Core Insights - DARE to PLAY™ Sildenafil Cream is a groundbreaking female arousal cream designed to enhance genital blood flow and arousal sensations, marking significant progress in women's sexual health [1][2][4] - The product is the first evidence-backed sildenafil cream formulation for women, manufactured under current Good Manufacturing Practice (cGMP) regulations [3][6] - Daré Bioscience aims to address the long-standing gap in women's sexual health solutions, providing a scientifically validated option for women experiencing arousal challenges [5][10] Product Overview - DARE to PLAY™ utilizes sildenafil, the same active ingredient in Viagra®, applied topically to improve genital blood flow without systemic effects [4][6] - The cream is available for prescription in select states, with plans for broader availability in the coming months [7][10] - The product is supported by multiple clinical trials and peer-reviewed research, ensuring its efficacy and safety [9][10] Market Opportunity - An estimated 20 million women in the U.S. face challenges related to genital arousal, highlighting a significant unmet need in the market [10] - The introduction of DARE to PLAY™ provides access to a clinically supported product for this underserved demographic [10] - Daré Bioscience is committed to closing the gap in women's health by advancing science-based solutions across various areas, including sexual health [12][13]

Core Insights - BriaCell Therapeutics Corp. presented positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium, highlighting the potential of its Bria-IMT regimen in treating metastatic breast cancer [1][6]. Group 1: Clinical Data and Findings - The Bria-IMT regimen shows promise in addressing unmet needs in metastatic breast cancer treatment, particularly for patients with CNS metastasis who have undergone a median of 6 prior treatments [2][6]. - The Phase 3 study involves a randomized trial comparing Bria-IMT plus immune checkpoint inhibitors, Bria-IMT monotherapy, and Treatment of Physician's Choice, with a pooled interim analysis of 116 patients [4][6]. - The regimen demonstrated a favorable safety profile with no treatment-related discontinuations due to adverse events, and the most common adverse events were low grade [7]. Group 2: Biomarkers and Predictive Indicators - Biomarkers such as the Neutrophil-to-Lymphocyte Ratio (NLR) have shown potential as predictors of clinical benefit, with favorable NLR values correlating with longer progression-free survival (PFS) [7][8]. - Positive Delayed Type Hypersensitivity (DTH) was identified as a key predictor of clinical benefit, with median overall survival significantly higher in DTH+ patients compared to DTH- patients [10][11]. - Th1-biased cytokines and chemokines may serve as potential predictive biomarkers for clinical responses to the Bria-IMT regimen, indicating enhanced immune activation [14][16]. Group 3: Future Directions - Further evaluation of cytokine and chemokine biomarkers is planned to establish more personalized therapeutic strategies for metastatic breast cancer patients with limited treatment options [3][8]. - Ongoing analysis of the Phase 3 study aims to mature the understanding of overall survival data and the role of biomarkers in predicting patient response [11][12].

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83% for patients treated with MDNA11 after progression on immune checkpoint inhibitors [1] - Combination therapy with KEYTRUDA shows an ORR of 50% and a DCR of 75% in MSS endometrial cancer, while MSS TMB-H tumors show an ORR of 25% and a DCR of 88% [1] Clinical Data - In monotherapy cohorts, ORR is 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients with disease control in monotherapy cohorts had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Safety Profile - MDNA11 shows a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, resolving typically within 48 hours [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg in monotherapy or in combination with KEYTRUDA [4] Recommended Dose - The preliminary recommended dose for expansion for both monotherapy and combination arms is established at 90 µg/kg Q2W, with a biological effective dose range set at 60 to 120 µg/kg [5] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3]

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83%, indicating the potential of MDNA11 in earlier lines of treatment [1] - Combination treatment with KEYTRUDA shows promising results, with an ORR of 50% and a DCR of 75% in MSS endometrial cancer [1][9] Clinical Data - In monotherapy expansion cohorts, ORRs are 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients treated with MDNA11 as the next treatment after immune checkpoint inhibitors had an ORR of 42% [8] - In MSS endometrial cancers, the ORR was 50% with a DCR of 75%, while TMB-H tumors showed an ORR of 25% and a DCR of 88% [9] Safety Profile - MDNA11 exhibits a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg, and Grade 3-4 events were mainly laboratory abnormalities without clinical sequelae [4] Overall Survival - In monotherapy cohorts, patients with disease control had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3] - The NEO-CYT trial provides external validation of MDNA11's approach, suggesting its potential as a de-risked drug candidate for earlier stage cancer patients [3]

WINNIPEG, Manitoba, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech”, “Kane” or the “Company”) today announces that Health Canada has approved its revyve® Antimicrobial Wound Gel Spray for use in Canada. Health Canada approved revyve Antimicrobial Wound Gel Spray revyve Antimicrobial Wound Gel Spray has been previously cleared under the FDA 510(k) process. This Health Canada approval represents another regulatory milestone for Kane and the Company’s commitment to advancing wo ...

Core Viewpoint - Karolinska Development AB's portfolio company, Modus Therapeutics, has initiated the second part of a phase 2a clinical study for sevuparin, targeting chronic kidney disease with anemia, following a successful first part that demonstrated safety and provided insights for dose selection [1][2][4]. Group 1: Clinical Study Details - The second part of the phase 2a study will focus on repeated dosing of sevuparin, assessing safety and clinically relevant efficacy outcomes, including hemoglobin and hepcidin levels, along with other kidney- and blood-related biomarkers [3]. - A total of 50 to 60 patients will be enrolled in this study [3]. Group 2: Company Background and Ownership - Karolinska Development holds a 54% direct and 1% indirect ownership stake in Modus Therapeutics [4]. - The company is a Nordic life sciences investment firm that seeks to identify and develop breakthrough medical innovations, aiming to create and grow companies that can deliver impactful medical products [5][6]. Group 3: Strategic Focus - Karolinska Development collaborates with leading universities and research institutes in the Nordic region to access world-class medical innovations, focusing on building companies around top scientists supported by experienced management teams [6]. - The company has a portfolio of eleven companies that target innovative treatments for serious diseases, led by a team of investment professionals with a strong track record [7].

MISSISSAUGA, Ontario, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the commercial launch of QAPs™ quality assessment products and availability of QUANTDx™ reference materials to support antigen or molecular tests for H3N2 strains of seasonal Influenza A (a.k.a., the “Flu”). H3N2, alongside H1N1, is a common type of Influenza A that circulates annually, with H3N2 more prone to “antigenic drift, ...

MediWound Reports New Clinical Data Demonstrating NexoBrid®’s Effectiveness in Preventing Traumatic Tattoos After Abrasion and Blast Injuries Prospective clinical data show NexoBrid® removes embedded particles in friction and blast wounds, reducing pigmented wound surface by >90% Traumatic tattoos form when dirt, metal, or explosive residue becomes permanently embedded in the skin; findings support further evaluation in acute trauma settings YAVNE, Israel, December 10, 2025 -- MediWound Ltd. (Nasdaq: MDWD ...

Core Insights - IDEAYA Biosciences has submitted an investigational new drug (IND) application for IDE574, a potential first-in-class KAT6/7 dual inhibitor, to the FDA, with plans to initiate a Phase 1 trial in Q1 2026 [1][7] Group 1: Product Development - IDE574 is designed to selectively inhibit KAT6 and KAT7, which are involved in tumor cell proliferation and survival, while sparing other KAT family members [2][3] - Preclinical studies indicate that dual inhibition of KAT6 and KAT7 by IDE574 disrupts tumor lineage identity and shows significant anti-tumor activity in lung and breast cancer models [2][3] - The company aims to present preclinical data on IDE574's pharmacologic profile and anti-tumor activity at a medical conference in the first half of 2026 [3][7] Group 2: Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, emphasizing the discovery and development of targeted therapies aligned with genetic disease drivers [4] - The company has developed a pipeline of product candidates targeting synthetic lethality and antibody-drug conjugates for solid tumor indications [4]

Core Viewpoint - Shares of French biotech company Abivax increased by 20% due to market speculation regarding a potential bid from U.S. pharmaceutical giant Eli Lilly [1] Company Summary - Abivax is a French biotech firm experiencing a significant rise in share price, attributed to rumors of interest from Eli Lilly [1] Industry Summary - The news highlights the potential for mergers and acquisitions within the biotech sector, particularly involving established pharmaceutical companies like Eli Lilly [1]