TURBT

CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates

Retrieved on: 
torsdag, maj 9, 2024
Clinical trial, Research and development, Safety, Progression-free survival, Research, RFS, BCG, Administration, ASCO, Disease, IPO, Patient, Symantec Endpoint Protection, TURBT, AUA, Bladder cancer, G&A, Pharmaceutical industry

Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC to be presented at ASCO 2024.

Key Points: 
  • Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC to be presented at ASCO 2024.
  • BOND-003 (BCG-Unresponsive, HR-NMIBC): Final results from the Phase 3 clinical trial of cretostimogene monotherapy by the end of 2024.
  • CORE-001 (BCG-Unresponsive, HR-NMIBC): Final results from the Phase 2 clinical trial of crestostimogene in combination with pembrolizumab in June 2024 at the 2024 ASCO Annual Meeting.
  • General and Administrative (G&A) Expenses: G&A expenses for the first quarter ended March 31, 2024 were $5.8 million compared with $2.1 million for the first quarter ended March 31, 2023.

UroGen Announces Results from ATLAS Showing Robust UGN-102 Durability of Response in New and Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer at AUA 2024

Retrieved on: 
lördag, maj 4, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Oncology, Professor, Disease, DFS, Patient, Cancer, Bladder cancer, ATLAS, NYU, TURBT, Pharmaceutical industry

In the Phase 3 ATLAS study, 282 patients with new or recurrent LG-IR-NMIBC were randomized to primary treatment with UGN-102 ± TURBT or TURBT alone.

Key Points: 
  • In the Phase 3 ATLAS study, 282 patients with new or recurrent LG-IR-NMIBC were randomized to primary treatment with UGN-102 ± TURBT or TURBT alone.
  • In the overall study population, Disease Free Survival (DFS) and DOR favored primary treatment with UGN-102 ± TURBT compared to TURBT alone.
  • Topline data from both the ATLAS trial and the Phase 3 ENVISION trial were initially shared in July of 2023.
  • Twelve-month DOR data from the pivotal Phase 3 ENVISION trial are expected in June 2024.

New Publication: Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy

Retrieved on: 
torsdag, mars 28, 2024
NMIBC, Biopsy, BLC, TURBT, Patient, Skin, WLC, MD, Cancer, Bladder cancer, Pathology

OSLO, Norway, March 28, 2024 /PRNewswire/ -- Photocure ASA, The Bladder Cancer Company, announces the publication of the study "Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry" in the journal Cancers this week.

Key Points: 
  • OSLO, Norway, March 28, 2024 /PRNewswire/ -- Photocure ASA, The Bladder Cancer Company, announces the publication of the study "Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry" in the journal Cancers this week.
  • This study aims to evaluate heterogeneity in characteristics of blue light cystoscopy (BLC®) for detection of malignant lesions among various races with non-muscle invasive bladder cancer (NMIBC).
  • The authors conclude that regardless of race, BLC increased the detection of bladder cancer when combined with WLC.
  • However, the difference was more pronounced in Asian patients: "Our study showed that regardless of race, BLC increases the detection of bladder cancer when combined with WLC.

New Publication: Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy

Retrieved on: 
torsdag, mars 28, 2024
NMIBC, Biopsy, BLC, TURBT, Patient, Skin, WLC, MD, Cancer, Bladder cancer, Pathology

OSLO, Norway, March 28, 2024 /PRNewswire/ -- Photocure ASA, The Bladder Cancer Company, announces the publication of the study "Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry" in the journal Cancers this week.

Key Points: 
  • OSLO, Norway, March 28, 2024 /PRNewswire/ -- Photocure ASA, The Bladder Cancer Company, announces the publication of the study "Racial Difference in Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry" in the journal Cancers this week.
  • This study aims to evaluate heterogeneity in characteristics of blue light cystoscopy (BLC®) for detection of malignant lesions among various races with non-muscle invasive bladder cancer (NMIBC).
  • The authors conclude that regardless of race, BLC increased the detection of bladder cancer when combined with WLC.
  • However, the difference was more pronounced in Asian patients: "Our study showed that regardless of race, BLC increases the detection of bladder cancer when combined with WLC.

CG Oncology Announces First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
tisdag, februari 27, 2024
FACS, PFS, Recurrence, BCG, Medical director, RFS, TURBT, Bladder cancer, Cancer, Patient, Disease, Face, Pharmaceutical industry

IRVINE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- 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 first patient has been dosed in the PIVOT-006 Phase 3 clinical trial of cretostimogene for the treatment of patients with intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT).

Key Points: 
  • “The dosing of the first patient in our PIVOT-006 trial advances cretostimogene earlier in the treatment paradigm for NMIBC patients who face limited treatment options, frequent disease recurrence and repetitive surgery,” said Arthur Kuan, Chairman and Chief Executive Officer, CG Oncology.
  • The initial induction course is six weekly doses of cretostimogene containing 1x1012 VPs per milliliter.
  • The primary endpoint of this trial is overall RFS, with secondary endpoints including RFS at 12 and 24 months and PFS.
  • Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer.”

UroGen Pharma Reports Third Quarter 2023 Financial Results

Retrieved on: 
tisdag, november 14, 2023
Biotechnology, Pharmaceutical, Health, Oncology, NDA, Medicine, Webcast, Rated R, NMIBC, RTW, Chemistry, Risk, TURBT, Patient, Investment, Probability, Research, Carcinoma, LG, FDA, Mitomycins, Conference, ATLAS, Software, Death, CMC, Nephrectomy, Growth, CRR, Recurrence, URS, Role, Pharmaceutical industry, Medical imaging, Dietary supplement, Video game, Agency

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent developments.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent developments.
  • “During the third quarter, UroGen achieved several notable milestones, including announcement of unprecedented positive results from our ENVISION and ATLAS Phase 3 trials of UGN-102 in LG-IR-NMIBC,” said Liz Barrett, President, and Chief Executive Officer of UroGen.
  • Activated sites on November 1, 2023 were 1,088, compared to 1,058 on August 1, 2023, while repeat accounts on November 1, 2023 were 296, compared to 267 on August 1, 2023.
  • Third Quarter 2023 Financial Results:
    JELMYTO Revenue: UroGen reported net product revenue of JELMYTO for the third quarter 2023 of $20.9 million, compared to $16.1 million in the third quarter of 2022.

UroGen will Present Scientific Advances in Bladder Cancer at the Annual Meeting of the Society of Urologic Oncology

Retrieved on: 
måndag, november 13, 2023
Research, Hospitals, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Cancer, NMIBC, Bladder cancer, Patient, LG, ATLAS, SUO, Pharmaceutical industry, TURBT

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, will highlight data from two key Phase 3 trials evaluating UGN-102, an investigational treatment in development for LG-IR-NMIBC at the 2023 Society of Urologic Oncology (SUO) annual meeting, November 28-December 1 in Washington D.C.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, will highlight data from two key Phase 3 trials evaluating UGN-102, an investigational treatment in development for LG-IR-NMIBC at the 2023 Society of Urologic Oncology (SUO) annual meeting, November 28-December 1 in Washington D.C.
  • These data presentations further UroGen’s mission of developing and commercializing innovative treatments for urothelial and specialty cancers that provide patients with novel non-surgical options to fulfill the unmet needs that exist with current standards of care.
  • “The ATLAS and ENVISION Phase 3 clinical trials broaden our understanding of potentially using a new approach to treat LG-IR-NMIBC,” says Mark Schoenberg, M.D., Chief Medical Officer of UroGen.
  • “We’re particularly excited that the SUO selected the ENVISION study as one of only two late-breaking trials designated for oral presentations, which we believe further reinforces its potential in advancing bladder cancer treatment.

New Health Economic analysis in France concludes there is insignificant cost difference between White Light and Blue Light Cystoscopy use when applying ccAFU guidelines

Retrieved on: 
fredag, oktober 6, 2023
HIV disease progression rates, Hospital, NMIBC, Guideline, BLC, Research, Private sector, Medicine, Cystoscopy, Risk, CIS, WLC, Health, Suspicion, Recurrence, Disease, BIM, Bladder cancer, Public sector, Cancer, MIBC, Cochrane, TURBT, Patient, White Light, Pharmaceutical industry

This health economic analysis aims to assess the financial impact of widely adopting Blue Light Cystoscopy (BLC®) as recommended in the French ccAFU guidelines.

Key Points: 
  • This health economic analysis aims to assess the financial impact of widely adopting Blue Light Cystoscopy (BLC®) as recommended in the French ccAFU guidelines.
  • The most recent ccAFU (Comité de cancérologie de l'Association française d'urologie) guidelines recommend the use of BLC in a number of different positions in the care pathway for NMIBC.
  • a large public hospital implementing the specific BLC recommendations within the ccAFU guidelines for 300 new patients per year and 2.)
  • Recurrence rates for BLC-assisted patients were estimated by applying a single overall hazard ratio estimate to all patient groups.

UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

Retrieved on: 
torsdag, augusti 10, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Database, Biopsy, Investment, Software, Nephrectomy, NDA, RDF, Rated R, Mitomycins, URS, Journal, Patient, Risk, RTW, Webcast, Growth, LG, Research, Urology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Recurrence, Death, Food, Conference, The Journal of Urology, ATLAS, Pharmaceutical industry, Video game, Security (finance), Bank, TURBT

“We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.

Key Points: 
  • “We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.
  • UroGen hosted an event to discuss and highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials on July 27th, 2023.
  • Generated record quarterly net product revenue of $21.1 million for the second quarter of 2023, representing ~27% growth over the second quarter of 2022.
  • The rate applied to cash payments incurred in 2023 is 13% based on global net product sales of JELMYTO in 2022.

The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
tisdag, augusti 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Duration, Clinical trial, NDA, Cancer, Bladder cancer, Mitomycins, Journal, Patient, Risk, FDA, Recurrence, TURBT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Food, Safety, The Journal of Urology, Pharmaceutical industry, Urology

TURBT is the current standard of care for patients with this type of cancer.

Key Points: 
  • TURBT is the current standard of care for patients with this type of cancer.
  • UroGen recently announced positive topline data from ATLAS and the Phase 3 ENVISION trial.
  • UGN-102 was generally well tolerated, with a side effect profile similar to that of previous clinical trials.
  • Assuming positive findings, a New Drug Application (NDA) is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in the same year.