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. develops, manufactures and sells regenerative medicine and tissue-innovation products for the Advanced Wound Care and Surgical & Sports Medicine markets. News about the company commonly covers product revenue by those markets, gross margin and profitability trends, and corporate updates tied to its Nasdaq-listed Class A common stock.
Company updates also focus on clinical and regulatory activity across its portfolio. Recurring subjects include PuraPly AM clinical evidence in diabetic foot ulcers, ReNu as a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis, FDA interactions, Biologics License Application activity, and coverage or payment developments affecting skin-substitute and wound-care products.
Organogenesis (Nasdaq: ORGO) reported peer-reviewed results from a 206-patient, prospective, multicenter randomized controlled trial evaluating Affinity plus standard of care (SoC) versus SoC alone in complex venous leg ulcers (VLUs). Results published in the Journal of Wound Care showed statistically significant improvements (p<0.05) in wound closure at weeks 12 and 16 for the Affinity + SoC arm across two baseline wound duration strata: wounds present >6 months and >24 months.
The trial included a four-week run-in and 24-week follow-up. According to Organogenesis, these data strengthen the evidence base for Affinity as a protective barrier in some of the hardest-to-heal chronic wounds and complement existing randomized and real‑world data in diabetic foot ulcers, supporting the clinical and economic rationale for broader coverage in VLUs and DFUs.
Organogenesis (Nasdaq: ORGO) will report second quarter fiscal 2026 financial results after market close on Thursday, August 6, 2026. Management will host a 5:00 p.m. ET conference call and live webcast, including a corporate update and Q&A session.
The webcast will be available at investors.organogenesis.com and archived for about one year.
Organogenesis (Nasdaq: ORGO) announced FDA acceptance for review of its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft for managing pain in symptomatic knee osteoarthritis.
The FDA set a PDUFA target action date of April 24, 2027. Knee osteoarthritis affects nearly 31 million Americans and is projected to exceed 34 million by 2027.
Organogenesis (Nasdaq: ORGO) reported Q1 2026 results for the quarter ended March 31, 2026. Net product revenue was $36.3M, down $50.4M (58%) from Q1 2025; Advanced Wound Care revenue fell to $29.5M (down 63%). Net loss was $53.2M, or $(0.44) per share. Cash and restricted cash totaled $92.1M; no outstanding debt. The company narrowed FY2026 revenue guidance to $270.0M–$310.0M, reflecting an assumed sequential recovery in H2 2026.
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.