Shares of BeyondSpring Inc. (NAS:BYSI) plunged 55.2% toward a record low in premarket trading Wednesday, after the biopharmaceutical company said that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration, saying the biopharmaceutical company's new drug application (NDA) for its treatment for chemotherapy-induced neutropenia (CIN) "cannot be approved in its present form." The FDA said the results of the single registration trial (106 Phase 3) "was not sufficiently robust" to demonstrate benefit and that a second "well controlled" trial would be required. "BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy," said Chief Executive Lan Huang. "The company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally." The stock had tumbled 55.2% over the past three months through Tuesday, while the iShares Biotechnology ETF (NAS:IBB) has shed 11.4% and the S&P 500 (S&P:SPX) has gained 1.0%.
Dec. 1, 2021, 8:37 a.m. EST