PBLA - Panbela stock surges 20% as EMA panel backs granting orphan drug status to cancer drug

• A committee of the European Medicines Agency (EMA) issued a positive opinion on Panbela Therapeutics' ( NASDAQ: PBLA ) application for orphan designation for ivospemin (SBP-101) to treat a type of pancreatic cancer.
• The EMA's Committee for Orphan Medicinal Products backed granting the status to ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA).
• "The opinion is timely, as we only a few weeks ago announced first patients enrolled in Europe in our ASPIRE trial. We continue to advance the global clinical trial, as we aim for interim analysis in early 2024," said Panbela President and CEO Jennifer Simpson.
• The company noted that SBP-101 has already received an orphan drug status in the U.S.
• The orphan drug status in the EU is aimed at therapies for treating or preventing diseases which affect fewer than five in 10,000 people in the EU. The designation provides incentives, including 10 years' of market exclusivity for the drug, if approved.
• PBLA +25.89% to $0.18 premarket Dec. 14

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