Ascelia Pharma

Ascelia Pharma is expected to release its Q2 2026 results on 20 August 2026. The following day at 10:00, CEO Magnus Corfitzen will present the results and provide an update on the company's latest developments in a live online event.

Ascelia Pharma announced today that the FDA has scheduled a Type A meeting for 9 September 2026 to discuss the Complete Response Letter issued in early July. The company has submitted a briefing package addressing each of the topics raised by the agency.

Following the FDA's Complete Response Letter for Orviglance and the subsequent publication of the redacted letter, we set out what the current share price implies, the scenarios we see into the Type A meeting, and our reading of the clinical issue at the centre of the case.