Cold urticaria

Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, May 6, 2024
AAAAI, Angioedema, Cell, Research, Enrollment, Itch, Atopic dermatitis, Injection, Congress, American Academy, Skin, PN, ILT4, Allergy, KIT, Cold urticaria, Therapy, Omalizumab, Neuropeptide, Patient, UAS7, Survival, PD-1, Rockefeller University, EAACI, Hypersensitivity, Clinical trial, Xeroderma, CSU, G&A, B cell, Prurigo nodularis, Myelocyte, Disease, Inflammation, Eosinophilic esophagitis, Pharmaceutical industry

HAMPTON, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Revenues: Total revenue was $0.2 million in the first quarter of 2024, compared to $1.0 million for the comparable period in 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $9.1 million in the first quarter of 2024, compared to $6.6 million for the comparable period in 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2024 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.

Jasper Therapeutics Announces First Patient Dosed in Phase 1b/2a SPOTLIGHT Clinical Study of Briquilimab in Chronic Inducible Urticaria

Retrieved on: 
Tuesday, March 19, 2024
Patient, Cold urticaria, CSU, Trial of the century, B cell, Therapy, Safety, Pharmacokinetics, CD117, Pharmaceutical industry

REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU.

Key Points: 
  • REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU.
  • The SPOTLIGHT study is evaluating a single administration, at two different dose levels, of subcutaneous briquilimab in adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD).
  • “We are excited to announce dosing of the first patient in the SPOTLIGHT study in patients with CIndU, our second clinical program evaluating briquilimab in a mast cell-mediated disease,” said Edwin Tucker, Chief Medical Officer of Jasper.
  • Jasper anticipates reporting preliminary data from the SPOTLIGHT study in the second half of 2024.

Jasper Therapeutics Highlights Recent Accomplishments and Key Upcoming Milestones

Retrieved on: 
Friday, January 5, 2024
Omalizumab, Subcutaneous, CD117, Risk, IND, EMA, FA, Chairperson, Cold urticaria, Therapy, MDS, Chronic, Fanconi anemia, ASH, Annual general meeting, European Medicines Agency, Syndrome, CSU, SVP, Patient, Acute myeloid leukemia, Safety, AML, CTA, Pharmaceutical industry

REDWOOD CITY, Calif., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant conditioning regimens, today announced its recent accomplishments, including the authorization by the European Medicines Agency (EMA) of the Company’s Clinical Trial Applications (CTA) for its Phase 1b/2a trials of briquilimab in CIndU and CSU, and outlined its corporate priorities and anticipated milestones for 2024. Called SPOTLIGHT – “Study (Phase 1b/2a) Of subcuTaneous brIquilimab in patients diaGnosed with cHronic inducible urTicaria” – the CIndU study will evaluate single doses of subcutaneous briquilimab in adult patients with cold urticaria or symptomatic dermographism.

Key Points: 
  • “2023 was a strategically important year for Jasper,” said Ronald Martell, President and Chief Executive Officer of Jasper.
  • “We secured IND clearance and CTA authorization for the Phase 1b/2a BEACON study of briquilimab in CSU and successfully dosed the first patient.
  • Our achievements in 2023 set the stage for a transformational year ahead with multiple key clinical milestones on the horizon across multiple indications.
  • Strengthened the organization with key leadership appointments including Thomas Wiggans as Chairperson of the Board of Directors, Scott Brun, M.D.

Third Harmonic Bio Announces Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
Molecule, Research, KIT, IND, Journal of the European Academy of Dermatology and Venereology, G&A, Inflammation, MAD, Cold urticaria, R, Pharmacokinetics, European Academy of Management, Medicine, Venereology, Safety, D, SAN, Pharmaceutical industry, Cryptocurrency, Patient, Dermatology

SAN FRANCISCO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • On October 31, 2023, Third Harmonic Bio announced the transition of Adrian S. Ray, Ph.D., from Chief Scientific Officer to Scientific Advisor effective November 1, 2023.
  • Additionally, the company announced that Robert Ho, Chief Financial Officer, is departing the organization on November 10, 2023.
  • R&D expenses for the nine months ended September 30, 2023 increased to $18.0 million, from $15.1 million for the same period in 2022.
  • G&A expenses for the nine months ended September 30, 2023 increased to $15.5 million, from $9.0 million for the same period in 2022.

Escient Pharmaceuticals Initiates Clinical Proof-of-Concept Study of EP262, a First-in-Class Oral MRGPRX2 Antagonist, in Chronic Inducible Urticaria

Retrieved on: 
Monday, September 25, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Pharmacodynamics, Dermatitis, Cold urticaria, MRGPRX2, Hives, Therapy, B cell, Atopic dermatitis, Patient, Safety, Pharmaceutical industry, Vaccine, Dermatology

Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in CALM-CIndU, an open label Phase 1b clinical proof-of-concept study of EP262 in subjects with chronic inducible urticaria (CIndU).

Key Points: 
  • Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in CALM-CIndU, an open label Phase 1b clinical proof-of-concept study of EP262 in subjects with chronic inducible urticaria (CIndU).
  • By blocking activation of MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell mediated diseases with an initial focus on chronic urticaria (hives) and atopic dermatitis (eczema).
  • EP262 represents a novel, targeted approach to the treatment of these disorders with the potential for once-daily oral administration without the side effects observed with other approaches.
  • “Following the successful completion of our Phase 1 first-in-human study earlier this year, our team is on track to initiate additional clinical proof-of-concept studies in chronic spontaneous urticaria and atopic dermatitis in the coming months.”

Celldex Reports Fourth Quarter and Year End 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 28, 2023
Well, GUF, GMP, IND, UAS7, AAAAI, Allergy, Patient, B cell, Cold urticaria, Inflammation, Research, Prurigo nodularis, R, Hypersensitivity, SRS, SD, Rockefeller University, D, ILT4, G&A, UCT, Prurigo, PD-1, Cell, Kinetics, Myelocyte, Aes, Growth, Hives, Gilead Sciences, Safety, American Academy, Eosinophilic esophagitis, Skin, KIT, Survival, Disease, CSU, Drug development, Annual general meeting, Omalizumab, Contingency, Pharmaceutical industry, Vaccine, Aluminium, Mineral wool, Cryptocurrency, Dermatology

HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.
  • Celldex believes her deep background in drug development strongly complements the current Board’s skills and experiences.
  • Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity.
  • The litigation settlement related loss had a ($0.32) impact on net loss per share for the twelve months ended December 31, 2022.

CoolHealth Enters U.S. Market With TargetCool™, A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization

Retrieved on: 
Wednesday, February 8, 2023
Cryoglobulinemia, Swelling, Pain, Patient, Skin, Inflammation, PRP, Early adopter, Paroxysmal cold hemoglobinuria, Hematoma, Temperature, Pain management, Cryofibrinogenemia, Cold urticaria, Skin temperature, Bolma recens, FDA, Filler (linguistics), Multimedia, Injection, Bruise, Toxin, Medical device

AUSTIN, Texas, Feb. 8, 2023 /PRNewswire/ -- Recens, Inc. dba CoolHealth ("CoolHealth"), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market with a breakthrough FDA-Class II medical device, TargetCool™. Leveraging groundbreaking, tuneable cooling technology, TargetCool rapidly cools the skin allowing providers to specifically set a "target" skin temperature down to the exact degree and second– a first in medical cooling. This allows providers to combine TargetCool™ with other needle-based procedures to minimize patient pain, bruising, inflammation and hematoma that may occur post-procedure. Through this, TargetCool is creating a new standard of care in cooling and opening the door to an array of new treatment possibilities.

Key Points: 
  • AUSTIN, Texas, Feb. 8, 2023 /PRNewswire/ -- Recens, Inc. dba CoolHealth ("CoolHealth"), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market with a breakthrough FDA-Class II medical device, TargetCool™.
  • Leveraging groundbreaking, tuneable cooling technology, TargetCool rapidly cools the skin allowing providers to specifically set a "target" skin temperature down to the exact degree and second– a first in medical cooling.
  • This allows providers to combine TargetCool™ with other needle-based procedures to minimize patient pain, bruising, inflammation and hematoma that may occur post-procedure.
  • Through this, TargetCool is creating a new standard of care in cooling and opening the door to an array of new treatment possibilities.

Celldex Therapeutics Presents Positive Data from Barzolvolimab Phase 1b Study in Chronic Inducible Urticaria at Global Urticaria Forum 2022

Retrieved on: 
Tuesday, December 6, 2022
Allergy, Hives, Skin temperature, WBC, ET, UCT, Fever, Consultant, Kinetics, Research, COVID-19, Wound healing, GUF, Judgement, B cell, Omalizumab, Phase II, Cancer, Skin, Knowledge, Risk, Hematology, Senior, Therapy, Annual report, Metabolic pathway, Hypersensitivity, Temperature, Dress, SCF, Exercise, Immune system, Disease, Safety, Patient, KIT, Cell, Intellectual property, Tryptase, Inflammation, AES, Angioedema, Form 10-K, Common, Survival, ID, Cold urticaria, Aluminium, Pharmaceutical industry, Tanning (leather), Vaccine, Copper

HAMPTON, N.J., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced new data from the Company’s open label Phase 1b clinical trial of barzolvolimab in patients with antihistamine refractory chronic inducible urticarias are being presented at the GA²LEN Global Urticaria Forum (GUF) held in Berlin, Germany. These diseases, which are often severe and debilitating, can significantly impact patients’ lives. Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity.All 9 of 9 (100%) cold urticaria patients who received a 1.5 mg/kg single full dose of barzolvolimab experienced a complete response as assessed by provocation testing, including 4 of 4 patients with omalizumab refractory disease. This cohort was added to the Phase 1b trial in patients with chronic inducible urticaria after Celldex previously reported a 95% complete response rate in July 2021 in patients with antihistamine-refractory cold urticaria and symptomatic dermographism who received a single 3.0 mg/kg dose of barzolvolimab.

Key Points: 
  • ET -
    HAMPTON, N.J., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced new data from the Company’s open label Phase 1b clinical trial of barzolvolimab in patients with antihistamine refractory chronic inducible urticarias are being presented at the GA²LEN Global Urticaria Forum (GUF) held in Berlin, Germany.
  • A randomized, double-blind, placebo-controlled, multi-dose Phase 2 subcutaneous study of barzolvolimab is currently enrolling patients with both cold urticaria and symptomatic dermographism.
  • Cold Urticaria 1.5 mg/kg intravenous cohort oral presentation: “Cold urticaria patients achieve complete response with 1.5 mg/kg barzolvolimab”
    10 patients received a single intravenous infusion of barzolvolimab at 1.5 mg/kg.
  • Additional Presentations: Encore presentations reviewing previously presented data from the Phase 1b study in chronic spontaneous urticaria and on wound healing are also being presented at GUF.

Escient Pharmaceuticals Announces Oral Presentation of Data Highlighting the Preclinical Development of EP262 at the 6th GA2LEN Global Urticaria Forum

Retrieved on: 
Wednesday, December 7, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Peptide, Therapy, Escient, Hives, CSU, Ligand, Itchy, Cytokine, Cold urticaria, Doctor of Philosophy, Skin, B cell, Patient, Translation (biology), Angioedema, Histamine, Chemokine, Pain, Sleep, MRGPRX4, Cholestatic pruritus, MRGPRX2, Tissue, Drug discovery, Atopic dermatitis, Pharmaceutical industry, Vaccine

Escient Pharmaceuticals, a clinical-stage company advancing novel small molecule therapeutics for the potential treatment of a broad range of neurosensory-inflammatory disorders, today announced the presentation of preclinical data related to the companys EP262 development program at the 6th GA2LEN Global Urticaria Forum being held in Berlin, Germany, December 7-8, 2022.

Key Points: 
  • Escient Pharmaceuticals, a clinical-stage company advancing novel small molecule therapeutics for the potential treatment of a broad range of neurosensory-inflammatory disorders, today announced the presentation of preclinical data related to the companys EP262 development program at the 6th GA2LEN Global Urticaria Forum being held in Berlin, Germany, December 7-8, 2022.
  • EP262, a potent, highly selective antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2), represents a novel, targeted approach to the treatment of mast cell-mediated disorders.
  • In chronic inducible urticaria (CIndU), hives are induced by specific triggers such as cold exposure (cold urticaria) or touch (symptomatic dermographism), among others.
  • Escient Pharmaceuticals is a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders.

Celldex Therapeutics Announces Multiple Upcoming Presentations of Barzolvolimab Data at GA²LEN Global Urticaria Forum (GUF) 2022

Retrieved on: 
Friday, December 2, 2022
Hives, CSU, Abstract (summary), ET, GUF, Therapy, Cancer, Wound healing, Inflammation, Patient, CET, Cold urticaria, Metabolic pathway, Immune system, Aluminium, Pharmaceutical industry

HAMPTON, N.J., Dec. 02, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that multiple presentations from the barzolvolimab development program will be presented at the 6th GA2LEN Global Urticaria Forum (GUF) being held December 7-8 in Berlin, Germany. Abstracts will be available on the meeting website on December 6th.

Key Points: 
  • Presentations at GUF 2022 are outlined below and include new data from both the Phase 1b 1.5 mg/kg cohort conducted in cold urticaria and long term follow data from the Phase 1b 3.0 mg/kg cohorts conducted in cold urticaria and symptomatic dermographism.
  • The chronic spontaneous urticaria (CSU) and wound healing presentations are Encore presentations and do not include new data.
  • The event will be webcast live and can be accessed by going to the "Events & Presentations" page under the "Investors & Media section of the Celldex Therapeutics website at www.celldex.com .
  • Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate.