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Nov 5, 2026, 4:01 PM ET
Celldex reported third quarter 2026 results with cash, cash equivalents and marketable securities of $650.3 million as of September 30, 2026.
Nasdaq: $CLDXImmunology antibodiesMast-cell biologyClinical and regulatory risk
CLDX Stock Hub: Celldex Therapeutics News, Barzolvolimab and CSU
Two positive CSU trials move the debate toward complete safety, regulatory review and differentiation. A planned 2027 filing remains distinct from an approved product. On November 5, Celldex reported $650.3 million of cash, cash equivalents and marketable securities at September 30, a third-quarter net loss of $75.6 million and an unchanged through-2028 funding outlook. The November 6 regular-session close was $29.87 (+5.66%).
Full research report · PDF
Celldex Therapeutics ($CLDX), research updated November 6, 2026
17 pages covering barzolvolimab CSU response, safety, durability, atopic-dermatitis development, cash runway and approval-contingent capital claims. This is a dated research snapshot; the hub follows later developments. For personal use only: redistribution prohibited.
Next company-guided clinical window
Late 2026 · atopic dermatitis Phase 2 data
Enrollment is complete in the Phase 2 atopic dermatitis study; the November 5 update expects topline data to be presented in late 2026, without a fixed readout date. Celldex also plans to announce additional barzolvolimab indications by year end. Third-quarter 2026 update
Additional CSU presentations and 52-week treatment follow-up are separate from the planned 2027 BLA. A planned submission is neither acceptance nor an FDA decision date. Management fireside chats are scheduled at the Guggenheim 3rd Annual Healthcare Innovation Conference on November 9 (9:00 a.m. ET) and the 9th Annual Evercore Healthcare Conference on December 1 (10:50 a.m. ET). Conference announcement
CLDX stock at a glance
Close · November 6, 2026
$29.87
Regular session; +5.66% versus $28.27 on November 5.
Cash + securities · September 30
$650.319M
Down from $717.6M at June 30; company outlook funds planned operations through 2028.
Operating cash use · 9M 2026
$188.0M
Nine months ended September 30; $65.0M in the third quarter.
Common shares · October 28
78,545,051
Cover count of the Q3 2026 Form 10-Q.
Shelf · renewed November 5
$300M ATM unsold
No ATM sales before the old shelf expired on November 3, 2026; a new automatic shelf (Form S-3ASR) for an unspecified amount was filed on November 5.
CSU randomized population
1,939
963 and 976 in the separate pivotal trials.
Week-12 complete response
42.1–45.7%
Active arms; placebo 9.3–12.6%, not active-comparator evidence.
First-approval milestone
$52.5M
Qualifying FDA/EMA approval; cash, stock or combination.
Where Celldex Therapeutics stands now
Barzolvolimab met the primary and key secondary endpoints in both pivotal CSU studies. The full safety package, ongoing exposure, regulatory requirements and eventual adoption remain distinct from statistical success. The October ownership filing concerns a September position, rather than a new clinical event.
The third-quarter report of November 5, 2026 showed no material revenue, R&D expenses of $67.4 million and G&A expenses of $14.8 million, the latter driven by barzolvolimab commercial planning; the net loss was $75.6 million, or $0.96 per share. Cash, cash equivalents and marketable securities were $650.3 million at September 30, after $65.0 million of third-quarter operating cash use, and Celldex continues to expect them to fund planned operations through 2028. The 10-Q adds that the shelf registration expired on November 3, 2026 without any sales under the $300 million ATM agreement; on November 5 Celldex filed a new automatic shelf registration statement on Form S-3ASR covering unspecified amounts of common stock, preferred stock, warrants, depositary shares and units, without announcing a specific offering. On the pipeline, the Phase 2 prurigo nodularis study is being discontinued after July data, while atopic dermatitis topline data are expected in late 2026. Third-quarter 2026 results · Q3 2026 Form 10-Q · November 5 shelf registration
A successful topline does not settle safety or the eventual label. The presentation reports two probable Grade 4 anaphylaxis cases after barzolvolimab, hair-color changes in about half of treated patients and more neutropenia than placebo. Ongoing studies, a planned BLA, contingent payments and further equity issuance affect the economic outcome.
The constructive case
Two independent randomized trials and $650.3 million of resources at September 30 support a development case if longer safety and regulatory review remain acceptable.
The cautious case
Safety restrictions, a narrow label, competition and future spending or stock issuance could limit returns despite positive pivotal endpoints.
Latest Celldex Therapeutics news
Nov 5, 2026
Celldex Reports Third Quarter Financial Results and Provides Corporate Update
Celldex reported third quarter 2026 financial results and a corporate update, including best-in-disease results from the Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies of barzolvolimab in CSU. The Company anticipates a BLA submission for barzolvolimab in CSU in 2027. Cash, cash equivalents and marketable securities were $650.3 million as of September 30, 2026, compared to $717.6 million as of June 30, 2026. Third quarter cash used in operating activities was $65.0 million.
Nov 4, 2026
Celldex to Present at Upcoming Investor Conferences
Celldex management will take part in fireside chats at two upcoming investor conferences. These are the Guggenheim 3rd Annual Healthcare Innovation Conference on November 9, 2026, and the 9th Annual Evercore Healthcare Conference on December 1, 2026. Webcasts will be available on the Events and Presentations page of the Investors section of the Celldex Website, with replays available for 90 days after each event.
Oct 7, 2026
FMR amendment reports September ownership
FMR reports 8,411,905.03 shares, 10.7%, and sole voting power over 8,396,651 shares as of September 30. The filing, signed October 6, is an ordinary-course ownership disclosure, not proof of a new October purchase.
Sep 22, 2026
Results presentation details pivotal safety
Two probable Grade 4 anaphylaxis cases followed barzolvolimab. Hair-color changes were 45.1–51.5% versus 4.5% with placebo; neutropenia was 9.1–11.7% versus 0.6%. Safety must be considered beside response.
Sep 22, 2026
Both pivotal CSU studies meet key endpoints
Both doses met primary and key secondary endpoints across EMBARQ-CSU1 and CSU2. Week-12 complete response was 42.1–45.7% in active arms versus 9.3–12.6% in placebo groups; the BLA plan is 2027.
Aug 14, 2026
Earlier holders report June positions
The historical filings report 4,686,187 shares for T. Rowe Price and 5,322,908 for Kynam as of June 30. Their reference date differs from the later FMR position.
CLDX stock catalysts: dermatitis data, longer CSU exposure and filing
- November 5, 2026 — Third-quarter 2026 results: net loss $75.6 million, $650.3 million of cash and securities at September 30, through-2028 funding outlook unchanged. Completed
- November 9, 2026 · 9:00 a.m. ET — Fireside chat at the Guggenheim 3rd Annual Healthcare Innovation Conference, webcast on the Celldex investor site. Investor conference
- December 1, 2026 · 10:50 a.m. ET — Fireside chat at the 9th Annual Evercore Healthcare Conference, webcast. Investor conference
- Late 2026 — Phase 2 atopic dermatitis topline data expected; enrollment complete. Company clinical window
- By year end 2026 — Additional barzolvolimab indications to be announced. Company plan
- Ongoing follow-up — CSU studies continue treatment through 52 weeks. Not a fixed public readout date
- 2027 — BLA submission planned. Submission plan, not FDA approval
Third-quarter 2026 update · Pipeline outlook · Pivotal program · Investor conferences
CLDX barzolvolimab: response, durability and safety
Week-12 and Week-24 complete response measure controlled treatment effects; they are not proof of permanent cure or off-treatment disease modification. Smaller Phase 2 follow-up can motivate a durability hypothesis without supplying missing pivotal follow-up. Anaphylaxis, neutropenia and hair-color effects matter for monitoring and possible label language.
CLDX cash runway, share dilution and approval obligations
The April equity financing, which raised $323.8 million net, replenished resources; at September 30, 2026 cash, cash equivalents and marketable securities were $650.3 million, after $188.0 million of operating cash use in the first nine months. The previous shelf registration expired on November 3, 2026 with the $300 million ATM program entirely unsold; a new automatic shelf registration (Form S-3ASR) was filed on November 5 for an unspecified amount of securities. An approval-contingent $52.5M milestone can be paid in stock or cash, and the 10-Q notes that paying it in cash could affect the funding outlook. Through-2028 guidance depends on the planned operating path rather than guaranteeing all later trials and commercialization are funded. Q3 2026 Form 10-Q · November 5 shelf registration
Merlintrader Health Score · $CLDX
3.50out of 5
Assessed November 6, 2026, after the third-quarter results. Weighted calculation: 4.0×30% + 3.5×30% + 3.0×20% + 3.0×10% + 3.5×10% = 3.50. This describes financial and operational robustness over twelve to eighteen months, not an investment recommendation.
Red flags
- Positive trials are not approval or superiority over another active medicine.
- Longer exposure and the complete safety profile matter.
- September 30 resources are historical; operating cash use rose to $188.0 million in the first nine months of 2026 and the company expects it to increase over the next twelve months.
- The 2027 BLA plan does not supply an FDA action date.
CLDX Stock FAQ: Celldex Therapeutics Questions Answered
When are Celldex’s next barzolvolimab trial results?
Celldex’s November 5, 2026, update expects topline data from the fully enrolled Phase 2 atopic-dermatitis study to be presented in late 2026, without a fixed release day, and plans to announce additional barzolvolimab indications by year end. The pivotal CSU results have already been reported, on September 22; those studies continue treatment through 52 weeks. The company plans a barzolvolimab BLA submission in 2027. Atopic-dermatitis data window. September 22 CSU results and filing plan.
Is Celldex’s barzolvolimab FDA approved?
Barzolvolimab remained investigational in Celldex’s September 22, 2026, update, which plans an FDA application in 2027. Both pivotal CSU trials met their primary and key secondary endpoints. The planned filing and further safety follow-up precede a regulatory decision; the results alone do not authorize commercial use. Pivotal results and planned BLA.
How much cash does Celldex have and what is its runway?
Celldex reported $650.3 million of cash, cash equivalents and marketable securities at September 30, 2026, down from $717.6 million at June 30. Operating cash use was $65.0 million in the third quarter and $188.0 million in the first nine months. Its November 5 update expects those resources to fund planned operations through 2028. The forecast does not remove the possibility of future share issuance or contingent milestone payments. September 2026 financial statements. Management funding outlook.
Can Celldex issue more CLDX shares despite its cash runway?
Celldex’s September 2026 10-Q reports that its shelf registration expired on November 3, 2026, with none of the $300 million registered under the ATM agreement sold. It also discloses a potential $52.5 million milestone on a qualifying first FDA or EMA approval, which can be settled in cash, stock or a combination. The company had 78,545,051 shares outstanding on October 28, 2026. On November 5, Celldex filed a new automatic shelf registration statement on Form S-3ASR, under which it may offer common stock, preferred stock, warrants, depositary shares and units in unspecified amounts through future prospectus supplements. Shelf expiry, ATM and approval milestone. New shelf registration. Funding outlook.
When are the next CLDX earnings?
Celldex published third-quarter 2026 results on November 5, 2026, for the quarter ended September 30, and filed its Form 10-Q the same day; the release did not announce a conference call. As of November 5, the date of the full-year 2026 report had not been announced. Third-quarter 2026 results. Company news archive. Company events calendar.
What does Celldex Therapeutics do?
Celldex Therapeutics develops antibody-based medicines for allergic, inflammatory and autoimmune diseases. Its lead candidate, barzolvolimab, targets KIT to inhibit mast-cell activity and is being developed for chronic urticarias and other conditions. Its August and September 2026 disclosures also describe the earlier-stage bispecific antibody CDX-622. Pipeline and company overview. Barzolvolimab program.
Does Celldex’s barzolvolimab complete response mean a permanent cure?
No. Celldex’s September 22, 2026, pivotal results define complete response as absence of itch and hives, measured by UAS7=0 at specified on-treatment visits. The placebo-controlled period lasted 24 weeks, with treatment continuing through 52 weeks. These results measure treatment response, without demonstrating a permanent off-treatment cure. Response definition and trial duration.
Who are Celldex’s largest institutional shareholders?
FMR was a major Celldex shareholder, reporting 8,411,905.03 shares, or 10.7%, as of September 30, 2026 in its October Schedule 13G amendment. That reporting date differs from the filing and signature dates. The ownership snapshot alone does not establish that the reported shares were purchased in October. FMR ownership amendment.
Primary sources
- November 5, 2026 · Third-quarter 2026 results: $650.3 million of cash and securities, through-2028 funding outlook (Form 8-K, Exhibit 99.1)
- November 5, 2026 · Form 10-Q for the quarter ended September 30, 2026: shelf expiry and ATM status
- November 5, 2026 · Form S-3ASR: new automatic shelf registration for unspecified amounts of securities
- November 4, 2026 · Fireside chats at Guggenheim (November 9) and Evercore (December 1) investor conferences
- October 7, 2026 · FMR amendment reports September ownership
- September 22, 2026 · Results presentation details pivotal safety
- September 22, 2026 · Both pivotal CSU studies meet key endpoints
- August 14, 2026 · Earlier holders report June positions
- August 6, 2026 · Financial resources and development outlook reported
- July 15, 2026 · Finance succession plan disclosed
- Financial statement
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Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases and market-data providers, and are stated with their reference dates. Data can change without notice, and figures published before a results release become outdated the moment that release is issued. Merlintrader makes no representation that the information is complete or current at the time of reading. Readers should verify every figure against the primary source before acting on it.
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