On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
If the forthcoming STAAR data, expected in the first half of 2025, are favorable, they could support a BLA submission for the treatment of Fabry disease in the second half of 2025, potentially two years earlier than previously expected.
Following discussions with Sangamo's management, analysts have expressed confidence in the Fabry program's prospects. The company has multiple potential paths forward, including either maintaining ownership of the program or establishing a collaboration. The updated model now anticipates a possible launch in 2026, a year earlier than the previously projected 2027.
The firm has increased the estimated probability of success for the program from 25% to 75%, reflecting a clearer development path and confidence in the STAAR program. Additionally, the estimated peak annual revenues have been raised to $900 million, up from the earlier forecast of $640 million, contingent upon approval.
The revised price target and sustained Buy rating underscore the firm's optimism regarding Sangamo's gene therapy program and its potential market impact.
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