SEED Receives FDA Rare Pediatric Disease and Orphan Drug Designations for Lead Oncology Asset RBM39 Degrader and Enters Strategic Transactions with New Investors
BeyondSpring, Inc. - Ordinary Shares (BYSI)
Last beyondspring, inc. - ordinary shares earnings: 4/30 07:00 am
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Source: GlobeNewswire
KING OF PRUSSIA, Pa., Jan. 28, 2025 (GLOBE NEWSWIRE) -- SEED Therapeutics Inc. (“SEED”), a biotechnology company pioneering the discovery of molecular glues for targeted protein degradation (TPD) using its proprietary RITE3™ platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease and Orphan Drug designations to SEED’s ST-01156 molecular glue. This novel agent degrades RBM39, an RNA splicing factor implicated in multiple mechanism-targeted solid tumor indications. SEED is advancing ST-01156 toward an Investigational New Drug (IND) application, with an expected IND filing in the first half of 2025. The Rare Pediatric Disease designation positions SEED to potentially receive an FDA priority review voucher upon approval of ST-01156. SEED also announced that its largest shareholder, BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring”), has entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED.
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News
- BeyondSpring Announces ESMO Asia Presentation on Plinabulin + Docetaxel Improving Survival in Large Phase 3 DUBLIN-3 Asian Subset for EGFR WT NSCLC Compared to Docetaxel, Strengthening the Case for a Global Registration Path [Yahoo! Finance]Yahoo! Finance
- BeyondSpring Announces ESMO Asia Presentation on Plinabulin + Docetaxel Improving Survival in Large Phase 3 DUBLIN-3 Asian Subset for EGFR WT NSCLC Compared to Docetaxel, Strengthening the Case for a Global Registration PathGlobeNewswire
- BeyondSpring Announces New Analyses of DUBLIN-3 Phase 3 Study Showing Survival Benefit of Plinabulin + Docetaxel in Post Anti-PD-(L)1 for Non-squamous EGFR WT NSCLC and a Reduction in Brain Metastasis Compared to Docetaxel at NACLC 2025 [Yahoo! Finance]Yahoo! Finance
- BeyondSpring Announces New Analyses of DUBLIN-3 Phase 3 Study Showing Survival Benefit of Plinabulin + Docetaxel in Post Anti-PD-(L)1 for Non-squamous EGFR WT NSCLC and a Reduction in Brain Metastasis Compared to Docetaxel at NACLC 2025GlobeNewswire
- BeyondSpring GAAP EPS of -$0.05 [Seeking Alpha]Seeking Alpha
BYSI
Sec Filings
- 12/15/25 - Form 8-K
- 11/21/25 - Form 8-K
- 11/17/25 - Form 424B5
- BYSI's page on the SEC website