Ascelia Pharma

Dagens aktienyheder med Scandinavian Medical Solutions, SP Group, GreenMobility A/S og Ascelia Pharma AB

Read the latest Ascelia Pharma one-pager following the FDA’s acceptance of the Orviglance new drug application (NDA) for review and the confirmation of an FDA decision date by 3 July 2026. This marks the official start of the regulatory review period and provides a clear timeline toward a potential first approval for the first gadolinium-free liver MRI contrast agent for patients with severe kidney impairment.

I dagens Morgenbørs ser vi ind i blandede futures globalt og en afventende stemning forud for Nvidias regnskab og jobtal senere på ugen. Herhjemme er der fokus på GreenMobility og FLS.

Dagens aktienyheder med GreenMobility A/S, Ascelia Pharma AB og Bioporto

Today, we hosted an event with Deputy CEO Julie Waras Brogren from Ascelia Pharma. The presentation focused on the financial results and regulatory milestones achieved during the third quarter, with particular emphasis on the investment case for Orviglance. The event concluded with a Q&A session.

Ascelia Pharma is expected to release its Q3 2025 interim report on 5 November 2025. Join us for a live presentation with Deputy CEO Julie Waras Brogren from Ascelia Pharma the following day at 12:00 PM CET, where she will present the financial results for the first nine months of 2025. Participants will have the opportunity to ask questions and gain insights into the company’s latest developments.

Mød ledelsen i Danske Bank, Ascelia Pharma, GrønlandsBANKEN og GomSpace og stil spørgsmål til dagens investorpræsentationer

Dagens aktienyheder med ISS, Sampo, Ascelia Pharma, Bioporto, og Scandinavian Medical Solutions

This morning, Ascelia Pharma (ACE) published its Q3 2025 results, marking a milestone quarter with the submission of the New Drug Application (NDA) for Orviglance to the US FDA in early September. The submission follows a successful clinical program, including the pivotal SPARKLE Phase 3 trial. The NDA will undergo a standard 10-month FDA review, with an expected PDUFA decision in Q3 2026.