Organogenesis (ORGO) Soars 59.38% on Record Q3 Revenue, CMS Policy Shift Boosts PMA Products

The share price rose to its highest level so far this month, with an intraday gain of 59.38%.

Organogenesis Holdings Inc. (ORGO) surged on strong third-quarter financial results and favorable regulatory developments. The company reported record Q3 revenue of $150.5 million, exceeding its guidance and analyst estimates, driven by 31% year-over-year growth in Advanced Wound Care revenue. A key catalyst was the Centers for Medicare & Medicaid Services’ (CMS) 2026 fee schedule, which prioritizes payments for FDA-approved (PMA) skin substitutes like Apligraf. Organogenesis highlighted its three PMA products as well-positioned to benefit from the policy shift, which aims to curb overuse of lower-regulatory-standard devices. Meanwhile, the company’s ReNu osteoarthritis therapy received FDA RMAT designation despite mixed Phase III trial results, with a potential Biologics License Application filing slated for early 2026.

The stock’s post-earnings volatility reflected investor optimism tempered by risks. While the revised 2025 revenue guidance and robust cash reserves ($64.4 million) bolstered confidence, concerns lingered over ReNu’s approval timeline and CMS reforms reducing coverage for non-PMA products. Analysts remain bullish, citing the company’s leadership in advanced wound care and strategic focus on evidence-based therapies. Organogenesis’s ability to navigate regulatory shifts and maintain margins amid market consolidation could determine its trajectory, with the stock trading at a discount to its median price target of $8.00. The broader regenerative medicine sector’s focus on clinical differentiation positions the company to capitalize on long-term demand for high-value treatments.