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
UP421 and SC291. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
UP421 FDA Regulatory Events
UP421 is a drug developed by Sana Biotechnology for the following indication: patient with type 1 diabetes without any immunosuppression.
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.
- Drug:
- UP421
- Announced Date:
- March 13, 2026
- Indication:
- patient with type 1 diabetes without any immunosuppression.
Announcement
Sana Biotechnology, Inc. announced 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana's hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without any immunosuppression.
AI Summary
Sana Biotechnology reported 14-month follow-up results from a first-in-human, investigator‑sponsored study that transplanted UP421 — an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune (HIP) technology — into a person with type 1 diabetes without any immunosuppression. At 14 months the HIP‑modified islets were safe, evaded immune detection, survived long term, and continued to produce insulin. C‑peptide levels at month 14 were comparable to levels seen in the first six months, and the data suggest that better blood‑glucose control improves islet function over time.
The full 14‑month dataset is being presented at the ATTD conference. Sana is also advancing HIP technology toward a stem cell‑derived candidate (SC451) designed as a one‑time therapy to normalize blood glucose without insulin or chronic immunosuppression, and plans to seek an IND and begin a Phase 1 trial as early as this year.
Read Announcement
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.
- Drug:
- SC291
- Announced Date:
- December 2, 2024
- Indication:
- B-cell malignancies
Announcement
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.
AI Summary
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.
Read Announcement
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