Organogenesis Completes FDA Meeting, Plans BLA Submission by End of 2025
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
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Should l Buy ORGO?
Source: Newsfilter
- Successful FDA Meeting: Organogenesis has successfully completed a Type-B meeting with the FDA, confirming plans to submit a rolling Biologics License Application (BLA) for ReNu by the end of 2025, marking a significant milestone in the field of regenerative medicine.
- Clinical Trial Scale: The ReNu clinical development program includes two large Phase 3 randomized controlled trials and a separate 200-patient trial, having been studied in over 1,300 patients, demonstrating its potential in treating knee osteoarthritis and addressing a growing medical need.
- Market Demand: Knee osteoarthritis affects approximately 31.1 million Americans, projected to rise to 34.4 million by 2027, and the launch of ReNu could provide new treatment options for this large patient population, potentially significantly improving their quality of life.
- Strategic Significance: The RMAT designation from the FDA for ReNu highlights its innovative nature in regenerative medicine, and if approved, it could provide a new revenue stream for Organogenesis while enhancing its competitive position in the market.
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Analyst Views on ORGO
Wall Street analysts forecast ORGO stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.740
Low
9.00
Averages
9.00
High
9.00
Current: 3.740
Low
9.00
Averages
9.00
High
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
- Securities Fraud Investigation: Pomerantz LLP is investigating claims of securities fraud against Organogenesis Holdings Inc., suggesting that the company and its executives may have engaged in unlawful business practices, prompting investors to reach out for more information.
- Impact of Healthcare Policy: On December 26, 2025, the Centers for Medicare & Medicaid Services announced the withdrawal of final Local Coverage Determinations related to skin substitute grafts, leading to increased competition from over 300 market participants for Organogenesis.
- 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 renowned firm in corporate and securities class litigation, having fought for the rights of victims of securities fraud for over 85 years, highlighting its expertise and influence in such cases.
See More
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.
See More
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.
See More
Organogenesis Faces Securities Fraud Investigation, Stock Drops 10.14%
- Investigation Launched: Pomerantz LLP is investigating whether Organogenesis Holdings Inc. has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to stock volatility.
- Policy Change Impact: On December 26, 2025, the Centers for Medicare & Medicaid Services withdrew final Local Coverage Determinations related to skin substitute grafts, meaning Organogenesis will face increased competition from over 300 market participants.
- 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 prospects.
- Legal Consequences: Pomerantz LLP, a prominent securities class action law firm, may lead to legal liabilities for Organogenesis, further impacting its market performance and investor trust.
See More
Avista Healthcare Partners Promotes Three Key Executives in Investment Team
- Team Promotions: Avista Healthcare Partners has promoted Ryan Moran and Garrett Lustig to Partners, and Elaine Tang to Principal, reflecting the firm's ongoing growth and commitment to talent development in the healthcare investment sector.
- Leadership Enhancement: Managing Partner David Burgstahler noted that these promotions underscore the depth and strength of the firm's leadership team, signaling a strong commitment to pursuing new investment opportunities in the healthcare industry.
- Rich Backgrounds: Ryan Moran, who joined Avista in 2018 after working at Morgan Stanley Capital Partners, currently serves on the boards of several pharmaceutical companies, showcasing his expertise in healthcare investments.
- Strategic Investment: Since its founding in 2005, Avista has invested over $10 billion in more than 50 healthcare businesses globally, focusing on companies with strong management teams and stable cash flows, highlighting its robust growth potential in the healthcare sector.
See More
Organogenesis Faces Securities Fraud Investigation, Stock Drops 10.14%
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Organogenesis Holdings Inc. has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to stock price volatility.
- Policy Change Impact: On December 26, 2025, the Centers for Medicare & Medicaid Services withdrew final Local Coverage Determinations related to skin substitute grafts, meaning Organogenesis will face increased competition from over 300 market participants.
- 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 prospects.
- Increased Legal Risks: As the investigation unfolds, Organogenesis may face legal liabilities and potential compensation claims, which could have long-term negative implications for the company's financial health and reputation.
See More
Pomerantz LLP Investigates Securities Fraud Claims Against Organogenesis Holdings
- Securities Fraud Investigation: Pomerantz LLP is investigating claims of securities fraud against Organogenesis Holdings Inc., suggesting that the company and its executives may have engaged in unlawful business practices, prompting investors to reach out for more information.
- Impact of Healthcare Policy: On December 26, 2025, the Centers for Medicare & Medicaid Services announced the withdrawal of final Local Coverage Determinations related to skin substitute grafts, leading to increased competition from over 300 market participants for Organogenesis.
- 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 renowned firm in corporate and securities class litigation, having fought for the rights of victims of securities fraud for over 85 years, highlighting its expertise and influence in such cases.
See More
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.
See More
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.
See More
Organogenesis Faces Securities Fraud Investigation, Stock Drops 10.14%
- Investigation Launched: Pomerantz LLP is investigating whether Organogenesis Holdings Inc. has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to stock volatility.
- Policy Change Impact: On December 26, 2025, the Centers for Medicare & Medicaid Services withdrew final Local Coverage Determinations related to skin substitute grafts, meaning Organogenesis will face increased competition from over 300 market participants.
- 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 prospects.
- Legal Consequences: Pomerantz LLP, a prominent securities class action law firm, may lead to legal liabilities for Organogenesis, further impacting its market performance and investor trust.
See More
Avista Healthcare Partners Promotes Three Key Executives in Investment Team
- Team Promotions: Avista Healthcare Partners has promoted Ryan Moran and Garrett Lustig to Partners, and Elaine Tang to Principal, reflecting the firm's ongoing growth and commitment to talent development in the healthcare investment sector.
- Leadership Enhancement: Managing Partner David Burgstahler noted that these promotions underscore the depth and strength of the firm's leadership team, signaling a strong commitment to pursuing new investment opportunities in the healthcare industry.
- Rich Backgrounds: Ryan Moran, who joined Avista in 2018 after working at Morgan Stanley Capital Partners, currently serves on the boards of several pharmaceutical companies, showcasing his expertise in healthcare investments.
- Strategic Investment: Since its founding in 2005, Avista has invested over $10 billion in more than 50 healthcare businesses globally, focusing on companies with strong management teams and stable cash flows, highlighting its robust growth potential in the healthcare sector.
See More
Organogenesis Faces Securities Fraud Investigation, Stock Drops 10.14%
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Organogenesis Holdings Inc. has engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to stock price volatility.
- Policy Change Impact: On December 26, 2025, the Centers for Medicare & Medicaid Services withdrew final Local Coverage Determinations related to skin substitute grafts, meaning Organogenesis will face increased competition from over 300 market participants.
- 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 prospects.
- Increased Legal Risks: As the investigation unfolds, Organogenesis may face legal liabilities and potential compensation claims, which could have long-term negative implications for the company's financial health and reputation.
See More
