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.
* 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
Liity Inderesin yhteisöön
Älä jää mistään paitsi – luo käyttäjätunnus ja ota kaikki hyödyt irti Inderesin palvelusta.
Ascelia Pharma on June the 3rd 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.We will await further clarity from the Type A meeting before updating our investment case from the 15th May 2026.
Yesterday, we hosted an event with Magnus Corfitzen, CEO of Ascelia Pharma. The presentation focused on the financial results and regulatory milestones achieved during the first quarter, with particular emphasis on the investment case for Orviglance. The event concluded with a Q&A session, with discussion centered on the status and outlook regarding potential partners and the upcoming potential approval of Orviglance.
Ascelia Pharma is expected to release its Q1 2026 results on 12 May 2026. The following day at 11:00, CEO Magnus Corfitzen will present the results and provide an update on the company's latest developments in a live online event.
The Q1 presentation arrives at a pivotal moment for Ascelia Pharma, with the FDA PDUFA decision date for Orviglance set for 3 July 2026 , and ongoing partnership discussions.
* Orviglance data accepted for presentation at high-quality congress * Cash runway into 2027 * Fair value range updated: SEK 2.0-5.4 (2.1-5.8) Orviglance on track for July approval; cash runway into 2027 Ascelia delivered a quarter largely in line with...
