CG Oncology announces Phase 3 BOND-003 data presented at AUA meeting
CG Oncology (CGON) announced that cretostimogene grenadenorepvec monotherapy data was presented at the Practice-Changing, Paradigm-Shifting Clinical Trials in Urology Plenary Session at the 2025 American Urological Association, AUA, Annual Meeting, in Las Vegas, Nevada. The Phase 3 BOND-003 Cohort C study is in patients with high-risk non-muscle invasive bladder cancer, NMIBC, unresponsive to Bacillus Calmette Guerin, BCG, treatment with carcinoma in situ with or without Ta or T1 disease. The study reported 75.5% complete response at any time, with 34 confirmed CRs at 24 months and 9 patients pending their 24-month assessment as of the cutoff date of March 14, 2025. The 12- and 24-month CR rates are 50.7% and 42.3% by K-M estimation, respectively. Median duration of response, DOR, is 28 months and is ongoing. Notably, 97.3% of patients were free from progression to muscle invasive disease at 24 months.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
6 days ago
- Yahoo
enGene Announces the Resignation of its Chief Medical Officer
BOSTON & MONTREAL, June 04, 2025--(BUSINESS WIRE)--enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, announced today that Dr. Raj Pruthi resigned from his role as Chief Medical Officer on June 3, 2025. Dr. Pruthi's resignation as Chief Medical Officer will take effect on June 16, 2025. He will be supporting the organization to ensure an orderly transition of his responsibilities before he departs. The Company intends to reallocate Dr. Pruthi's responsibilities to the Company's other urology and clinical experts. The Company thanks Dr. Pruthi for his dedication and service and wishes him the best in his future endeavors. About enGene enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene's lead program is detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with Non-Muscle Invasive Bladder Cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 study, which includes a pivotal cohort studying detalimogene in Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS). Detalimogene was developed using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. To learn more, please visit and follow us on LinkedIn, X and BlueSky. Forward-Looking Statements Certain statements contained in this press release may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). enGene's forward-looking statements include, but are not limited to, statements regarding enGene's management teams' expectations, hopes, beliefs, intentions, goals, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate", "appear", "approximate", "believe", "continue", "could", "estimate", "expect", "foresee", "intends", "may", "might", "plan", "possible", "potential", "predict", "project", "seek", "should", "would", and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about the transition of the responsibilities of the chief medical officer. Many factors, risks, uncertainties and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company's ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company's clinical development plans and ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission ("SEC") on EDGAR, including those described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at or You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene's assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. View source version on Contacts For media contact:media@ For investor contact:investors@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
6 days ago
- Business Wire
enGene Announces the Resignation of its Chief Medical Officer
BOSTON & MONTREAL--(BUSINESS WIRE)--enGene Holdings Inc. (Nasdaq: ENGN or 'enGene' or the 'Company'), a clinical-stage, non-viral genetic medicines company, announced today that Dr. Raj Pruthi resigned from his role as Chief Medical Officer on June 3, 2025. Dr. Pruthi's resignation as Chief Medical Officer will take effect on June 16, 2025. He will be supporting the organization to ensure an orderly transition of his responsibilities before he departs. The Company intends to reallocate Dr. Pruthi's responsibilities to the Company's other urology and clinical experts. The Company thanks Dr. Pruthi for his dedication and service and wishes him the best in his future endeavors. About enGene enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene's lead program is detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with Non-Muscle Invasive Bladder Cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 study, which includes a pivotal cohort studying detalimogene in Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS). Detalimogene was developed using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. To learn more, please visit and follow us on LinkedIn, X and BlueSky. Forward-Looking Statements Certain statements contained in this press release may constitute 'forward-looking statements' within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and 'forward-looking information' within the meaning of Canadian securities laws (collectively, 'forward-looking statements'). enGene's forward-looking statements include, but are not limited to, statements regarding enGene's management teams' expectations, hopes, beliefs, intentions, goals, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate', 'appear', 'approximate', 'believe', 'continue', 'could', 'estimate', 'expect', 'foresee', 'intends', 'may', 'might', 'plan', 'possible', 'potential', 'predict', 'project', 'seek', 'should', 'would', and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about the transition of the responsibilities of the chief medical officer. Many factors, risks, uncertainties and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company's ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company's clinical development plans and ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission ('SEC') on EDGAR, including those described in the 'Risk Factors' section of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at or You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene's assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
Health Line
7 days ago
- Health Line
Does Medicare Cover BCG Treatment for Bladder Cancer?
BCG is an immunotherapy treatment. Medicare may cover BCG when medically necessary to treat certain types of bladder cancer or after a transurethral resection of bladder tumor (TURBT). Bacillus Calmette-Guerin (BCG) is the standard immunotherapy drug for bladder cancer. Immunotherapy uses your own immune system to attack cancer cells. With BCG, the doctor inserts a catheter into your bladder to deposit a drug made from a weakened strain of Mycobacterium bovis, a vaccine for tuberculosis. Original Medicare (parts A and B) covers approved treatments and services for bladder cancer that your healthcare team deems medically necessary, which can include BCG. Read on to learn about when Medicare might cover BCG, your eligibility for coverage, and your anticipated costs. Are you eligible for BCG treatment for bladder cancer with Medicare? Doctors tend to recommend BCG treatment for carcinoma in situ and non-muscle invasive bladder cancer, which includes noninvasive (stage 0) and minimally invasive (stage 1) bladder cancers. They also typically would suggest it after you've received a procedure known as transurethral resection of bladder tumor (TURBT) to reduce your chance of the cancer returning. Generally, Original Medicare should approve BCG if you need it under these circumstances. Part A will cover it while you're hospitalized, whereas Part B will cover it if you get the treatment as an outpatient. If you're enrolled in Medicare Advantage (Part C), you should receive the same coverage. Is Anktiva covered by Medicare? The U.S. Food and Drug Administration (FDA) has approved the drug Anktiva for use alongside BCG treatment. Like BCG, Anktiva is administered into the bladder. Medicare Part A and B may cover Anktiva if medically necessary, with covered BCG treatment. Note that Parts A and B should cover the drug itself and not just the catheter administration procedure. This is because you cannot administer the medication to yourself, in which case it would fall under the coverage of Medicare Part D. That said, currently there is a shortage of the BCG drug. For this reason, according to the Centers for Medicare & Medicaid Services (CMS), Medicare may approve your treatment at a dose less than the usual dose of 81 milligrams (mg) or 1 vial per session. How much does BCG treatment for bladder cancer cost? A 2021 study analyzed the administration of BCG therapy within the Veterans Affairs Health System between 2000 and 2015. After one year, the median cost was around $29,459, increasing to $55,267 by two years, and reaching $117,361 at five years. That said, your share of this cost after your Medicare coverage kicks in depends on the part of Medicare responsible for your coverage. Under Part B, after you've met the 2025 deductible of $257, Part B will pay for 80% of any covered treatment or service. You also have to pay a monthly premium, which starts at $185, depending on your income. Under Part A, in most cases, you don't have a premium, though you must meet a $1,676 deductible. Once you do, Part A will cover your treatment fully for the first 60 days of hospitalization. After that, you begin to incur a daily cost that increases over time until you become responsible for the full, remaining cost. If you're covered by Part C, your plan is managed by a private insurer, which means your premium, deductible, and coinsurance depend on your plan. According to the Centers for Medicaid & Medicare (CMS), the average monthly premium for Part C plans is around $17.00 in 2025. In addition, to remain enrolled in a Part C plan, you still have to pay the Part B premium. That said, some Part C may cover your Part B premium. Where can you get help with the cost of BCG treatment for bladder cancer? Several factors affect the cost of treating bladder cancer, including: how aggressive the cancer is the stage at which it was diagnosed the treatment prescribed by your doctor Managing your medical expenses starts with ensuring that your doctor accepts your Original Medicare or Part C plan. If you're enrolled in Original Medicare, you can also consider enrolling in a Medicare supplement plan (Medigap) to help with out-of-pocket costs, such as copayments and deductibles. You can choose from 10 different plans, depending on factors like your location and coverage needs. However, you cannot use Medigap with Medicare Advantage (Part C) plans. You may also wish to check if you qualify for a Medicare Savings Program (MSP) and Extra Help, and if you might dually qualify for Medicare and Medicaid. Outside of Medicare, you may wish to check non-profit financial assistance programs. What other treatments does Medicare cover for bladder cancer? Medicare Part A covers inpatient hospital stays, including cancer treatments and diagnostics you receive as an inpatient. Part A also offers: some coverage for care at home, such as skilled nursing and physical therapy limited coverage for care in a skilled nursing facility after 3 days in the hospital care in a hospice In the case of medically necessary outpatient treatments and services to treat bladder cancer, Medicare Part B covers: visits with your doctor (including oncologists and other specialists) diagnostic testing (lab tests, ultrasound, etc.) many chemotherapy drugs administered through an IV at your doctor's office or a clinic some chemotherapy drugs administered orally outpatient clinic radiation treatments durable medical equipment, such as feeder pumps and wheelchairs Any treatment drugs you can take yourself would fall under Part D coverage. That said, Medicare may not cover every medication. Always confirm coverage and expected costs before receiving treatment. If Medicare doesn't cover the treatment you need, discuss payment plans or other options with your doctor. Takeaway Medicare covers treatment and services for bladder cancer; however, you may still have significant out-of-pocket costs depending on factors like recommended treatment or the stage of your cancer. You can work with your doctor to develop a treatment plan that maximizes your Medicare coverage. If you have additional coverage, such as a Medicare Part D (prescription drug) plan or a Medigap (Medicare supplement) plan, many of your out-of-pocket costs will be covered.
