iCAD collaborates with Microsoft to offer radiology providers the option for automated patient reporting on mammography results through PowerScribe integration About iCAD, Inc. NASHUA, N.H., April 29, 2025 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) ("iCAD" or the "Company"), a global leader in clinically proven AI-powered cancer detection solutions, announced today a collaboration with Microsoft, to include a set of AI-powered mammography solutions in iCAD's ProFound Breast Health Suite on Microsoft's Pr ...

Core Points - Telix Pharmaceuticals has received marketing authorization in France for its prostate cancer PET imaging agent, Illuccix®, which is used for detecting PSMA-positive lesions in adults with prostate cancer [1][2][3] Group 1: Product Approval and Clinical Impact - Illuccix® is indicated for use in various clinical settings, including primary staging of high-risk prostate cancer patients and suspected recurrent cases [2][8] - The approval is based on robust clinical data, including findings from the VISION trial, which is the largest Ga-68-based PSMA data set [3] - The product aims to improve the accuracy of prostate cancer management compared to conventional imaging methods, thus establishing a new standard of care [2][4] Group 2: Market Access and Collaboration - The approval allows hospitals and clinics in France to prepare PSMA-PET scans on-site, enhancing accessibility and reducing delays in diagnosis [3][4] - Telix will collaborate with IRE ELiT S.A. for the marketing and promotion of Illuccix® to healthcare professionals in France [6][7] - The partnership aims to ensure reliable access to PSMA-PET imaging technologies, addressing the growing demand across Europe [5][7] Group 3: Prostate Cancer Statistics in France - Prostate cancer is the most common cancer among men in France, with over 57,000 new cases diagnosed annually, significantly outpacing lung and bowel cancers [10] - The disease is also a leading cause of cancer-related deaths in men, with over 9,200 fatalities reported in 2022 [10]

Transaction Values Vesicor at a Pre-money Equity Value of $70 millionBusiness Combination is Expected to be Completed in the Fourth Quarter of 2025 DANVILLE, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Black Hawk Acquisition Corp. (Nasdaq: BKHAU, BKHA, BKHAR), a special purpose acquisition company, (“Black Hawk”) announced the signing of a Business Combination Agreement (“BCA”) on April 26, 2025, with Vesicor Therapeutics, Inc. (“Vesicor”, “Vesicor Therapeutics” or “the Company”), a California-based early de ...

Summary of Protara Therapeutics (TARA) Update / Briefing April 28, 2025 Company Overview - **Company**: Protara Therapeutics - **Focus**: Development of TARA-two, an investigational treatment for non-muscle invasive bladder cancer (NMIBC) Key Industry Insights - **Clinical Trial**: Ongoing Phase II ADVANCE-two clinical trial of TARA-two in NMIBC patients - **Treatment Landscape**: TARA-two is positioned as a competitive option in the evolving NMIBC treatment landscape, particularly for BCG unresponsive patients Core Findings and Arguments 1. **Positive Interim Results**: TARA-two demonstrated a complete response (CR) rate of 100% at any time and 100% at six months in the BCG unresponsive cohort, with rates of 80% at nine months and 67% at twelve months [12][15] 2. **Durable Responses**: The treatment shows durable responses at twelve months in both BCG unresponsive and naive cohorts, with 76% CR at any time in the naive cohort [15] 3. **Safety Profile**: TARA-two exhibited a favorable safety profile, with most adverse events being grade one and transient, and no patients discontinued due to adverse events [16] 4. **Mechanism of Action**: TARA-two activates a broader immunologic profile compared to other therapies, potentially leading to durable antitumor responses [9][14] 5. **Regulatory Engagement**: The company is in discussions with the FDA regarding the design of registrational studies for both BCG unresponsive and naive patient populations [15][81] Additional Important Insights 1. **Patient Enrollment**: The company has seen an increase in trial enrollment due to site expansion efforts, with 17 patients currently enrolled [12][28] 2. **Future Milestones**: Protara anticipates additional data updates and milestones throughout the year, including a preplanned analysis of 25 BCG unresponsive patients by the end of 2025 [19][29] 3. **Combination Therapy Potential**: The company is exploring systemic priming and combination therapies to enhance treatment efficacy and patient quality of life [45][47] 4. **Market Positioning**: TARA-two is viewed as a potential best-in-class treatment for NMIBC, with characteristics that drive adoption among healthcare providers [32][33] Conclusion - Protara Therapeutics is making significant strides in the development of TARA-two for NMIBC, with promising interim results and a strong safety profile. The company is well-positioned to capitalize on upcoming milestones and regulatory discussions, potentially transforming the treatment landscape for patients with NMIBC.

Core Viewpoint - Tempest Therapeutics presented new data at the 2025 AACR Annual Meeting supporting the immune-mediated anti-cancer activity of amezalpat, reinforcing its potential as a novel cancer treatment [1][2]. Group 1: Amezalpat's Mechanism and Efficacy - Amezalpat reduces tumor-promoting immunosuppression by M2 macrophages and T regulatory cells, leading to immune activation [2]. - The drug is an inhibitor of PPAR-alpha, which regulates fatty acid oxidation, a pathway utilized by immunosuppressive cells associated with poor cancer prognosis [2]. - Clinical data indicate that amezalpat shows superiority in overall survival when combined with atezolizumab and bevacizumab in advanced HCC patients compared to standard care [3]. Group 2: Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing small molecule therapeutics with tumor-targeted and immune-mediated mechanisms [4]. - The company is headquartered in Brisbane, California, and is advancing a diverse portfolio of product candidates aimed at treating various tumors [4].

90% of patients achieved high grade disease-free status at any time point with NDV-01, demonstrating strong proof-of-concept for sustained-release “GEM/DOCE” formulation* NDV-01 showed promising clinical activity in BCG-naïve and BCG-unresponsive patients, with favorable overall tolerability Data to be reviewed at Investor Event on April 28, 2025 at 4:30 PM ET CORAL GABLES, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechn ...

Core Insights - CG Oncology, Inc. announced positive results from the Phase 3 BOND-003 study of cretostimogene grenadenorepvec for high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG treatment, presented at the 2025 American Urological Association Annual Meeting [1] Study Results - The study reported a 75.5% complete response (CR) rate at any time, with 34 confirmed CRs at 24 months and nine patients pending assessment as of March 14, 2025 [2] - The 12-month and 24-month CR rates were estimated at 50.7% and 42.3%, respectively, with a median duration of response (DOR) of 28 months [3] - 97.3% of patients were free from progression to muscle-invasive disease at 24 months [3] - In Cohort P, patients with BCG-unresponsive Ta/T1 disease without CIS showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months [3] Safety Profile - A well-tolerated safety profile was observed, with no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported among 110 highly pretreated patients [4] - Patients who experienced TRAEs had a median resolution time of one day, and 97.3% completed all expected treatments, indicating favorable adherence [4][5] Market Reaction - Following the announcement, CGON stock increased by 39.9%, reaching $31.30 [6]

Core Insights - Alpha Tau Medical Ltd. has successfully closed a registered direct offering, raising approximately $36.9 million through the sale of 14,110,121 ordinary shares at a price of $2.612 per share [1][2] - The investment comes at a crucial time for Alpha Tau, which is experiencing significant growth with four active U.S. trial approvals and expansion into multiple internal organ applications [1][4] - Alpha Tau plans to utilize the net proceeds for general corporate purposes, including research and development, manufacturing expansion, and potential commercialization of its product candidates [2] Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and commercialization of the Alpha DaRT technology for treating solid tumors [6] - The Alpha DaRT technology involves intratumoral delivery of radium-224 to enable targeted alpha-irradiation of tumors, aiming to destroy cancer cells while sparing healthy tissue [7] Strategic Partnership - An affiliate of Oramed Pharmaceuticals has entered into an agreement to provide Alpha Tau with strategic services, including investor and public relations, over the next three years [3] - Both companies express strong confidence in the partnership, with expectations for significant advancements in clinical and commercial efforts [4]

Core Insights - Mainz Biomed N.V. is focused on molecular genetics diagnostics for early cancer detection and is progressing towards FDA premarket approval for its products [1][4] Company Developments - The company reported significant progress in Q1 2025, driven by strong clinical results from three studies published in 2024 [1] - The eAArly DETECT 2 study has commenced, evaluating a next-generation colorectal cancer test with results expected by the end of 2025 [4] - Mainz Biomed has signed a license agreement with Liquid Biosciences to access novel mRNA biomarkers for early pancreatic cancer detection, achieving 95% sensitivity and 98% specificity in independent validation [4] - A strategic partnership with labor team w ag has been established to introduce the ColoAlert CRC screening test to the Swiss market, addressing the urgent need for early detection in Switzerland [4] - The enhanced ColoAlert CRC screening test has been launched in Germany, coinciding with Colorectal Cancer Awareness Month in March 2025 [4] Regulatory Compliance - Mainz Biomed has regained compliance with Nasdaq's minimum stockholders' equity requirement and the minimum bid price requirement, ensuring full compliance with all Nasdaq continued listing requirements [4]

Core Insights - Ascentage Pharma presented results from five preclinical studies at the 2025 AACR Annual Meeting, showcasing its innovative drug pipeline targeting hematological malignancies [1][3][19] Group 1: Drug Candidates and Their Mechanisms - The five drug candidates presented include olverembatinib (HQP1351), lisaftoclax (APG-2575), APG-2449, APG-5918, and AS03157, each targeting different pathways in cancer treatment [2][19] - Olverembatinib combined with lisaftoclax showed strong synergistic effects in overcoming venetoclax resistance in acute myeloid leukemia (AML) models, indicating potential for new therapeutic strategies [4][7] - APG-5918, an EED inhibitor, demonstrated potent antitumor activity and synergized with enzalutamide in preclinical prostate cancer models, suggesting a promising combination therapy [10][16] - APG-2449, a FAK inhibitor, enhanced the antitumor activity of chemotherapy in small-cell lung cancer (SCLC) models, supporting its further clinical development [13][17] - AS03157, an IAP antagonist, showed high affinity for cIAP1 and XIAP, with potent antiproliferative activities in cancer cell lines, indicating its potential as a therapeutic candidate [25] Group 2: Clinical Development and Regulatory Status - Olverembatinib is already approved in China and included in the National Reimbursement Drug List, while a New Drug Application for lisaftoclax has been accepted for Priority Review by the China CDE [21][22] - Ascentage Pharma has received 16 Orphan Drug Designations from the US FDA and 1 from the EMA for its investigational drug candidates, highlighting its commitment to addressing unmet medical needs [22][19] Group 3: Company Overview and Strategic Goals - Ascentage Pharma is focused on discovering and developing therapies for hematological malignancies, with a robust pipeline of innovative drug candidates [19][20] - The company aims to strengthen its R&D capabilities and accelerate clinical development programs to meet global clinical needs [23]