Pericarditis

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Retrieved on: 
Tuesday, April 2, 2024

"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

Retrieved on: 
Wednesday, February 21, 2024

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

Retrieved on: 
Monday, March 11, 2024

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

Retrieved on: 
Wednesday, February 28, 2024

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

Retrieved on: 
Thursday, February 15, 2024

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

Retrieved on: 
Monday, January 15, 2024

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

Retrieved on: 
Tuesday, January 2, 2024

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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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

Retrieved on: 
Tuesday, January 2, 2024

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

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41[...]

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

Cardiol Therapeutics Announces Massachusetts General Hospital, Largest Teaching Hospital of Harvard Medical School, as the 8th Major Medical Centre Participating in MAvERIC-Pilot

Retrieved on: 
Tuesday, December 5, 2023

MAvERIC-Pilot is a Phase II Study in Recurrent Pericarditis and is Anticipated to Complete Patient Recruitment during Q1 2024

Key Points: 
  • "We are delighted to have the world-renowned Massachusetts General Hospital contributing to our MAvERIC-Pilot study enrollment," commented Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development.
  • "Mass General has been consistently ranked as a top hospital in the United States and has the largest hospital-based research program in the country.
  • We look forward to the support of Mass General's clinicians and participating patients towards reaching full enrollment in this ground-breaking study."
  • MAvERIC-Pilot is enrolling 25 patients at eight prominent medical research centers in the United States that specialize in pericarditis care.