FDA Submission to Change the Primary Endpoint into an Industry First and Robust Clinical Measure for Superiority of CIN Phase 3 Study
BeyondSpring, Inc. - Ordinary Shares (BYSI)
Last beyondspring, inc. - ordinary shares earnings: 4/30 07:00 am
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ir.beyondspringpharma.com
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Source: GlobeNewswire
NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a New York-based global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that, following discussions with the U.S. Food and Drug Administration (FDA), the Company has formally changed the primary endpoint for its Study 106 Phase 3 superiority clinical trial with first-in-class lead asset, Plinabulin, for chemotherapy-induced neutropenia (CIN) prevention. For more than 20 years, the standard primary endpoint for CIN trials has been the duration of severe (Grade 4) neutropenia (DSN). The new primary endpoint will be the rate of the prevention of Grade 4 neutropenia – a more clinically meaningful and trial-sensitive endpoint – and will be used to establish superiority of the Plinabulin-G-CSF combination over G-CSF alone. A robust plan will be submitted to the FDA to prospectively validate this new primary e
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- BeyondSpring GAAP EPS of -$0.05 [Seeking Alpha]Seeking Alpha
- BeyondSpring Reports Third-Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswire
- BeyondSpring (NASDAQ:BYSI) had its "sell (d)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
BYSI
Sec Filings
- 11/21/25 - Form 8-K
- 11/17/25 - Form 424B5
- 11/12/25 - Form 10-Q
- BYSI's page on the SEC website