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CASI PHARMACEUTICALS' PARTNER JUVENTAS ANNOUNCES NEW DRUG APPLICATION FOR CNCT19 ACCEPTED BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION

Retrieved on: 
Thursday, December 15, 2022

It has been granted the Orphan Drug Designation from the FDA and the Breakthrough Designation status by the China Center of Drug Evaluation (CDE).

Key Points: 
  • It has been granted the Orphan Drug Designation from the FDA and the Breakthrough Designation status by the China Center of Drug Evaluation (CDE).
  • The r/r B-ALL NDA submission for CNCT19 contains the initial data from study NCT04684147, a Phase II, single-arm, open-label, single-dose, multicenter clinical trial.
  • CASI and Juventas will work side by side to deliver CNCT19 to patients in China, and eventually worldwide."
  • The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.

Kezar Life Sciences Presents Positive Complete Results from the MISSION Phase 2 Trial Evaluating Zetomipzomib in Lupus Nephritis at the American College of Rheumatology Convergence 2022

Retrieved on: 
Monday, November 14, 2022

The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.

Key Points: 
  • The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.
  • Patients in the MISSION Phase 2 clinical trial received zetomipzomib without induction therapy, which represents a significant difference from other recently published clinical trials in LN.
  • In the MISSION Phase 2 clinical trial, 17 of 21 enrolled patients reached end-of-treatment at Week 25 and end-of-study at Week 37.
  • Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor has completed a Phase 2 clinical trial in lupus nephritis.

Kezar Life Sciences Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 10, 2022

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.

Key Points: 
  • Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.
  • Kezar presented positive complete results for the 37-week Phase 2 MISSION clinical trial at the American Society of Nephrologys (ASN) Kidney Week 2022 Annual Meeting.
  • General and administrative expenses for the third quarter of 2022 increased by $1.0 million to $5.0 million compared to $4.0 million in the third quarter of 2021.
  • Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing novel treatments for immune-mediated and oncologic disorders.

Kezar Life Sciences Presents Positive Complete Results from the MISSION Phase 2 Trial Evaluating Zetomipzomib in Lupus Nephritis at ASN’s Kidney Week 2022 Annual Meeting

Retrieved on: 
Thursday, November 3, 2022

The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.

Key Points: 
  • The MISSION Phase 2 clinical trial was an open-label study designed to demonstrate the responder rate of zetomipzomib in patients with active LN.
  • Patients in the MISSION Phase 2 clinical trial received zetomipzomib without induction therapy, which represents a significant difference from other recently published clinical trials in LN.
  • In the MISSION Phase 2 clinical trial, 17 of 21 enrolled patients reached end-of-treatment at Week 25 and end-of-study at Week 37.
  • Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor has completed a Phase 2 clinical trial in lupus nephritis.

InfoComm Southeast Asia Back In-person

Retrieved on: 
Friday, October 14, 2022

InfoComm Southeast Asia 2022 will take place from 2 to 4 November at the Bangkok International Trade and Exhibition Centre (BITEC).

Key Points: 
  • InfoComm Southeast Asia 2022 will take place from 2 to 4 November at the Bangkok International Trade and Exhibition Centre (BITEC).
  • InfoComm Southeast Asia is the region's premier Professional AudioVisual (Pro-AV) and Transformative Technology tradeshow, featuring trailblazing international and local solution providers.
  • InfoComm Southeast Asia is where entrepreneurs, business leaders and technical professionals will discover the latest Pro-AV solutions that are transforming every industry.
  • Visitors can expect to see:
    To enhance show experience for visitors, InfoComm Southeast Asia has introduced facilitative tools on the Show website.

CRISPR Therapeutics Presents Positive Results from its Phase 1 COBALT™-LYM Trial of CTX130™ in Relapsed or Refractory T Cell Malignancies at the 2022 European Hematology Association (EHA) Congress

Retrieved on: 
Saturday, June 11, 2022

ZUG, Switzerland and CAMBRIDGE, Mass., June 11, 2022 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today presented positive results from the Company’s ongoing Phase 1 COBALT™-LYM trial evaluating the safety and efficacy of CTX130™, its wholly-owned allogeneic CAR-T cell therapy targeting CD70 for the treatment of both solid tumors and certain hematologic malignancies.

Key Points: 
  • Clinically meaningful responses were observed with CTX130 with a higher percentage of patients responding at higher dose levels.
  • In addition, 90% of patients at DL3+ had clinical benefit defined as a stable disease or better response.
  • These preliminary data demonstrate that CTX130 has the potential to provide meaningful clinical benefit with a well-tolerated safety profile.
  • CRISPR THERAPEUTICS standard character mark and design logo, CTX130 and COBALT are trademarks and registered trademarks of CRISPR Therapeutics AG.