Organogenesis Submits BLA for ReNu, Expected Completion in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 24 2025
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Source: NASDAQ.COM
- BLA Submission Initiated: Organogenesis has begun the submission of a Biologics License Application for ReNu to the FDA, expected to be completed in the first half of 2026, which will provide a new treatment option for knee arthritis patients, particularly those classified as severe.
- Clinical Trial Support: The application for ReNu is backed by three large randomized controlled trials enrolling over 1,300 patients, demonstrating its efficacy in treating knee osteoarthritis and further solidifying its market potential.
- Strong Market Demand: Currently, approximately 31.1 million Americans are affected by knee osteoarthritis, with projections rising to 34.4 million by 2027, and the launch of ReNu will fill a gap in non-surgical biologic therapies to meet the growing patient needs.
- Improved Financial Performance: Organogenesis reported a net income of $21.6 million in Q3 2025, up from $12.3 million in the same quarter last year, indicating strong performance in the biologics market and future growth potential.
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Analyst Views on ORGO
Wall Street analysts forecast ORGO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ORGO is 9.00 USD with a low forecast of 9.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 4.010
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9.00
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9.00
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9.00
Current: 4.010
Low
9.00
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9.00
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9.00
About ORGO
Organogenesis Holdings Inc. is a regenerative medicine company focused on the development, manufacture and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. It offers a portfolio of regenerative products to address patient needs across the continuum of care. Its wound care products include Apligraf for the treatment of venous leg ulcers and diabetic foot ulcers (DFUs); Dermagraft for the treatment of DFUs; PuraPly AM as an antimicrobial barrier, cross-linked with extracellular matrix scaffold for a variety of wound types; and Affinity, Novachor and NuShield placental allografts to address a variety of wound sizes and types as a protective barrier and extracellular matrix scaffold. Its sports medicine products include NuShield as a surgical barrier and PuraForce as a reinforcement matrix in targeted soft tissue repairs; and Affinity, Novachor, PuraPly MZ, PuraPly AM and PuraPly SX for the management of open wounds in a surgical setting.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Pomerantz LLP Investigates Securities Fraud Claims Against Organogenesis Holdings Inc.
- Securities Fraud Investigation: Pomerantz LLP is investigating claims against Organogenesis Holdings Inc. for potential securities fraud and other unlawful business practices, aiming to protect investor rights and possibly lead to a class action lawsuit.
- Impact of Policy Changes: On December 26, 2025, the Centers for Medicare & Medicaid Services withdrew final Local Coverage Determinations related to skin substitute grafts, increasing competitive pressure on Organogenesis from over 300 market participants.
- Stock Price Decline: Following this news, Organogenesis's stock price fell by $0.59, or 10.14%, closing at $5.28 per share on December 30, 2025, indicating market concerns regarding the company's future prospects.
- Legal Firm Background: Pomerantz LLP is a prominent law firm specializing in securities, antitrust, and corporate class litigation, having recovered millions of dollars for victims of securities fraud over its 85-year history, showcasing its expertise and influence in the field.
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Organogenesis Faces Securities Fraud Investigation, Stock Drops 10.14%
- Securities Fraud Investigation: Pomerantz LLP is investigating Organogenesis Holdings Inc. for potential securities fraud involving the company and its executives, which could undermine investor confidence and lead to stock volatility.
- Increased Market Competition: The withdrawal of final Local Coverage Determinations by the Centers for Medicare & Medicaid Services means Organogenesis will face competition from over 300 market participants, potentially impacting its market share and profitability.
- Stock Price Reaction: Following this news, Organogenesis's stock price fell by $0.59, or 10.14%, closing at $5.28 per share on December 30, 2025, reflecting market concerns about the company's future outlook.
- Potential Legal Consequences: Pomerantz LLP, a prominent securities class action firm, may lead to legal liabilities for Organogenesis, further affecting its financial health and investor trust.
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