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Organogenesis Holdings Faces Setback in ReNu Phase 3 Trial

Story Highlights
  • Organogenesis announced its second Phase 3 trial of ReNu did not meet its primary endpoint.
  • The company plans to discuss a BLA submission with the FDA using combined Phase 3 data.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Organogenesis Holdings Faces Setback in ReNu Phase 3 Trial

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Organogenesis Holdings ( (ORGO) ) has issued an announcement.

On September 25, 2025, Organogenesis Holdings announced that its second Phase 3 trial of ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis, did not achieve statistical significance for its primary endpoint. Despite this, the trial showed a numerical improvement in baseline pain reduction and maintained a favorable safety profile. The company plans to request a pre-Biologics License Application meeting with the FDA to discuss using combined data from both Phase 3 studies to support a BLA approval, emphasizing ReNu’s potential to address unmet medical needs in knee osteoarthritis.

The most recent analyst rating on (ORGO) stock is a Hold with a $5.00 price target. To see the full list of analyst forecasts on Organogenesis Holdings stock, see the ORGO Stock Forecast page.

Spark’s Take on ORGO Stock

According to Spark, TipRanks’ AI Analyst, ORGO is a Neutral.

Organogenesis Holdings’ overall stock score is primarily influenced by its financial performance challenges, including declining revenue and profitability. The technical analysis suggests a neutral trend with potential for upward movement. Valuation is negatively impacted by unprofitability and lack of dividends. The earnings call highlights both strategic opportunities and significant challenges.

To see Spark’s full report on ORGO stock, click here.

More about Organogenesis Holdings

Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. The company offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care.

Average Trading Volume: 847,083

Technical Sentiment Signal: Buy

Current Market Cap: $621.6M

See more insights into ORGO stock on TipRanks’ Stock Analysis page.

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