Ascelia Pharma AB Announces Positive Outcomes of FDA Meeting and Confirms Plan to Submit the NDA for Orviglance mid-2025 “We are very pleased with the outcome of our meeting with the FDA and look forward to advancing the NDA submission for Orviglance in order to submit in the middle of the year, as planned. This meeting with the FDA is another significant step forward in bringing Orviglance to market,” said Magnus Corfitzen, CEO of Ascelia Pharma AB. #AsceliaPharma #update #NDA
Ascelia Pharma AB
Tillverkning av läkemedel
Malmö, Skane County 2 427 följare
Ascelia Pharma is an oncology-dedicated orphan drug company listed on Nasdaq Stockholm under the ticker ACE.
Om oss
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance® (former working name Mangoral) and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). About Orviglance (Mangoral) Orviglance* (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study. About Oncoral Oncoral is a novel oral irinotecan tablet in development. Irinotecan is a chemotherapy with established potent anti-tumor effect – even in difficult to treat cancers. Oncoral is a daily tablet 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. Oncoral is initially developed for the treatment of gastric cancer, a cancer form with unmet needs and the opportunity for Orphan Drug status in the US and Europe. Following successful Phase 1 results, Phase 2 clinical development for Oncoral is in preparation. *Trademark is registered in Europe and several other markets and submitted for registration in the US.
- Webbplats
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http://www.ascelia.com
Extern länk för Ascelia Pharma AB
- Bransch
- Tillverkning av läkemedel
- Företagsstorlek
- 11–50 anställda
- Huvudkontor
- Malmö, Skane County
- Typ
- Publikt aktiebolag
- Grundat
- 2000
- Specialistområden
- Contrast Media, Radiology, Chronic Kidney Disease, MRI, Acute Kidney Injury, NSF, Contrast Induced Nephropathy, Orphan drug, Oncology och Drugdevelopment
Adresser
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Primär
Hyllie Boulevard 34
Malmö, Skane County 215 32, SE
Anställda på Ascelia Pharma AB
Uppdateringar
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Did you miss when Magnus Corfitzen, CEO at Ascelia Pharma AB presented at Carnegie Investment Bank Healthcare day yesterday? Now you can watch the video and hear more about our latest updates and outlook. #AsceliaPharma #oncology #MRI #Unmetneed
Ascelia Pharma - Fokus hälsovård
https://www.youtube.com/
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Join us on Wednesday, March 26th at 14:05 for an insightful presentation by our CEO, Magnus Corfitzen, at the upcoming investor seminar hosted by Økonomisk Ugebrev A/S. This will be an opportunity to discover the latest developments and future plans of Ascelia Pharma AB. To register: 👇
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Today is World Kidney Day Thank you World Kidney Day for raising awareness about the importance of recognizing risk factors and ensuring timely testing to enhance early detection and intervention. This year's theme, "Are Your Kidneys OK? Detect early, protect kidney health," underscores the critical need for proactive measures to safeguard kidney health. Let's continue to support and promote initiatives that advance kidney health for everyone. #WorldKidneyDay #KidneyHealth #EarlyDetection #HealthAwareness
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Join Julie Waras Brogren, Deputy CEO and Jennie Wilborgsson, VP Clinical Development at Ascelia Pharma AB at the Nexus Conference in Basel on March 13-14, 2025, and be part of the conversation driving the future of biopharma! 🌟 Julie Waras Brogren will share insights on "Optimizing Supply Chain Strategies for Product Launches" and join a dynamic panel discussion on "Partnerships in Supply Procurement: Driving Innovation and Collaboration." 🌟 Jennie Wilborgsson will delve into "Evaluating the Right Outsourcing Approach from a Biotech Perspective." For more information on the conference: https://lnkd.in/dbxy9NKX #BioPharma #SupplyChain #ClinicalTrials #Innovation #Collaboration #Networking
Strengthen your industry knowledge at our 𝟔𝐭𝐡 𝐁𝐢𝐨𝐏𝐡𝐚𝐫𝐦𝐚 𝐒𝐮𝐩𝐩𝐥𝐲 𝐂𝐡𝐚𝐢𝐧 & 𝐋𝐨𝐠𝐢𝐬𝐭𝐢𝐜𝐬 𝐍𝐞𝐱𝐮𝐬! Panel Focus: "𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬 𝐢𝐧 𝐒𝐮𝐩𝐩𝐥𝐲 𝐏𝐫𝐨𝐜𝐮𝐫𝐞𝐦𝐞𝐧𝐭 – 𝐃𝐫𝐢𝐯𝐢𝐧𝐠 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧" 📅13th-14th March, 2025 📍 Hyperion Hotel, Basel, Switzerland 𝐌𝐞𝐞𝐭 𝐎𝐮𝐫 𝐄𝐬𝐭𝐞𝐞𝐦𝐞𝐝 𝐏𝐚𝐧𝐞𝐥𝐢𝐬𝐭𝐬: Daniel Hurni, Director Manufacturing Network Strategy at Bristol Myers Squibb (𝐌𝐨𝐝𝐞𝐫𝐚𝐭𝐨𝐫) Julie Waras Brogren, Deputy CEO at Ascelia Pharma AB Stefan Ibing, Head of Legal International Commercial at Apellis Pharmaceuticals 𝐄𝐯𝐠𝐞𝐧𝐢𝐚 𝐈𝐜𝐡𝐢𝐠𝐞𝐲𝐞𝐯𝐚 𝐌𝐚𝐬𝐬𝐚𝐫𝐢 Associate Director, EU Commercial Supply Chain at Mirum Pharmaceuticals, Inc. Deniz Guneren, Head Technical Operations EPM at Medison Pharma Mark your calendar for expert-driven discussions on supply chain innovation and procurement success! Secure your slot by clicking the link 🔗https://lnkd.in/dSz-gc7c #BioPharma #SupplyChain #Logistics #StrategicPartnerships #Innovation #NEXUSconference #Procurementdirect #Collaboration #InnovationInPharma #Basel
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Magnus Corfitzen, CEO at Ascelia Pharma AB will present at Carnegie Investment Bank Healthcare day in Stockholm on March 13, 2025 at 10:50 📆 . Don't miss this opportunity to hear about our latest advancements and how we are addressing unmet medical needs. The presentation will be available on our website: www.ascelia.com #update #AsceliaPharma #Unmetneed
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March is #NationalKidneyMonth! 🩺 Let's raise awareness about kidney disease! This year, the focus is on taking charge of our health. Chronic kidney disease (CKD) affects 10% of the global population and can lead to serious complications. By adopting a healthy lifestyle, we can better manage and prevent CKD. To read more on how to manage CKD: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Ascelia Pharma AB works to improve the life of people living with rare cancer conditions and kidney disease. #KidneyHealth #NationalKidneyMonth #HealthyLiving #NIDDK
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Today is #Rare Disease Day We thank Rare Disease Day and the National Organization for Rare Disorders for advocating equal opportunities for people with rare diseases. At Ascelia Pharma AB, we strive to improve the lives of people with rare cancer conditions by providing fair and equal access to diagnosis and care. #Showyourstripes #RareDiseaseDay #LightupForRare
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Did you miss today's presentation of full-year and Q4 report with Julie Waras Brogren, Deputy CEO of Ascelia Pharma AB? Take a few minutes to tune in and catch up on the updates using the link below! You can also read the entire press release and the report on our website: www.ascelia.com #asceliapharma #unmetneed #oncology
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Today Ascelia Pharma AB released it's Q4 and Full Year Report 2024: Completion of Full Study Report Reinforces Successful Outcomes of SPARKLE Phase 3 Study “In 2024, we have met several major milestones with the successful results from our Orviglance pivotal Phase 3 study, SPARKLE. The positive headline results and subsequent Full Study Report mark the completion of clinical development for Orviglance. The results showed that Orviglance significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint with statistical significance for all three readers (<0.001). The results of the secondary endpoint analysis further reinforce the successful study outcomes and support the NDA process and potential clinical value of Orviglance. It’s encouraging to see how the medical community has welcomed Orviglance with the acceptance of SPARKLE Phase 3 data for presentation in four oral presentations and three abstracts at key scientific conferences thus far. We are in a strong position to deliver on our key priorities ahead; to submit the New Drug Application (NDA) for Orviglance to the US Food and Drug Administration (FDA) expected mid-2025 and to continue advancing the dialogue with potential partners to commercialize Orviglance and make it available to patients in need of a high-quality liver imaging option without gadolinium related safety risks. With the fully subscribed SEK 105 million Rights Issue financing in Q3 2024, our cash runway extends until late 2025; well beyond the NDA submission for Orviglance. Our runway can be significantly extended with financing from warrants and partnering.”, said Magnus Corfitzen, CEO at Ascelia Pharma AB Pharma. #fullyearreport2024 #orphanonconlogy #MRI
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