Company to present three posters at SITC Annual Meeting 2025BOSTON, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the company will have three poster presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2025, including the first clinical data on the novel CoREST inhibitor TNG260 in non-small cell lung canc ...

Regeneron Pharmaceuticals FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: September 24, 2025 Key Points Commercial Performance - **EYLEA HD Performance**: - 5% sequential growth in demand in Q1 and 16% in Q2 attributed to effective commercial execution and physician-patient education [4][5] - Demand is expected to increase further once headwinds are resolved, particularly regarding reimbursement and prefilled syringe preferences [5][6] - Upcoming PDUFA dates: late October for prefilled syringe and late November for RVO and Q4 dosing [8] Pipeline Developments - **DUPIXENT**: - Strong performance across all eight approved indications, with ongoing growth in established indications like asthma and new launches in COPD, CSU, and bullous pemphigoid [15][16] - 70% of top-tier pulmonologists have prescribed DUPIXENT for COPD, indicating positive reception [18] - Strategic focus on lifecycle opportunities and adjacent type 2 pathways to maintain growth post-DUPIXENT exclusivity expiration in 2031 [21][23] - **Oncology Pipeline**: - Recent approvals for bispecifics, with a focus on Linezyth for multiple myeloma [24] - Plans to launch studies in earlier lines of treatment, combining Linezyth with carfilzomib, expected by the end of 2025 [26][28] - **Complement and Factor XI Programs**: - Promising data in myasthenia gravis (MG) with a focus on quarterly dosing advantages [35] - Factor XI program aims to reduce bleeding risks associated with anticoagulants, with ongoing Phase 3 studies [39][40] R&D and Capital Allocation - **R&D Investment Strategy**: - Focus on internal R&D as a primary capital allocation priority, with a robust pipeline driving long-term shareholder value [50][52] - Share repurchase program and dividend implementation to enhance shareholder returns [51] - **External Innovation**: - Active exploration of licensing and collaboration opportunities, though M&A remains a secondary focus [50][55] Market Outlook and Strategic Vision - **Pipeline Potential**: - The breadth and depth of the pipeline are viewed as unprecedented, with confidence in the ability to drive future growth [57][58] - Ongoing preclinical opportunities in various therapeutic areas, including genetics and rare diseases, are expected to yield significant advancements [59] Regulatory and Competitive Landscape - **Biosimilars Impact**: - Gradual uptake of existing biosimilars noted, with potential for increased pricing pressure as more entrants are expected in 2026 [11][12] - **DTC Advertising Restrictions**: - Generalized communication from the administration regarding DTC advertising, with no specific implications for Regeneron noted [19] Conclusion - Regeneron Pharmaceuticals is positioned for continued growth through its strong product pipeline, strategic R&D investments, and proactive market engagement. The company remains focused on addressing competitive pressures while leveraging its innovative capabilities to enhance patient outcomes and shareholder value.

Core Insights - Nanobiotix SA announced new results from an ongoing Phase 1 study evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors for advanced cancer patients, specifically focusing on primary cutaneous melanoma [1][4] - The study involved 21 patients who had previously shown resistance to anti-PD-1 treatments, and the combination therapy demonstrated a favorable safety profile [1] - The stock price of Nanobiotix (NBTX) increased by 22.03%, reaching $12.45 [4] Patient Outcomes - A total of 16 patients experienced treatment-emergent adverse events (TEAEs) of grade 1, grade 2, or grade 3+ related to the overall therapeutic regimen [2] - Among 19 evaluable patients, the best observed objective response rate (ORR) was 47.4%, with four complete responses and five partial responses [5] - The disease control rate (DCR) across all lesions was 78.9%, and a DCR of 100% was observed in tumors that were injected and irradiated [5] - The median overall survival (mOS) for all treated patients was 14.6 months [5] Immune Response Insights - A relationship was noted between the depth of local response and systemic tumor regression, indicating potential priming or reactivation of the immune response [4]

Core Insights - NuCana plc has initiated the dosing of the first patients in the expansion study of NUC-7738 in combination with pembrolizumab for patients with PD-1 inhibitor-resistant melanoma, with initial data expected in Q4 2025 and final data in 2026 [1][2] - The company reported a net loss of £24.1 million for Q2 2025, which includes a significant loss on revaluation of warrants, compared to a net loss of £7.0 million in Q2 2024 [7][11] - NuCana's cash and cash equivalents increased to £8.4 million as of June 30, 2025, up from £4.0 million at the end of Q1 2025, with additional funds raised through an ATM offering expected to extend the cash runway into 2029 [4][6] Clinical Development - NUC-7738 is designed to impact gene expression in cancer cells and has shown a favorable safety profile, meaningful tumor volume reduction, and prolonged progression-free survival in patients with PD-1 inhibitor refractory metastatic melanoma [2] - NUC-3373, another lead program, is a targeted thymidylate synthase inhibitor with immune-modulating properties, currently in a Phase 1b/2 study, showing notable tumor volume reductions and prolonged progression-free survival in patients with advanced solid tumors [2][5] Financial Position - As of June 30, 2025, NuCana's total assets were £16.2 million, with total equity attributable to equity holders amounting to £7.4 million [12][13] - The company has raised gross proceeds of £38.4 million in 2025 through various financing initiatives, positioning it well for upcoming clinical milestones [2][6] Anticipated Milestones - Initial data from the Phase 1/2 expansion study of NUC-7738 is expected in 2025, with regulatory guidance from the FDA anticipated in 2026 [5] - Additional data from the ongoing Phase 1b/2 study of NUC-3373 is also expected to be announced later in 2025 [5]

Summary of IO Biotech Conference Call Company and Industry - **Company**: IO Biotech - **Industry**: Biotechnology, specifically focused on cancer treatment and immunotherapy Key Points and Arguments 1. **Phase Three Trial Results**: The conference call discussed the top line results of the phase three pivotal trial of CELMBIA, which showed clinical improvement in progression-free survival (PFS) when combined with pembrolizumab for advanced melanoma patients [3][6][22] 2. **Statistical Significance**: The trial achieved a median PFS of 19.4 months for the combination therapy versus 11.0 months for the control, with a hazard ratio of 0.77 and a p-value of 0.056, narrowly missing the threshold for statistical significance [7][22] 3. **Subgroup Analysis**: Improvement in PFS was observed across virtually all pre-specified subgroups, including those with poor prognostic factors like PD-L1 negative and BRAF mutant patients [24][30] 4. **Unmet Medical Need**: There is a significant unmet need in the first-line advanced melanoma setting, with 50% of patients progressing within one year of treatment [9][12] 5. **FDA Submission Plans**: IO Biotech plans to discuss the path forward with the FDA in the fall and aims to submit a Biologics License Application (BLA) by the end of the year [8][18][36] 6. **Safety Profile**: The combination therapy was well tolerated, with no new safety signals observed, and injection site reactions were the most common local side effects [27][28] 7. **Market Opportunity**: The company sees a strong market opportunity for CELMBIA, especially given the high unmet need and the favorable safety profile compared to existing therapies [33][60] Additional Important Content 1. **Mechanism of Action**: The T1 technology platform used in CELMBIA activates T cells to target both tumor cells and immune suppressive cells, enhancing the immune response against cancer [16][17] 2. **Future Trials**: IO Biotech is also testing CELMBIA in other indications and earlier stages of cancer, indicating a broader application of their technology [18][19] 3. **Cash Position**: The company ended the quarter with over $28 million in cash, which is expected to cover several important milestones, including the potential BLA submission [35][36] 4. **Regulatory Engagement**: IO Biotech has had multiple meetings with the FDA and has received breakthrough designation, indicating a positive regulatory outlook [72][78] 5. **Competitive Landscape**: The combination therapy is positioned favorably against existing treatments, with a focus on ease of administration and reduced toxicity [60][61] This summary encapsulates the critical insights from the conference call, highlighting the company's advancements, statistical findings, and strategic plans moving forward in the biotechnology sector.

Financial Performance Overview - The company reported consolidated revenues of $997 million for Q1 FY26, reflecting an 11% year-over-year growth and flat sequentially [8] - EBITDA margin stood at 26.7%, slightly above the target of 25% [7] - Gross profit margin decreased by 350 basis points year-over-year to 56.9%, attributed to price erosion in the generic segment [8] - Profit after tax attributable to equity holders was $166 million, a 2% increase year-over-year but an 11% decline sequentially [12] Business Line Performance - North American business generated $400 million, a 17% year-over-year decline due to price erosion and timing of product procurement [21] - European generic business reported $131 million, a 124% year-over-year increase, driven by new product launches [22] - Emerging markets reported revenue growth of 10% year-over-year, supported by higher volumes and new product introductions [22] - The PSAI business reported $95 million, with a year-over-year growth but a 14% sequential decline [24] Market Performance - The company's India business achieved a revenue of INR 14.71 billion, with a year-over-year growth of 11% and a sequential increase [23] - The Russia business showed a 17% year-over-year growth, indicating resilience despite macroeconomic challenges [22] - The US generic market experienced softness, primarily due to price erosion in selected products [21] Strategic Direction and Industry Competition - The company is focused on scaling its presence in consumer health, innovative therapies, and biosimilars [16] - Strategic collaborations, such as with Albo Tech for pembrolizumab, are aimed at enhancing the biosimilar pipeline [18] - The company is actively exploring partnerships and acquisitions to diversify its portfolio and strengthen its market position [26] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in achieving flat to single-digit growth in the US base business, contingent on successful product launches [32] - The company anticipates a recovery in the US market with the launch of five new products in the upcoming quarters [21] - Management highlighted a commitment to sustainability, achieving an 'A' rating in the climate category from the Carbon Disclosure Project [20] Other Important Information - The company has a net cash surplus of $341 million as of June 30, 2025 [14] - R&D spending for the quarter was $73 million, remaining flat year-over-year, with a focus on complex generics and biosimilars [10] - The company plans to maintain R&D investments at 7-7.5% of sales for the full fiscal year [10] Q&A Session Summary Question: Performance of the US business quarter-on-quarter - Management indicated that the US base business decreased, primarily due to timing issues, and expects flat to single-digit growth for FY26 [32] Question: Outlook for Revlimid - Management expects similar sales levels for Revlimid in the upcoming quarters, with a decline anticipated in Q3 [34] Question: Timeline for semaglutide launches - Management plans to launch semaglutide in Canada and other markets in calendar 2026, with a focus on capacity for the Canadian launch [35][41] Question: Gross margin trends and SG&A costs - Management expects gross margins to remain stable for the year, with SG&A costs projected to be in the 28-29% range [44][45] Question: Update on biosimilar abatacept trials - The readout for the phase two trials is expected on November 25, with plans to submit the BLA following positive results [58] Question: Cost-saving measures and R&D spending - Management indicated potential discretionary cost savings of 500-600 basis points, with flexibility in R&D spending based on business performance [60][98] Question: Capacity for semaglutide and market share - Management expressed confidence in selling the planned 12 million pens, citing strong demand and a strategy to be first to market [66] Question: Status of generic liraglutide filing - Management confirmed plans to launch generic liraglutide in the coming quarters, with some markets expected to be first to market [71]

Financial Data and Key Metrics Changes - The company finished Q1 with over $360 million in cash, having raised around $400 million last year, indicating a strong financial position to support ongoing clinical development [54][55] - The run rate for Q1 was approximately $50 million, which is expected to increase, but the company has sufficient capital to execute current plans [55][56] Business Line Data and Key Metrics Changes - The lead molecule, Ivo, has shown strong positive trends in overall survival in clinical trials, particularly in the HARMONY studies, with a hazard ratio of 0.777 indicating favorable outcomes [4][5][7] - The company has over 22 ongoing trials, with 11 being Phase III studies, and has enrolled over 3,000 patients, demonstrating a robust clinical development pipeline [9][10] Market Data and Key Metrics Changes - The total addressable market for Ivo is estimated to be 1% to 2% of the overall market, with significant opportunities in non-small cell lung cancer (NSCLC) [11][12] - The company is actively engaging in multi-regional studies to validate the efficacy of Ivo across different patient populations, particularly comparing data from China and Western countries [17][19] Company Strategy and Development Direction - The company aims to differentiate Ivo from existing PD-1 therapies by focusing on its unique efficacy and safety profile, particularly in the frontline NSCLC setting [12][13][14] - There is a strategic emphasis on expanding the clinical development plan and exploring combinatorial strategies with other drugs, leveraging Ivo's favorable safety profile [41][49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for Ivo to change standards of care in NSCLC, despite challenges in achieving statistical significance in overall survival [20][24][26] - The company is optimistic about the collaboration with Akeso and the potential for Ivo to address significant unmet needs in cancer treatment [33][35] Other Important Information - The company has initiated tech transfer for manufacturing capabilities, which will enhance its ability to produce Ivo in its territories, including the U.S., Europe, and Japan [56][57] - The management highlighted the importance of partnerships and collaborations to maximize the potential of Ivo and navigate the competitive landscape [46][48] Q&A Session Summary Question: What are the next steps for the HARMONY study? - The company plans to work strategically with the FDA regarding the filing of a Biologics License Application (BLA) and is focused on ensuring the right next steps for the clinical program [11][12] Question: What factors contributed to the trial not achieving statistical significance in overall survival? - Management indicated that the trial's design and patient enrollment dynamics, particularly the proportion of patients from different regions, played a role in the outcomes observed [20][21][22] Question: How does the company view competition in the market? - Management sees competition as validation of their product's potential and emphasizes the importance of establishing strong partnerships to succeed in the market [46][48]

Event to Discuss the Changing Landscape of HNSCC in context with the Merck KN-689 study and the Rapidly Increasing Incidences of HPV16-positive HNSCC in the United States and Europe Webinar to be held Tuesday, June 17, 2025, 12:00 PM ET PRINCETON, N.J., June 09, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that it will host a v ...

Core Insights - NuCana plc is advancing its clinical development programs for its lead anti-cancer medicines, NUC-7738 and NUC-3373, with a focus on key milestones towards commercialization [2][4][7] - The company has initiated an expansion study of NUC-7738 in combination with pembrolizumab for patients with PD-1 inhibitor-resistant melanoma, with initial data expected in Q4 2025 and final data in 2026 [1][2] - Financial results for Q1 2025 show a net loss of £2.5 million, a significant reduction from £6.8 million in Q1 2024, indicating improved financial performance [6][10] Clinical Development Updates - NUC-7738 has shown a favorable safety profile and meaningful tumor volume reduction in patients with PD-1 inhibitor refractory metastatic melanoma, leading to the initiation of an expansion trial [2][4] - NUC-3373 is being evaluated in a Phase 1b/2 study in combination with pembrolizumab for advanced solid tumors and with docetaxel for lung cancer, with notable tumor volume reductions reported [2][4] - The company plans to meet with the U.S. FDA to discuss the regulatory strategy for NUC-7738 based on the promising results from ongoing studies [2][4] Financial Position - As of March 31, 2025, NuCana had cash and cash equivalents of £4.0 million, down from £6.7 million at the end of 2024, but has since raised an additional £8.8 million to extend its cash runway into Q4 2026 [4][5][6] - The company reported a basic and diluted loss per ordinary share of £0.02 for Q1 2025, compared to £0.13 for the same period in 2024, reflecting improved financial health [6][10] - Total assets decreased from £14.774 million at the end of 2024 to £11.601 million as of March 31, 2025, primarily due to cash outflows [11][12]

Core Insights - TuHURA Biosciences is advancing its Phase 3 trial of IFx-Hu2.0 as an adjunctive therapy with Keytruda® for patients with advanced or metastatic Merkel cell carcinoma (MCC) [1][2][4] - The trial is designed under the FDA's Accelerated Approval Pathway and Special Protocol Assessment (SPA) agreement, aiming to address primary resistance to checkpoint inhibitors [1][3][4] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, particularly in the context of MCC [5][6] - The company’s lead product, IFx-Hu2.0, is an innate immune agonist intended to activate the immune response in patients who do not respond to existing checkpoint inhibitor therapies [3][6] Trial Design and Objectives - The Phase 3 trial will evaluate IFx-Hu2.0 (0.1 mg) administered weekly for three weeks alongside pembrolizumab (200 mg) every three weeks, compared to pembrolizumab plus placebo [4] - The trial aims to enroll 118 CPI-naïve patients across approximately 22 to 25 U.S. sites, with primary endpoints focusing on overall response rate (ORR) and secondary endpoints including progression-free survival (PFS) and safety [4] Clinical Background - Merkel cell carcinoma is characterized as a rare and aggressive tumor type, with poor survival rates for patients who do not respond to first-line checkpoint inhibitor therapy [3] - Previous Phase 1b trials indicated that IFx-Hu2.0 could achieve an overall response rate of 63% in patients who progressed on pembrolizumab or avelumab, with response durations ranging from 6 to 33 months [3]