FDA Events for Sana Biotechnology (SANA)
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 Timeline and 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.
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Sana Biotechnology FDA Events - Frequently Asked Questions
As of now, Sana Biotechnology (SANA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sana Biotechnology (SANA) has reported FDA regulatory activity for SC291.
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."
Currently, Sana Biotechnology has one therapy (SC291) targeting the following condition: B-cell malignancies.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SANA) was last updated on 7/12/2025 by MarketBeat.com Staff
