Organogenesis Announces Initiation of Biologics License Application for ReNu®
Rhea-AI Summary
Organogenesis (Nasdaq: ORGO) has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee arthritis.
Initial modules were submitted under rolling review with final modules expected in the first half of 2026. Company executives said ReNu, if approved, would be the first non-surgical biologic therapy for knee osteoarthritis across all patients, including the most severe. Knee osteoarthritis is estimated to affect 31.1 million Americans, rising to 34.4 million by 2027, with end-stage management typically a total knee replacement.
Positive
- Rolling BLA submission initiated to FDA on Dec 23, 2025
- Final BLA modules expected in H1 2026
- ReNu aims to be first non-surgical biologic for knee OA if approved
- Targets ~31.1 million US knee OA patients (projected 34.4M by 2027)
Negative
- BLA is under review and approval is not yet granted, timing and outcome uncertain
- No regulatory approval or commercialization terms disclosed in the announcement
News Market Reaction
On the day this news was published, ORGO gained 2.09%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers showed mixed moves: AQST (+2.23%), EOLS (+2.42%), ESPR (+2.28%), AKBA (+0.61%), while SIGA slipped (-0.16%). With no peers in the momentum scanner, ORGO’s BLA news appears more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 15 | Regulatory update | Positive | +0.2% | FDA Type-B meeting cleared path for rolling BLA submission for ReNu. |
| Nov 06 | Earnings, guidance | Positive | -2.0% | Record Q3 revenue and raised 2025 guidance accompanied by share price decline. |
| Nov 03 | Policy/reimbursement | Positive | -5.9% | CMS finalized payment reform seen as supportive for PMA products and access. |
| Oct 31 | Equity incentives | Negative | -5.9% | Inducement stock options and RSUs granted to new CTO, adding equity overhang. |
| Oct 01 | Earnings scheduling | Neutral | -0.2% | Announcement of Q3 2025 earnings date and accompanying conference call details. |
Recent history shows mixed reactions: modest alignment to regulatory/clinical milestones but several instances where positive fundamental or policy news coincided with share price declines.
Over the last six months, Organogenesis has reported multiple milestones, including ReNu Phase 3 data references and a Dec 15 FDA meeting confirming a rolling BLA plan, which saw only a 0.21% price move. Strong Q3 2025 financials on Nov 6 with raised guidance were followed by a -2.02% reaction, and favorable CMS payment reform commentary on Nov 3 coincided with a -5.88% move. Today’s BLA initiation continues the ReNu regulatory trajectory outlined in prior disclosures.
Market Pulse Summary
This announcement advances Organogenesis’s ReNu program from FDA meeting confirmation to an actual rolling BLA submission, with final modules targeted for the first half of 2026. It addresses a large knee osteoarthritis population estimated at 31.1 million Americans, projected to reach 34.4 million by 2027. Recent history shows mixed share-price responses to positive news, so investors may monitor subsequent FDA feedback, any additional ReNu data, overall execution on guidance, and future regulatory updates to gauge the program’s impact.
Key Terms
biologics license application regulatory
food and drug administration regulatory
fda regulatory
rolling review regulatory
amniotic suspension allograft medical
knee osteoarthritis medical
degenerative joint disease medical
AI-generated analysis. Not financial advice.
Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026
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 most severe.”
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,” “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 timing of regulatory submissions and interactions. 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 timing of our submissions to the FDA; 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, 2024 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
FAQ
What did Organogenesis (ORGO) announce on December 23, 2025 about ReNu?
When does ORGO expect to complete the ReNu BLA submission?
What is ReNu and what condition does it target (ORGO)?
If approved, how would ReNu change treatment for knee osteoarthritis (ORGO)?
How many Americans are affected by knee osteoarthritis referenced by ORGO?
Does the ORGO announcement include approval or commercial launch details for ReNu?
