Pericarditis

Monte Rosa Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

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木曜日, 5月 9, 2024
Transfer, FDA, Research, Inflammation, Cell cycle, IND, CNS, Prostate cancer, AACR, Cancer, Autoimmunity, Lung cancer, Traffic barrier, MGD, Food, European Alliance, Conference, Roche, DDW, Pericarditis, Therapy, NSCLC, Rat, Ulcerative colitis, Poster, NLRP3, CCNE1, SCLC, Finance, Triple-negative breast cancer, Consultant, Public expenditure, Obesity, Gout, GLP, DSM-IV codes, Clinical trial, Toxicology, CDK2, G&A, Investigational New Drug, MYC, Research and development, EULAR, Carcinoma, Administration, Rheumatoid arthritis, Neoplasm, POC, Dermatology, Growth, Pharmaceutical industry

“We’re excited by the significant advances made across our entire portfolio, including both our oncology and immunology/inflammation programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.

Key Points: 
  • “We’re excited by the significant advances made across our entire portfolio, including both our oncology and immunology/inflammation programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.
  • The Company is on track to determine the recommended Phase 2 dose (RP2D) in Q2 2024 and report Phase 1 study results in H2 2024.
  • Announce the recommended Phase 2 dose for the MRT-2359 Phase 1/2 study in Q2 2024 and report Phase 1 clinical results in H2 2024.
  • Net Loss: Net loss for the first quarter of 2024 was $32.0 million, compared to $33.3 million for the fourth quarter of 2023.

Kiniksa Pharmaceuticals Reports First Quarter 2024 Financial Results and Recent Portfolio Execution

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火曜日, 4月 23, 2024
American College, Investment, RESONANCE, Partnership, Webcast, Growth, Prescription, Patient, Patient satisfaction, ID, Pericarditis, Telephone, KNSA, Pharmaceutical industry

HAMILTON, Bermuda, April 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported first quarter 2024 financial results and recent portfolio execution.

Key Points: 
  • – ARCALYST® (rilonacept) Q1 2024 net product revenue of $78.9 million, representing 85% year-over-year growth –
    HAMILTON, Bermuda, April 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported first quarter 2024 financial results and recent portfolio execution.
  • Total revenue for the first quarter of 2024 was $79.9 million, compared to $48.3 million for the first quarter of 2023.
  • Total operating expenses for the first quarter of 2024 were $96.4 million, compared to $59.5 million for the first quarter of 2023.
  • Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, April 23, 2024, to discuss first quarter 2024 financial results and recent portfolio execution.

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

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火曜日, 4月 2, 2024
Hypertrophy, Heart, CRDL, Patient, Mayo Clinic, PPAR, Agent handling, Cleveland Clinic, Fibrosis, European, Therapy, Myocarditis, Analysis, American Heart Association, Human, Massachusetts General Hospital, Pericarditis, MMT, Heart failure, American College, Safety, ODD, Cardiology, Clinical professor, Disease, Pericardium, Research, World Heart Federation, Management, University, Death, Pericardial effusion, Maverick, Reactive oxygen species, TSX, Priority review, FDA, Conversation, Financial statement, Inflammation, Fast Track, Calcium, Wound healing, API, Pharmaceutical industry

"Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Key Points: 
  • "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.
  • In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  • In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study.
  • In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline.

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

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水曜日, 2月 21, 2024
Freedom, Recurrence, Scar, Inflammation, FDA, Quality of life, TSX, C-reactive protein, Pericardial fluid, Pericarditis, Viral, CRDL, Safety, Pericardium, Therapy, Chronic pain, Fatigue, Length of stay, Patient, News, Heart, Hospital, Research, NRS

Topline Results Expected in Q2 2024

Key Points: 
  • "Having achieved full patient enrollment, we are now positioned to announce high-level MAvERIC-Pilot clinical trial data in the second quarter of this year.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

Monte Rosa Therapeutics Announces Initiation of IND Enabling Studies for MRT-8102, A First-in-Class NEK7 Directed Molecular Glue Degrader and NLRP3/IL-1β Pathway Inhibitor

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月曜日, 3月 11, 2024
Diabetes, Liver disease, Inflammation, Obesity, Cardiovascular disease, Growth, NLRP3, NIMA, Pericarditis, Gout, Therapy, CNS, Interleukin, DSM-IV codes, IND, MGD, Central nervous system disease, Pharmaceutical industry

BOSTON, March 11, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced a novel development candidate, MRT-8102, a potent, highly selective and orally bioavailable NIMA related kinase 7 (NEK7)-directed MGD. MRT-8102 is expected to be developed for the treatment of inflammatory diseases driven by interleukin-1β (IL-1β) and the NLRP3 inflammasome, which are critical elements of the inflammatory process. This is the first development candidate to be declared from the Company’s NEK7 development program.

Key Points: 
  • This is the first development candidate to be declared from the Company’s NEK7 development program.
  • “In preclinical non-human primate studies, MRT-8102 has demonstrated potent and selective degradation of NEK7, reducing downstream IL-1β.
  • We believe MRT-8102 has the potential to be developed in multiple inflammatory diseases, including gout, pericarditis and other cardiovascular diseases.
  • IND-enabling studies are underway, and we plan to file our first IND for the program in the first quarter of 2025.

Kiniksa Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Portfolio Execution

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水曜日, 2月 28, 2024
Real-World Evidence, Cohort, KNSA, C-reactive protein, Rheumatoid factor, Recurrence, Investment, Telephone, Partnership, Growth, ID, Joint, Genentech, Roche, Rheumatoid arthritis, American College, Webcast, Patient, Pericarditis, Paradigm, Prescription, CD40, Pharmaceutical industry

HAMILTON, Bermuda, Feb. 28, 2024 (GLOBE NEWSWIRE) --  Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported fourth quarter and full-year 2023 financial results and recent portfolio execution.

Key Points: 
  • Total revenue for the fourth quarter of 2023 was $83.4 million, compared to $61.9 million for the fourth quarter of 2022.
  • Total operating expenses for the fourth quarter of 2023 were $83.3 million, compared to $55.8 million for the fourth quarter of 2022.
  • Net income for the fourth quarter of 2023 was $25.2 million, compared to net income of $4.5 million for the fourth quarter of 2022.
  • Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Wednesday, February 28, 2024, to discuss fourth quarter and full-year 2023 financial results and recent portfolio execution.

Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

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木曜日, 2月 15, 2024
Fast Track, Recurrence, Scar, Inflammation, FDA, Quality of life, TSX, C-reactive protein, Myocarditis, Pericardial fluid, Pericarditis, Viral, CRDL, ODD, Safety, Pericardium, Therapy, Chronic pain, Fatigue, Length of stay, Patient, News, Disease, Heart, Hospital, Research, NRS, Priority review, Pharmaceutical industry

Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

Amini LLC Recovers Full Satisfaction of $52 Million Judgment Against Lynn Tilton

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月曜日, 1月 15, 2024
Legal, Professional Services, Maniscalco, Pericarditis, Em (typography), The Honourable, Judgement, Amini, Interview, Sale, Sidley Austin, District court, Bankruptcy, PPAS

In a landmark legal victory, Amini LLC announces the successful recovery of a full payment totaling $52 million, following its decisive judgment against Lynn Tilton on behalf of Trustee Salvatore LaMonica.

Key Points: 
  • In a landmark legal victory, Amini LLC announces the successful recovery of a full payment totaling $52 million, following its decisive judgment against Lynn Tilton on behalf of Trustee Salvatore LaMonica.
  • In June 2017, Mr. LaMonica, as Chapter 7 Trustee of TransCare, Lynn Tilton’s regional ambulance and paratransit company, engaged Amini LLC to investigate the circumstances surrounding TransCare’s bankruptcy filing.
  • By February 2018, Amini brought suit against Tilton, the sole director of TransCare, and Tilton’s Patriarch Partners Administrative Services, LLC (“PPAS”), Transcare’s secured lender.
  • “To succeed in this field against well-heeled and tenacious adversaries demands strategic thinking and unrelenting focus at every stage of litigation,” commented Bijan Amini, founding member of Amini LLC.

Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 11, Status: Authorised

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火曜日, 1月 2, 2024
People, Marketing, Immunodeficiency, INN, Risk, Sensation, Messenger, Nausea, RMP, Alpha, Myocarditis, Vaccination, Heart, Inflammation, Assessment, SARS, Fever, Anatomy, Paresthesia, IIA, Hypoesthesia, Skin, COVID-19 vaccine, Fatigue, ATC, Red, Pain, Ageing, Republic, Omicron, Allergy, Tenderness, Pregnancy, Safety, Medical Subject Headings, Group, Immune system, Antibody, EMA, International, Injection, Language, Select, Patient, Originality, Vomiting, Pericarditis, Anaphylaxis, System, Vaccine, Headache, Clinical trial, Swelling, Temperature, COVID-19, European Medicines Agency, SARS-CoV-2, Rash

Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 11, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

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火曜日, 1月 2, 2024
People, Marketing, Immunodeficiency, INN, Risk, Sensation, Messenger, Delta, Nausea, RMP, Vaccination, Heart, Inflammation, Back pain, SARS, Hardness, Bruise, Anatomy, IIA, Odynophagia, Hypoesthesia, Skin, Chills, Diarrhea, Fever, Fatigue, ATC, Pain, Ageing, Pregnancy, Somnolence, Arthralgia, Medical Subject Headings, Agency, Immune system, Allergy, Antibody, EMA, International, Language, Pfizer–BioNTech COVID-19 vaccine, Dizziness, Select, Patient, Vomiting, Erythema, Pericarditis, Lymph, System, Vaccine, Weakness, Headache, Abdominal pain, Swelling, Hypersensitivity, Temperature, COVID-19, SARS-CoV-2, Myalgia, Paresthesia, Rash

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 30/03/2023, Revision: 3, Status: Authorised