Before the Move: Watch Beyondspring, Calliditas into upcoming PDUFAs

Jefferies analyst Maury Raycroft believes both events will be stock-moving, skewed to the upside
Ahead of BeyondSpring's (BYSI) Prescription Drug User Fee Act, or PDUFA, date for its plinabulin for chemotherapy-induced neutropenia, or CIN, Jefferies analyst Maury Raycroft said he expects the event to be stock-moving and thinks "expectations for approval have come in." He sees the stock going up over 70% if the treatment is approved. Meanwhile Calliditas Therapeutics' (CALT) nefecon PDUFA date for immunoglobulin A nephropathy, or IgAN, is also approaching, and Raycroft believes there is a "good chance" of approval based on the totality of the data.

BEYONDSPRING PLINABULIN PDUFA: BeyondSpring's plinabulin PDUFA deadline for CIN is set for Tuesday, November 30, and Jefferies analyst Maury Raycroft expects the event to be stock-moving. He thinks "expectations for approval have come in," but the analyst currently estimates potential for the stock to be up over 70%, if approved, and down 40%, if a Complete Response Letter comes from the FDA. The event is "interesting," he argued, because there is readthrough to BeyondSpring's second filing opportunity in non-small cell lung cancer, which is based on recent Phase 3 data. His view is that plinabulin should get approved based on the total data package demonstrating plinabulin's benefit, with some additional confidence coming from the drug having Breakthrough Therapy Designation.
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