Actuate Therapeutics (ACTU) said Tuesday that the European Medicines Agency has granted orphan medicinal product designation to elraglusib for the treatment of pancreatic ductal adenocarcinoma.
The company said the designation is granted to therapies intended for the treatment of life-threatening diseases "that affect no more than two in 10,000 people in the European Union and for which no satisfactory therapy is available."
The label also provides certain benefits like reduced regulatory fees, and a potential 10-year market exclusivity, the firm said. It also has an orphan drug designation for Elraglusib in the US for the same indication.
"We look forward to reporting topline data from our Phase 2 trial in 1H 2025 and working closely with the EMA and the FDA to accelerate elraglusib's clinical development program in metastatic pancreatic cancer," said Chief Executive Officer Daniel Schmitt.
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