Ascelia Pharma

Ascelia Pharma

Phase 3
Malmö, SwedenFounded 2009ascelia.com

Ascelia Pharma is a publicly traded biotech company dedicated to improving the lives of people with rare oncology-related conditions by identifying, developing, and commercializing novel drugs. The company's most advanced asset, Orviglance, has successfully completed a pivotal Phase 3 study and its New Drug Application (NDA) has been accepted for review by the FDA, representing a significant regulatory milestone. With a second candidate, Oncoral, advancing in clinical development and a clear focus on orphan oncology, Ascelia aims to address significant unmet medical needs in areas like liver metastases and gastric cancer.

Founded
2009
Focus
Diagnostics

AI Company Overview

Ascelia Pharma is a publicly traded biotech company dedicated to improving the lives of people with rare oncology-related conditions by identifying, developing, and commercializing novel drugs. The company's most advanced asset, Orviglance, has successfully completed a pivotal Phase 3 study and its New Drug Application (NDA) has been accepted for review by the FDA, representing a significant regulatory milestone. With a second candidate, Oncoral, advancing in clinical development and a clear focus on orphan oncology, Ascelia aims to address significant unmet medical needs in areas like liver metastases and gastric cancer.

Technology Platform

Development of novel drug formulations for orphan oncology, including a manganese-based oral MRI contrast agent and an oral tablet formulation of the chemotherapy irinotecan.

Funding History

4

Total raised: $65M

Series B$20MFlerie InvestMar 15, 2020
IPO$20MUndisclosedDec 15, 2019
Series B$15MUndisclosedMay 15, 2018
Series A$10MIndustrifondenMay 15, 2018

Opportunities

Orviglance has the potential to become the first approved oral, non-gadolinium contrast agent for liver MRI in renally impaired patients, capturing a clear unmet need.
Oncoral offers a novel, convenient oral chemotherapy option for gastric cancer, a market with limited innovation.
Orphan Drug Designations for both candidates could provide significant market exclusivity and commercial advantages.

Risk Factors

The company faces significant regulatory risk with the ongoing FDA review of Orviglance.
As a pre-revenue company, it is dependent on raising additional capital to fund operations and commercialization.
Successful market adoption and reimbursement for a novel diagnostic agent are not guaranteed.

Competitive Landscape

Orviglance's main competitors are gadolinium-based contrast agents (GBCAs), which are contraindicated for its target patient population, and unenhanced MRI, which is less effective. It is positioned as a first-in-class solution. Oncoral competes with intravenous irinotecan and other chemotherapies, differentiating through its oral formulation and potential safety benefits.

Company Info

TypeTherapeutics
Founded2009
LocationMalmö, Sweden
StagePhase 3
RevenuePre-revenue

Therapeutic Areas

OncologyRare Diseases
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