This section highlights FDA-related milestones and regulatory updates for drugs developed by Cue Biopharma (CUE).
Over the past two years, Cue Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CUE-401 and CUE-101. 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.
CUE-401 FDA Regulatory Timeline and Events
CUE-401 is a drug developed by Cue Biopharma for the following indication: In the Treatment of Autoimmune 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:
- CUE-401
- Announced Date:
- April 15, 2026
- Indication:
- In the Treatment of Autoimmune Disease
Announcement
Cue Biopharma, announced that it will present new preclinical data for its lead autoimmune and inflammatory disease candidate, CUE-401, as part of a poster at IMMUNOLOGY2026, the annual meeting of the American Association of Immunologists (AAI) taking place in Boston, Massachusetts, April 15-19, 2026.
AI Summary
Cue Biopharma said it will present new preclinical data for its lead autoimmune and inflammatory disease candidate, CUE-401, as a poster at IMMUNOLOGY2026. The meeting is the American Association of Immunologists’ annual conference and will be held in Boston, Massachusetts, April 15–19, 2026. The poster will summarize recent lab and animal‑model findings for CUE-401, offering early evidence about the candidate’s biological activity and how it might be used to treat immune‑driven conditions. The data are preclinical, meaning they were generated before human testing.
Headquartered in Boston, Cue Biopharma is led by a team with deep expertise in immunology, protein engineering, and the design and clinical development of protein biologics. Presenting at IMMUNOLOGY2026 gives the company a chance to share results with researchers, get feedback from peers, and explore scientific and development next steps for CUE-401.
Read Announcement- Drug:
- CUE-401
- Announced Date:
- March 9, 2026
- Indication:
- In the Treatment of Autoimmune Disease
Announcement
Cue Biopharma, announced that it will deliver a poster presentation on the company's lead asset, CUE-401, at the World Immune Regulation Meeting (WIRM) being held March 11-14, 2026 in Davos, Switzerland.
AI Summary
Cue Biopharma announced it will deliver a poster presentation on its lead asset, CUE-401, at the World Immune Regulation Meeting (WIRM) in Davos, Switzerland, March 11–14, 2026. The poster appears in Session P5 – Autoimmunity and Innate Immunity under the title “CUE-401: A Novel Bifunctional TGF‑beta/IL‑2 Fusion Protein for the Treatment of Autoimmune and Inflammatory Diseases.” Natasha M. Girgis, Director of Translational Pharmacology, will present on Day 2, Thursday, March 12, 2026, from 8:00–11:00 p.m. CET (3:00–6:00 p.m. EDT).
The presentation will show new in vitro data that support CUE-401’s potential to restore immune balance by directly inhibiting proinflammatory immune cells through the effects of TGF‑beta. Cue Biopharma is a clinical-stage company in Boston developing novel biologics designed to selectively engage and modulate disease-specific T cells for autoimmune and inflammatory conditions. The poster will share preclinical evidence aimed at advancing CUE-401 as a targeted immune therapy.
Read Announcement- Drug:
- CUE-401
- Announced Date:
- February 17, 2026
- Indication:
- In the Treatment of Autoimmune Disease
Announcement
Cue Biopharma, announced preclinical safety and tolerability data that further supports the preclinical profile of CUE-401, the Company's lead autoimmune asset.
AI Summary
Cue Biopharma reported preclinical safety and tolerability data for CUE-401 from two non‑GLP studies in mice and non‑human primates. Both studies used a step‑up dosing schedule with weekly intravenous doses that increased over time. In the murine study (24 animals, 12 males and 12 females) animals received escalating doses of 1, 3 and 10 mg/kg; all dose levels were well tolerated and no adverse events were observed. In the non‑human primate study (6 animals, 3 males and 3 females) dosing was also escalated weekly and animals likewise showed good tolerability with no reported adverse events.
These proof‑of‑concept results reinforce a promising preclinical profile for CUE-401 and its potential as an autoimmune therapy. The absence of observed toxicities across species and doses supports continued preclinical development and helps inform dose selection and study design for subsequent steps toward clinical testing.
Read Announcement- Drug:
- CUE-401
- Announced Date:
- June 24, 2025
- Indication:
- In the Treatment of Autoimmune Disease
Announcement
Cue Biopharma announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA).
AI Summary
Cue Biopharma recently announced it received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The feedback focused on the design of their first-in-human trial, including plans for dose escalation, selecting study groups, and a safety monitoring plan. Based on this information, the company plans to file an IND application after completing the final enabling studies.
The feedback is an important step for Cue Biopharma’s lead candidate, CUE-401, which is designed to treat autoimmune diseases. CUE-401 is a unique bispecific fusion protein that works by inducing and expanding regulatory T cells. This approach uses a combination of a modified interleukin 2 (IL-2) and transforming growth factor beta (TGF-β) to help rebalance the immune system and reduce harmful autoimmune responses.
Read Announcement
CUE-101 FDA Regulatory Timeline and Events
CUE-101 is a drug developed by Cue Biopharma for the following indication: HPV+ recurrent/metastatic head and neck cancer.
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:
- CUE-101
- Announced Date:
- July 16, 2025
- Indication:
- HPV+ recurrent/metastatic head and neck cancer
Announcement
Cue Biopharma, Inc. today provided a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series.
Read Announcement- Drug:
- CUE-101
- Announced Date:
- July 1, 2025
- Indication:
- HPV+ recurrent/metastatic head and neck cancer
Announcement
Cue Biopharma, provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series.
AI Summary
Cue Biopharma recently provided an update on its most advanced clinical stage asset, CUE-101, which is part of the CUE-100 series. In the Phase 1 trial, CUE-101 was studied in combination with pembrolizumab for patients with recurrent metastatic HPV-positive head and neck cancer. The trial showed promising results, with an overall response rate (ORR) of 50% in treatment-naïve patients. Additionally, the study reported a 12‑month overall survival rate of 88% and a median overall survival of 32 months. These early results suggest that CUE-101 may help stimulate and expand tumor-specific T cells, potentially offering a stronger immune response against the cancer.
The positive clinical data highlights CUE-101’s potential as a breakthrough approach in cancer therapy, demonstrating enhanced activity compared to historical data for pembrolizumab alone. These findings may support future strategic partnerships and further development of this innovative treatment.
Read Announcement- Drug:
- CUE-101
- Announced Date:
- June 4, 2024
- Indication:
- HPV+ recurrent/metastatic head and neck cancer
Announcement
Cue Biopharma, announced updated data from its ongoing Phase 1 trial evaluating its lead oncology asset from the CUE-100 series of biologics, CUE-101.
AI Summary
Cue Biopharma announced new update data from its ongoing Phase 1 trial evaluating CUE-101, the lead oncology asset from its CUE-100 series. The trial is testing CUE-101 in combination with the cancer drug pembrolizumab in patients with recurrent or metastatic HPV16+ head and neck squamous cell carcinoma. In the first-line treatment setting, the combination achieved an impressive overall response rate of 46% and a 12-month overall survival rate of 96%. Additionally, when used as a single agent in patients treated in second line and beyond, CUE-101 led to a median overall survival of 20.8 months, significantly longer than historical results from similar treatments. These promising statistics suggest that CUE-101 may offer an improved treatment alternative, potentially benefiting patients battling this aggressive form of cancer.
Read Announcement
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