1. ORGO initiates submission for ReNu Biologics License Application to FDA. 2. ReNu aims to treat symptomatic knee arthritis; first non-surgical biologic option. 3. Knee OA affects 31.1 million Americans, projected growth to 34.4 million by 2027. 4. ReNu has meaningful clinical data with prior FDA RMAT designation already obtained. 5. Significant potential market as current management options often lead to knee replacements.
FAQ
Why Bullish?
The initiation of the BLA for ReNu signals confidence in future growth, much like situations where companies, after submitting BLA for promising drugs, experienced notable stock price surges. For instance, Amgen's BLA submission for innovative therapies often led to positive market responses, highlighting market optimism for high-demand solutions.
How important is it?
The article discusses critical regulatory developments for ORGO's flagship product, influencing investor expectations heavily. The potential for ReNu to be a game-changing treatment in a vast market supports the high score.
Why Long Term?
The impact will unfold over years as ReNu gains FDA approval and market acceptance. Previous instances, such as with Regeneron's Dupixent, demonstrated significant long-term stock performance improvements following successful regulatory approvals.
Organogenesis Initiates Biologics License Application for ReNu®
CANTON, Mass., Dec. 23, 2025 – Organogenesis Holdings Inc. (Nasdaq: ORGO), a pioneering company in regenerative medicine, has announced the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ReNu®, a cryopreserved amniotic suspension allograft targeting symptomatic knee arthritis. The company aims to finalize the BLA submission, with the last modules expected to be submitted in the first half of 2026.
Significance of the ReNu® BLA
Patrick Bilbo, Chief Operating Officer of Organogenesis, stated, “This is another significant achievement for the ReNu clinical development program and a pivotal moment for Organogenesis.” If approved, ReNu would mark the first non-surgical biologic therapy designed to alleviate knee osteoarthritis pain for all patients, especially those classified as most severe.
Knee Osteoarthritis: A Growing Concern
Knee osteoarthritis (OA) is a degenerative joint disease currently affecting approximately 31.1 million Americans, with projections indicating this figure could rise to 34.4 million by 2027. It ranks among the leading causes of disability and poor quality of life due to its characteristic pain and functional deficits. In advanced cases, total knee replacement is often the only remaining option when all other treatments have been exhausted.
About ReNu®
ReNu consists of amniotic fluid cells and micronized amniotic membrane, rich in cellular, growth factor, and extracellular matrix components. The product has been evaluated in three large randomized controlled trials (RCTs) involving over 1,300 patients and received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee OA in 2021. Previously, it was marketed under Section 361 of the Public Health Service Act and available commercially for about six years.
Company Background: Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is recognized for its commitment to developing, manufacturing, and commercializing advanced wound care solutions and surgical products. Its comprehensive portfolio of innovative regenerative products addresses diverse patient needs throughout the continuum of care. For more information, visit www.organogenesis.com.
Forward-Looking Statements
This release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements pertain to expectations or forecasts about future events, including the timing of regulatory submissions and potential approvals for ReNu. Factors that could impact these statements include:
- Clinical development risks
- Regulatory authority determinations that may affect commercialization
- Potential changes in FDA requirements for approval
- Market acceptance and competition
Investors are cautioned not to place undue reliance on these forward-looking statements, which reflect views as of their dates. Although the company may update these statements periodically, there is no obligation to do so unless required by securities laws.