TLDR
- SGMO’s stock soars 9.95% after FDA approves gene therapy submission for Fabry.
- SGMO’s breakthrough gene therapy gains FDA nod, stock surges nearly 10%.
- Sangamo stock spikes 9.95% after FDA rolls out review for Fabry disease therapy.
- FDA greenlights Sangamo’s gene therapy submission, driving a 9.95% stock jump.
- Sangamo stock rises 9.95% on FDA approval for gene therapy aimed at Fabry.
Sangamo Therapeutics, Inc. (SGMO) saw its stock price rise by 9.95%, reaching $0.4233 as of 2:40 PM EST.
Sangamo Therapeutics, Inc., SGMO
This surge followed an announcement regarding the company’s gene therapy for Fabry disease. The stock’s rapid increase began in the early morning hours, peaking around 9 AM and stabilizing above $0.39 thereafter. This surge coincided with the U.S. Food and Drug Administration (FDA) accepting Sangamo’s request for a rolling submission of its Biologics License Application (BLA) for isaralgagene civaparvovec, or ST-920.
FDA Acceptance Boosts Sangamo’s Stock Price
The FDA’s acceptance of Sangamo’s request marks a key milestone for the company. Sangamo plans to initiate the rolling submission for the BLA under an accelerated approval pathway later this quarter. The acceptance follows an October 2025 meeting between Sangamo and the FDA, where the agency agreed to use eGFR slope as a key endpoint. This decision is crucial for the company’s gene therapy aimed at treating Fabry disease, a rare genetic disorder that affects multiple organs.
Nathalie Dubois-Stringfellow, Ph.D., Chief Development Officer at Sangamo, expressed enthusiasm about the decision. She emphasized that the company is excited about the potential of ST-920 to transform the treatment landscape for Fabry disease patients. She further confirmed that the company would proceed with the rolling submission later this quarter, which aligns with the FDA’s timeline.
Gene Therapy’s Potential for Fabry Disease Treatment
Sangamo’s gene therapy, isaralgagene civaparvovec, has shown promising results in clinical trials. The Phase 1/2 STAAR study, presented at the International Congress of Inborn Errors of Metabolism 2025, demonstrated its potential as a durable, one-time treatment for Fabry disease. The study highlighted meaningful clinical benefits across multiple organs and showed a positive eGFR slope at 52 weeks for all patients.
The FDA’s decision to consider eGFR slope as a primary approval endpoint strengthens the prospects for the therapy. The company’s ongoing efforts in gene therapy research and development underscore the potential to offer a transformative solution for patients. Sangamo remains confident in the ability of ST-920 to provide a significant improvement over current treatments.
Sangamo’s Continued Progress and Regulatory Support
Sangamo’s progress with isaralgagene civaparvovec has been recognized by several regulatory bodies. In addition to the FDA, the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has granted the therapy multiple designations. These include Orphan Drug and Fast Track designations from the FDA, as well as PRIME eligibility from the EMA and the Innovative Licensing and Access Pathway from MHRA.
Sangamo is well-positioned to continue advancing the therapy through the regulatory process. The FDA’s rolling submission acceptance is a significant step forward, and the company’s commitment to addressing the unmet needs of Fabry disease patients remains a top priority. The recent stock surge reflects investor confidence in the company’s progress toward bringing this promising gene therapy to market.
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