Core Viewpoint - Tempest Therapeutics, Inc. reported progress in its clinical oncology portfolio, including the clearance to initiate a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China, and is actively exploring strategic alternatives to maximize value for stockholders and patients [2][5]. Recent Highlights - Clearance received to proceed with pivotal trial of amezalpat combination therapy for first-line HCC in China [5]. - Orphan drug designation granted by the European Medicines Agency (EMA) for amezalpat for HCC treatment [5]. - New mechanism-of-action data for amezalpat presented at the 2025 AACR Annual Meeting [5]. - Orphan Drug designation granted by the FDA for TPST-1495 for familial adenomatous polyposis (FAP) [5]. Financial Results Second Quarter 2025 - Cash and cash equivalents decreased to $14.3 million from $30.3 million as of December 31, 2024, primarily due to cash used in operating activities [6]. - Net loss for the quarter was $7.9 million, with a net loss per share of $2.07, compared to a net loss of $9.6 million and $5.52 per share for the same period in 2024 [6][15]. - Research and development expenses were $3.9 million, down from $5.8 million in the same quarter of 2024 [6]. - General and administrative expenses increased to $4.1 million from $3.7 million in the same period of 2024, mainly due to one-time separation costs [7]. Year-to-Date - For the six months ended June 30, 2025, net loss was $18.7 million, with a net loss per share of $5.17, compared to $17.5 million and $10.15 per share for the same period in 2024 [11]. - Research and development expenses for the six months were $11.5 million, up from $10.2 million in 2024 [11]. - General and administrative expenses remained stable at $7.4 million compared to the same period in 2024 [11]. Balance Sheet Overview - Total assets decreased to $24.5 million as of June 30, 2025, from $41.5 million at the end of 2024 [13]. - Current liabilities decreased to $7.1 million from $14.2 million as of December 31, 2024 [13]. - Stockholders' equity decreased to $9.8 million from $19.1 million at the end of 2024, with an accumulated deficit of $225.8 million [13].

Core Insights - AIM ImmunoTech Inc. will present significant clinical advancements of its drug Ampligen at the 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland, focusing on pancreatic cancer and other solid tumors [1][2] - The presentations will include data from the ongoing Phase 2 clinical trial for pancreatic cancer and the positive therapeutic effects of Ampligen on endometriosis, which is linked to ovarian cancer [1][3] Oncology - AIM will showcase data from its pancreatic cancer Early Access Program and the Phase 2 clinical trial at Erasmus Medical Center, highlighting the DURIPANC study that evaluates the combination of Ampligen and AstraZeneca's durvalumab for late-stage metastatic pancreatic cancer [3][4] - Preliminary results from the DURIPANC study indicate that Ampligen is well-tolerated, with promising early signs of improved progression-free survival (PFS) and overall survival (OS) compared to historical data [4][6] - Dr. Kalinski will discuss Ampligen's efficacy in treating various solid tumors, including late-stage recurrent ovarian cancer and triple-negative breast cancer, emphasizing the unmet healthcare needs these therapies address [5] Endometriosis - The upcoming presentation on endometriosis will analyze data from AIM's clinical trials for Chronic Fatigue Syndrome, revealing that approximately 80% of female participants experienced symptom improvement, highlighting Ampligen's potential in treating endometriosis [7][9] - Endometriosis affects around 190 million women globally and is associated with chronic pain and infertility, underscoring the need for new treatment options beyond radical surgeries [8] Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for various cancers, immune disorders, and viral diseases, with Ampligen being a first-in-class investigational drug that acts as a TLR3 agonist [10]

Core Insights - Moleculin Biotech, Inc. announced promising preclinical data for its lead drug candidate, Annamycin, showing significant efficacy against various liver cancers, including hepatocellular carcinoma, colorectal liver metastases, and pancreatic ductal adenocarcinoma liver metastases [1][4][5] - Annamycin is currently in late-stage clinical development for the treatment of acute myeloid leukemia (AML) in combination with cytarabine, with preliminary data expected in the second half of 2025 [1][7] Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viruses, with Annamycin being a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity [6][8] - The company is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, along with a portfolio of antimetabolites for potential treatment of pathogenic viruses and certain cancer indications [8] Preclinical Findings - Annamycin demonstrated targeted accumulation in organs, particularly the liver, spleen, lungs, and pancreas, leading to higher concentrations compared to doxorubicin, which is critical for treating liver-localized tumors [5] - In orthotopic hepatocellular carcinoma models, Annamycin showed excellent anti-tumor activity, significantly reducing tumor progression and improving survival rates [5] - The drug also exhibited significant efficacy in inhibiting metastatic growth in colorectal liver metastasis models and showed promising results in managing advanced pancreatic cancer with liver involvement [5] Safety Profile - Annamycin has a favorable safety profile, showing low or no cardiotoxicity, which is a significant advantage over traditional anthracyclines like doxorubicin, often limited by dose-dependent cardiac side effects [5]

Hospital Establishment & Growth - The Kachar Cancer Hospital Society was formed in 1992 by local citizens driven by the pain of cancer, lacking a concrete plan initially [2][3] - The hospital was established in 1996 after community fundraising efforts, including door-to-door campaigns and selling lottery tickets [4][5] - The hospital started modestly with few rooms, beds, and volunteer doctors, but with a strong desire to provide care [5] - The hospital evolved into a center for treatment, learning, and humanity, driven by a shared mission and the support of the community, donors, and patients [13][14] Core Values & Philosophy - The hospital's policy was to ensure that no one should be turned away for lack of resources [6] - The hospital aimed to provide the best quality of care with compassion, ensuring access for everyone, not just the wealthy [11] - The hospital emphasizes learning from patients' stories and adapting protocols accordingly [12] - The hospital believes that ordinary people can achieve extraordinary things by harnessing their inner power to bring about change [14][15] Community & Support - The community's support was crucial, with people coming together to contribute their skills and resources [4][10] - The hospital received continuous trust from the community, both locally and elsewhere, as well as from donors [13][14]

About ZUSDURI 24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the 24-month DOR of 72.2% (95% CI 64.1%, 78.8%) by Kaplan-Meier estimate in patients who achieved CR at three m ...

Financial Performance - Revuforj net revenue in 2Q25 reached $28.6 million, representing a 43% quarter-over-quarter growth[6] - Niktimvo net revenue reported by Incyte in 2Q25 was $36.2 million, a substantial increase from $13.6 million in the first two months of Q1 launch[9] - Syndax reported $9.4 million in collaboration revenue from Niktimvo in 2Q25, achieving profitability in the first full quarter[9] - Syndax holds a strong financial position with $518 million in cash and equivalents as of June 30, 2025[28] Product Pipeline and Market Opportunity - Syndax estimates a $5B+ Total Addressable Market (TAM) for Revuforj and another $5B+ TAM for Niktimvo, indicating a $10B+ market opportunity across R/R and frontline indications[4, 30] - The initial Niktimvo indication represents a $2B U S market opportunity, with potential for label and geographic expansion leading to a $5B+ TAM[19, 20] - Approximately 33% of KMT2A patients are estimated to have proceeded to hematopoietic stem cell transplantation (HSCT) following Revuforj treatment[6, 12] Clinical Data and Development - Phase 2 Relapsed/Refractory (R/R) mNPM1 AML data for Revumenib showed a 26% (20/77) CR+CRh rate and a 48% (37/77) Overall Response Rate (ORR)[26] - Phase 1 R/R NUP98r AML data for Revumenib showed a 60% (3/5) ORR[26] - Over 80% of bone marrow transplant centers have ordered Niktimvo[18]

Core Viewpoint - Exelixis, Inc. reported mixed results for Q2 2025, with adjusted earnings beating estimates but revenues missing expectations, leading to a decline in stock price in pre-market trading [2][3][25] Financial Performance - Adjusted earnings were 75 cents per share, exceeding the Zacks Consensus Estimate of 65 cents, but down from 84 cents in the same quarter last year [2][8] - Net revenues totaled $568.3 million, missing the Zacks Consensus Estimate of $579 million and reflecting a 10.8% year-over-year decline [3][8] - Net product revenues were $520 million, marking an 18.8% increase year-over-year, primarily driven by increased sales volume [5][8] Product Performance - Cabometyx generated revenues of $517.9 million, falling short of the Zacks Consensus Estimate of $527 million but surpassing the model estimate of $511.3 million [6][8] - The demand for Cabometyx's new indication for neuroendocrine tumors accounted for just over 4% of total demand in Q2, with expectations for growth [9][25] Collaboration and Revenue Sources - Collaboration revenues plummeted 70% to $48.2 million from $199.6 million in the prior year, largely due to a significant milestone payment recognized in the previous quarter [10][25] Expenses - Research and development expenses were $200.3 million, down 5.1% year-over-year, while selling, general, and administrative expenses rose 2.1% to $134.9 million [11][25] Stock Repurchase Program - Exelixis has repurchased $796.3 million of its common stock at an average price of $36.69 per share, with $204 million remaining under the current repurchase plan [12][13] Guidance - The company maintains its 2025 revenue guidance of $2.25 billion to $2.35 billion, with net product revenues expected between $2.05 billion and $2.15 billion [14][15] Pipeline Developments - Exelixis is advancing its pipeline with zanzalintinib, which has shown promising results in the STELLAR-303 study for metastatic colorectal cancer [16][18] - The company has three ongoing phase I studies and plans to initiate a phase I study for XB371 soon [23] Legal Settlement - In July 2025, Exelixis settled patent litigation with Biocon Pharma, allowing Biocon to market a generic version of Cabometyx in the U.S. starting January 1, 2031, if approved [24]

Core Insights - GLP-1 agonist drugs like Zepbound and Mounjaro are gaining popularity for weight loss and diabetes treatment, with potential applications in other health areas, including cancer [1][6] - A study indicates that GLP-1 agonists may reduce breast cancer tumor size, suggesting a new growth opportunity for Eli Lilly if these drugs gain oncology approval [2][4] - Eli Lilly's sales surged by 45% year-over-year to $12.7 billion in Q1 2025, with Zepbound and Mounjaro contributing $6.2 billion [8] Company Performance - Eli Lilly's stock trades at a premium of 65 times its trailing earnings, reflecting strong growth expectations [9] - The company's PEG ratio of 1.2 suggests it may not be overvalued relative to its medium-term growth potential [9] - Despite a modest 4% increase in stock price this year, Eli Lilly is considered a strong long-term investment opportunity in the healthcare sector [10][11] Future Potential - Ongoing research may expand the indications for GLP-1 drugs, potentially enhancing their market presence and sales [7] - If tirzepatide proves effective in treating cancer, it could significantly boost Eli Lilly's revenue [2][7]

Core Insights - Sona Nanotech Inc has received ethics committee approval for a pilot cancer study, marking a significant step in its clinical development pathway focused on late-stage melanoma patients [1][4][8] - The current early feasibility study involves 10 patients with late-stage melanoma who have not responded to other treatments, with results expected within the current quarter [2][6] - The upcoming pilot study will expand to 30 to 40 patients, aiming to assess safety and efficacy after operational adjustments from the initial study [7][8] Company Developments - The company is currently conducting its first human trial, which is essential for understanding the medical device's functionality in a clinical setting [5][6] - The timeline for transitioning to the pilot study is contingent on obtaining regulatory approval, with hopes to initiate by late this year or early next year [8][9] - The company is focused on efficiently moving from one study to the next, demonstrating a proactive approach in its clinical development strategy [9]

Cancer has already become a much less deadly disease than it was 30 years ago. Three decades from now, scientists will almost certainly have even more control https://t.co/gtQqVr8pvuIllustration: Eiko Ojala https://t.co/JruoBSOSid ...