Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain
Organogenesis Holdings Inc. - Class A (ORGO)
Last organogenesis holdings inc. - class a earnings: 3/9 04:05 pm
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Source: GlobeNewswire
Clinical Development Program Appropriate for Rolling BLA Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the successful completion of a planned Type-B meeting with the Food and Drug Administration (FDA) resulting in confirmation to initiate a rolling Biologics Licenses Application (BLA) for ReNu planned before the end of December. “We are excited about the outcome of our FDA meeting and reaching this important milestone in the ReNu program,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are pleased the ReNu clinical development program consisting of two large Phase 3 randomized controlled trials (RCT), a separate 200-patient RCT, extensive commercial history and Regenerat
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News
- Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain [Yahoo! Finance]Yahoo! Finance
- Organogenesis (NASDAQ:ORGO) had its "sell (d+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Organogenesis (NASDAQ:ORGO) had its price target raised by analysts at BTIG Research from $7.00 to $9.00. They now have a "buy" rating on the stock.MarketBeat
- Organogenesis (NASDAQ:ORGO) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=ORGO&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen<MarketBeat
- Organogenesis Holdings Inc. (ORGO) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
ORGO
Earnings
- 5/8/25 - Miss
ORGO
Sec Filings
- 11/26/25 - Form 4
- 11/25/25 - Form 144
- 11/24/25 - Form 144
- ORGO's page on the SEC website