Core Insights - The first results from Cohort 4 of the Phase 2b SunRISe-1 study indicate that TAR-200 shows strong disease-free survival rates and bladder preservation potential in patients with high-grade papillary bladder cancer [1][2][3] - Over 95% of patients demonstrated a progression-free survival rate at 9 months, highlighting the effectiveness of TAR-200 in a high-risk patient population [1][2] Company Overview - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, is focused on innovative treatments for bladder cancer, particularly targeting patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [1][5] - The company aims to provide alternatives to radical cystectomy, which has been the standard treatment for HR-NMIBC patients for over 40 years [1][4] Product Details - TAR-200 is an investigational intravesical gemcitabine releasing system designed for sustained local release of gemcitabine into the bladder, offering a new approach to treating early-stage bladder cancer [3][4] - The product is administered in an outpatient setting without the need for anesthesia, allowing for a more convenient treatment option for patients [2][3] Clinical Study Insights - The interim analysis from Cohort 4 of the SunRISe-1 study reported disease-free survival rates of 85.3% at six months and 81.1% at nine months for patients treated with TAR-200 monotherapy [1][2] - A significant 94.2% of patients avoided radical cystectomy at a median follow-up of 12.8 months, indicating the potential of TAR-200 to provide durable disease control [1][2] Safety Profile - The safety profile of TAR-200 was consistent with previous studies, with most treatment-related adverse events being low grade and resolving quickly [2][3] - Common treatment-related adverse events included dysuria (40.4%), pollakiuria (30.8%), and urinary urgency (26.9%), with no treatment-related deaths reported [2][3]

Core Insights - Johnson & Johnson announced promising results from the Phase 2b SunRISe-1 study of TAR-200, showing over 82% of patients achieved complete response (CR) and more than half remained cancer-free for at least one year [1][4] - TAR-200 is positioned as a transformative treatment for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (HR-NMIBC), particularly those ineligible for radical cystectomy [1][8] Company Overview - Johnson & Johnson is focused on healthcare innovation, aiming to provide less invasive and more effective treatment options for complex diseases [9] - The company has initiated a new drug application with the FDA for TAR-200 under the Real-Time Oncology Review program, following its Breakthrough Therapy Designation [6][4] Study Details - The SunRISe-1 study enrolled 85 patients, with a complete response rate of 82.4% and a median duration of response of 25.8 months [1][7] - The study specifically targets patients with carcinoma in situ, with or without papillary disease, who have not responded to BCG therapy [7] Treatment Efficacy - The treatment demonstrated a high level of sustained disease control, with 52.9% of responders maintaining CR at one year and 86.6% remaining cystectomy-free [1][2] - Most treatment-related adverse events were mild, with only 3.5% of patients discontinuing treatment due to adverse effects [2] Market Context - Bladder cancer is among the ten most common cancers globally, with limited treatment options available for patients who do not respond to initial BCG therapy [1][8] - High-risk non-muscle invasive bladder cancer accounts for 15-44% of NMIBC cases, characterized by high-grade tumors and a tendency to recur [8]

Core Insights - The Phase 2b SunRISe-1 study results indicate that over 82% of patients with high-risk non-muscle invasive bladder cancer achieved a complete response (CR), with more than half remaining cancer-free for at least one year after treatment [1][2][3] - TAR-200, an intravesical gemcitabine releasing system, shows promise in transforming treatment outcomes for patients who are BCG-unresponsive and ineligible for radical cystectomy [1][2][3] Study Results - As of March 2025, 82.4% of the 85 enrolled patients achieved CR, with a 95% confidence interval of 72.6-89.8 [1] - 52.9% of responders maintained CR at one year, and the median duration of response was 25.8 months [1] - At 12 months, 86.6% of responders remained cystectomy-free [1] Treatment Tolerability - The treatment was well-tolerated, with 83.5% of patients experiencing mild treatment-related adverse events, primarily low-grade urinary symptoms [1] - Only 3.5% of patients discontinued treatment due to adverse events, and there were no treatment-related deaths [1] Clinical Significance - The results were presented at the 2025 American Urological Association Annual Meeting, highlighting the potential of TAR-200 to address significant unmet needs in bladder cancer treatment [1][2] - The study emphasizes the importance of patient quality of life, as TAR-200 is designed to fit into patients' lives without interrupting their daily activities [1][2] Background on Bladder Cancer - Bladder cancer is among the ten most common cancers globally, with limited treatment options available for patients who do not respond to initial BCG therapy [1][4] - High-risk non-muscle invasive bladder cancer (HR-NMIBC) accounts for 15-44% of NMIBC cases and is characterized by a high likelihood of recurrence and progression [4] About TAR-200 - TAR-200 is an investigational system designed for sustained local release of gemcitabine into the bladder, currently being evaluated in multiple clinical trials [2][3] - The ongoing Phase 2b SunRISe-1 study specifically targets patients with BCG-unresponsive HR-NMIBC [3]

Shares of NovoCure (NVCR 0.43%) are edging higher on Thursday. The company's stock gained 0.11% as of 3:30 p.m. ET after fluctuating between gains and losses throughout the session. This muted reaction comes as the S&P 500 gained 0.3% and the Nasdaq Composite rose 0.6%.Why? The medical technology company reported solid first-quarter results. The company also provided several key updates that investors reacted positively to.NovoCure shared important updatesA key highlight from NovoCure's earnings call was th ...

TARPON SPRINGS, Fla., April 25, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP®) patient selection technology today announced the presentation of a poster containing data on a new DRP for the monoclonal antibody drug daratumumab. The post ...

Company Overview - HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [12]. Recent Developments - HUTCHMED announced new and updated data from studies of its compounds, including savolitinib, fruquintinib, and surufatinib, which will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 [1]. - The company is actively involved in multiple clinical trials, including the SACHI and SAFFRON trials, assessing the combination of savolitinib with TAGRISSO® (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC) [10][11]. Product Information - Savolitinib is a selective MET tyrosine kinase inhibitor developed by HUTCHMED and AstraZeneca, approved in China for treating adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations [7][6]. - Fruquintinib is being studied in various treatment regimens for metastatic colorectal cancer (mCRC), with ongoing trials evaluating its efficacy in combination with other therapies [2][3]. Market Context - Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for approximately 80% of cases. A significant portion of NSCLC patients in Asia have epidermal growth factor receptor (EGFR) mutations, which are targetable by therapies like savolitinib [4][5]. - The prevalence of MET aberrations in NSCLC patients who progress after EGFR TKI treatment is notable, with studies indicating that 15-50% of these patients may present with such mutations [8][9]. Clinical Trial Highlights - The SACHI trial met its primary endpoint of progression-free survival (PFS) during its interim analysis, leading to the acceptance of a New Drug Application (NDA) in China [10]. - The SAFFRON trial is ongoing, assessing the combination of savolitinib and TAGRISSO® against platinum-based chemotherapy in a specific patient population [11]. Future Prospects - HUTCHMED is focused on expanding the clinical development of its compounds, with promising data from ongoing trials expected to support potential regulatory filings in the US and other global markets [9][11].

HOUSTON, April 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that an abstract regarding the Company's next-generation anthracycline, Annamycin, has been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025, at the McCormick Place Co ...

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the EuroGen Pharma fourth quarter and full year 2024 earnings call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, head of investor relations. Please go ahead. Thank you, operator. Good morning, everyone. and welcome to Eurogen Pharma's fourth quarter and full year 2024 financial results and business update conference call. Earlier t ...

BriaPro is developing novel antibodies to B7-H3, a key cancer antigen and immune checkpointHighly expressed on the cell surfaces of both tumor and immune cells, B7-H3 is a promising anti-cancer target for drugs both effecting cancer cells and blocking immune checkpoint activityBriaPro expects to advance anti-B7-H3 antibodies into development of proprietary antibody-drug conjugates, T cell engagers, and targeted immune checkpoint inhibitors with potential applications in multiple cancer indicationsBriaPro ha ...

As biotech investors know, companies in the industry can sometimes earn significant returns in relatively short periods, like a year, thanks to excellent clinical or regulatory progress. And based on Wall Street's projections, several notable biotechs could see their shares soar in the next 12 months.Of course, it wouldn't be wise to rush to invest in these companies for that reason alone, but it might be worth looking deeper into what the Street considers severely undervalued drugmakers. Read on to learn m ...