SOUTH SAN FRANCISCO, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today announced that company management will participate in fireside chats during two upcoming investor conferences in July: H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025, at 2:30 p.m. ETBTIG Virtual Biotech Conference on We ...

Corporate Strategy & Financial Position - BioNTech plans to strengthen its position through the acquisition of Biotheus, securing global control of BNT327 and expanding its immunotherapy capabilities[8] - The company reported a strong balance sheet with approximately €174 billion in total cash, cash equivalents, and security investments as of December 31, 2024[8] Oncology Pipeline & Clinical Development - BioNTech is advancing its oncology portfolio with 15 ongoing Phase 2 and Phase 3 trials[8] - BNT327 is being studied in 20+ clinical trials across multiple indications, with 3 global potentially registrational trials planned[36] - BNT327, in combination with chemotherapy, demonstrated a 738% objective response rate (ORR) in the ITT population in 1L TNBC[40] - Autogene cevumeran induced neoantigen-specific T cell responses in 71% of patients in a first-in-human study[65] mRNA Cancer Immunotherapy & Technology - BioNTech is prioritizing novel mRNA cancer immunotherapy, including FixVac and iNeST, targeting tumor-associated antigens and mutations[24] - The company has treated >450 patients and selected 18000 neoantigens using its iNeST platform[15] - BioNTech is leveraging AI to enhance its scientific capabilities and pioneer personalized immunotherapies[12] 2025 Priorities & Outlook - In 2025, BioNTech expects multiple randomized Phase 2 data readouts and will execute 7 ongoing Phase 2 trials and first novel combination trials[91] - The company aims to advance 3 global registration-enabling trials in potential fast-to-market indications in 2025[92]

Company Overview - Tango Therapeutics, Inc. (TNGX) shares increased by 7.5% to close at $5.16, with notable trading volume compared to typical sessions, and a total gain of 157.4% over the past four weeks [1][2] Pipeline Developments - The company recently dosed the first patient in the TNG456 phase I/II study targeting MTAP-deleted solid tumors, particularly glioblastoma, which has contributed to positive market sentiment regarding its pipeline of precision cancer medicines [2] Financial Expectations - Tango Therapeutics is projected to report a quarterly loss of $0.36 per share, reflecting a year-over-year decline of 50%, with expected revenues of $5.79 million, down 70.9% from the previous year [3] - The consensus EPS estimate for the quarter has been revised slightly higher in the last 30 days, indicating a potential for price appreciation if the trend continues [4] Industry Context - Tango Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where it holds a Zacks Rank of 3 (Hold) [5] - Another company in the same industry, Protagonist Therapeutics (PTGX), experienced a 1.1% decline in its stock price, with a monthly return of 17.5% [5][6]

Core Insights - Kura Oncology and Kyowa Kirin announced the acceptance of an abstract for the KOMET-001 trial of ziftomenib for R/R NPM1-m AML for oral presentation at the ASCO Annual Meeting in June 2025 [1][2] - Ziftomenib is the only investigational therapy with Breakthrough Therapy Designation from the FDA for treating R/R NPM1-m AML, which represents about 30% of AML cases [2][7] - The trial achieved its primary endpoint of complete remission and was well-tolerated with limited myelosuppression [2][3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational therapy [7] - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [8] Trial Details - The KOMET-001 trial is designed to assess the clinical activity, safety, and tolerability of ziftomenib in patients with R/R NPM1-m AML [2] - Positive topline results were previously announced, indicating a statistically significant primary endpoint achievement [2] - A trial-in-progress abstract for the KOMET-015 trial will also be presented at the ASCO Annual Meeting [3][4] Upcoming Events - Kura will host a virtual investor event on June 2, 2025, to discuss the trial results and provide insights from company management and investigators [5][6]

Fort Lee, NJ, May 16, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that Ron Bentsur, Chairman and Chief Executive Officer, will present at the 3rd Annual H.C. Wainwright Global BioConnect Investor Conference. Event3rd Annual H.C. Wainwright BioConnect Investor Conferen ...

MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025 Strong Balance Sheet with $294.4 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients wit ...

Core Insights - OnKure Therapeutics is making progress in its PIKture-01 trial, with additional data expected in the second half of 2025, including mature single-agent and initial combination data [1][2] - The company plans to expand its PI3Ka franchise with a pan-mutant selective development candidate announcement anticipated in Q2 2025 [1][3] - As of March 31, 2025, OnKure has approximately $96.7 million in cash and cash equivalents, which is expected to fund operations through multiple anticipated milestones into Q4 2026 [1][4] Business Highlights and Upcoming Milestones - The PIKture-01 trial Part A has completed dose escalation, with only one patient experiencing dose-limiting toxicities at the highest dose level [3] - Preliminary data from Part A showed that OKI-219 was well tolerated across all dose levels, with no significant adverse events reported [3] - In Part B of the PIKture-01 trial, OnKure is actively enrolling patients to evaluate OKI-219 in combination with fulvestrant for treating PI3Kα mutated HR+/HER2- metastatic breast cancer, with initial combination data expected in the second half of 2025 [6] Financial Results - Research and development expenses for Q1 2025 were $13.0 million, an increase from $8.6 million in Q1 2024, primarily due to higher personnel-related costs and clinical trial expenses [5] - General and administrative expenses for Q1 2025 were $4.0 million, up from $1.3 million in Q1 2024, driven by increased personnel-related costs and legal expenses [7] - The net loss for Q1 2025 was $15.9 million, compared to a net loss of $9.5 million in Q1 2024, with a net loss per share of $1.19 [8][16]

– NDA submitted in 1Q 2025 for ziftomenib for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – – Data from Phase 1b/2 registration-directed trial of ziftomenib selected for oral presentation at ASCO Annual Meeting – – $45.0 million milestone payment earned for NDA submission under collaboration agreement with Kyowa Kirin – – First patients dosed in Phase 1 trial of ziftomenib plus imatinib in GIST – – $703.2 million in pro forma cash, together with anticipated collabor ...

Phase 1a dose-escalation study data update: treatment with NXP900 resulted in exposure levels leading to robust pharmacodynamic responses across a range of tolerated doses; NXP900 has an acceptable safety profile, dose limiting toxicity dose level has not been identified in doses up to 250 mg/day Preclinical posters strengthen the NXP900 clinical development strategy as single agent in biomarker-targeted cancers and in combination with market leading therapies to overcome resistance in NSCLC Fort Lee, NJ ...

Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]