1. Organogenesis plans to submit a rolling BLA for ReNu by December 2025. 2. ReNu targets knee osteoarthritis, affecting a projected 34.4 million Americans by 2027. 3. Federal approval could address major medical needs in a growing patient population. 4. ReNu is based on promising clinical trials with RMAT designation from the FDA. 5. Forward-looking statements caution against overreliance on anticipated regulatory success.
FAQ
Why Bullish?
The initiation of the rolling BLA indicates strong commercial potential. Historical success in similar FDA approvals led to price increases in other biotech firms.
How important is it?
The potential BLA submission and ReNu’s market focus on knee OA could significantly influence ORGO’s growth trajectory.
Why Long Term?
The rolling BLA and eventual approval could take time to materialize, affecting future sales.
Organogenesis Announces FDA Meeting Success and Upcoming BLA Submission for ReNu® Targeting Knee Osteoarthritis
CANTON, Mass., December 15, 2025 (GLOBE NEWSWIRE) — Organogenesis Holdings Inc. (Nasdaq: ORGO), a prominent player in regenerative medicine, has announced a significant milestone in its clinical development program. The company has successfully completed a Type-B meeting with the Food and Drug Administration (FDA), confirming plans to initiate a rolling Biologics License Application (BLA) for its product, ReNu, anticipated to be submitted by the end of December 2025.
Details of the ReNu Program
The successful outcome of the FDA meeting was met with enthusiasm by Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are excited about the outcome of our FDA meeting and reaching this important milestone in the ReNu program,” stated Bilbo. He highlighted that the ReNu clinical development program includes:
- Two large Phase 3 randomized controlled trials (RCT)
- A separate 200-patient RCT
- Extensive commercial history
- Regenerative Medicine Advanced Therapy (RMAT) designation
He emphasized that if approved, ReNu would meet a significant medical need for a rapidly growing patient population suffering from knee osteoarthritis (OA).
The Increasing Impact of Knee Osteoarthritis
Knee OA is a degenerative joint disease expected to impact approximately 31.1 million Americans, with projections suggesting that this number could rise to 34.4 million by 2027. This condition is one of the leading causes of disability in the United States and is characterized by debilitating pain and decreased functionality. Patients facing advanced stages of knee OA often resort to total knee replacement after exhausting other treatment options.
Overview of ReNu®
ReNu is a cryopreserved amniotic suspension allograft designed specifically for managing symptomatic knee osteoarthritis. It comprises a complex composition of amniotic fluid cells, micronized amniotic membrane, and various cellular, growth factor, and extracellular matrix components. Notably, ReNu has been validated through three large RCTs involving over 1,300 patients and received FDA RMAT designation for knee OA in 2021. Previously, the product was marketed under Section 361 of the Public Health Service Act and was available for nearly six years.
About Organogenesis
Organogenesis Holdings Inc. is a leader in regenerative medicine, dedicated to the development, manufacturing, and commercialization of innovative solutions for advanced wound care and surgical and sports medicine markets. The company provides a broad portfolio of regenerative products targeted to meet the diverse needs of patients across the continuum of care.
For detailed information about Organogenesis and its products, visit www.organogenesis.com.
Forward-Looking Statements
This announcement contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Such statements include expectations regarding future events, including the timing of the regulatory submission and potential approval of ReNu. It is important to recognize that these forecasts may be influenced by risks and uncertainties inherent in clinical development and regulatory processes. Various factors, including the need for additional evidence for BLA approval by the FDA, may impact the successful commercial launch of ReNu.
Investors are advised not to place undue reliance on these prospective statements, which are not guaranteed, and to consider the risks detailed in Organogenesis's filings with the Securities and Exchange Commission.