CDE

Kezar Life Sciences Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
木曜日, 3月 14, 2024

(Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.

Key Points: 
  • (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 increased by $7.7 million to $22.6 million, compared to $14.9 million in the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 increased by $0.6 million to $5.8 million compared to $5.2 million in the fourth quarter of 2022.
  • Restructuring and impairment charges for the fourth quarter of 2023 were $6.2 million.

Sanyou Bio: Sanyou's Intelligence-Enabled Innovative Biologics R&D Platform Leads in the New Era of Biological Drug Development

Retrieved on: 
水曜日, 3月 27, 2024

This is the driving force behind Sanyou's development of an intelligence-enabled innovative biologics R&D platform.

Key Points: 
  • This is the driving force behind Sanyou's development of an intelligence-enabled innovative biologics R&D platform.
  • This system finds extensive applications across various domains, including research and development, data management, project management, quality control, and marketing.
  • By optimizing drug development processes and supporting intelligence-enabled decision-making, it comprehensively enhances R&D efficiency and accuracy, potentially playing a critical role in drug development.
  • In drug development, the modeling and prediction of drug developability analysis aims to comprehensively enhance the efficiency of the drug development process.

ALCANTARA CONTINUES ITS PARTNERSHIP WITH GERMAN CAR OF THE YEAR PROGRAM

Retrieved on: 
火曜日, 3月 26, 2024

DETROIT, March 26, 2024 /PRNewswire/ -- Alcantara, a leading "Made in Italy" luxury brand and the first Italian industrial company certified as Carbon Neutral, will continue its partnership with the annual German Car of the Year (GCOTY) program in 2024.

Key Points: 
  • DETROIT, March 26, 2024 /PRNewswire/ -- Alcantara, a leading "Made in Italy" luxury brand and the first Italian industrial company certified as Carbon Neutral, will continue its partnership with the annual German Car of the Year (GCOTY) program in 2024.
  • The GCOTY program opens with a Car Design Event (CDE) attended by more than 100 automotive designers and journalists April -10 at the Drivers & Business Club at Motorworld in Munich.
  • GCOTY's Summer Testing Event takes place June 24-27 in Alsfeld, Germany and features new-model test drives, concept-car displays, technical presentations and product exhibits.
  • Prior to announcing the 2025 German Car of the Year in November, GCOTY also will host a classic-car event Sept. 16-17 at the Nationales Automuseum in Dietzhoelztal, Germany.

Cargill Awards More Than $3 Million Grant to National FFA Organization

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火曜日, 3月 19, 2024

INDIANAPOLIS, March 19, 2024 /PRNewswire-PRWeb/ -- Cargill awarded a three-year grant of $3.15 million to the National FFA Organization in support of its commitment to shape future agriculture leaders.

Key Points: 
  • Cargill awarded a three-year grant of $3.15 million to the National FFA Organization in support of its commitment to shape future agriculture leaders.
  • INDIANAPOLIS, March 19, 2024 /PRNewswire-PRWeb/ -- Cargill awarded a three-year grant of $3.15 million to the National FFA Organization in support of its commitment to shape future agriculture leaders.
  • "We are honored to receive this grant from Cargill," said Molly Ball, president of the National FFA Foundation and chief marketing officer of the National FFA Organization.
  • The National FFA Organization is a school-based national youth leadership development organization of more than 945,000 student members as part of 9,163 local FFA chapters in all 50 states, Puerto Rico and the U.S. Virgin Islands.

AnHeart Therapeutics and Innovent Announce China’s NMPA has Accepted Second New Drug Application for Taletrectinib for First-Line Treatment of ROS1-Positive Lung Cancer

Retrieved on: 
火曜日, 3月 5, 2024

This NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 TKIs.

Key Points: 
  • This NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 TKIs.
  • In 2023, China’s NMPA accepted taletrectinib’s first NDA and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 TKIs.
  • Both NDAs in China are based on positive results from the Phase 2 TRUST-I (NCT04395677) trial.
  • “I am pleased this second NDA for taletrectinib has been accepted in China.

Coeur Announces Flow-Through Shares Private Placement to Advance Silvertip Exploration

Retrieved on: 
月曜日, 2月 26, 2024

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it has arranged a private placement (the “Offering”) of 7,704,725 flow-through common shares of the Company that will qualify as “flow-through shares” within the meaning of subsection 66(15) of the Income Tax Act (Canada) (the “flow-through shares”) for gross proceeds of approximately $25 million (C$34 million), resulting in a 27% premium.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it has arranged a private placement (the “Offering”) of 7,704,725 flow-through common shares of the Company that will qualify as “flow-through shares” within the meaning of subsection 66(15) of the Income Tax Act (Canada) (the “flow-through shares”) for gross proceeds of approximately $25 million (C$34 million), resulting in a 27% premium.
  • The flow-through shares will be privately placed with investors in certain provinces in Canada pursuant to applicable exemptions from the prospectus requirements.
  • The flow-through shares will only be offered and sold outside the United States pursuant to Regulation S under the Securities Act of 1933, as amended (the “U.S.
  • Securities Act”).

Everest Medicines and Kezar Life Sciences Receive IND Approval from China NMPA for PALIZADE Trial in Lupus Nephritis

Retrieved on: 
月曜日, 2月 26, 2024

Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).

Key Points: 
  • Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).
  • Everest will join Kezar and enroll patients in China as part of the ongoing PALIZADE trial, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib or placebo in patients with active LN.
  • In September 2023, Everest obtained exclusive rights to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia.
  • “With the approval of the zetomipzomib IND in China, Everest now has three medicines in the renal space either commercialized or in clinical development.

Coeur Reports Year-End 2023 Mineral Reserves and Resources

Retrieved on: 
火曜日, 2月 20, 2024

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today reported year-end 2023 proven and probable reserves of 3.2 million ounces of gold and 243.9 million ounces of silver, net of depletion.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today reported year-end 2023 proven and probable reserves of 3.2 million ounces of gold and 243.9 million ounces of silver, net of depletion.
  • Measured and indicated resources totaled 3.2 million ounces of gold, 196.3 million ounces of silver, 1,517 million pounds of zinc and 768.7 million pounds of lead, reflecting year-over-year increases for all metals driven by additions at Palmarejo, Rochester, Wharf and Silvertip.
  • Inferred resources were 2.0 million ounces of gold, 92.5 million ounces of silver, 481.8 million pounds of zinc and 199.8 million pounds of lead, signifying year-over-year increases of approximately 14%, 32%, 27% and 20%, respectively.
  • “Coeur’s total exploration investment in 2023 was lower than in recent years and resource expansion was our primary goal for the year, which was achieved across all of our sites.

NUS researchers invent new triple-junction tandem solar cells with world-record efficiency

Retrieved on: 
火曜日, 3月 5, 2024

Solar cells can be fabricated in more than two layers and assembled to form multi-junction solar cells to increase efficiency.

Key Points: 
  • Solar cells can be fabricated in more than two layers and assembled to form multi-junction solar cells to increase efficiency.
  • When assessing performance, the NUS scientists found that perovskite solar cells incorporated with cyanate can achieve a higher voltage of 1.422 volts compared to 1.357 volts for conventional perovskite solar cells, with a significant reduction in energy loss.
  • The researchers also tested the newly engineered perovskite solar cell by continuously operating it at maximum power for 300 hours under controlled conditions.
  • The researchers stacked a perovskite solar cell and a silicon solar cell to create a dual-junction half-cell, providing an ideal base for the attachment of the cyanate-integrated perovskite solar cell.

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

Retrieved on: 
金曜日, 2月 23, 2024

SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

Key Points: 
  • EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low.
  • IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ".
  • She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China.
  • Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells.