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第二项后期ReNu研究错过了关键终点，器官发生遭遇挫折
2025-09-26 05:12
- Organogenesis (NASDAQ:ORGO) said a second phase 3 trial of its cryopreserved amniotic suspension allograft ReNu missed its primary endpoint.
- The first late-stage trial met the important mark.
- ReNu, which is under investigation for treating knee osteoarthritis, did not achieve a statistically significant change in pain reduction.
- Organogenesis said it would ask for a pre-BLA meeting with the US FDA by the end of October to examine a submission pathway, "including using the combined efficacy analysis from both Phase 3 studies to support a BLA approval," according to company COO Patrick Bilbo.
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- Organogenesis Holdings Inc. (ORGO) Q2 2025 Earnings Call Transcript
- Organogenesis Holdings GAAP EPS of -$0.10 misses by $0.06, revenue of $101M misses by $3.75M
- Seeking Alpha’s Quant Rating on Organogenesis Holdings
- Historical earnings data for Organogenesis Holdings
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