Organogenesis Holdings Inc.

Organogenesis Holdings Inc. announced the publication of positive results from a prospective, multicenter, randomized controlled trial (RCT) evaluating its product, Affinity, for complex venous leg ulcers (VLUs). The trial demonstrated statistically significant improvements in wound closure at weeks 12 and 16 for the Affinity + standard of care group compared to standard of care alone. These findings, published in the Journal of Wound Care, reinforce Affinity's clinical benefit for hard-to-heal wounds and complement existing data for diabetic foot ulcers.

Organogenesis Holdings Inc. announced that it will report its second quarter of fiscal year 2026 financial results after the market closes on Thursday, August 6th. Following the release, management will host a conference call at 5:00 p.m. Eastern Time to discuss the results, provide a corporate update, and conduct a question and answer session. The live webcast will be accessible through the company's investor relations website.

Organogenesis Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for ReNu®. ReNu® is a cryopreserved, amniotic suspension allograft designed to treat pain in symptomatic knee osteoarthritis (OA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027, marking a significant step towards potentially bringing a new non-surgical biologic therapy to market for millions of Americans suffering from knee OA.

Organogenesis Holdings Inc. held its 2026 Annual Meeting of Stockholders on June 15, 2026, where three proposals were approved. Stockholders re-elected Garrett Lustig and elected nine other directors to the board. Additionally, the compensation paid to named executive officers was approved on an advisory basis, and the appointment of RSM US LLP as the independent registered public accounting firm for fiscal year 2026 was ratified.

Organogenesis Holdings Inc. reported a significant decline in total revenue for the first quarter of 2026, falling to $37.2 million from $86.7 million in the prior year. The company also experienced a widened net loss of $53.2 million, or $0.44 per share, compared to a net loss of $18.8 million, or $0.17 per share, in Q1 2025. In response to weakened financial performance, Organogenesis initiated a restructuring plan in March 2026, reducing its workforce by 10% and closing its St. Petersburg, Florida facility, incurring an $8.8 million charge.

Organogenesis Holdings Inc. reported a challenging first quarter for 2026, with net revenue decreasing by 58% to $36.3 million and net loss widening to $53.2 million. The company also updated its full-year 2026 revenue guidance, now expecting a decline of 45% to 52% compared to 2025, citing a more measured recovery in market-related headwinds. Despite the difficult start, the CEO expressed confidence in driving market share gains in the second half of 2026.

Organogenesis Holdings Inc. announced its 2026 Annual Meeting of Stockholders to be held virtually on June 15, 2026, at 11:00 a.m. Eastern time. Stockholders of record as of April 23, 2026, will vote on the re-election of nine directors, an advisory resolution on named executive officer compensation, and the ratification of RSM US LLP as the independent auditor for fiscal year 2026. The company also expects Garrett Lustig to be re-elected as a Preferred Director.

Organogenesis Holdings Inc. announced the completion of its rolling Biologics License Application (BLA) submission to the FDA for ReNu®, a cryopreserved, amniotic suspension allograft for symptomatic knee osteoarthritis (OA). The submission included clinical and chemistry, manufacturing, and controls (CMC) modules, following the initiation of non-clinical modules in December 2025. This milestone represents a significant step in bringing a new regenerative therapy to patients suffering from knee OA, a condition affecting millions of Americans.