Sangamo Therapeutics Initiates Key Regulatory Submission for Kidney Disease Candidate

Sangamo Therapeutics has taken a significant step forward in the regulatory pathway for its investigational therapy ST-920. The company announced yesterday the commencement of a rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration. In a concurrent development, regulators have agreed to the use of the eGFR slope at 52 weeks as a valid clinical endpoint for an accelerated approval process. This progress raises questions about whether it can alleviate the substantial financial pressures facing the biotech firm.

The submission leverages data from the registrational Phase 1/2 STAAR study. Results from this trial demonstrated a positive mean annualized eGFR trend across evaluated doses at the 52-week mark. Securing formal agreement from the FDA to accept the eGFR slope endpoint represents a crucial de-risking event for the product's regulatory review. Under the rolling submission model, Sangamo will submit completed modules on an ongoing basis, with the goal of finalizing the complete BLA by the second quarter of 2026.

The company also received Fast Track designation for a separate candidate, ST-503, on December 2.

Financial Health and Exchange Compliance

Despite this regulatory advancement, Sangamo's financial position remains challenging. The company's third-quarter 2025 report showed a marked year-over-year revenue decline and continued substantial net losses. Its market capitalization currently stands at approximately $147 million.

Should investors sell immediately? Or is it worth buying Sangamo Therapeutics?

In a separate corporate update, the Nasdaq stock exchange granted a 180-day extension to Sangamo. The company now has until April 27, 2026, to elevate its share price above the $1.00 minimum bid requirement for a minimum of ten consecutive trading days to maintain its listing.

From a technical perspective, the stock is testing support levels near its 52-week low of $0.38, with its 14-day Relative Strength Index hovering around 41. Equity researchers currently maintain a consolidated "Hold" rating on the shares. Market observers note that a successful regulatory outcome alone does not guarantee an influx of capital; securing additional non-dilutive financing or a strategic partnership appears necessary to fund future commercial development.

Forward-Looking Milestones

The near-term calendar is defined by several key events. These include anticipated FDA feedback on submitted BLA modules, a potential "Day-60" notification, and a decision on Priority Review status following the full submission in Q2 2026. The Nasdaq compliance deadline of April 27, 2026, serves as a fixed timeline in the background.

Advancing through the regulatory steps as planned would improve the odds of an accelerated approval for ST-920. However, the overarching question regarding the company's ability to fund commercialization efforts persists in the absence of new financial resources.