Organogenesis Announces Initiation of Biologics License Application for ReNu®
Organogenesis Holdings Inc. - Class A (ORGO)
Last organogenesis holdings inc. - class a earnings: 3/9 04:05 pm
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Source: GlobeNewswire
CANTON, Mass., Dec. 23, 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 initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for ReNu,® a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee arthritis. Organogenesis plans to complete the BLA submission with the final modules submitted in the first half of 2026. “This is another significant achievement for the ReNu clinical development program and a pivotal moment for Organogenesis,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “If approved, ReNu would be the first non-surgical biologic therapy to address knee osteoarthritis pain for all patients, especially for those classified as
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ORGO
News
- Organogenesis (NASDAQ:ORGO) had its "buy" rating reaffirmed by analysts at BTIG Research. They now have a $9.00 price target on the stock.MarketBeat
- Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain [Yahoo! Finance]Yahoo! Finance
- Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis PainGlobeNewswire
- 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
ORGO
Earnings
- 5/8/25 - Miss
ORGO
Sec Filings
- 12/18/25 - Form 4
- 12/16/25 - Form 144
- 11/26/25 - Form 4
- ORGO's page on the SEC website