Buy Rating for Organogenesis Holdings: FDA Progress and Favorable Policy Changes Drive Optimism

Analyst Ryan Zimmerman of BTIG maintained a Buy rating on Organogenesis Holdings, retaining the price target of $9.00.

Ryan Zimmerman has given his Buy rating due to a combination of factors that positively impact Organogenesis Holdings. The company recently completed a successful Type-B meeting with the FDA, which allows them to proceed with their Biologics License Application for ReNu by the end of December. This development is significant as it revitalizes the potential of ReNu, which had been largely discounted by investors after not meeting the primary endpoint in a previous trial. The advancement towards FDA approval is seen as a favorable long-term opportunity for the company.
Additionally, changes in CMS policies regarding skin substitutes present a potential benefit for Organogenesis. The new classification system, effective January 2026, could allow for increased utilization of products, including those from Organogenesis, if they are covered at the discretion of Medicare Administrative Contractors. Although there remains some uncertainty regarding pricing, the updates are less restrictive than previous policies and may favor cost-effective products like those from Organogenesis. These developments, combined with a valuation based on a 1.5x discount to peers, support Zimmerman’s optimistic outlook and Buy rating.