Sana Biotechnology, Inc. SANA has soared in the stock market following the announcement of the U.S. Food and Drug Administration’s (FDA) clearance of the company’s Investigational New Drug (IND) application. This pivotal move allows Sana to kick off a study of SC262 in patients with relapsed or refractory B-cell malignancies, particularly those who have previously undergone CD19-directed CAR T therapy.

Doug Williams, President of Research and Development at Sana, emphasized the significance of this milestone, stating that “Patients who have failed a CD19-directed CAR T therapy represent a significant unmet need, and this population is growing as more patients receive these therapies.” He added, “SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T therapy platform.”

The company’s trajectory has been marked by earlier successes, including the FDA Clearance of Investigational New Drug Application for SC291, a Hypoimmune-modified, CD19-directed allogeneic CAR T therapy. This therapeutic option is targeted toward patients with lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis, reflecting Sana’s commitment to addressing diverse medical needs.

Investors are anticipating a flurry of data releases from Sana Biotechnology this year, with the revelation of initial proof of concept data for SC262 slated for later in the year. These developments have spurred a surge in enthusiasm, propelling SANA shares higher by 2.24% to $5.01 in Friday’s trading.

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