Shattuck Labs' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Shattuck Labs (STTK).
Over the past two years, Shattuck Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SL-325. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SL-325 FDA Regulatory Timeline and Events
SL-325 is a drug developed by Shattuck Labs for the following indication: In inflammatory bowel disease.
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:
- SL-325
- Announced Date:
- October 1, 2026
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs announced its plans to evaluate SL-325 in a Phase 2 clinical trial in patients with moderate to severe hidradenitis suppurativa (HS).
Read Announcement- Drug:
- SL-325
- Announced Date:
- June 5, 2026
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs, Inc announced that it will host an investor call and webcast on Monday, June 8, 2026 at 8:00 a.m. ET to present comprehensive Phase 1 clinical data for SL-325, including safety, tolerability, pharmacokinetics, receptor occupancy, pharmacodynamic and immunogenicity results and provide a pipeline update.
AI Summary
Shattuck Labs, Inc. said it will hold an investor call and webcast on Monday, June 8, 2026 at 8:00 a.m. ET to share full Phase 1 clinical data for SL-325. The company plans to review safety, tolerability, pharmacokinetics, receptor occupancy, pharmacodynamic, and immunogenicity results, along with an update on its pipeline.
The event will include remarks from several leaders, including CEO Taylor Schreiber, Chief Medical Officer Lini Pandite, Chief Scientific Officer Suresh De Silva, Vice President of Clinical Development Michael Choi, and Chief Financial Officer Andrew Neill. After the presentations, the team will answer questions from investors.
The webcast will be available on Shattuck Labs’ website, and a replay will remain online for about 30 days after the event.
Read Announcement- Drug:
- SL-325
- Announced Date:
- March 5, 2026
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs, Inc provided recent business highlights.
AI Summary
Shattuck Labs reported recent business highlights centered on SL-325, its lead DR3 blocking antibody. The Phase 1 clinical trial is nearly complete and remains ongoing, with topline human data expected in the second quarter of 2026. The company plans to start a Phase 2 trial in patients with Crohn's disease in the third quarter of 2026. SL-325 is the first DR3 blocking antibody to produce human clinical data, and the company emphasized its potential for treating Crohn's disease, ulcerative colitis, and other immune-mediated conditions.
Shattuck also noted management appointments and outlined upcoming corporate events, a capital markets update, fourth-quarter and full-year 2025 financial results, and financial guidance. The company said it will use its investor relations website to disclose material information and included standard forward-looking statements. For investor inquiries, contact Andrew Neill, Chief Financial Officer, at [email protected].
Read Announcement- Drug:
- SL-325
- Announced Date:
- August 21, 2025
- Target Action Date:
- Q3 2025
- Estimated Target Date Range:
- July 1, 2025 - September 30, 2025
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs, Inc announced that The Company is on track to dose the first participant in its Phase 1 SL-325 clinical trial in healthy volunteers in Q3 2025 –
Read Announcement- Drug:
- SL-325
- Announced Date:
- August 21, 2025
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs, Inc announced that the Company's Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) for SL-325 for the treatment of inflammatory bowel disease is in effect. SL-325, a potentially first-in-class DR3 blocking antibody, is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody, demonstrated high-affinity binding to human DR3 and potent inhibition of TL1A binding to DR3 in preclinical studies, and a favorable safety profile in non-human primate studies.
Read Announcement- Drug:
- SL-325
- Announced Date:
- February 20, 2025
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs announced positive preclinical data from an IND-enabling GLP toxicology study of SL-325 in non-human primates (NHP).
AI Summary
Shattuck Labs announced positive preclinical data from a GLP toxicology study of SL-325 in non-human primates. SL-325 is a high-affinity DR3 blocking antibody designed to treat inflammatory bowel disease. In the study, conducted in cynomolgus macaques, the drug was given in three doses and showed no evidence of toxicity or residual agonism. The research confirmed that SL-325 achieved full and durable receptor occupancy at low doses, with no sign of unwanted immune cell activation, such as CD4 or CD8 T cell stimulation. These findings suggest that the antibody has a favorable pharmacokinetic profile, which may allow for extended dosing intervals in future treatments.
The promising results support plans to file an IND by the third quarter of 2025 and to soon begin Phase 1 clinical trials. This marks an important step forward in the development of new treatments for inflammatory bowel disease, highlighting the potential for SL-325 to offer effective and durable therapy for patients.
Read Announcement
Shattuck Labs FDA Events - Frequently Asked Questions
As of now, Shattuck Labs (STTK) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Shattuck Labs (STTK) has reported FDA regulatory activity for SL-325.
The most recent FDA-related event for Shattuck Labs occurred on October 1, 2026, involving SL-325. The update was categorized as "evaluation," with the company reporting: "Shattuck Labs announced its plans to evaluate SL-325 in a Phase 2 clinical trial in patients with moderate to severe hidradenitis suppurativa (HS)."
Currently, Shattuck Labs has one therapy (SL-325) targeting the following condition: In inflammatory bowel disease.
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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
FDA progress for NASDAQ:STTK last updated on 10/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
