Sangamo Targets Summer BLA Amid NASDAQ Delisting Appeal

Sangamo Therapeutics announced on May 14, 2026, its intention to complete the Biologics License Application (BLA) submission for its gene therapy candidate, ST-920, as early as summer 2026. This potential regulatory milestone is set against a critical challenge, as the company is simultaneously preparing to appeal a delisting notice from the NASDAQ stock exchange. The appeal hearing is scheduled for June 2026, creating a period of significant uncertainty for the biotechnology firm, whose stock has traded below the exchange's required $1.00 minimum bid price.

What is the Significance of the ST-920 BLA Submission?

A BLA submission to the U.S. Food and Drug Administration (FDA) is a pivotal step in bringing a new biological product to market. For Sangamo, submitting the BLA for ST-920 represents the culmination of years of clinical development. A successful submission and subsequent approval would allow the company to commercialize the therapy in the United States, potentially generating its first significant revenue stream from the product.

ST-920 is an investigational gene therapy developed for the treatment of Fabry disease, a rare genetic disorder. The therapy is designed to enable a patient's body to produce the alpha-galactosidase A (α-Gal A) enzyme, which is deficient in individuals with the condition. The global market for Fabry disease treatment is substantial, with estimates projecting it to exceed $3.5 billion by 2030.

Achieving this regulatory milestone is Sangamo's primary pathway to creating fundamental value. Positive news from the FDA could dramatically alter the company's financial trajectory and investor sentiment. The timeline, with submission targeted for summer 2026, places this catalyst just after the critical delisting hearing.

Why is Sangamo Facing NASDAQ Delisting?

Sangamo's primary operational challenge is its non-compliance with NASDAQ's listing requirements. The exchange mandates that a company's stock maintain a minimum bid price of at least $1.00 per share. Sangamo's stock (SGMO) has failed to meet this requirement, trading below the $1.00 threshold for more than 30 consecutive business days, which triggered the initial delisting notice.

Failure to regain compliance and a subsequent delisting would have severe consequences. The stock would be relegated to the Over-the-Counter (OTC) markets, which are less regulated and have significantly lower trading volume. This would reduce the stock's liquidity and likely lead to many institutional investors being forced to sell their positions, putting further downward pressure on the share price.

This risk presents a direct counter-argument to the optimism surrounding the ST-920 program. Even a successful BLA submission could be overshadowed if the company loses its place on a major national exchange. The delisting threat complicates capital-raising efforts, a critical function for a clinical-stage biotechnology company without major product revenue.

How Does the Delisting Appeal Process Work?

The June hearing provides Sangamo an opportunity to present a formal plan to a NASDAQ Hearings Panel to regain compliance. The company must convince the panel that it has a viable strategy to raise its stock price above the $1.00 minimum for a sustained period, typically 10 consecutive business days.

A common strategy presented in such appeals is a reverse stock split. This action consolidates the number of existing shares, which mathematically increases the price per share without changing the overall market capitalization of the company. For example, a 1-for-20 reverse split would turn 20 shares worth $0.50 each into one share worth $10.00.

While effective for meeting NASDAQ's rule, reverse stock splits are often viewed negatively by investors as they do not address the underlying business issues that caused the low stock price. The appeal grants Sangamo a temporary stay on delisting, providing a crucial window to execute its plan and await clinical or regulatory news that could organically boost its valuation.

Q: What is Fabry disease?

A: Fabry disease is a rare genetic disorder caused by a deficiency of the enzyme alpha-galactosidase A (α-Gal A). This deficiency leads to the harmful buildup of a substance called globotriaosylceramide (Gb3) in cells throughout the body, affecting the kidneys, heart, and nervous system. Sangamo's ST-920 is a gene therapy designed to deliver a functional copy of the gene responsible for producing the α-Gal A enzyme, aiming to provide a one-time, long-lasting treatment.

Q: What happens if Sangamo's appeal is denied?

A: If the NASDAQ Hearings Panel denies the appeal and any further options are exhausted, Sangamo's stock will be delisted from the NASDAQ Global Select Market. Trading would then typically move to an OTC market, such as the OTCQB or OTC Pink. This shift dramatically reduces visibility, liquidity, and access to institutional capital. It makes it much harder for the company to raise funds and for shareholders to trade their positions efficiently, often resulting in a lower valuation.

Q: Is a reverse stock split a positive signal for investors?

A: Generally, a reverse stock split is not considered a positive signal. It is a mechanical fix to a compliance problem, not a solution to a fundamental business problem. While it can prevent delisting, the action is often undertaken by companies in financial distress. History shows that many companies that undergo a reverse stock split see their stock price continue to decline afterward, as it does not create new value. However, for a biotech with a near-term catalyst like a BLA submission, it can be a necessary tool to bridge a difficult period.

Bottom Line

Sangamo is in a race to achieve a major regulatory milestone with its lead drug candidate before its exchange listing status is potentially revoked.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. CFD trading carries high risk of capital loss.