Sana Biotechnology (SANA) FDA Events

Sana Biotechnology's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Sana Biotechnology (SANA). Over the past two years, Sana Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SC291. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SC291 FDA Regulatory Events

SC291 is a drug developed by Sana Biotechnology for the following indication: B-cell malignancies. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Designation Grant - December 2,2024

Fast Track

• Drug: SC291
• Announced Date: December 2, 2024
• Indication: B-cell malignancies

Sana Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for SC291 in relapsed/refractory systemic lupus erythematosus (SLE), which includes extrarenal lupus and lupus nephritis.

Sana Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its therapy SC291 in relapsed/refractory systemic lupus erythematosus (SLE). This includes patients with extrarenal lupus and lupus nephritis. Fast Track designation helps speed up the clinical development and review process for drugs that treat serious conditions and address unmet medical needs.

SC291 is a hypoimmune-modified, CD19-directed allogeneic CAR T therapy. It is being evaluated in the GLEAM trial, which is enrolling patients with B-cell mediated autoimmune diseases such as SLE. The company expects to share initial clinical data from the trial in 2025. Dr. Dhaval Patel, Chief Scientific Officer at Sana, highlighted the potential of SC291 to offer an off-the-shelf treatment option for patients with few alternatives.

Sana Biotechnology FDA Events - Frequently Asked Questions

Has Sana Biotechnology received FDA approval?

As of now, Sana Biotechnology (SANA) has not received any FDA approvals for its therapy in the last two years.

What drugs has Sana Biotechnology submitted to the FDA?

In the past two years, Sana Biotechnology (SANA) has reported FDA regulatory activity for SC291.

What is the most recent FDA event for Sana Biotechnology?

The most recent FDA-related event for Sana Biotechnology occurred on December 2, 2024, involving SC291. The update was categorized as "Designation Grant," with the company reporting: "Sana Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for SC291 in relapsed/refractory systemic lupus erythematosus (SLE), which includes extrarenal lupus and lupus nephritis."

What conditions do Sana Biotechnology's current drugs treat?

Currently, Sana Biotechnology has one therapy (SC291) targeting the following condition: B-cell malignancies.