Drugs / Amniotic Suspension Allograft
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ReNu | osteoarthritis, knee | 2026-04-28 | “today announced the completion of a rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for ReNu®” organogenesis.com ↗ |
| Filed | US (FDA) | ReNu | osteoarthritis, knee | 2025-12-23 | “today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for ReNu” organogenesis.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04636229 | Dec 2020 → Jul 2023 | osteoarthritis, knee | Organogenesis | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-06 | Organogenesis | Regulatory Organogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis organogenesis.com ↗ |
| 2026-04-28 | Organogenesis | Regulatory Organogenesis Completes Rolling Submission of Biologics License Application for ReNu® organogenesis.com ↗
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 completion of a rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for ReNu®, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis (OA). |
| 2025-12-23 | Organogenesis | Regulatory Organogenesis Announces Initiation of Biologics License Application for ReNu® organogenesis.com ↗
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. |
| 2025-12-15 | Organogenesis | Regulatory Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain organogenesis.com ↗ |
| 2025-09-25 | Organogenesis | Results Organogenesis Provides Update on Second Phase 3 ReNu® Study organogenesis.com ↗
The study demonstrated a numerical improvement of -0.51 favoring ReNu (p=0.0393 one-sided p-value, compared to p=0.023 target threshold). |
| 2024-11-11 | Organogenesis | Results Organogenesis Reports Positive Interim Analysis of Second Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis organogenesis.com ↗
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 favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA). |
| 2024-08-08 | Organogenesis | Results Organogenesis Shares ReNu® Program Update organogenesis.com ↗
Subgroup analysis demonstrated most severe (KL4) subjects responded comparably to moderate (KL3) |
| 2024-05-02 | Organogenesis | Results Organogenesis Achieves Primary Endpoint in Phase 3 Clinical Trial of ReNu® for Knee Osteoarthritis organogenesis.com ↗ |
| 2023-03-01 | Organogenesis | Results Organogenesis Reports Positive Interim Analysis of Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis organogenesis.com ↗
The DMC recommended that the trial proceed without modification and without increase to sample size. |
| 2021-01-11 | Organogenesis | Regulatory Organogenesis ReNu® Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation For Osteoarthritis of the Knee organogenesis.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted ReNu®, a cryopreserved amniotic suspension allograft for the management of symptoms associated with knee osteoarthritis (OA), Regenerative Medicine Advanced Therapy (RMAT) designation. |
| 2019-10-05 | Organogenesis | Results New ReNu® Data from Organogenesis Highlighted at ICRS 2019 World Congress organogenesis.com ↗
Research highlights at ICRS include two podium presentations demonstrating the use of ReNu in reducing the severity of symptoms associated with knee osteoarthritis (OA) |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amniotic Suspension Allograft | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04636229 ↗ |
| Known as | ASA | “A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With...” NCT04636229 ↗ |