Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®
Rhea-AI Summary
Organogenesis (Nasdaq: ORGO) completed a rolling Biologics License Application (BLA) submission to the FDA for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis (OA).
The company began rolling submission in December 2025 and finished with clinical and CMC modules on April 28, 2026. Knee OA affects an estimated 31.1 million Americans, projected to reach 34.4 million by 2027.
Positive
- Completed rolling BLA submission to FDA for ReNu
- Submission includes both clinical and CMC modules
- Addresses large U.S. patient base: 31.1M current, 34.4M projected by 2027
Negative
- Regulatory outcome uncertain; approval depends on FDA review
- No approval or commercial timing announced with submission completion
News Market Reaction – ORGO
In the Apr 29 session, ORGO declined 4.17%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 06 | Clinical trial data | Positive | +0.9% | PuraPly AM trial met primary endpoint in DFU with statistically significant closure. |
| Apr 06 | Regulatory update | Positive | +0.9% | FDA Type B meeting confirmed ReNu program suitability for rolling BLA by end 2025. |
| Apr 06 | Earnings date set | Neutral | +0.0% | Announcement of Q1 2026 earnings release and conference call on May 7, 2026. |
| Feb 26 | Earnings results | Negative | -13.2% | Record 2025 results paired with 2026 revenue guidance of $350M–$420M, below 2025. |
| Feb 19 | Earnings date set | Neutral | +0.3% | Notice of Q4 and FY 2025 earnings release and related conference call timing. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news—clinical, regulatory, and earnings-related—has generally seen price reactions align with the underlying news sentiment.
Over the past few months, ORGO reported positive clinical data for PuraPly AM in a 170-patient DFU trial and outlined an FDA-supported rolling BLA plan for ReNu. It also posted record 2025 results with net product revenue of $563.0M but guided to lower 2026 revenue of $350M–$420M, which coincided with a notable share decline of -13.24%. Today’s completion of the ReNu BLA rolling submission builds directly on the prior FDA meeting and BLA plan.
Key Terms
biologics license application regulatory
food and drug administration regulatory
fda regulatory
amniotic suspension allograft medical
knee osteoarthritis medical
degenerative joint disease medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
If approved, ReNu® will revolutionize treatment options for millions of patients with knee OA pain
CANTON, Mass., April 28, 2026 (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 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).
“We are pleased to complete the BLA submission for ReNu®, which represents a significant milestone in our drive to bring a new regenerative therapy to knee OA patients,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are confident in the progress of our regulatory engagement and look forward to continuing our productive discussions with the FDA during the review process.”
Organogenesis initiated the rolling BLA submission in December 2025 with non-clinical modules and has now completed the application with the submission of the clinical and chemistry, manufacturing, and controls (CMC) modules.
Knee OA is a degenerative joint disease that is estimated to affect nearly 31.1 million Americans and projected to grow to 34.4 million Americans by 2027. It is ranked among the most common causes of disability and poor quality of life, generally characterized by pain and functionality deficits. End stage management of the disease in these patients is typically a total knee replacement when all other treatment options are exhausted.
About ReNu®
ReNu is a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components. ReNu has been studied in three large RCTs consisting of more than 1,300 patients and received FDA RMAT designation for Knee OA in 2021. ReNu was previously marketed under Section 361 of the Public Health Service Act and was commercially available for approximately six years.
About Organogenesis Holdings Inc.
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. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “planned,” “intend,” “seek,” “anticipate,” “believe,” “expect,” “confident,” “estimate,” “potential” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, including statements regarding the anticipated impact ReNu, if approved, will have on treatment options. These statements concern, and these risks and uncertainties include, among others: the risks and uncertainties inherent in clinical development; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to develop or commercialize ReNu; the likelihood and timing of possible regulatory approval and commercial launch of ReNu; the FDA may conclude the data we submit for ReNu is not sufficient for BLA approval; the FDA may require additional evidence for ReNu before we can get a BLA approved, which we may not be able to obtain; that other clinical trials of ReNu may produce different results; ongoing regulatory obligations and oversight impacting ReNu; unforeseen safety issues resulting from the administration of ReNu in patients; competing products and product candidates that may be superior to our products and product candidates; uncertainty of market acceptance and commercial success of ReNu and the impact of studies (whether conducted by us or others and whether mandated or voluntary) on the commercial success of ReNu; our ability to manufacture and manage supply components for ReNu; the availability and extent of reimbursement of ReNu from third-party payers, including private payer healthcare and insurance programs and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers, including local coverage determinations by Medicare Part A/B Medicare Administrative Contractors; new policies and procedures adopted by such payers; unanticipated expenses; the costs of developing, producing, and selling ReNu; our ability to meet our sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; and other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company's Form 10-K for the year ended December 31, 2025 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
Investor Inquiries: ICR Healthcare Mike Piccinino, CFA OrganoIR@westwicke.com Press and Media Inquiries: Organogenesis Communications@organo.com