Celldex Therapeutics, Inc. reports developments as a clinical-stage biotechnology company focused on mast cell biology and antibody-based therapeutics for allergic, inflammatory, autoimmune and other mast cell-mediated diseases. Company updates center on barzolvolimab, a humanized monoclonal antibody being studied across chronic spontaneous urticaria, cold urticaria and symptomatic dermographism, as well as pipeline work that includes CDX-622 in asthma.
Recurring news themes include clinical data presentations at allergy and dermatology meetings, financial results, corporate updates and capital actions. Celldex also reports financing activity tied to its common stock and development priorities for its antibody-based immunology pipeline.
Celldex (NASDAQ: CLDX) reported third-quarter financial results and progress toward a planned regulatory submission for barzolvolimab in chronic spontaneous urticaria (CSU). Both Phase 3 CSU studies met their primary and all key secondary endpoints across both dose groups. Efficacy persisted or deepened through Week 24; treatment continues to Week 52. Celldex anticipates a biologics license application in 2027.
Third-quarter net loss widened to $75.557 million from $67.044 million, while loss per share narrowed to $0.96 from $1.01. Cash, cash equivalents and marketable securities fell to $650.3 million from $717.6 million at June 30; Celldex expects funding to support planned operations through 2028. Phase 3 cold urticaria and symptomatic dermographism enrollment continues. Atopic dermatitis data are expected in late 2026, while the Phase 2 prurigo nodularis study is being discontinued.
Celldex (NASDAQ:CLDX) announced that management will participate in fireside chats at two upcoming healthcare investor conferences in November and December. The Guggenheim 3rd Annual Healthcare Innovation Conference chat is scheduled for November 9, 2026, at 9:00am ET; the 9th Annual Evercore Healthcare Conference chat is on December 1, 2026, at 10:50am ET. Webcasts will be available on Celldex’s investor website, with replays available for 90 days following each event.
Celldex (CLDX) reported positive topline Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 results for barzolvolimab in chronic spontaneous urticaria (CSU).
Both randomized, double-blind, placebo-controlled trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, with LS mean changes of about -20 for both barzolvolimab doses versus -10.7 and -11.4 on placebo (p<.00001 in both studies). All key secondary endpoints were also met.
Complete response (UAS7=0) rates at Week 24 reached 49.0–54.0% for the 150 mg dose and 45.1–48.4% for the 300 mg dose, versus 15.4–17.6% on placebo. In omalizumab-refractory CSU, Week 12 complete response rates were 41.7–55.3% on barzolvolimab versus 9.3–15.1% on placebo. Angioedema resolution (AAS7=0) at Week 12 was 62.7–74.3% on barzolvolimab versus 33.7–33.8% on placebo. Barzolvolimab was well tolerated through 24 weeks, and a BLA submission is planned for 2027.
Celldex (CLDX) will participate in a fireside chat at the Cantor Global Healthcare Conference on September 10, 2026 at 8:00 a.m. ET.
A live webcast and replay of the presentation will be available for 90 days on the Celldex website under the Investors section, on the Events and Presentations page.
Celldex (NASDAQ:CLDX) reported second quarter 2026 results and a pipeline update. Cash, cash equivalents and marketable securities were $717.6 million at June 30, 2026, boosted by $323.8 million in net proceeds from an April underwritten public offering, with cash expected to fund operations through 2028. Q2 R&D expenses were $67.5 million and G&A expenses $13.1 million, leading to a net loss of $73.5 million, or ($0.94) per share.
The Phase 3 barzolvolimab chronic spontaneous urticaria program (EMBARQ-CSU1/2) fully enrolled 1,939 patients six months ahead of guidance, with topline data expected Sept/Oct 2026 and a planned 2027 BLA. A Phase 3 barzolvolimab study in cold urticaria and symptomatic dermographism is ongoing, and Phase 2 atopic dermatitis data are expected in late 2026. The Phase 2 prurigo nodularis study did not meet endpoints and is being discontinued. First-in-human Phase 1 data for bispecific CDX-622 showed rapid, profound, dose-dependent reductions in serum tryptase and good tolerability, supporting expansion into additional inflammatory indications.
Celldex (NASDAQ:CLDX) reported topline Phase 2 results for subcutaneous barzolvolimab in prurigo nodularis (PN). The 140‑patient, randomized, placebo‑controlled study did not meet its primary endpoint of ≥4‑point WI‑NRS itch reduction at Week 12 or key secondary endpoints, at either 150mg or 300mg Q4W after a 450mg loading dose.
According to Celldex, barzolvolimab produced rapid, profound and sustained systemic mast cell depletion, shown by significant serum tryptase reductions, but this did not improve itch or skin lesions versus placebo, suggesting mast cells may not be a key PN driver. Based on these data, the company is discontinuing the PN Phase 2 study. Safety and tolerability were favorable and consistent with prior trials, including with the new 450mg loading regimen. Barzolvolimab continues in Phase 3 studies for chronic spontaneous urticaria, symptomatic dermographism and cold urticaria, and in a Phase 2 study in atopic dermatitis, with CSU Phase 3 topline data expected in September/October 2026.
Celldex (NASDAQ:CLDX) announced that Senior Vice President and Chief Financial Officer Sam Martin plans to retire in 2027. Martin, CFO since 2017 and with Celldex since 2009, will remain in his role through March 2027 while the company conducts a CFO search.
According to Celldex, Martin has helped guide its evolution toward a late-stage immunology company. The company highlights a robust pipeline and notes that key data from two Phase 3 barzolvolimab trials are expected later in 2026.
Celldex (NASDAQ:CLDX) reported long-term Phase 2 data for barzolvolimab in chronic spontaneous urticaria (CSU) with angioedema. Treatment produced rapid, significant and durable angioedema improvements that persisted seven months after final dosing.
Up to 64% of baseline angioedema patients were angioedema-free at Week 76. Two Phase 3 CSU trials (1,939 patients) are fully enrolled, with topline data expected in Q4 2026 and a planned BLA filing in 2027.
Celldex (NASDAQ:CLDX) reported first-in-human Phase 1 results for CDX-622, a bispecific antibody targeting soluble SCF and TSLP, at the EAACI 2026 meeting.
According to Celldex, CDX-622 produced rapid, profound, dose-dependent, durable serum tryptase reductions, showed monoclonal-like pharmacokinetics, and was well-tolerated without dose-limiting toxicities, serious related events, or immunogenicity. Non-human primate data supported selective mast cell depletion without measurable effects on spermatogenesis or melanogenesis.
Celldex (NASDAQ:CLDX) will present new data from its mast cell–targeting pipeline at the 2026 European Academy of Allergy and Clinical Immunology Congress in Istanbul, Türkiye, on June 12-15, 2026.
Three presentations cover barzolvolimab in chronic spontaneous and cold urticaria and first-in-human Phase 1 data for bispecific antibody CDX-622 in healthy volunteers.