JAK3

Global Psoriatic Arthritis Drug Landscape Research Report 2024: Comprehensive Insights About 20+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Therapy, Acquisition, Arthritis, Psoriasis, Psoriatic arthritis, TEM, Inflammation, Malignancy, News, Atopic dermatitis, Route, Phase II, JAK1, KCNA3, JAK3, Discovery, Cell, Bristol Myers Squibb, Multiple sclerosis, Administration, Cytokine, Rheumatoid arthritis, TYK2, Clinical trial, NDA, Lluís Companys, Immune system, JAK2, Pharmaceutical industry

This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.
  • A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines.
  • The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development.
  • Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Monday, November 6, 2023
Janus, Research, Lilly, Eli Lilly and Company, AD, Plasma, Half-life, PD, Psoriatic arthritis, Washington University in St. Louis, Biomarker, JAK3, EPI, G&A, Health, Rheumatoid arthritis, MAD, JAK, R, RA, ITK, ACRS, Ulcerative colitis, Osteoporosis, Pharmacokinetics, Hidradenitis suppurativa, PK, Methotrexate, Pancreatic cancer, Safety, Atopic dermatitis, Collection, Chapter 11, Title 11, United States Code, Therapy, Patient, MK2, Pharmaceutical industry, Vaccine, Palladium, Cryptocurrency, Rare-earth element, Tobacco, Hydraulic machinery

WAYNE, Pa., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2023 and provided a corporate update.

Key Points: 
  • Net loss was $29.3 million for the third quarter of 2023 compared to $20.0 million for the third quarter of 2022.
  • Total revenue was $9.3 million for the third quarter of 2023 compared to $19.0 million for the third quarter of 2022.
  • Research and development (R&D) expenses were $23.9 million for the quarter ended September 30, 2023 compared to $23.7 million for the prior year period.
  • General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2023 compared to $5.8 million for the corresponding prior year period.

Aclaris Therapeutics Announces Positive Results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor

Retrieved on: 
Monday, September 18, 2023
PK, PD, Diarrhea, ITK, JAK3, Atopic dermatitis, Biomarker, Ulcerative colitis, ACRS, Patient, BID, MAD, Therapy, Headache, Safety, Rheumatoid arthritis, Disease, Pharmaceutical industry, Dietary supplement

WAYNE, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138.

Key Points: 
  • WAYNE, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138.
  • Based on these results, Aclaris will progress this program into a Phase 2a proof of concept study in patients with ulcerative colitis, its previously announced intended first clinical development target, and anticipates initiation of the trial in early 2024.
  • Aclaris is also exploring the potential of conducting a second proof of concept trial in an additional T cell-mediated autoimmune disease.
  • ATI-2138-PKPD-102 was a two-week Phase 1 MAD trial to investigate the safety, tolerability, PK and PD of ATI-2138 in healthy volunteers.

European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, Health, Science, Other Science, Pharmaceutical, Janus, Inc., TEC, Civil service commission, Hepatocellular carcinoma, MHLW, PFE, JAK3, European Directive on Traditional Herbal Medicinal Products, ALLEGRO, Medicine, SALT, Alopecia areata, EMA, Committee, Hair, European Commission, Patient, Committee for Medicinal Products for Human Use, Janus kinase 3, European Medicines Agency, FDA, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Food, Alopecia totalis, CHMP, Vaccine, Pharmaceutical industry, EU, Pfizer

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.
  • LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata.
  • At week 24, 49.2% of participants reported a response of “moderate” to “great” improvement in their alopecia areata compared to 9.2% with placebo.
  • ALLEGRO-LT (NCT04006457) is an ongoing Phase 3, open-label, long-term study, with safety and efficacy data being collected for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater scalp hair loss.

FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata

Retrieved on: 
Friday, June 23, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Janus, Yale School of Medicine, Inc., TEC, Diarrhea, Hepatocellular carcinoma, National Alopecia Areata Foundation, PFE, Aes, JAK3, Dermatology, ALLEGRO, Acne, Yale school, SALT, Hives, Associate, Rash, Alopecia areata, Hair, Patient, Autoimmune disease, Severity, Janus kinase 3, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Food, Pharmaceutical industry, Lancet, Pfizer

It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.

Key Points: 
  • It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
  • “LITFULO is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer.
  • “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”
    The FDA approval was based on results of clinical trials in alopecia areata.
  • “We believe the approval of LITFULO is a significant advancement for the treatment of alopecia areata, particularly for teens.

ASN002 (Gusacitinib) Emerging Drug Insight and Market 2023 - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 23, 2023
Health, Pharmaceutical, Janus, Clinical trial, HE, JAK, JAK3, News, SYK, B cell, JAK1, Research, United Kingdom, EU4, T helper 17 cell, Keratinocyte, CHE, T helper cell, Neutrophil, Book, Pancreatic serous cystadenoma, Macrophage, JAK2, TYK2, Cytokine, Lymphoma, Epithelium, SWOT, Fine chemical, Pharmaceutical industry, Vaccine, Hand eczema

The "ASN002 (Gusacitinib) Emerging Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "ASN002 (Gusacitinib) Emerging Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • Further, it also consists of future market assessments inclusive of the ASN002 (Gusacitinib) market forecast, analysis for Hand Eczema in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Hand Eczema.
  • Other emerging products for Hand Eczema (HE) are expected to give tough market competition to ASN002 (Gusacitinib) and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • What is the clinical trial status of the study related to ASN002 (Gusacitinib) in Hand Eczema (HE) and study completion date?

Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update

Retrieved on: 
Tuesday, November 8, 2022
Janus, MK2, GLOBE, Rheumatoid arthritis, Private Securities Litigation Reform Act, IND, Lilly, Ulcerative colitis, Risk, Atopic dermatitis, Headache, Patent, PK, Eli Lilly and Company, Food, Psoriatic arthritis, Hidradenitis suppurativa, JAK3, G&A, COVID-19, HS, Therapy, Methotrexate, Annual report, MAD, R, NASDAQ, SAD, Alopecia areata, Safety, U.S. Securities and Exchange Commission, Pharmacokinetics, Biomarker, Program, JAK, ITJ, Female, AD, Absorption, Research, Patient, ACRS, Male, ITK, RA, FDA, PD, Pharmaceutical industry, Copper, Risk management, Publishing, Hydraulic machinery, Reinsurance

WAYNE, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2022 and provided a corporate update.

Key Points: 
  • If allowed, Aclaris intends to initiate a Phase 1 MAD trial of ATI-2138 in healthy subjects by the end of 2022.
  • Net loss was $20.0 million for the third quarter of 2022 compared to $21.1 million for the third quarter of 2021.
  • Total revenue was $19.0 million for the third quarter of 2022 compared to $1.7 million for the third quarter of 2021.
  • These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata

Retrieved on: 
Friday, September 9, 2022
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Janus, European Medicines Agency, Janus kinase 3, Severity, EMA, NDA, Hair, NYSE, Autoimmune disease, New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Alopecia areata, Doctor of Philosophy, Pfizer, PFE, Hair loss, SALT, MAA, Food, Inflammation, JAK3, American Academy, Immunology, Inc., Patient, European Academy of Allergy and Clinical Immunology, FDA, Immune system, Population, Eyelash, United Kingdom, TEC, ALLEGRO, Face, Congress, Scalp, Marketing, Eyebrow, Alopecia totalis, Journal of the European Academy of Dermatology and Venereology, Pharmaceutical industry, Venereology, Dermatology

Alopecia areata affects approximately 6.8 million people in the U.S. and around 147 million people globally.

Key Points: 
  • Alopecia areata affects approximately 6.8 million people in the U.S. and around 147 million people globally.
  • Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023.
  • The randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study investigated ritlecitinib in patients 12 years of age and older with alopecia areata (n=718).
  • Alopecia areata is an autoimmune disease that has underlying immuno-inflammatory pathogenesis and targets hair follicles, which results in hair loss.

CTI BioPharma Announces Presentation at the 2022 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Tuesday, May 10, 2022
Janus, Thrombocytopenia, ASCO, Cytokine, Pacritinib, TYK2, Nasdaq, Haematopoiesis, CSF1R, JAK2, Company, JAK3, JAK1, FMS, Primary myelofibrosis, Patient, Vera, American Society of Clinical Oncology, FDA, CTI, Ruxolitinib, Society, CTIC, CD135, FLT3, Annual general meeting, Acquisition, Platelet, Pharmaceutical industry

SEATTLE, May 10, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced one poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2021.

Key Points: 
  • SEATTLE, May 10, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced one poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2021.
  • Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.
  • CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.
  • VONJOTM is a trademark of CTI BioPharma Corp.

Asana BioSciences Announces Dosing of First Patient in Phase 1 Trial of ASN004, a Novel 5T4-Antibody-Drug-Conjugate

Retrieved on: 
Friday, April 8, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Janus, DAR, Principal, Motor neuron, Itch, Cough, Neck, Pharmacokinetics, ADC, Clinical research, Cancer, Monomethyl auristatin F, 5T4, Doctor of Philosophy, Head, Asana, Program, Neoplasm, Janus kinase, Pain, LLC, Safety, JAK3, JAK1, TYK2, ATP, SYK, PI3K, Neuron, JAK, Kinase, Atopic dermatitis, JAK2, Patient, Large-cell lung carcinoma, Respiratory disease, Vaccine, Pharmaceutical industry

ASN004 incorporates a novel single-chain Fv-Fc antibody linked to a clinically validated Auristatin F hydroxypropylamide cytotoxic payload, and drug to antibody ratio (DAR) of approximately 10-12.

Key Points: 
  • ASN004 incorporates a novel single-chain Fv-Fc antibody linked to a clinically validated Auristatin F hydroxypropylamide cytotoxic payload, and drug to antibody ratio (DAR) of approximately 10-12.
  • In preclinical cancer models, a single dose of ASN004 achieved complete and durable tumor regression leading to tumor-free survivors.
  • Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.
  • In a Phase 1b study in atopic dermatitis patients, topical application of ASN008 showed rapid onset of pruritus relief (NCT03798561).