Celldex Therapeutics

Celldex Therapeutics, Inc. engages in the business of development, manufacturing and commercialization of novel therapeutics for human health care. Its drug candidates have the ability to engage the human immune system and directly inhibit tumors to treat specific types of cancer and other diseases. Its pipeline includes Varlilumab, CDX-1140, and CDX-301, and CDX-3379. The company was founded by Anthony S. Marucci and Tibor Keler in 1983 and is headquartered in Hampton, NJ.

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HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company's Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation.

Celldex Announces First Patient Dosed in Phase 1 Healthy Volunteer Study of CDX-622, a Bispecific Antibody, for the Treatment of Inflammatory Diseases

HAMPTON, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in fireside chats at two upcoming conferences:

Celldex Therapeutics to Present at Upcoming Investor Conferences

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.64 per share versus the Zacks Consensus Estimate of a loss of $0.69. This compares to loss of $0.81 per share a year ago.

Celldex Therapeutics (CLDX) Reports Q3 Loss, Tops Revenue Estimates

HAMPTON, N.J., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update.

Celldex Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Celldex's primary revenue driver is Barzolvolimab, now in Phase 3 for CSU, targeting unmet needs in inflammatory diseases. Barzolvolimab has shown strong Phase 2 efficacy for CSU, though safety concerns may affect patient adherence. Celldex's solid cash position and long runway reduce dilution risks, supporting the continued development of its pipeline.

Celldex Therapeutics' Strong Cash Runway Supports Barzolvolimab's Path To Market

HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with 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. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD.

Celldex Announces Barzolvolimab Met All Primary and Secondary Endpoints with High Statistical Significance in Positive Phase 2 Study in Chronic Inducible Urticaria

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that 12 week results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024.

Celldex Announces Upcoming Late Breaking Oral Presentation of 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria at ACAAI 2024

Celldex stock falls due to safety concerns related to the treatment of urticaria patients with barzolvolimab in a phase II study, despite robust efficacy data.

CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study

- 71% of patients (150 mg Q4W) achieved complete response at Week 52 - - Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks - - Robust improvement across omalizumab-experienced/refractory/naïve disease - - Well tolerated through 52 weeks - - Enrollment to Global Phase 3 CSU trials underway - - Company to host webcast today at 12:00 pm ET/6:00 pm CEST -

Celldex Therapeutics Presents Landmark 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV 2024

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company's Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Amsterdam on September 25-28, 2024.

Celldex Announces Upcoming Late Breaking Oral Presentation of 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV Congress 2024

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to loss of $0.65 per share a year ago.

Celldex Therapeutics (CLDX) Reports Q2 Loss, Tops Revenue Estimates

HAMPTON, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2024 and provided a corporate update.

Celldex Reports Second Quarter 2024 Financial Results and Provides Corporate Update

HAMPTON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with 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. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD.

Celldex Therapeutics Presents Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria

- EMBARQ-CSU1 and EMBARQ-CSU 2 will enroll more than 1800 patients suffering from CSU - - Studies include both biologic naïve and experienced patients -

Celldex Therapeutics Initiates Global Phase 3 Program for Barzolvolimab in Patients with Chronic Spontaneous Urticaria

HAMPTON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 6th at 10:00 am ET. A webcast of the presentation will be available on the "Events & Presentations” page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

Celldex Therapeutics to Present at Jefferies Healthcare Conference

- Clinically meaningful and statistically significant improvements across multiple angioedema measurements and barzolvolimab dose groups - - Sustained activity with rapid onset within 2 weeks - - Data further support barzolvolimab clinical benefit to patients with CSU -

Celldex Therapeutics Presents Data Demonstrating Profound Improvements in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2024

The mean of analysts' price targets for Celldex (CLDX) points to an 87.3% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Think Celldex (CLDX) Could Surge 87.27%: Read This Before Placing a Bet

HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company's Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN). 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 the function and survival of the mast cell. Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN where mast cells are associated with pruritic sensory neurons in PN lesions.

Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Prurigo Nodularis

Celldex Therapeutics is a biopharmaceutical company with a strong pipeline of potential treatments. The company has a solid financial outlook, which is a positive factor for investors. If you respect the risks of investing based on phase 2 data, CLDX has a lot of promise yet unrealized.

Celldex Therapeutics: Rising High, With Room For Further Growth

The consensus price target hints at a 67.8% upside potential for Celldex (CLDX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Believe Celldex (CLDX) Could Rally 67.77%: Here's is How to Trade

- Phase 3 CSU studies expected to initiate in summer 2024 - - Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 - - Enrollment completed in Phase 2 CIndU study; 12 week data expected 2H 2024 - - Phase 2 PN study initiated; enrollment progressing in Phase 2 EoE study - - Atopic dermatitis selected as next indication; Phase 2 study to initiate by YE 2024 -

Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update

HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company's Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—temperatures below skin temperature in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. 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. In February 2024, the Company presented positive 12 week primary endpoint results from its ongoing Phase 2 study of barzolvolimab in the most common form of chronic urticaria—chronic spontaneous urticaria (CSU).

Celldex Announces Completion of Enrollment in Phase 2 Study of Barzolvolimab in Patients with Chronic Inducible Urticaria

The heavy selling pressure might have exhausted for Celldex (CLDX) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

Down -14.61% in 4 Weeks, Here's Why You Should You Buy the Dip in Celldex (CLDX)

Celldex (CLDX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About Celldex (CLDX) Rating Upgrade to Buy

Celldex (CLDX) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

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