FDA Events for Turnstone Biologics (TSBX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Turnstone Biologics (TSBX).
Over the past two years, Turnstone Biologics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TIDAL-01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TIDAL-01 - FDA Regulatory Timeline and Events
TIDAL-01 is a drug developed by Turnstone Biologics for the following indication: In patients with colorectal cancer, head and neck cancer, and uveal melanoma.
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:
- TIDAL-01
- Announced Date:
- October 11, 2024
- Indication:
- In patients with colorectal cancer, head and neck cancer, and uveal melanoma.
Announcement
Turnstone Biologics Corp. announced a strategic prioritization of its pipeline, as well as a workforce reduction of approximately 60% and changes to its leadership team, to focus resources on the continued advancement of its Phase 1 program, TIDAL-01.
AI Summary
Turnstone Biologics Corp. has announced a major strategic shift to concentrate on its clinical-stage pipeline, focusing its efforts on advancing its Phase 1 program, TIDAL-01. This program tests their innovative Selected TIL therapy, which aims to treat high unmet-needs in patients with solid tumors. As part of the restructuring, the company is reducing its workforce by about 60% to streamline operations and allocate resources efficiently. These changes are expected to extend the company’s cash runway into the second quarter of 2026. Additionally, Turnstone has made significant leadership transitions to support this clinical focus, appointing new heads in key areas including clinical development, manufacturing, and finance. The move reflects the company's intent to concentrate on its promising TIDAL-01 trial data, better position its operations for near-term value creation, and strengthen its future growth prospects.
Read Announcement
Turnstone Biologics FDA Events - Frequently Asked Questions
As of now, Turnstone Biologics (TSBX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Turnstone Biologics (TSBX) has reported FDA regulatory activity for TIDAL-01.
The most recent FDA-related event for Turnstone Biologics occurred on October 11, 2024, involving TIDAL-01. The update was categorized as "Provided Update," with the company reporting: "Turnstone Biologics Corp. announced a strategic prioritization of its pipeline, as well as a workforce reduction of approximately 60% and changes to its leadership team, to focus resources on the continued advancement of its Phase 1 program, TIDAL-01."
Currently, Turnstone Biologics has one therapy (TIDAL-01) targeting the following condition: In patients with colorectal cancer, head and neck cancer, and uveal melanoma..
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:TSBX) was last updated on 7/13/2025 by MarketBeat.com Staff
