Bladder cancer

CG Oncology Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

Retrieved on: 
Tuesday, January 30, 2024

All of the shares were offered by CG Oncology.

Key Points: 
  • All of the shares were offered by CG Oncology.
  • The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $437.0 million.
  • CG Oncology’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol “CGON.”
    Morgan Stanley, Goldman Sachs & Co. LLC and Cantor acted as joint book-running managers for the offering.
  • Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on January 24, 2024.

enGene Appoints Lee Giguere as Chief Legal Officer and Corporate Secretary

Retrieved on: 
Tuesday, January 30, 2024

Experienced biotech executive brings public company expertise in legal, corporate governance, and compliance to support enGene during late-stage clinical development and anticipated future commercial launch of its lead program EG-70

Key Points: 
  • Experienced biotech executive brings public company expertise in legal, corporate governance, and compliance to support enGene during late-stage clinical development and anticipated future commercial launch of its lead program EG-70
    BOSTON and MONTREAL, Jan. 30, 2024 /PRNewswire/ - enGene Holdings Inc. ("enGene," (Nasdaq: ENGN), a clinical-stage genetic medicines company whose lead program is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced the appointment of Lee Giguere as Chief Legal Officer and Corporate Secretary.
  • "I am delighted to welcome Lee, an experienced public biotech legal executive, to enGene as we advance the development of EG-70 in our ongoing pivotal-stage LEGEND study in BCG-unresponsive non-muscle invasive bladder cancer," said Jason D. Hanson, Chief Executive Officer of enGene.
  • Mr. Giguere previously served as Chief Legal Officer and Secretary of Obsidian Therapeutics, a clinical-stage cell and gene therapy company.
  • Mr. Giguere commented: "I am thrilled to join enGene as we work to transform the management of bladder cancer, beginning with BCG-unresponsive NMIBC.

AUA, SUO Release Amendment to Non-Muscle Invasive Bladder Cancer Guideline

Retrieved on: 
Wednesday, January 24, 2024

BALTIMORE, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline amendment for the diagnosis and treatment of non-muscle invasive bladder cancer.

Key Points: 
  • BALTIMORE, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline amendment for the diagnosis and treatment of non-muscle invasive bladder cancer.
  • Bladder cancer continues to be a significant health issue in the United States, with non-muscle invasive bladder cancer (NMIBC) accounting for approximately 75% of the estimated 82,000 new cases diagnosed in 2023.
  • “One of the fastest growing spaces in Urologic Oncology is in the treatment of non-muscle invasive bladder cancer,” said Dr. Jeffrey M. Holzbeierlein, SUO president and chair for the guideline amendment.
  • Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment.

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Urothelial Carcinoma After Surgery

Retrieved on: 
Friday, January 26, 2024

Median DFS was 29.0 months (95% CI, 21.8-not evaluable [NE]) for KEYTRUDA and 14.0 months (95% CI, 9.7-20.20) for observation, an improvement of 15 months.

Key Points: 
  • Median DFS was 29.0 months (95% CI, 21.8-not evaluable [NE]) for KEYTRUDA and 14.0 months (95% CI, 9.7-20.20) for observation, an improvement of 15 months.
  • AMBASSADOR (A031501)/KEYNOTE-123 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT03244384 ) evaluating KEYTRUDA versus observation for the adjuvant treatment of patients with localized MIUC and locally advanced resectable urothelial carcinoma.
  • 17.4% of patients receiving KEYTRUDA withdrew from the trial without event versus 27.2% from the observation arm.
  • Grade ≥3 adverse events occurred in 48.4% of patients receiving KEYTRUDA versus 31.8% of patients under observation.

European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Friday, January 26, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240125523192/en/
    “The EV-302 pivotal trial demonstrated the benefits of combining PADCEV with pembrolizumab for advanced bladder cancer.
  • Patients with bladder cancer in Europe face poor outcomes at the advanced stage, and innovative therapies that extend survival are needed.
  • If approved, the combination would be the first alternative to a chemotherapy-based treatment for this patient population.
  • The EMA’s Committee for Medicinal Products for Human Use (CHMP) and subsequently the European Commission (EC) are expected to share their opinions and decisions on the Type II variation application in calendar year 2024.

CG Oncology Announces Pricing of Upsized Initial Public Offering

Retrieved on: 
Thursday, January 25, 2024

CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share.

Key Points: 
  • CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share.
  • All of the shares are being offered by CG Oncology.
  • The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $380.0 million.
  • In addition, CG Oncology has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

BIO-TECHNE'S ADVANCED CELL DIAGNOSTICS (ACD) SETS NEW STANDARD IN SPATIAL BIOLOGY WITH PROTEASE-FREE RNASCOPE MULTIOMICS

Retrieved on: 
Monday, January 29, 2024

MINNEAPOLIS, Jan. 29, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Advanced Cell Diagnostics (ACD), a Bio-Techne spatial biology brand, has set a new standard with the development of a next-generation, protease-free RNAscope spatial multiomics workflow. Optimized for same-slide detection of protein and RNA biomarkers with unparalleled sensitivity and tissue morphology, the newly developed RNAscope spatial multiomics workflow is compatible with both manual and automated assays. ACD's novel protease-free RNAscope workflow is incorporated in Bio-Techne's recently announced best-in-class multiomics application on Lunaphore's COMET platform.

Key Points: 
  • Advanced Cell Diagnostics (ACD), a Bio-Techne spatial biology brand, achieves technical breakthrough enabling protease-free, same-slide detection of protein and RNA biomarkers using industry-leading RNAscope™ technology.
  • MINNEAPOLIS, Jan. 29, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Advanced Cell Diagnostics (ACD) , a Bio-Techne spatial biology brand, has set a new standard with the development of a next-generation, protease-free RNAscope spatial multiomics workflow.
  • Optimized for same-slide detection of protein and RNA biomarkers with unparalleled sensitivity and tissue morphology, the newly developed RNAscope spatial multiomics workflow is compatible with both manual and automated assays.
  • ACD's novel protease-free RNAscope workflow is incorporated in Bio-Techne's recently announced best-in-class multiomics application on Lunaphore's COMET platform.

Asieris Releases Phase III Clinical Study and Real-World Research Data for APL-1706, a Bladder Cancer Diagnosis and Management Drug, at the 2024 ASCO-GU

Retrieved on: 
Monday, January 29, 2024

The study included 158 patients enrolled in a randomized controlled trial (RCT), with 37 patients in the training group and 6 patients randomly assigned to the non-Blue Light Cystoscopy (BLC) group, one patient withdrew.

Key Points: 
  • The study included 158 patients enrolled in a randomized controlled trial (RCT), with 37 patients in the training group and 6 patients randomly assigned to the non-Blue Light Cystoscopy (BLC) group, one patient withdrew.
  • A total of 114 patients were in the full analysis set.
  • Nineteen patients were included in the real-world study (RWS).
  • The new drug application (NDA) for APL-1706 was accepted by the National Medical Products Administration (NMPA) in November 2023.

Phase 4 Study Evaluating Use of ADSTILADRIN® (nadofaragene firadenovec-vncg) in Real-World Setting

Retrieved on: 
Wednesday, January 24, 2024

ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.

Key Points: 
  • ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.
  • “I am thrilled to be part of this ongoing research and among the first uro-oncologists to be treating patients with ADSTILADRIN in a clinical setting.
  • Final results from this prospective, multi-institutional study are expected at the end of 2026.
  • Trials in Progress Poster Session B: Urothelial Carcinoma
    Abstract #TPS705, Friday, Jan. 26 at 5:45 - 6:45 p.m. PST

End Drug Shortages Alliance Announces New Chair and Board Members for 2024

Retrieved on: 
Tuesday, January 23, 2024

The End Drug Shortages Alliance (EDSA) announces the appointment of Terri Lyle Wilson, vice president of pharmacy for The Children’s Hospital Association, as its new chair.

Key Points: 
  • The End Drug Shortages Alliance (EDSA) announces the appointment of Terri Lyle Wilson, vice president of pharmacy for The Children’s Hospital Association, as its new chair.
  • Wilson succeeds past-board chair Eric Tichy, PharmD, MBA, FCCP, division chair, pharmacy supply solutions, Mayo Clinic.
  • Tichy helped launch the End Drug Shortages Alliance in 2021 and was appointed chair in December 2021.
  • "I am very grateful to Eric for his leadership and am honored to step into the role of board chair for the End Drug Shortages Alliance," said Wilson.