Welcome to our dedicated page for Organogenesis Hldgs news (Ticker: ORGO), a resource for investors and traders seeking the latest updates and insights on Organogenesis Hldgs stock.
Organogenesis Holdings Inc. (Nasdaq: ORGO) is a regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. The Organogenesis news feed highlights company announcements, clinical updates, financial results, and regulatory developments that help investors and healthcare professionals understand how the business is evolving.
News about Organogenesis frequently covers its regenerative medicine portfolio and its position in the skin substitutes and cellular and tissue-based products (CTP) market. The company issues press releases on quarterly and year-to-date financial performance, including net product revenue from Advanced Wound Care and Surgical & Sports Medicine products, net income or loss, and adjusted metrics such as adjusted net income and adjusted EBITDA. These updates often include management commentary on market conditions, reimbursement dynamics, and expectations for future periods.
A major theme in Organogenesis news is the development of ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis. The company publishes detailed updates on Phase 3 randomized controlled trials, including pain and function outcomes, safety observations, and plans for regulatory submissions. Announcements have described FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ReNu, plans for a Biologics License Application (BLA), and the initiation of a rolling BLA submission.
Additional news items include commentary on Centers for Medicare & Medicaid Services (CMS) payment reforms for skin substitutes/CTPs, participation in investor conferences, and corporate governance developments such as inducement equity grants and stockholder meeting results. By following this page, readers can review a chronological record of how Organogenesis communicates its financial performance, clinical progress, reimbursement environment, and corporate actions.
Organogenesis (Nasdaq: ORGO) completed a rolling Biologics License Application (BLA) submission to the FDA for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis (OA).
The company began rolling submission in December 2025 and finished with clinical and CMC modules on April 28, 2026. Knee OA affects an estimated 31.1 million Americans, projected to reach 34.4 million by 2027.
Organogenesis (Nasdaq: ORGO) reported that a prospective, multi-center randomized controlled trial of 170 patients showed PuraPly AM plus standard of care achieved the primary endpoint of statistically significant diabetic foot ulcer (DFU) wound closure at 12 weeks (p < 0.0477).
Organogenesis said the trial evaluated safety and efficacy, plans peer-reviewed publication, and believes results will support future coverage decisions for PuraPly AM.
Organogenesis (Nasdaq: ORGO) said it completed a Type B meeting with the FDA and received confirmation that the ReNu clinical development program is appropriate for a rolling Biologics License Application (BLA) submission expected by the end of 2025. The program includes two large Phase 3 randomized controlled trials, extensive commercial history, and RMAT designation.
The company plans to initiate a rolling BLA for ReNu before the end of December and said, if approved, ReNu could address knee osteoarthritis pain for millions of patients.
Organogenesis (Nasdaq: ORGO) will report first quarter fiscal 2026 results after market close on May 7, 2026. Management will host a conference call and live webcast at 5:00 p.m. Eastern Time the same day to discuss results and provide a corporate update with Q&A.
The live webcast is accessible via the company investor website and will be archived for approximately one year.
Organogenesis Holdings (Nasdaq: ORGO) reported record 2025 results with net product revenue $563.0M and fourth-quarter net product revenue of $225.1M (Q4 2025 vs Q4 2024 +78%). Net income was $37.0M for FY2025 and $43.7M in Q4 2025. Adjusted EBITDA was $98.1M for FY2025 and $84.2M for Q4. As of Dec 31, 2025 the company held $94.3M cash with no outstanding debt. Fiscal 2026 guidance assumes total net revenue $350M–$420M, reflecting an expected near-term revenue decline and recovery later in 2026.
Organogenesis (Nasdaq: ORGO) will report fourth quarter and fiscal year 2025 financial results after market close on Thursday, February 26, 2026.
Management will host a conference call and live webcast at 5:00 p.m. ET on February 26 to discuss results and provide a corporate update; the webcast will be archived on the company website for about one year.
Avista Healthcare Partners (ORGO) announced on January 5, 2026 three promotions within its investment team: Ryan Moran and Garrett Lustig were promoted to Partner, and Elaine Tang was promoted to Principal.
The announcement highlights each executive's tenure and background: Moran joined Avista in 2018 with prior roles at Morgan Stanley Capital Partners and Bank of America Merrill Lynch; Lustig joined in 2015 from Centerview Partners; Tang joined in 2022 from Partners Group. Each exec currently serves on multiple portfolio company boards, including Organogenesis (Nasdaq: ORGO) for Lustig.
David Burgstahler, CEO, said the promotions reflect Avista's growth and focus on developing leadership as the firm pursues healthcare investment opportunities.
Organogenesis (Nasdaq: ORGO) has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee arthritis.
Initial modules were submitted under rolling review with final modules expected in the first half of 2026. Company executives said ReNu, if approved, would be the first non-surgical biologic therapy for knee osteoarthritis across all patients, including the most severe. Knee osteoarthritis is estimated to affect 31.1 million Americans, rising to 34.4 million by 2027, with end-stage management typically a total knee replacement.
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.
Organogenesis Holdings (Nasdaq: ORGO) reported Q3 2025 net product revenue of $150.5M, up 31% year-over-year, driven by Advanced Wound Care ($141.5M, +31%) and Surgical & Sports Medicine ($9.0M, +25%). Q3 net income was $21.6M versus $12.3M in Q3 2024; adjusted EBITDA was $30.1M. Nine-month net product revenue declined 5% to $338.0M and the nine-month operating loss was $18.6M. Cash and equivalents were $64.4M at Sept 30, 2025. For FY2025 the company updated guidance to $500.0M–$525.0M in net product revenue and adjusted EBITDA of $45.5M–$68.3M.