MALMÖ, SE / ACCESS Newswire / April 11, 2025 / Ascelia Pharma (STO:ACE):
The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.
Ascelia Pharma AB (publ) (ticker: ACE) today published its Annual Report 2024, which is now available on the company's website.
Magnus Corfitzen, CEO, Ascelia Pharma, says: In 2024, we met several major milestones for our lead asset Orviglance. We announced a successful outcome of the pivotal Phase 3 study, SPARKLE, with positive headline results and subsequent Full Study Report which mark the completion of the clinical development of 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 New Drug Application (NDA) process and potential clinical value of Orviglance.
In March 2025, we announced the outcomes from a planned meeting with the US Food and Drug Administration (FDA), providing positive guidance for the Orviglance NDA in order to progress with the submission mid-2025 as planned. We are in a strong position to execute on our key priorities in 2025; to submit the NDA and to continue the dialogue with potential partners for the commercialization of Orviglance and make it available to patients in need of a high-quality liver imaging option without gadolinium related safety risks.
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.
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 furthermore be significantly extended during 2025 with financing from warrants and partnering."
About us
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 and Oncoral - in development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.
Contacts:
Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel: +46 735 179 118
Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)
Email: jwb@ascelia.com
Tel: +46 735 179 116
This information was submitted for publication, through the agency of the contact persons set out above.
This information is information that Ascelia Pharma is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-04-11 13:50 CEST.
Attachments
Ascelia Pharma Annual Report 2024
5493002YR9VCJJPWYN08-2024-12-31-0-sv final
SOURCE: Ascelia Pharma
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