Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain
Rhea-AI Summary
Organogenesis (Nasdaq: ORGO) announced a successful Type-B meeting with the FDA and confirmation to initiate a rolling BLA submission for ReNu planned before the end of December 2025. The company said ReNu's clinical program—two large Phase 3 randomized controlled trials, a separate 200-patient RCT, extensive commercial history, and RMAT designation—was considered appropriate for BLA submission. Management stated that, if approved, ReNu could address a significant unmet need in knee osteoarthritis, a condition affecting an estimated 31.1 million Americans, projected to reach 34.4 million by 2027.
Positive
- Rolling BLA submission planned before end of December 2025
- RMAT designation for ReNu confirmed in program description
- Two large Phase 3 randomized controlled trials documented
- Separate 200-patient RCT included in clinical program
- Company cited extensive commercial history for ReNu
Negative
- BLA is planned but not yet submitted as of December 15, 2025
- Regulatory approval is pending and not guaranteed
News Market Reaction
On the day this news was published, ORGO gained 0.21%, reflecting a mild positive market reaction. Argus tracked a peak move of +15.0% during that session. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $613M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
While ORGO was up about 1.05%, key peers like AQST (-5.14%) and AKBA (-4.17%) were down, pointing to a stock-specific catalyst rather than a sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 06 | Earnings results | Positive | -2.0% | Record Q3 revenue, higher guidance but shares declined post-release. |
| Nov 03 | Policy/reimbursement | Positive | -5.9% | CMS reimbursement reforms viewed favorably but stock traded lower. |
| Oct 31 | Equity incentives | Neutral | -5.9% | Inducement options and RSUs for new CTO accompanied by share weakness. |
| Oct 01 | Earnings date set | Neutral | -0.2% | Scheduled Q3 earnings call with minimal but negative price reaction. |
| Sep 25 | Clinical trial update | Negative | -4.5% | Second Phase 3 ReNu trial missed primary endpoint; shares moved lower. |
Recent history shows a tendency for shares to trade lower on positive or neutral news, with only clearly negative clinical data aligning with a negative price move.
This announcement follows a challenging Phase 3 update for ReNu on Sep 25, 2025, where a trial missed its primary endpoint despite numerical pain improvement. Since then, ORGO delivered record Q3 2025 revenue and raised full-year guidance on Nov 6, yet the stock fell. Earlier CMS reimbursement reform commentary and routine governance or HR items also coincided with modest declines. Today’s FDA confirmation of a rolling BLA marks clinical and regulatory progression for ReNu after those mixed trial results.
Market Pulse Summary
This announcement outlines FDA agreement on a rolling BLA for ReNu, backed by two Phase 3 RCTs, a 200-patient trial, and RMAT designation. It follows a mixed Phase 3 outcome disclosed in late September 2025 and record Q3 2025 revenue. Key risks remain around how regulators weight the totality of efficacy data and the large but competitive knee osteoarthritis market, where prevalence is projected to reach 34.4 million Americans by 2027.
Key Terms
type-b meeting regulatory
biologics licenses application regulatory
rct medical
regenerative medicine advanced therapy regulatory
osteoarthritis medical
AI-generated analysis. Not financial advice.
Clinical Development Program Appropriate for Rolling BLA
Submission Expected by the End of 2025
CANTON, Mass., Dec. 15, 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 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.
“We are excited about the outcome of our FDA meeting and reaching this important milestone in the ReNu program,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are pleased the ReNu clinical development program consisting of two large Phase 3 randomized controlled trials (RCT), a separate 200-patient RCT, extensive commercial history and Regenerative Medicine Advanced Therapy (RMAT)-designation is appropriate for BLA submission. If approved, we believe that ReNu will address a significant medical need for a large and growing patient population.”
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 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 15, 2025 about ReNu?
Does ReNu have RMAT designation and Phase 3 data for a BLA (ORGO)?
When does ORGO plan to file the ReNu BLA with the FDA?
How large is the knee osteoarthritis population cited by ORGO for ReNu?
What does the December 15, 2025 announcement mean for ORGO shareholders?
