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. However, there has been notable pushback on the program, plus a filing from investors questioning patient source/geographic representation, trial quality/integrity, and midstream Phase 3 endpoint change, he added. If plinabulin gets approved for CIN, the analyst expects investors to give the stock credit for this indication and also have increased confidence in NSCLC. BeyondSpring is planning to have a pre-New Drug Application meeting in the fourth quarter of 2021 and then potentially file the NSCLC NDA in the first half of 2022, the analyst noted.
CALLIDITAS NEFECON PDUFA: Calliditas' nefecon PDUFA for IgAN is scheduled for December 15 and Raycroft believes that, as long as there are no safety surprises, there is a "good chance" of approval based on the totality of data for the treatment. The analyst expects this approval to be stock-moving, and sees odds being "skewed to the upside," based in part on the stock's 77% pullback since September 9 to date. Raycroft thinks the stock could be down currently because of investor perceptions that the Food and Drug Administration has shifted views on using urine protein-creatinine ratio, or UPCR, as a surrogate endpoint for accelerated approval for nephrology-based drugs and general concerns around Calliditas' PDUFA being delayed, given the FDA requested additional eGFR analyses as part of their review. However, based on Key Opinion Leaders feedback, he does not think the FDA has shifted its view much on the use of UPCR for accelerated approval.
PRICE ACTION: In Tuesday afternoon trading, shares of BeyondSpring have gained about 1% to $13.19, while Calliditas' stock has advanced almost 3% to $18.45.
"Before the Move" is The Fly's recurring series of exclusive stories that identify potentially market moving events, along with analyst predictions, ahead of the news.
