RICHMOND, Calif. - Sangamo Therapeutics, Inc. (NASDAQ:SGMO), a genomic medicine company with a market capitalization of $492 million, today announced the forthcoming reacquisition of development and commercialization rights for giroctocogene fitelparvovec, a gene therapy candidate for hemophilia A, following Pfizer Inc. (NYSE:PFE)'s decision to terminate their collaboration. According to InvestingPro data, the company has seen remarkable stock performance, with a 614% return over the past six months, though it faces challenges with cash burn. Sangamo will consider all available options, including seeking a new partner, to advance the program after positive Phase 3 trial results.
The AFFINE trial, completed in July 2024, met its primary and key secondary objectives, demonstrating the therapy's efficacy compared to standard prophylaxis in patients with moderately severe to severe hemophilia A. Despite these outcomes, Pfizer will not proceed with regulatory submissions or commercialization, prompting Sangamo to regain control of the program effective April 21, 2025. InvestingPro analysis reveals the company operates with a moderate debt level, maintaining a current ratio of 1.35, which could impact its ability to advance the program independently. Subscribers can access 12 additional ProTips and comprehensive financial metrics on the platform. The company expressed disappointment but remains committed to seeking a path forward for the promising treatment.
Sangamo CEO Sandy Macrae emphasized the therapy's potential as a life-changing treatment and the company's dedication to advancing its genomic medicine pipeline. While the company's stock trades near its InvestingPro Fair Value, investors should note that analysts anticipate a sales decline in the current year, with revenue dropping 74% in the last twelve months to $52.29 million. For detailed insights and expert analysis, consider accessing the comprehensive Pro Research Report available on InvestingPro, covering this and 1,400+ other US equities. Sangamo's ongoing projects include a neurology-focused pipeline and a Fabry gene therapy program, with a potential Biologics License Application submission anticipated in the second half of 2025.
As part of the transition, all participants in the AFFINE trial will continue to be monitored. The trial's positive results showed a statistically significant reduction in annual bleeding rates post-treatment, with giroctocogene fitelparvovec being generally well tolerated.
The company also highlighted its partnerships with Genentech and Astellas, along with advanced discussions for its Fabry gene therapy program, as drivers for its neurology genomic medicine pipeline. Enrollment for a Phase 1/2 study of ST-503 for idiopathic small fiber neuropathy is expected to begin in mid-2025, and a Clinical Trial Authorisation submission for a prion disease program is planned for Q4 2025, contingent on securing additional funding.
Sangamo Therapeutics focuses on developing genomic medicines for serious neurological diseases with limited or no treatment options. The company's approach involves zinc finger epigenetic regulators and a capsid discovery platform to potentially address neurological disorders and expand delivery capabilities.
This news is based on a press release statement and reflects Sangamo's current expectations and plans for the future of its gene therapy candidate and ongoing projects.
In other recent news, Sangamo Therapeutics entered a $20 million licensing agreement with Astellas Pharma, granting Astellas an exclusive worldwide license to Sangamo's STAC-BBB capsid technology for gene therapy applications in neurological diseases. This technology, developed by Sangamo, aims to address the challenges associated with treating neurological disorders. The deal could potentially bring Sangamo up to $1.3 billion in milestone payments and tiered royalties on net sales of products developed through the collaboration.
Additionally, Sangamo experienced a surge in shares following Roche (LON:0QQ6)'s decision to discontinue its gene therapy program for hemophilia A. Sangamo is currently collaborating with Pfizer on a competing gene therapy targeting the same condition.
Furthermore, Truist Securities upgraded Sangamo's stock from Hold to Buy, highlighting several key developments such as a potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filing for a Phase 3 Hemophilia A gene therapy in early 2025. They also noted the expected full data for the treatment of Fabry disease in the first half of 2025, potentially making Sangamo an attractive partner for advancing the treatment.
Lastly, during their Third Quarter 2024 earnings call, Sangamo reported significant advancements in their gene therapy programs, including progress in their Fabry disease program and a collaboration with Pfizer on a hemophilia A treatment. They are preparing for multiple BLA submissions and received a $50 million milestone payment from Genentech, indicating a strong financial position.
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