CDE

Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

Retrieved on: 
Jeudi, avril 25, 2024
FDA, Annual, Pharmacy, NMPA, Private, Partnership, CDE, PDUFA, CEPS, European Medicines Agency, News, Annual report, Intangibles, DMD, U.S. FDA, Catalyst Pharmaceuticals, Tax, CHF, MHRA, Duchenne muscular dystrophy, Quality of life, Leber's hereditary optic neuropathy, Vamorolone, BST, Public, EMA, Marketing, File, Sale, Medication, Treasury, NDA, Health care, Duchenne, Bond, Patient, Bank statement, AGM, Growth, Cryptocurrency

As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.

Key Points: 
  • As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.
  • Financially, Santhera reported a 2023 revenue of CHF 103.4 million and net income of CHF 54.8 million, driven by the Catalyst licensing deal.
  • After closing of the transaction in July 2023, Santhera received an upfront payment of USD 90 million (USD 75 million in cash and USD 15 million equity investment).
  • SIX Exchange Regulation has permitted Santhera to publish its 2023 Annual Report by May 31, 2024, at the latest.

A Potential First-In-Class Drug: CDE Approved Single-Arm Pivotal Clinical Study of LBL-024, An Anti-PD-L1/4-1BB Bispecific Antibody Developed by Leads Biolabs

Retrieved on: 
Mardi, avril 30, 2024
FDA, News, Safety, NMPA, National Medical Products Administration, Immunotherapy, Trial of the century, Tumor microenvironment, CDE, IND, PD-L1, Disease, CD137, Patient, Antibody, Quality of life, Pharmaceutical industry

LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies.

Key Points: 
  • LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies.
  • It binds to PD-L1 with high affinity, blocking the PD-L1/PD-1 immunosuppressive pathway while conditionally activating the 4-1BB costimulatory pathway in the tumor microenvironment.
  • Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said " The approval of this pivotal clinical study is an encouraging news.
  • The approval of the single-arm pivotal clinical study by CDE will help accelerate the marketing process of LBL-024 and bring more effective treatment options to patients as early as possible."

Coeur Publishes 2023 ESG Report

Retrieved on: 
Mardi, avril 23, 2024
Professional Services, Environmental, Social and Governance (ESG), Mining, Minerals, Environment, Sustainability, Environmental Issues, Natural Resources, Climate change, Report, Total, Ecosystem, Safety, Biodiversity, Health, MSHA, Responsibility, CDE, Carbon, ESG, Coeur, GHG

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today published its 2023 ESG Report (the “Report”), highlighting the Company’s efforts to advance its environmental, social and governance strategy, priorities and practices and its responsible mining operations.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today published its 2023 ESG Report (the “Report”), highlighting the Company’s efforts to advance its environmental, social and governance strategy, priorities and practices and its responsible mining operations.
  • The Report details Coeur’s public ESG targets, best-in-class corporate governance practices and positive environmental and social impacts that are aligned with generating long-term value for stockholders.
  • "Advancing ESG principles aligned with long-term value and maintaining Coeur’s position as a leader in safe and responsible mining remains our highest priority, reflecting our commitment to Pursue a Higher Standard, as highlighted in our 2023 ESG Report.
  • A copy of the Report and a separate document containing ESG data can be found on the Responsibility section of the Company’s website: https://www.coeur.com/responsibility/responsibility-overview/ .

Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA

Retrieved on: 
Mercredi, mars 27, 2024
Diagnosis, NMPA, Patient, Ageing, NDA, Breakthrough, CDE, Duchenne muscular dystrophy, Therapy, Vamorolone, Safety, File, DMD, Neuromuscular disease, Pharmaceutical industry

Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.

Key Points: 
  • Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.
  • The Center for Drug Evaluation (CDE) of the Chinese drug authority NMPA accepted the filing and granted priority review for vamorolone in DMD for patients aged 4 years and older which could, subject to a positive outcome, lead to approval by Q1 2025.
  • Duchenne muscular dystrophy is a rare neuromuscular disease affecting about 70,000 patients in China.
  • The submission is further supported by a study which investigated the pharmacokinetic parameters of vamorolone in healthy adult Chinese volunteers.

Coeur Announces First Quarter 2024 Earnings Call

Retrieved on: 
Mardi, avril 9, 2024
Natural Resources, Other Natural Resources, Mining, Minerals, CDE, Senior, Central Time

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it will report its first quarter 2024 operational and financial results after the New York Stock Exchange closes for trading on Wednesday, May 1, 2024.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it will report its first quarter 2024 operational and financial results after the New York Stock Exchange closes for trading on Wednesday, May 1, 2024.
  • The Company will be hosting a conference call at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) on Thursday, May 2, 2024.
  • Hosting the call will be Mitchell J. Krebs, President and Chief Executive Officer of Coeur, who will be joined by Thomas S. Whelan, Senior Vice President and Chief Financial Officer, Michael “Mick” Routledge, Senior Vice President and Chief Operating Officer, Aoife McGrath, Senior Vice President of Exploration, and other members of management.
  • A replay of the call will be available through May 9, 2024.

Expanded Rochester Mine Achieves Commercial Production; Ramp-Up on Schedule

Retrieved on: 
Lundi, avril 8, 2024
Natural Resources, Other Natural Resources, Mining, Minerals, CDE, Merrill–Crowe process, Gold, Silver, Coeur, Uranium mining

Commissioning of the new three-stage crushing circuit and truck load-out facility was completed on March 7.

Key Points: 
  • Commissioning of the new three-stage crushing circuit and truck load-out facility was completed on March 7.
  • Since then, the crushing circuit has operated at an average throughput of nearly 70,000 tons per day1 and has exceeded 88,000 tons per day, leading to the declaration of commercial production as of the end of the first quarter.
  • Ramp-up to full design capacity of 88,000 tons per day—or approximately 32 million tons per year—remains on schedule for completion during the first half of 2024.
  • Materially higher production levels are anticipated to build throughout the second half of 2024 consistent with completion of Rochester’s ramp-up.

FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Retrieved on: 
Dimanche, avril 7, 2024
PART, EGFR, Mutation, BTD, NSCLC, Disease, Progression-free survival, Patient, Heel, Corr, NDA, Breakthrough, Non-Euclidean geometry, Doctor of Philosophy, CDE, Society, ESMO, Safety, ASCO, FDA, Annual general meeting, Food, Pharmaceutical industry

SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

Key Points: 
  • SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
  • This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1).
  • This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."
  • Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.

Coeur to Present at Gold Forum Europe

Retrieved on: 
Jeudi, avril 4, 2024
Natural Resources, Other Natural Resources, Mining, Minerals, CDE, Senior, Central European Time

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) announced today that Senior Vice President and Chief Financial Officer Thomas S. Whelan will present at Gold Forum Europe in Zurich, Switzerland on Wednesday, April 10, 2024 at 1:10 p.m. Central European Time.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) announced today that Senior Vice President and Chief Financial Officer Thomas S. Whelan will present at Gold Forum Europe in Zurich, Switzerland on Wednesday, April 10, 2024 at 1:10 p.m. Central European Time.
  • Gold Forum Europe is an invitation-only investment conference.
  • Presentation materials will be made available on the Company’s website at www.coeur.com .

LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China

Retrieved on: 
Mardi, mars 19, 2024
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Cardiovascular disease, NMPA, PCSK9, CVD, MAA, Refrigeration, CMC, EMA, CDE, Clinical trial, Therapy, National Medical Products Administration, Pharmaceutical industry

LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

Key Points: 
  • LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
  • In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories.
  • The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten.
  • “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA.

Spring Capital Successfully Exits Investment in Catenda, a Leader in Construction Project Software

Retrieved on: 
Vendredi, mars 15, 2024
Software, Networks, Professional Services, Hardware, Electronic Design Automation, Data Management, Technology, Other Construction & Property, Other Manufacturing, Construction & Property, Finance, Other Technology, Manufacturing, Construction, Private equity, Partnership, SINTEF, Sale, GRO, Capital, CDE, Polaris, IRR, BIM, Dependent and independent variables, Security (finance)

As the lead investor, Spring Capital has sold all its shares in the transaction on a high IRR for itself and co-investors.

Key Points: 
  • As the lead investor, Spring Capital has sold all its shares in the transaction on a high IRR for itself and co-investors.
  • Founded in 2009 as a spin-off from SINTEF, Catenda is a leader in Building Information Management (BIM) & Common Data Environment (CDE) software.
  • Since Spring Capital’s investment through its Scandinavian investment entity Polaris, Catenda has grown significantly, becoming a trusted partner for construction companies and municipalities seeking innovative solutions for large-scale projects.
  • Construction companies across Europe and Japan have widely adopted the company's software, seeking to streamline operations and improve project outcomes.