Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
CUE Catalyst Timeline
Dated clinical, regulatory and corporate events for Cue Biopharma, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Cue Biopharma, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How CUE actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-21 | CUE-221 (UB-221) | Phase 2 data presentation | Phase 2 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CUE-101 Small moleculeNCT07172256 | Head and Neck Squamous Cell Carcinoma | Phase 2 | NOT YET_RECRUITING | 30 | Feb 1, 2031 |
Clinical Trial Results
Readouts, endpoints and source filings for every CUE program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| CUE-221 | chronic spontaneous urticaria | Phase 2 | 2026-09-20 | The primary endpoint of percentage of patients with HSS7=0 at week 12 was dose-responsive and met at all dose levels.; The key secondary endpoint of percentage of patients with UAS7=0 at week 12 was dose responsive and met statistical significance at the 4 mg/kg highest dose level.; The percentage of participants who achieved HSS7=0 further increased beyond the Week 12 primary endpoint, peaking at Week 22 across all CUE-221 dose groups.; Clinically meaningful benefit was maintained for up to 12 weeks off treatment (through week 28) at the 4 mg/kg dose level.; A higher rate of complete resolution of hives was observed for the 4 mg/kg dose group relative to the lower dose groups and placebo.; Post hoc analysis at Week 28 demonstrated a statistically significant difference versus omalizumab (delta = 36%).Read More | Cue Biopharma Announces Positive Topline Results from CUE-221 Phase 2 Study in Chronic Spontaneous UrticariaRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Lin Shao-LeeDirector, Officer (Chief Executive Officer) | Sell | -5,423 718,830 held | $27.19 | 08/13/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in CUE
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| SILVERARC CAPITAL MANAGEMENT, LLC | 0.5 % | 1.47 M | 403.40 K | 31.71% ( 97.12 K) |
CUE Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How CUE ranks across every disease it competes in
CUE News
Cue Biopharma Announces Positive Topline Results from CUE-221 Phase 2 Study in Chronic Spontaneous Urticaria
Cue Biopharma announced positive topline results from its Phase 2 study of CUE-221 in chronic spontaneous urticaria. The trial showed significant efficacy and a favorable safety profile, indicating CUE-221 may offer a better therapeutic option compared to existing treatments like XOLAIR. The company plans to initiate further studies based on these encouraging results.
Read more →Cue Biopharma Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Cue Biopharma reported its second quarter 2026 financial results, highlighting a recent IND submission for CUE-221 aimed at food allergies and a completed $50 million private placement to support clinical development. The company anticipates Phase 2 data for CUE-221 by the end of Q3 2026 and plans to initiate a Phase 1 study for CUE-401 by year-end. Despite a notable increase in operating expenses and a significant net loss, Cue Biopharma's leadership changes and financing efforts position it for future growth.
Read more →Cue Biopharma Announces Appointment of James M. Ahlers as Chief Financial Officer and CUE-221 Investigational New Drug Submission
Cue Biopharma has appointed James M. Ahlers as Chief Financial Officer to enhance its financial leadership. This announcement coincides with the company's recent Investigational New Drug submission for CUE-221, targeting food allergies, and an expected Phase 2 data readout by the end of the quarter. Ahlers brings over 25 years of financial experience in the biotech sector.
Read more →Cue Biopharma Appoints Dominic Borie, M.D., Ph.D., as Chief Medical Officer and Head of Research & Development
Cue Biopharma has appointed Dr. Dominic Borie as Chief Medical Officer and Head of Research & Development. Dr. Borie brings over two decades of experience in immunology and clinical development. The company is focused on advancing its immunology programs, including the upcoming Phase 2 data readout for CUE-221 and the initiation of a Phase 1 trial for CUE-401. Cue recently secured $50 million in funding to support its clinical development efforts.
Read more →Cue Biopharma Announces $50.0 Million Private Placement
Cue Biopharma has announced a $50 million private placement agreement with accredited investors, involving the sale of shares and pre-funded warrants. The funds will be used to advance clinical development and for general corporate purposes. The placement is expected to close by July 13, 2026, pending customary conditions. CEO Shao-Lee Lin expressed optimism about the company's future and upcoming clinical milestones.
Read more →Sumita Ray, J.D.
Ms. Sumita Ray has over 25 years of experience in the biotech sector, serving in various legal and compliance roles. Notably, she was the Chief Legal, Compliance & Administrative Officer at Vaxxinity and has held similar positions at Instil Bio and Calithera BioSciences. Ms. Ray has also worked with major companies like Astrazeneca and Genentech, and currently serves on the Board of Directors of Biomea Fusion.
Read more →Cue Biopharma Announces Board Transition and Addition of New Directors with Continued Company Evolution
Cue Biopharma has announced a transition in its board of directors, with the resignation of four independent members and the appointment of Daniel Camardo and Viola Meehan. This change is part of the company's strategic growth as it aims to enhance its capabilities for late-stage clinical activities. The new directors bring extensive experience in biopharma and finance, which is expected to support Cue's mission in developing therapies for immunological disorders.
Read more →Cue Biopharma to Present at the 2026 Jefferies Global Healthcare Conference
Cue Biopharma, a clinical-stage therapeutics company, will present at the Jefferies Global Healthcare Conference on June 3, 2026. CEO Shao-Lee Lin will discuss the company's innovative therapies aimed at treating immunological disorders. The presentation will be available via a live audio webcast, which will be archived for 90 days.
Read more →Cue Biopharma Reports First Quarter 2026 Financial Results and Recent Strategic Developments
Cue Biopharma reported its first quarter 2026 financial results, revealing significant progress in its pipeline and strategic direction. Among the highlights, the company secured an exclusive license for CUE-221 aimed at allergic diseases and hosted a virtual R&D day focusing on its innovative CUE-401 program for autoimmune treatment. Financially, Cue reported an increase in revenue and completed a successful private placement, bolstering its operational capacity. New CEO Shao-Lee Lin emphasizes the company's mission to deliver transformative therapies in the immunology sector.
Read more →Cue Biopharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - May 7, 2026
Cue Biopharma announced the granting of inducement equity awards to seven new employees, including CEO Shao-Lee Lin. The awards were part of the 2026 Inducement Stock Incentive Plan and were approved by independent directors. Dr. Lin received stock options and restricted stock units, while other employees received similar grants. The company focuses on developing therapies for immunological disorders.
Read more →Cue Biopharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cue Biopharma announced the granting of inducement equity awards to seven new employees, including its new CEO, Dr. Shao-Lee Lin. The awards, approved by independent directors, include stock options and restricted stock units. This move is part of the company's strategy to attract talent as it advances its portfolio of therapies for immunological disorders.
Read more →Cue Biopharma Names Shao-Lee Lin M.D., Ph.D., CEO, President and Board Director to Lead Continued Growth and Transformation into a Clinical-Stage Company
Cue Biopharma has appointed Dr. Shao-Lee Lin as the new CEO, President, and Board Director to spearhead its transformation into a clinical-stage company. Dr. Lin brings over 25 years of biopharmaceutical experience and is expected to advance the company's clinical pipeline and goals, particularly regarding CUE-401, a potential treatment for autoimmune diseases. The company also indicates ongoing development of CUE-401 and additional programs aimed at significant near-term milestones in treatment options for allergic diseases, with a new Phase 2 program to be detailed in a future release.
Read more →Cue Biopharma Expands Pipeline with Exclusive License from Ascendant Health Sciences Ltd. for Clinical-Stage Dual-Mechanism Anti-IgE Antibody
Cue Biopharma has announced an exclusive license agreement with Ascendant Health Sciences for the anti-IgE monoclonal antibody Ascendant-221, aimed at treating allergic diseases. This move positions Cue as a clinical-stage company with innovative therapies targeting autoimmune and inflammatory disorders. Ascendant-221 is currently under evaluation in a Phase 2 clinical trial for chronic spontaneous urticaria, with plans for Cue to initiate a global Phase 2b trial in food allergies following the completion of the ongoing study. The agreement includes a $15 million upfront fee and potential future payments that could total up to $676.5 million.
Read more →Cue Biopharma Announces $30 Million Private Placement
Cue Biopharma announced a $30 million private placement financing agreement with accredited investors. This funding is intended to enhance the company's clinical pipeline, including the acquisition and development of its lead asset, Ascendant-221. The PIPE financing is set to close around May 4, 2026, subject to customary conditions. Additionally, the financing includes pre-funded warrants and common stock warrants, which require stockholder approval for execution.
Read more →Cue Biopharma Announces 1-for-30 Reverse Stock Split
Cue Biopharma has announced a 1-for-30 reverse stock split to increase its stock price and comply with Nasdaq listing requirements. This decision was approved by stockholders during the recent Annual Meeting. The split will reduce the total number of outstanding shares significantly while not affecting the company's authorized shares. The company continues to develop its innovative therapeutic biologics.
Read more →Cue Biopharma to Present New Preclinical Data on Lead Autoimmune and Inflammatory Disease Candidate CUE-401 at IMMUNOLOGY2026
Cue Biopharma announced that it will present new preclinical data on its lead candidate CUE-401 at IMMUNOLOGY2026. The data highlights CUE-401's potential to induce antigen-specific T regulatory cells, suggesting promising therapeutic applications for autoimmune diseases. The candidate features a novel bifunctional design combining TGF-beta and IL-2 to enhance immune regulation. While the presentation could enhance visibility, Cue Biopharma faces ongoing financial and operational challenges as it develops its innovative therapies.
Read more →Cue Biopharma to Receive $7.5 Million Preclinical Milestone Payment from Boehringer Ingelheim Collaboration and License Agreement
Cue Biopharma has announced a $7.5 million preclinical milestone payment from Boehringer Ingelheim after the selection and approval of its first compound for lead optimization. This milestone validates the potential of CUE-501 for targeted depletion of specific B cells in autoimmune diseases. The company also stands to earn up to $337.5 million in additional milestone payments.
Read more →Cue Biopharma Announces CEO Transition
Cue Biopharma has appointed Lucinda Warren as interim CEO following Usman Azam's resignation. Warren, who has significant experience in the biopharmaceutical sector, aims to advance the company's lead asset, CUE-401, into clinical trials by the second half of 2026. The board expresses confidence in her leadership during this transition period.
Read more →