ARAV - Aravive stock pops on FDA orphan drug status for batiraxcept to treat pancreatic cancer

• The U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to Aravive's ( NASDAQ: ARAV ) batiraxcept to treat pancreatic ductal adenocarcinoma cancer (PDAC).
• PDAC is a type of cancer that forms in the pancreas and starts in the cells that line the ducts which carry digestive enzymes out of the pancreas.
• The FDA grants orphan drug status to therapies which treat or prevent rare diseases which affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.
• Batiraxcept is currently being evaluated in a phase 1b/2 trial as first-line therapy in combination with chemotherapies gemcitabine and nab-paclitaxel in patients with locally advanced (nonresectable stage 2 or stage 3) or metastatic (stage 4) pancreatic adenocarcinoma.
• "Three patients from our P1b trial are still responding to treatment with 15mg/kg batiraxcept, gemcitabine and nab-paclitaxel after 1 year and one patient has a confirmed complete response," said Aravive CEO Gail McIntyre.
• McIntyre added that the company is also evaluating higher doses of batiraxcept to see if more patients can benefit from the triplet regimen.
• The Houston-based company noted that batiraxcept previously received ODD in the EU for platinum resistant recurrent ovarian cancer (PROC) and was also granted fast track designation by the FDA in PROC and clear cell renal cell carcinoma (ccRCC).
• ARAV +3.66% to $1.98 premarket March 1

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