This section highlights FDA-related milestones and regulatory updates for drugs developed by Organogenesis (ORGO).
Over the past two years, Organogenesis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ReNu and NuShield. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ReNu FDA Regulatory Timeline and Events
ReNu is a drug developed by Organogenesis for the following indication: for Knee Osteoarthritis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ReNu
- Announced Date:
- April 6, 2026
- Indication:
- for Knee Osteoarthritis
Announcement
Organogenesis Holdings Inc 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.
AI Summary
Organogenesis Holdings Inc. announced it completed a planned Type-B meeting with the U.S. Food and Drug Administration. The company said the meeting was successful and that the FDA confirmed Organogenesis may begin a rolling Biologics License Application (BLA) submission for its product ReNu. The rolling BLA is planned to start before the end of December.
This confirmation is an important regulatory milestone. A rolling BLA lets the company submit parts of the application to the FDA as those sections are ready, rather than waiting to file the entire package at once. That can speed the review process and keep regulatory discussions active. Organogenesis’ next steps will focus on preparing and submitting the required BLA modules so the FDA can begin its review.Read Announcement
- Drug:
- ReNu
- Announced Date:
- December 23, 2025
- Indication:
- for Knee Osteoarthritis
Announcement
Organogenesis Holdings Inc 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. .
Read Announcement- Drug:
- ReNu
- Announced Date:
- December 15, 2025
- Indication:
- for Knee Osteoarthritis
Announcement
Organogenesis Holdings Inc. 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.
AI Summary
Organogenesis Holdings announced it completed a planned Type-B meeting with the FDA and received confirmation to begin a rolling Biologics License Application (BLA) for ReNu, planned before the end of December. The FDA agreed the company’s clinical development program is appropriate for BLA submission. That program includes two large Phase 3 randomized controlled trials, a separate 200-patient randomized controlled trial, and extensive commercial experience with the product. The company called the outcome an important milestone toward potential approval.
ReNu is a cryopreserved amniotic suspension allograft developed to manage symptomatic knee osteoarthritis. It contains amniotic fluid cells, micronized amniotic membrane, growth factors, and extracellular matrix components, and has been studied in large randomized trials involving more than 1,300 patients. Organogenesis plans to initiate the rolling BLA process this year to seek marketing approval.
Read Announcement- Drug:
- ReNu
- Announced Date:
- September 25, 2025
- Indication:
- for Knee Osteoarthritis
Announcement
Organogenesis Holdings announced that the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA), did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial.
AI Summary
Organogenesis Holdings announced that its second Phase 3 randomized controlled trial of ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis, did not meet its primary endpoint despite showing a numerical improvement over the first trial.
At six months, baseline pain reduction with ReNu was –6.9 compared to –6.0 in the first Phase 3 study. The difference versus saline was –0.51 favoring ReNu (one-sided p=0.0393), missing the company’s p=0.023 target. In the first trial, ReNu achieved a –0.72 improvement (p=0.0177). The second trial did show statistically significant maintenance of function (p<0.0001).
Organogenesis said it remains confident in ReNu’s potential as an innovative pain management therapy. The company plans to request a pre-BLA meeting with the FDA by the end of October to discuss using combined data from both Phase 3 studies in its Biologics License Application.
ReNu has now been studied in three large trials involving over 1,300 patients and continues to demonstrate a favorable safety profile.
Read Announcement
NuShield FDA Regulatory Events
NuShield is a drug developed by Organogenesis for the following indication: For Diabetic Foot Ulcers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NuShield
- Announced Date:
- October 1, 2024
- Indication:
- For Diabetic Foot Ulcers
Announcement
Organogenesis Holdings Inc. announced the publication of "Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial" in the Journal of Wound Care.
AI Summary
Organogenesis Holdings Inc. announced the publication of its study, "Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial," in the Journal of Wound Care. The research involved 218 patients with diabetic foot ulcers and compared treatment with NuShield—the company’s dehydrated amnion chorion membrane—plus standard care against standard care alone. Results showed that the NuShield group experienced a 48% greater chance of wound closure, achieving faster healing times over a 12‐week period. The study’s findings, demonstrating statistically significant improvements compared to the standard of care (p=0.04), support the potential for NuShield to meet Medicare coverage requirements under proposed Local Coverage Determinations. This publication strengthens Organogenesis’ position in developing advanced wound care therapies aimed at reducing complications and amputations in patients with diabetic foot ulcers.
Read Announcement
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