CELLDEX THERAPEUTICS, INC.

(CLDX)
  Report
Delayed Nasdaq  -  04:00 2022-08-12 pm EDT
37.33 USD   +8.11%
08/09SVB Securities Adjusts Celldex Therapeutics' Price Target to $64 From $68, Keeps Outperform Rating
MT
08/08CELLDEX THERAPEUTICS : Reports Second Quarter 2022 Financial Results and Provides Corporate Update - Form 8-K
PU
08/08CELLDEX : Q2 Earnings Snapshot
AQ
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

Celldex Therapeutics, Inc. Presents Positive Interim Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at EAACI 2022

06/30/2022 | 06:01pm EDT

Celldex Therapeutics, Inc. announced interim data from the Company's ongoing Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Data show that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, as measured through the urticaria activity score over 7 days (UAS7), with a mean UAS7 reduction of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the ongoing 3.0 mg/kg dose group (n=9) at week 8 (reflects one dose), demonstrating meaningful symptom improvements for patients. Complete response as measured by UAS7=0 was 57.1% for patients in the 1.5 mg/kg dose group at week 12 and 44.4% for the patients in the 3.0 mg/kg dose group at week 8 (reflects one dose; ongoing). Summary of Data from Ongoing Phase 1b CSU Trial of Barzolvolimab: As of the data cut-off on May 23, 2022, 34 patients with CSU were enrolled and treated [26 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg; n=9 in 3.0 mg/kg) and 8 placebo]. The 0.5 mg/kg and 1.5 mg/kg cohorts had completed study participation through 24 weeks; 7 of 12 patients in the 3.0 mg/kg cohort had completed week 12; enrollment in the 4.5 mg/kg cohort was ongoing. Adverse events through data cutoff and hematology data through week 12 were included for all dose groups; clinical activity and tryptase data were included through week 12 for 0.5 mg/kg and 1.5 mg/kg, and through week 8 for 3 mg/kg (ongoing; reflecting the administration of only one dose). Interim Clinical Activity Results: Barzolvolimab results in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. Mean reduction from baseline in urticaria activity (UAS7) of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the 3.0 mg/kg dose group (n=9) at week 8 (reflects one dose; ongoing), demonstrating clinically meaningful symptom improvements for patients. Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and 44.4% at week 8 (reflects one dose; ongoing) in the 3 mg/kg dose group which is a key therapeutic goal. 75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects one dose; ongoing). Patients with prior omalizumab therapy had similar symptom improvement as all patients. All three doses of barzolvolimab markedly improved urticaria symptoms and disease control, with rapid improvement in itch and hives. As predicted, the lowest dose of 0.5 mg/kg resulted in suboptimal clinical activity compared to the higher doses. Rapid onset of responses after initial dosing and sustained durability were observed; onset as early as 1 week after the first dose. Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.


© S&P Capital IQ 2022
All news about CELLDEX THERAPEUTICS, INC.
08/09SVB Securities Adjusts Celldex Therapeutics' Price Target to $64 From $68, Keeps Outper..
MT
08/08CELLDEX THERAPEUTICS : Reports Second Quarter 2022 Financial Results and Provides Corporat..
PU
08/08CELLDEX : Q2 Earnings Snapshot
AQ
08/08CELLDEX THERAPEUTICS, INC. Management's Discussion and Analysis of Financial Condition..
AQ
08/08Celldex Therapeutics, Inc. Reports Earnings Results for the Second Quarter and Six Mont..
CI
08/08Earnings Flash (CLDX) CELLDEX THERAPEUTICS Posts Q2 Loss $-0.77
MT
08/08Earnings Flash (CLDX) CELLDEX THERAPEUTICS Posts Q2 Revenue $200,000
MT
08/08Celldex Reports Second Quarter 2022 Financial Results and Provides Corporate Update
AQ
07/21Celldex Therapeutics Doses First Patient in Phase 2 Trial of Potential Treatment for In..
MT
07/21Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Patients wit..
AQ
More news
Analyst Recommendations on CELLDEX THERAPEUTICS, INC.
More recommendations
Financials (USD)
Sales 2022 1,03 M - -
Net income 2022 -114 M - -
Net cash 2022 306 M - -
P/E ratio 2022 -15,7x
Yield 2022 -
Capitalization 1 746 M 1 746 M -
EV / Sales 2022 1 400x
EV / Sales 2023 1 118x
Nbr of Employees 133
Free-Float 99,8%
Chart CELLDEX THERAPEUTICS, INC.
Duration : Period :
Celldex Therapeutics, Inc. Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends CELLDEX THERAPEUTICS, INC.
Short TermMid-TermLong Term
TrendsBullishBullishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 6
Last Close Price 37,33 $
Average target price 65,67 $
Spread / Average Target 75,9%
EPS Revisions
Managers and Directors
Anthony S. Marucci President, Chief Executive Officer & Director
Sam Martin CFO, Secretary, Treasurer & Senior Vice President
Karen Lipton Shoos Chairman
Tibor Keler Chief Scientific Officer & Executive VP
Diane C. Young Chief Medical Officer & Senior Vice President
Sector and Competitors
1st jan.Capi. (M$)
CELLDEX THERAPEUTICS, INC.-3.39%1 746
MODERNA, INC.-32.60%66 966
IQVIA HOLDINGS INC.-12.88%45 846
LONZA GROUP AG-25.13%44 851
SEAGEN INC.10.05%31 380
ALNYLAM PHARMACEUTICALS, INC.37.90%28 068