CDE

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

Retrieved on: 
Monday, January 8, 2024

Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.

Key Points: 
  • Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.
  • Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis.
  • Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization.
  • Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates.

Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

Retrieved on: 
Thursday, December 21, 2023

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Gracell's Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate GC012F in rSLE patients.
  • As announced Nov. 27, the Company will also commence Phase 1/2 clinical study in the U.S. An IIT is underway to evaluate GC012F for the treatment of rSLE.
  • “This milestone marks our rapid progress in advancing development of GC012F in rSLE, an autoimmune disease with high unmet need,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform.

McEwen Mining Closes Flow-Through Financing

Retrieved on: 
Thursday, December 14, 2023

TORONTO, Dec. 14, 2023 (GLOBE NEWSWIRE) -- McEwen Mining Inc. (NYSE: MUX) (TSX: MUX) is pleased to announce the closing of the previously announced private placement financing of 1,903,000 flow-through common shares for total gross proceeds of US$16.1 million (Cdn$22,016,150).

Key Points: 
  • TORONTO, Dec. 14, 2023 (GLOBE NEWSWIRE) -- McEwen Mining Inc. (NYSE: MUX) (TSX: MUX) is pleased to announce the closing of the previously announced private placement financing of 1,903,000 flow-through common shares for total gross proceeds of US$16.1 million (Cdn$22,016,150).
  • McEwen will not make any public offering of the securities in the United States.
  • The forward-looking statements and information expressed, as at the date of this news release, McEwen Mining Inc.'s (the "Company") estimates, forecasts, projections, expectations or beliefs as to future events and results.
  • The NYSE and TSX have not reviewed and do not accept responsibility for the adequacy or accuracy of the contents of this news release, which has been prepared by management of McEwen Mining Inc.

McEwen Mining Announces Flow-Through Financing

Retrieved on: 
Wednesday, November 22, 2023

TORONTO, Nov. 22, 2023 (GLOBE NEWSWIRE) -- McEwen Mining Inc. (NYSE: MUX) (TSX: MUX) is pleased to announce a financing to fund continued exploration and development at the Fox Complex in the Timmins region of Ontario.

Key Points: 
  • TORONTO, Nov. 22, 2023 (GLOBE NEWSWIRE) -- McEwen Mining Inc. (NYSE: MUX) (TSX: MUX) is pleased to announce a financing to fund continued exploration and development at the Fox Complex in the Timmins region of Ontario.
  • McEwen will not make any public offering of the securities in the United States.
  • The forward-looking statements and information expressed, as at the date of this news release, McEwen Mining Inc.'s (the "Company") estimates, forecasts, projections, expectations or beliefs as to future events and results.
  • The NYSE and TSX have not reviewed and do not accept responsibility for the adequacy or accuracy of the contents of this news release, which has been prepared by management of McEwen Mining Inc.

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

Retrieved on: 
Thursday, December 21, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
  • LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication.
  • LIVTENCITY was granted Breakthrough Therapy Designation by China Center for Drug Evaluation (CDE) in 2021.
  • “This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”
    The NMPA approval is based on the results of the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies – ganciclovir, valganciclovir, cidofovir or foscarnet – for the treatment of patients with CMV infection/disease refractory* to prior therapies.

AnHeart Therapeutics and Innovent Announce China’s NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation

Retrieved on: 
Monday, December 18, 2023

The CDE accepted the NDA in November 2023.

Key Points: 
  • The CDE accepted the NDA in November 2023.
  • “Taletrectinib’s Priority Review Designation reinforces the urgent need for patients with ROS1-positive NSCLC who were previously treated with ROS1 TKIs in China and the significant clinical advance that taletrectinib may represent for these patients,” said Bing Yan, MD, Chief Medical Officer, AnHeart.
  • “We look forward to working with the regulatory authorities as they conduct their review of taletrectinib to hopefully bring this breakthrough investigational therapy to patients as soon as possible.”
    “Taletrectinib’s potential as a best-in-class precision therapy is further underscored by the Priority Review Designation,” said Dr. Hui Zhou, Senior Vice President of Innovent.
  • Priority Review Designation allows the CDE to prioritize the review process and evaluation resources for NDAs, which helps accelerate the market access of innovative drugs.

Coeur Appoints Rob Krcmarov to Board of Directors

Retrieved on: 
Tuesday, December 12, 2023

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced the appointment of Mr.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced the appointment of Mr.
  • Rob Krcmarov to the Company’s Board of Directors, effective December 11.
  • An international mining executive and geologist, Mr. Krcmarov has held leadership roles at site, regional and corporate levels throughout his approximately 35 years in the natural resources industry.
  • I am looking forward to contributing to Coeur’s exciting future in my capacity as a board member.”

AnHeart Therapeutics and Innovent Announce China’s NMPA Has Accepted a New Drug Application for Taletrectinib (ROS1 Inhibitor)

Retrieved on: 
Wednesday, November 22, 2023

The NDA acceptance in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.

Key Points: 
  • The NDA acceptance in China is based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients.
  • Results from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 .
  • “Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally.
  • We would like to thank all the doctors and patients who participated in the clinical trials that support this submission,” said Bing Yan, MD, Chief Medical Officer, AnHeart.

Coeur Announces Agreement to Acquire Concessions Near the Palmarejo Mine from Fresnillo

Retrieved on: 
Monday, November 20, 2023

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that its subsidiary, Coeur Mexicana, S.A. de C.V., has signed a purchase agreement with a subsidiary of Fresnillo plc (“Fresnillo”) to acquire mining concessions adjacent to the Palmarejo gold-silver complex located in the state of Chihuahua, Mexico.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that its subsidiary, Coeur Mexicana, S.A. de C.V., has signed a purchase agreement with a subsidiary of Fresnillo plc (“Fresnillo”) to acquire mining concessions adjacent to the Palmarejo gold-silver complex located in the state of Chihuahua, Mexico.
  • View the full release here: https://www.businesswire.com/news/home/20231120902019/en/
    Together, the concessions comprise nearly 7,000 acres and include claims adjacent to two primary zones within Palmarejo’s existing footprint as shown in yellow on the map below.
  • The first set of concessions cover the southeast extensions of the Independencia and Nacion deposits where mining currently takes place.
  • The second set of concessions, located to the northeast, surrounds multiple targets containing mineralization and historic resources that were added through the 2015 acquisition of Paramount Gold and Silver.

733Park Advises CDE Services, Inc. in its Acquisition by Milestone Partners

Retrieved on: 
Tuesday, November 14, 2023

733Park , a mergers and acquisitions advisory firm, has successfully advised CDE Services, Inc. in its acquisition by Milestone Partners, a private equity firm.

Key Points: 
  • 733Park , a mergers and acquisitions advisory firm, has successfully advised CDE Services, Inc. in its acquisition by Milestone Partners, a private equity firm.
  • “We are beyond happy to have advised CDE Services in their acquisition by Milestone Partners,” said 733Park founder Lane Gordon , “It was a pleasure to represent CDE and to bring this transaction to fruition; we are sure that both teams will encounter more successes together.
  • The second half of 2023 has been extremely busy for 733Park as buyers have adjusted to the ‘new’ interest rate environment and have returned in droves.
  • We are bullish on our payment industry and SaaS M&A transaction volume as well as valuations going into 2024.”
    Milestone Partners is a private equity firm that specializes in partnering with management on investments, specifically targeting “leveraged buyouts and recapitalizations of lower middle-market businesses in technology-enabled services and financial solutions industries”.