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Cue Biopharma, Inc.

CUE
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$27.66
▲ +5.8 · +25.98%

Financials

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52W LOW $4.9752W HIGH $45.50
Volume
394.64 K
Value Traded
8.17 M
Short % Float
5.33%
+13.55%Week
-1.21%1 Month
-10.54%3 Month
+95.21%6 Month
-95%5 Year
-94.03%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
200.93 M
EPS (TTM)
-22.59
P/E Ratio
-
Ent. Value
183.54 M
Total Shares
7.26 M
Float Shares
6.23 M
Insiders
14.18%
Institutions
22.79%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
IND Submission
CUE-401
autoimmune disease (lead autoimmune candidate)
INDBiologicsImmunology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

CUE Catalyst Timeline

Dated clinical, regulatory and corporate events for Cue Biopharma, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Cue Biopharma, Inc.

410Total events
7Upcoming
46Tier-1 (high impact)
2017 to 2027Coverage

Upcoming catalysts 2

T2Trial Initiation
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CUE-401
T2Milestone Payment
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Event history 50

●R&D DayPresentation
Conference call and webcast to present Phase 2 CUE-221 results
▲Topline ReadoutCUE-221Clinical Data
Positive topline results from Phase 2 CUE-221 study in CSU
chronic spontaneous urticariasource ↗
▲Primary Endpoint MetCUE-221Clinical Data
Primary endpoint of HSS7=0 at week 12 met at all dose levels
chronic spontaneous urticariasource ↗
▲Secondary Endpoint DataCUE-221Clinical Data
Key secondary endpoint of UAS7=0 at week 12 met at 4 mg/kg
chronic spontaneous urticariasource ↗
▲Subgroup AnalysisCUE-221Clinical Data
Post hoc Week 28 analysis showed statistically significant difference vs omalizumab
chronic spontaneous urticariasource ↗
▲Safety Data UpdateCUE-221Clinical Data
CUE-221 demonstrated favorable safety profile with no treatment-related SAEs
chronic spontaneous urticariasource ↗
▲Additional DataCUE-221Clinical Data
Post hoc Week 28 analysis showed statistically significant difference vs omalizumab
chronic spontaneous urticariasource ↗
●IND SubmissionCUE-221IND
IND submitted to FDA for CUE-221 in food allergy
food allergysource ↗
▼Equity OfferingCorporate
Completed $50 million private placement
●Management ChangeCorporate
Appointment of Chief Medical Officer and Head of R&D
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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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 %
2026-09-21CUE-221 (UB-221) Phase 2 data presentation Phase 2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D25 / 100
Pipeline Score
$14M
Pipeline Value
Richly Valued
Valuation Signal
2
Drugs Scored
0.1x
rNPV / MCap
Top 82%
Micro Cap
(rank 541 of 660)
Percentile Rank
Cue Biopharma, Inc. faces pipeline headwinds (25/100), with $522M risk-adjusted pipeline value, led by CUE-101 in Head and Neck Squamous Cell Carcinoma (Phase 2), but cash runway is a concern.
Showing 1 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
CUE-101 Small moleculeNCT07172256Head and Neck Squamous Cell CarcinomaPhase 2 NOT YET_RECRUITING 30Feb 1, 2031
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Clinical Trial Results

Readouts, endpoints and source filings for every CUE program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
CUE-221 chronic spontaneous urticariaPhase 22026-09-20The 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 MoreCue Biopharma Announces Positive Topline Results from CUE-221 Phase 2 Study in Chronic Spontaneous UrticariaRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Lin Shao-LeeDirector, Officer (Chief Executive Officer)Sell -5,423 718,830 held$27.19 08/13/2026
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Hedge Fund 13F Activity

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)
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Shares held by hedge funds each quarter, and who bought or sold.

CUE Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How CUE ranks across every disease it competes in

Competitive Position is a premium feature
See how CUE ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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CUE News

-CUE
Sep 20, 2026
CUEPhases
▼ -23.7%on this 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
Aug 14, 2026
CUEGeneral
▼ -19.2%on this news

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
Aug 3, 2026
CUEGeneral

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.

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-CUE
Jul 13, 2026
CUEGeneral
▼ -15.9%on this news

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.

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-CUE
Jul 10, 2026
CUEGeneral

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 →
-CUE
Jun 10, 2026
CUEGeneral
▼ -9.4%on this newsshared move

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.

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-CUE
Jun 3, 2026
CUEGeneral
▼ -6%on this news

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.

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-CUE
May 22, 2026
CUEConferences/Events
▲ +6.8%on this news

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.

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-CUE
May 14, 2026
CUEGeneral
▼ -14%on this news· ran to -31% by day 3

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.

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-CUE
May 8, 2026
CUEGeneral

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
May 7, 2026
CUEGeneral
▲ +5.2%on this newsshared move

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.

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-CUE
Apr 30, 2026
CUEGeneral
▲ +13.4%on this news· ran to +169% by day 3shared move

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.

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-CUE
Apr 30, 2026
CUEGeneral
▲ +13.4%on this news· ran to +169% by day 3shared move

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.

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-CUE
Apr 30, 2026
CUEGeneral
▲ +13.4%on this news· ran to +169% by day 3shared move

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.

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-CUE
Apr 23, 2026
CUEGeneral

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.

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-CUE
Apr 15, 2026
CUEPhases
▲ +65.4%on this news· ran to +94% by day 3

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.

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-CUE
Apr 8, 2026
CUEGeneral
▲ +45.5%on this news· ran to +151% by day 3

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.

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-CUE
Mar 30, 2026
CUEGeneral
▼ -5.6%on this news· ran to -25% by day 3

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.

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About Cue Biopharma, Inc.

Boston, MA 29 employees cuebiopharma.com
Headquarters40 GUEST STREET, BOSTON, MA, 02135
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