Core Insights - The SACHI Phase III study demonstrated that the combination of savolitinib and osimertinib significantly improves progression-free survival (PFS) in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification compared to chemotherapy [1][4][9] Study Overview - SACHI is a Phase III clinical trial focusing on the combination of savolitinib and osimertinib for treating patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on first-line EGFR inhibitor therapy [2] Efficacy Results - In the intention-to-treat population, the median PFS was 8.2 months for the savolitinib plus osimertinib group versus 4.5 months for the chemotherapy group, with a hazard ratio (HR) of 0.34 [4] - The independent review committee assessed median PFS at 7.2 months for the combination therapy compared to 4.2 months for chemotherapy, with an HR of 0.40 [4] - The objective response rate (ORR) was 58% for the combination group compared to 34% for chemotherapy, and the disease control rate (DCR) was 89% versus 67% [5] Safety Profile - The combination therapy exhibited a tolerable safety profile, with treatment-emergent adverse events of Grade 3 or above occurring in 57% of patients in both the savolitinib plus osimertinib and chemotherapy groups [7][8] Regulatory Status - The Independent Data Monitoring Committee concluded that the study met its primary endpoint of PFS, leading to the conclusion of patient enrollment [9] - A New Drug Application (NDA) for the combination therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [9] Company Background - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [13]

SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced that Martin Babler, President and Chief Executive Officer of Alumis, will present at the Jefferies Global Healthcare Conference on June 4, 2025 at 3:10 p.m. ET. A live webcast will be available on the Alumis website in the "Investors" section under the “Events” page. A replay of the c ...

Design Therapeutics is a clinical-stage biotechnology company developing a new class of therapies based on its platform of GeneTAC gene targeted chimera small molecules. The company's GeneTAC molecules are designed to either dial up or dial down the expression of a specific disease-causing gene to address the underlying cause of disease. In addition to its clinical-stage GeneTAC programs, DT-216P2, in development for patients with Friedreich ataxia, and DT-168, for Fuchs endothelial corneal dystrophy, the c ...

Poster Presentation Details Title: OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care endocrine therapy for patients with ER+, HER2- advanced breast cancer after endocrine and CDK4/6 inhibitor therapy Abstract Number: TPS1131 Poster Number: 104b Poster Session: Breast Cancer – Metastatic Date/Time: June 2, 2025 from 9:00am–12:00pm CT / 10:00am–1:00pm ET "Metastatic breast cancer treatment continues to be challenged by resistance mechanisms resulting i ...

Core Insights - HUTCHMED is set to present new data on its compounds at the ASCO Annual Meeting from May 30 to June 3, 2025, in Chicago, USA [1] Group 1: Savolitinib - The SACHI Phase III study results of savolitinib in combination with osimertinib for EGFR mutation-positive NSCLC will be presented, showing that it met the primary endpoint of progression-free survival (PFS) [2] - Additional data from the SAVANNAH Phase II study indicates that the combination of savolitinib and osimertinib showed better efficacy outcomes compared to savolitinib plus placebo, with promising CNS activity [3] Group 2: Ranosidenib - Results from the Phase I study of ranosidenib (HMPL-306) indicate it was well tolerated, with target inhibition and durable responses, particularly in lower-grade glioma patients, showing an objective response rate (ORR) of 7.1% and a disease control rate (DCR) of 100% [4] Group 3: Fruquintinib - The FRUSICA-1 Phase II study results for fruquintinib plus sintilimab in advanced endometrial cancer patients showed an ORR of 37.0% and a DCR of 88.9%, with durable responses regardless of prior chemotherapy [5] - A Phase IV study involving 2,798 colorectal cancer patients demonstrated a manageable safety profile for fruquintinib, with Grade 3 or above treatment-emergent adverse events occurring in 23.94% for monotherapy and 26.06% for combination therapy [6]

Company Overview - Alumis Inc. has completed its merger with ACELYRIN, Inc., establishing itself as a leading clinical-stage biopharma company with a differentiated portfolio of therapies and a strong balance sheet [1][3] - Each ACELYRIN stockholder will receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned, with ACELYRIN common stock ceasing to trade on NASDAQ [2] Financial Position - The merger significantly strengthens Alumis' balance sheet, allowing for the advancement of its late-stage portfolio and the development of transformative therapies for patients [3] - Alumis now has a cash runway that extends into 2027, supporting multiple planned key data readouts [3] Product Pipeline - Alumis is developing next-generation targeted therapies for immune-mediated diseases, including oral tyrosine kinase 2 inhibitors such as ESK-001 for systemic immune-mediated disorders and A-005 for neuroinflammatory diseases [5] - The pipeline also includes lonigutamab, an anti–insulin-like growth factor 1 receptor therapy for thyroid eye disease, along with several preclinical programs identified through a precision approach [5] Advisory Team - Morgan Stanley & Co. LLC served as the financial advisor to Alumis, while Cooley LLP acted as its legal counsel [4] - Guggenheim Securities, LLC served as the financial advisor to ACELYRIN, with Fenwick & West LLP and Paul Hastings LLP providing legal counsel [4]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [2] - The company's lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [2] - Celcuity is headquartered in Minneapolis and provides further information on its website [2] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [2] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [2] - Another Phase 3 clinical trial, VIKTORIA-2, is recruiting patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [2] Investor Engagement - Brian Sullivan, CEO and Co-founder of Celcuity, will present at investor conferences and be available for one-on-one meetings [1] - Live webcasts of the presentations will be accessible on the company's website, with replays available shortly after the events [1] - Upcoming events include a fireside chat at the TD Cowen: 6th Annual Oncology Innovation Summit on May 28, 2025, and at the Jefferies Global Healthcare Conference on June 5, 2025 [3]

REDWOOD CITY, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that it will report financial results for the first quarter of 2025 on Wednesday, May 7, 2025, after market close. At 4:30 p.m. ET that day (1:30 p.m. PT), members of Revolution Medicines’ senior management team will host a webcast to discuss the financial results for the quarter and pr ...

Core Insights - Abpro Holdings, Inc. and Celltrion have presented preclinical data for ABP-102/CT-P72, a bispecific T-cell engager targeting HER2-overexpressing tumors, at the AACR Annual Meeting 2025, indicating its potential to outperform existing HER2-targeted therapies in efficacy and safety [1][2][3] Company Overview - Abpro is a biotechnology company focused on next-generation antibody therapies for severe diseases, utilizing its proprietary DiversImmune® platform [9] - Celltrion is a leading biopharmaceutical company based in South Korea, specializing in innovative therapeutics and has a global presence in over 110 countries [11] Product Development - ABP-102/CT-P72 is designed to selectively target HER2-overexpressing tumor cells while minimizing toxicity in normal tissues, representing a significant advancement in bispecific antibody therapies [2][6] - The product is co-developed with Celltrion and aims to address toxicity barriers that have previously limited HER2-targeted T-cell engagers [3][7] Preclinical Findings - Preclinical data suggest that ABP-102/CT-P72 achieves potent cytotoxicity in HER2-overexpressing cancer models while significantly reducing activity against HER2-low cells, addressing limitations of prior therapies [8] - In vivo studies indicate that ABP-102/CT-P72 can achieve up to a two-fold increase in tumor suppression compared to a benchmark HER2 x CD3 bispecific antibody [8] - The engineered design of ABP-102/CT-P72 minimizes cytokine-related toxicities and has shown improved tolerability in dose escalation studies, suggesting a broader therapeutic window [5][8] Clinical Development Plans - Clinical trials for ABP-102/CT-P72 are planned to commence in the first half of 2026, with the aim of bringing this promising therapy to patients with HER2-driven cancers [5][6]

Company Overview - HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [12]. Recent Developments - HUTCHMED announced new and updated data from studies of its compounds, including savolitinib, fruquintinib, and surufatinib, which will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 [1]. - The company is actively involved in multiple clinical trials, including the SACHI and SAFFRON trials, assessing the combination of savolitinib with TAGRISSO® (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC) [10][11]. Product Information - Savolitinib is a selective MET tyrosine kinase inhibitor developed by HUTCHMED and AstraZeneca, approved in China for treating adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations [7][6]. - Fruquintinib is being studied in various treatment regimens for metastatic colorectal cancer (mCRC), with ongoing trials evaluating its efficacy in combination with other therapies [2][3]. Market Context - Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for approximately 80% of cases. A significant portion of NSCLC patients in Asia have epidermal growth factor receptor (EGFR) mutations, which are targetable by therapies like savolitinib [4][5]. - The prevalence of MET aberrations in NSCLC patients who progress after EGFR TKI treatment is notable, with studies indicating that 15-50% of these patients may present with such mutations [8][9]. Clinical Trial Highlights - The SACHI trial met its primary endpoint of progression-free survival (PFS) during its interim analysis, leading to the acceptance of a New Drug Application (NDA) in China [10]. - The SAFFRON trial is ongoing, assessing the combination of savolitinib and TAGRISSO® against platinum-based chemotherapy in a specific patient population [11]. Future Prospects - HUTCHMED is focused on expanding the clinical development of its compounds, with promising data from ongoing trials expected to support potential regulatory filings in the US and other global markets [9][11].