The price of Sangamo Therapeutics, Inc.’s (NASDAQ: SGMO) stock is increasing sharply on the US stock charts today, maintaining the upward trend from the previous trading session. After climbing 24.14% the day before, to $2.16, SGMO shares were up 15.74% to $2.50 as of the most recent pre-market check. This increase follows the company’s announcement of the release date of its third-quarter 2024 financial results.
Sangamo to Announce Financial Results Next Week
Sangamo (SGMO) disclosed that following the market close on Tuesday of next week, it will announce its third-quarter financial results. On that day, SGMO will also have a conference call to go over its financial results and give an update on new business ventures. Since it may provide further details about the company’s financial status and future direction, investors are anxiously expecting this statement.
SGMO on Path to Broadened Regulatory Pathway
In a noteworthy development, Sangamo recently revealed encouraging information on isaralgagene civaparvovec (ST-920), a gene therapy candidate being investigated to treat Fabry disease. A clear regulatory track for Accelerated Approval was confirmed to Sangamo after a fruitful exchange with the U.S. Food and Drug Administration (FDA).
This clearance may expedite the treatment, which is a much needed remedy for the crippling illness. The FDA has acknowledged that a major determinant of the possibility of Accelerated Approval will be information from the current Phase 1/2 STAAR research. Specifically, the eGFR slope at 52 weeks will serve as an intermediate clinical endpoint across all patients.
As a result, the complete dataset to support this pathway is expected to be available by the first half of 2025, unlocking the possibility of a Biologics License Application (BLA) submission by late 2025—three years earlier than previously projected.
Potential for Early BLA Submission
The expedited regulatory process could eliminate the need for an additional registrational study, a significant step forward for Sangamo and its efforts to bring ST-920 to market faster. As Fabry disease remains a critical unmet medical need, this breakthrough in the regulatory process holds great promise for patients and shareholders alike.