reports
- 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
- Jacob Mekhael
- Thomas Vranken
Hyloris FIRST LOOK: New pipeline addition with RedHill & valacyclovir ...
Hyloris announced a new licensing agreement with RedHill Biopharma to bring in ex-US rights for ondansetron ER, a serotonin blocker that provides relief from nausea and vomiting with chemotherapy, radiotherapy and post-operative recovery. Meanwhile, the FDA accepted oral liquid valacyclovir's regulatory submission for review with a PDUFA date set for October 12, 2025. We intend to incorporate ondansetron ER in a future update of our model and look forward to the valacyclovir decision, while reit...
- Hilde Van Boxstael
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Hyloris New reformulation product addition in gastric acid conditions
Hyloris announced that it has entered into an exclusive licensing agreement to develop a ready-to-use formulation for intravenous (IV) administration of pantoprazole (proton pump inhibitor, PPI) to treat gastric acid-related conditions. According to management, there is limited clinical development required as the efficacy of the reference drug has already been established, and Hyloris expects to enter the first markets (likely US and EU) in 3 years. Note that according to guidance from the 1H24...
- Jacob Mekhael
Hyloris FIRST LOOK: Signs exclusive UK licence and supply agreement fo...
Hyloris announced that an exclusive licence and distribution agreement has been signed with Colonis Pharma for XTRAZA (tranexamic acid oral rinse) in the UK, where Hyloris will receive undisclosed milestones and will supply the product to Colonis in the UK. A phase 3 trial for the candidate is ongoing in the US and EU, with data previously guided for 1H25, which means the product could reach market in 2026. For reference, we estimate peak sales of € 27m for tranexamic acid oral rinse in the US w...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
- Thomas Vranken
Hyloris FIRST LOOK: US deal on tranexamic acid RTU with Avenacy
Hyloris announced an exclusive license and supply agreement with Avenacy for tranexamic acid RTU in the US. The deal is set up as a profit sharing agreement with commercialisation expected to start in 2025. We reiterate our € 5 TP and Hold rating.
- Jacob Mekhael
Hyloris Valacyclovir oral suspension deal with Rosemont, appoints new ...
Hyloris announced an exclusive license and supply agreement with Rosemont Pharmaceuticals for its Valacyclovir oral suspension in the US. In addition, the company appointed a new CFO, Christophe Maréchal, who previously served as CFO and co-CEO of Mithra. We reiterate our € 5 TP and HOLD rating.
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Thomas Vranken
- Wim Lewi
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Wim Lewi
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