24/7 Market News Snapshot 22 October, 2024 – Sangamo Therapeutics, Inc. Common Stock (NASDAQ:SGMO)

October 22, 2024

DENVER, Colo., 22 October, 2024 (247marketnews.com) – (NASDAQ:SGMO) are discussed in this article.
Sangamo Therapeutics, Inc. has made significant strides in the biotechnology arena, showcased by a remarkable surge in its stock, which soared by approximately 21.91% to reach $1.113 in premarket trading with a trading volume of 1.27 million shares. This interest from investors is buoyed by the company’s recent strategic engagement with the U.S. Food and Drug Administration (FDA) concerning its innovative gene therapy candidate, isaralgagene civaparvovec (ST-920), designed to treat Fabry disease.

The recent interaction with the FDA established a pathway for potential Accelerated Approval under the FDA’s Accelerated Approval Program, confirming that data from the ongoing Phase 1/2 STAAR study will be pivotal for approval. The FDA recognized the eGFR slope at 52 weeks across all participants as a crucial intermediate endpoint. The dataset anticipated to support this application is expected to be available by the first half of 2025, with an ambitious goal of submitting a Biologics License Application (BLA) by the latter half of 2025, significantly ahead of prior timelines.

Given the serious health implications of Fabry disease, particularly in impacting kidney function and potentially leading to end-stage renal failure, the developments surrounding ST-920 present a critical medical advancement. Preliminary results from the STAAR study, which include data from 18 participants, show promising improvements in amino acid levels and renal function, substantiating the therapy’s potential to reshape treatment approaches for this debilitating disease.

Sangamo’s CEO, Sandy Macrae, expressed optimism about ST-920’s ability to alleviate the manifestations of Fabry disease and highlighted the company’s commitment to achieving BLA readiness while exploring collaboration opportunities to expedite the therapy’s availability to patients who face urgent healthcare needs.

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