Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital.
Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.
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.
* Type A meeting with the FDA scheduled for September 9 * Implementing cost-saving measures * Conf call at 10am CET Recent and upcoming relevant events Following the July 2, 2026 Complete Response Letter for Orviglance, which cited concerns over the ...
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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.
The FDA's Complete Response Letter (CRL) for Orviglance (NDA 220544) is now publicly accessible in redacted form through the FDA's openFDA transparency database. The letter's specifics raise the odds of a more demanding path to approval than previously indicated.
* CRL questions SPARKLE endpoint analysis; re-read rejected *Ascelia disputes both points; expresses confidence * Type A meeting next; outcomes range widely The CRL's stated grounds In the CRL (Complete Response Letter), the FDA states that SPARKLE failed...
Ascelia Pharma provided a follow-up update yesterday, July 12, on the Complete Response Letter received on July 3. This is the first substantive detail the company has disclosed on the nature of the FDA's clinical concerns since the CRL, and it meaningfully narrows, though does not close, the range of scenarios we flagged in our July 3 note.
* Additional clinical data and product documentation requested * Urgent FDA meeting to discuss next steps * Very low visibility: Valuation suspended until more clarity Additional clinical data and product documentation requested Ascelia Pharma announced...
Ascelia Pharma today received a Complete Response Letter (CRL) from the FDA. The FDA stated it cannot approve the application for Orviglance in its present form and has requested additional clinical data and product documentation. This alters the investment case materially, and feedback from the Type A meeting with the FDA is the main short-term catalyst
