CEO’s Message
We have started 2026 with strong activity and important progress. This week’s press release confirming our agreement with the FDA on our iPSP marks another significant milestone for AcuCort.
Our agreement with the FDA on our iPSP (Initial Paediatric Study Plan) for Zeqmelit® marks a key step towards the submission of a New Drug Application (NDA) in the United States. While the process has been lengthy, the outcome is highly favourable. The agreement allows us to move forward, and it is important to outline what this means in practice:
The agreement we have reached with the FDA means that we are not required to conduct a paediatric study prior to submitting our New Drug Application (NDA) in the United States, which we intend to do this year. This removes a key regulatory uncertainty and significantly streamlines our path forward.
With this in place, only one step remains before we can submit our NDA – the renewal of our Small Business Waiver (SBW). We expect the FDA to accept our application.
In parallel with our regulatory progress, we continue to build our commercial footprint. The agreement with Glenmark Pharmaceuticals is a clear example of this, marking our expansion from a Nordic base into a broader European market of approximately 200 million people. Together with our progress in the United States, this strengthens our position in the internationalisation of Zeqmelit®.
– Jonas Jönmark
In summary, we are in a strong position, with reduced regulatory risk, a clearer path to the US market, and a growing commercial platform in Europe. In June, we will also attend Bio International in San Diego, a partnering conference I very much look forward to.
Jonas Jönmark
CEO, AcuCort
BioStock highlights the iPSP news and interviews Jonas Jönmark
Read article from BioStock here (swedish – translate in browser)
Watch Jonas Jönmark discuss the Glenmark agreement, Zeqmelit’s broader indications, and the company’s pharmacovigilance work.
Latest news
- AcuCort publishes Annual Report for 2025
- AcuCort and the FDA agree on iPSP
- AcuCort to participate in Bio Europe Spring – focus on international partnerships
- AcuCort signs commercial agreement with Glenmark Pharmaceuticals for Germany and five additional European countries
- AcuCort Secures New Order for Zeqmelit® – Continued Growth Across the Nordics
Missed the last newsletter? Read it here