reports
- ING Helpdesk
- 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 ...
- ING Helpdesk
- 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
- Jakub Krawczyk
- Jakub Krawczyk
- Robert Jan Vos
- ING Helpdesk
Benelux Morning Notes
ABN AMRO: NFLI reaching c.30% level in its ABN stake reduction. ABN AMRO: Relaunch of Belgium private banking using MeesPierson brand. Elia: FY25 profit outlook unchanged, minor reduction in capex. Greenyard: Disappointing 2H24/25, guidance lowered. NN Group, ASR: Parliament votes against amendment to Dutch Pension Reform
- Guy Sips
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Thomas Vranken
- ING Helpdesk
- Jacob Mekhael
- Kristof Samoy
- Thibault Leneeuw
- Thomas Couvreur
- Wim Hoste
- Hans D’Haese
- Maxime Stranart
Greenyard/Take-out bid crystalizes Greenyard's fair value/HOLD
Greenyard's founding Deprez family, together with US investment management firm Solum Partners, are launching a takeover bid on Greenyard at €7.40 per share. A total of 67% of the shares, held by the Hein Deprez family and related parties, Greenyard and other strategic shareholders, have been committed to tender. Although we believe the timing of the offer is opportunistic, in our view it has a high probability of success, considering near-term uncertainties linked to the current trading environ...
- Robert Jan Vos
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