Given the size of the market, we expect this will be a high volume product and Hyloris...
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Couvreur
- Jacob Mekhael
Hyloris FIRST LOOK: FY24 results come with a detailed pipeline update
Hyloris reported FY24 results with YE24 cash of € 23.6m (YE23: € 30.4m). Revenue grew to € 8.5m (from € 2.1m), though we note this included one-off milestone payments ($ 2.1m as well as an additional undisclosed amount). We are encouraged by the planned 9 regulatory submissions by YE26, though point out that US filing fees range $ 2-4m. Additionally, Hyloris will require extra funding to commercialise the near-term cardiology products in the US and is exploring multiple options. As such, while w...
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Lewi
- Jacob Mekhael
Hyloris FIRST LOOK: Positive IDMC recommendation for Alenura phase 2 i...
Hyloris announced that the independent data monitoring committee (IDMC) reviewed the phase 2 trial of Alenura (bladder instillation combining lidocaine and heparin) in interstitial cystitis/bladder pain syndrome (IC/BPS) and concluded that there were no safety concerns and that the efficacy signals observed justified continued investigation. The recommendation is a positive sign for the program particularly as the IDMC saw unblinded data, though we note that they also recommended that the enrolm...
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Couvreur
- Wim Hoste
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Lewi
- Jacob Mekhael
Hyloris FIRST LOOK: Positive study results for Dofetilide IV, plans FD...
Hyloris announced positive results from a pivotal clinical study evaluating its proprietary Dofetilide IV formulation (potassium channel blocker), an antiarrhythmic to treat atrial fibrillation. Based on company guidance of FDA submission in the coming months, the product could be approved in the US by 2026 taking into account the 10 month FDA review timeline, and we look forward to learn more about the company's US commercialisation plans for its cardiology products. Note that Hyloris has previ...
- Guy Sips
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Vranken
- Wim Hoste
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