Business
BeyondSpring Announces First Quarter 2021 Financial Results and Provides a Corporate Update
- NDA Filed by U.S. Food and Drug Administration (FDA) and given Priority Review for plinabulin plus G-CSF for the prevention of CIN. A PDUFA date of November
About this update from Beyondspring, Inc.
[{"type":"text","content":"- NDA Filed by U.S. Food and Drug Administration (FDA) and given Priority Review for plinabulin plus G-CSF for the prevention of CIN. A PDUFA date of November 30, 2021 has been assigned by the FDA - Highlighted PROTECTIVE-2 Phase 3 data at two scientific conferences – ASCO and FOCIS – showing plinabulin in combination with G-CSF to have superior benefit in reducing the incidence and severity of febrile neutropenia and hospitalization rates and better QoL compared to pegfilgrastim alone - Advanced clinical development of combination plinabulin + checkpoint inhibitors in PD-1/PD-L1-resistant tumors: presented promising Phase 1 anti-cancer data in PD-1/PD-L1-resistant SCLC at ASCO 2021; dosed first patient in a triple IO combination Phase 1 study in seven advanced solid tumors NEW YORK, June 16, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate events. “This quarter was marked by meaningful progress on the road toward building our lead first-in-class asset, plinabulin, as a pipeline in a drug, from treating chemotherapy side effects to treating cancer directly,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring. “We are grateful that our NDA for chemotherapy-induced neutropenia (CIN) prevention was filed by the U.S. FDA with priority review. Our plinabulin and G-CSF combination has the potential to elevate the standard of care in CIN for the first time in 30 years. In addition, in the coming months, we plan to announce topline anti-cancer overall survival data from the Phase 3 DUBLIN-3 trial in NSCLC. We are building clinical evidence to demonstrate that plinabulin is a potent antigen presenting cell (APC) inducer with potential to be a ‘game changer’ in cancer treatment for severely unmet medical needs.” Recent Corporate Highlights Lead Asset Plinabulin, a “Pipeline in a Drug” Clinical Update June 2021: Announced Food and Drug Administration (FDA) filing of New Drug Application with Priority Review for plinabulin and G-CSF combination for the prevention of CIN. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for No...