Organogenesis Hldgs Inc Stock Price, News & Analysis

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.

Organogenesis (Nasdaq: ORGO) applauded CMS’s finalization of payment reform for skin substitutes/CTPs under the CY 2026 Physician Fee Schedule announced Nov. 3, 2025.

The company highlighted that CMS finalized FDA classifications and a per centimeter-square payment methodology for both physician office and hospital outpatient settings, and said CMS recognized the clinical differentiation of PMA products, which the company believes will increase access and support higher payment and expanded access for PMA technologies. Organogenesis reiterated its multi-decade leadership and said its evidence-based portfolio positions it well for the skin substitutes market in 2026 and beyond.

The release contains forward-looking statements and cautions that actual outcomes are subject to risks and uncertainties described in the company’s SEC filings.

Organogenesis (Nasdaq: ORGO) announced inducement equity awards tied to its newly hired Chief Technology Officer, Michael Catarina, effective October 29, 2025.

The Board granted 82,542 non‑statutory stock options (NSOs) with an exercise price of $4.17 per share and 47,962 restricted stock units (RSUs). Both awards vest in substantially equal annual installments over four years beginning October 20, 2025, subject to continued employment. Although granted outside the 2018 Equity Incentive Plan, the awards are governed by that plan's terms and the related award agreements.

The awards were made as an inducement material to Mr. Catarina’s acceptance of employment pursuant to Nasdaq Listing Rule 5635(c)(4).

Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical and Sports Medicine markets, has scheduled its Q3 2025 earnings release for November 6, 2025, after market close.

Management will host a conference call at 5:00 p.m. Eastern Time on the same day, featuring a corporate update and Q&A session. Investors can join via webcast or teleconference using the dial-in numbers 800-715-9871 (US) or 646-307-1963 (international) with access code 9073428. The webcast will be available on the company's investor relations website for approximately one year.

Organogenesis (NASDAQ: ORGO) announced that its second Phase 3 trial for ReNu®, a treatment for knee osteoarthritis (OA), did not meet its primary endpoint despite showing improved pain reduction. The trial demonstrated a numerical improvement of -0.51 favoring ReNu (p=0.0393) compared to saline, falling short of the p=0.023 target threshold.

Key highlights include baseline pain reduction of -6.9 at six months in the second Phase 3 study, improving from -6.0 in the first Phase 3 study. The company maintains confidence in ReNu's potential and plans to request a pre-BLA meeting with the FDA by end of October to discuss submission pathway, leveraging combined efficacy analysis from both Phase 3 studies.

ReNu has been studied in three large RCTs with over 1,300 patients and has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation.

Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical & Sports Medicine markets, has announced its participation in two major healthcare investor conferences in September.

Management will present at the Cantor Fitzgerald Global Healthcare Conference on September 3 at 2:10 p.m. ET and the Morgan Stanley Global Healthcare Conference on September 10 at 2:35 p.m. ET. Both events will take place in New York City and feature fireside chat sessions that will be available via webcast on the company's investor relations website for approximately 30 days after the events.

Organogenesis Holdings (NASDAQ: ORGO) reported Q2 2025 financial results showing a decline in performance. The company posted net product revenue of $100.8 million, down 23% from $130.2 million in Q2 2024. The Advanced Wound Care segment saw a 25% decrease to $92.7 million, while Surgical & Sports Medicine revenue increased 16% to $8.1 million.

The company reported a net loss of $9.4 million ($0.10 per share), an improvement from a $17.0 million loss in Q2 2024. Adjusted EBITDA turned negative at $(3.6) million, compared to positive $15.6 million in the prior year. The company maintained a strong balance sheet with $73.7 million in cash and no debt.

For full-year 2025, Organogenesis updated guidance, projecting revenue between $480-$510 million, representing flat to 6% growth, with net income ranging from $(6.4) million to $16.4 million.