Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026CANTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Admini ...

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Clinical Development Program Appropriate for Rolling BLA Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the successful completion of a planned Type-B meeting with the Food and Drug Administration (FDA) resulting in co ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Organogenesis Holdings Inc. following the failure of a key clinical trial for its product ReNu, which has led to a significant drop in the company's stock price [1][2]. Group 1: Company Performance - On September 25, 2025, Organogenesis announced that its second phase 3 trial for the cryopreserved amniotic suspension allograft ReNu did not meet its primary endpoint, failing to show a significant change in pain reduction [1]. - Following this announcement, Organogenesis's stock price decreased by $0.58 per share, or 12.39%, closing at $4.10 per share on September 26, 2025 [2]. Group 2: Legal Investigation - Pomerantz LLP is representing investors in investigating claims against Organogenesis and its officers/directors regarding possible securities fraud or other illegal business practices [1]. - The firm has a long history in corporate and securities class litigation, having recovered substantial damages for victims of securities fraud and corporate misconduct [3].

Core Insights - Organogenesis Holdings Inc. announced topline data from the second Phase 3 randomized controlled trial of ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis management [1][6] Study Results - The trial did not achieve statistical significance for its primary endpoint, although ReNu showed a numerical improvement in baseline pain reduction compared to the first Phase 3 trial [3][5] - Baseline pain reduction at six months for ReNu was -6.9 in the second Phase 3 study, compared to -6.0 in the first Phase 3 study [3] - The primary endpoint assessed the difference in knee pain reduction between ReNu and saline groups using the WOMAC pain scale [4] Statistical Analysis - The study demonstrated a numerical improvement of -0.51 favoring ReNu with a one-sided p-value of 0.0393, compared to the target threshold of 0.023 [5] - The first Phase 3 trial achieved a statistically significant improvement of -0.72 with a p-value of 0.0177 [5] Future Steps - The company plans to request a pre-BLA meeting with the FDA to discuss the submission pathway, including a combined efficacy analysis from both Phase 3 studies to support a BLA approval [6] Market Reaction - Following the announcement, Organogenesis Holdings shares fell by 15.49% to $3.95, trading within a 52-week range of $2.61 to $6.71 [7]

Core Insights - The second Phase 3 trial of ReNu did not achieve statistical significance for its primary endpoint, but showed a numerical improvement in pain reduction compared to the first Phase 3 trial [1][2][3] - The company plans to request a pre-BLA meeting with the FDA to discuss the submission pathway for ReNu, leveraging data from both Phase 3 trials [3][6] - ReNu has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating its potential to address an unmet medical need in knee osteoarthritis [3][7] Study Results - The second Phase 3 trial involved 594 patients and demonstrated a baseline pain reduction of -6.9 for ReNu compared to -6.0 in the first Phase 3 trial [1][10] - The primary endpoint assessed the difference in knee pain reduction at six months using the WOMAC pain scale, with a numerical improvement of -0.5 favoring ReNu in the second trial [2][10] - The first Phase 3 trial achieved a statistically significant improvement of -0.7 favoring ReNu [2] Market Context - Knee osteoarthritis affects over 30 million Americans and is a leading cause of disability and poor quality of life [4] - The company believes that if approved, ReNu will meet a significant unmet medical need for patients suffering from symptomatic knee osteoarthritis [4][6]

Core Viewpoint - The article does not provide any specific insights or analysis related to a company or industry, focusing instead on the author's qualifications and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in engineering, computer science, business management, and computer applications from various institutions [1]. - The author collaborates with another professional but emphasizes independent analysis and adherence to guidelines [1]. - There is a clear statement of no current stock or derivative positions in any mentioned companies, indicating a lack of conflict of interest [2]. Group 2 - The article includes disclaimers about past performance not guaranteeing future results and clarifies that no investment advice is being provided [3]. - It highlights that the views expressed may not reflect those of the platform as a whole, indicating a diversity of opinions among contributors [3]. - The article notes that the analysts may not be licensed or certified, which could impact the credibility of the analysis [3].

Core Viewpoint - Organogenesis Holdings Inc. reported a significant decline in net revenue for the first quarter of 2025, primarily due to a decrease in Advanced Wound Care product sales, while Surgical & Sports Medicine products showed growth. The company remains optimistic about its commercial strategy and ongoing product development, particularly the ReNu project [1][3][4]. Financial Performance - Net revenue for Q1 2025 was $86.7 million, down from $110.0 million in Q1 2024, representing a decrease of $23.3 million or 21% [4][7]. - Advanced Wound Care products generated $79.9 million in revenue, a decrease of 23% year-over-year, while Surgical & Sports Medicine products saw an increase to $6.8 million, up 11% [4][7]. - Gross profit for Q1 2025 was $63.0 million, or 73% of net revenue, compared to $81.3 million, or 74% of net revenue in Q1 2024, marking a decrease of $18.3 million or 23% [5]. - Operating expenses rose to $89.7 million, an increase of 5% from $85.1 million in Q1 2024, with R&D expenses decreasing by 17% to $10.6 million [6]. - The company reported a net loss of $18.8 million for Q1 2025, compared to a net loss of $2.1 million in Q1 2024, reflecting an increase in net loss of $16.7 million [9][10]. Cash Position - As of March 31, 2025, the company had $110.5 million in cash and cash equivalents, down from $136.2 million at the end of 2024, with no outstanding debt [11]. Guidance for Fiscal Year 2025 - The company reaffirmed its revenue guidance for 2025, expecting net revenue between $480.0 million and $535.0 million, which represents a year-over-year change of roughly flat to an increase of 11% [12][14]. - Expected net revenue from Advanced Wound Care products is projected to be between $450.0 million and $500.0 million, while Surgical & Sports Medicine products are expected to generate between $30.0 million and $35.0 million [14].