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]

Summary of Bicara Therapeutics (BCAX) Update / Briefing June 01, 2025 Company and Industry Overview - **Company**: Bicara Therapeutics - **Industry**: Oncology, specifically focusing on head and neck cancer treatment Key Points and Arguments 1. **Treatment Efficacy**: Updated data shows deep and durable responses with Fiserafusp alfa (Fysera) plus pembrolizumab in patients with HPV negative head and neck cancer, addressing a significant unmet medical need in this patient population [1][3][79] 2. **Current Standard of Care**: The current standard of care, pembrolizumab, has a low response rate of only 19% in HPV negative head and neck cancer patients, highlighting the need for more effective therapies [3][11] 3. **Mechanism of Action**: Fysera is designed to inhibit TGF beta directly at the tumor site, which helps to remodel the tumor microenvironment (TME) and allows immune cells to penetrate the tumor, leading to improved treatment outcomes [4][5][85] 4. **Clinical Data**: In a phase 1b study, the combination of Fysera and pembrolizumab demonstrated a 54% confirmed response rate and an 89% disease control rate among HPV negative patients, with 80% of responders achieving at least 80% tumor shrinkage [19][21] 5. **Survival Metrics**: The median overall survival for HPV negative patients treated with Fysera plus pembrolizumab is reported at 21.3 months, significantly better than the typical 9-12 months seen with standard treatments [21][94] 6. **Durability of Response**: The median duration of response (DOR) is 21.7 months, indicating that the treatment not only provides a response but also maintains it over time [20][23] 7. **Patient Demographics**: The study population included patients with a high burden of disease, with 47% presenting with bulky tumors and a significant proportion having low CPS scores, which are typically associated with poorer outcomes [16][17][90] 8. **Safety Profile**: The combination therapy has a manageable safety profile, with adverse events primarily related to EGFR and TGF beta, which are generally mild and resolve quickly [18][19] 9. **Future Trials**: Bicara is advancing to a pivotal phase 2/3 trial (FORTIFY HN01) focusing on HPV negative patients, designed to demonstrate improved overall survival compared to pembrolizumab alone [28][30] 10. **Commercial Opportunity**: The company views the potential approval of Fysera as a significant commercial opportunity in a market with high unmet needs for effective treatments in HPV negative head and neck cancer [33][34] Additional Important Insights - **Unmet Medical Need**: There is a critical need for therapies that not only extend survival but also improve the quality of life for patients suffering from head and neck cancer [11][90] - **Distinct Disease Biology**: HPV negative and HPV positive head and neck cancers are recognized as distinct diseases, each requiring tailored treatment approaches [12][92] - **Regulatory Strategy**: The trial design and patient selection are informed by historical data and FDA feedback, aiming to ensure a robust demonstration of efficacy and safety [30][39] This summary encapsulates the critical findings and strategic direction of Bicara Therapeutics as presented in the June 2025 briefing, emphasizing the innovative approach to treating HPV negative head and neck cancer.

New data shared at the 14th C1-inhibitor Deficiency & Angioedema Workshop supports berotralstat use at all stages of lifeRESEARCH TRIANGLE PARK, N.C., May 30, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new data which highlights the reduction in the percentage of days with hereditary angioedema (HAE) symptoms among young children initiating berotralstat in the APeX-P trial, and the broad safety and efficacy outcomes observed across all age groups of patients taking ...

Core Insights - Gain Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation allosteric small molecule therapies [1][2] - The company will present at the GBA1 Meeting 2025 on June 5, 2025, with a focus on its lead drug candidate, GT-02287, for treating Parkinson's disease [1][2] - Gain's innovative Magellan™ platform is designed to accelerate drug discovery for various difficult-to-treat disorders, including neurodegenerative diseases and rare genetic disorders [3] Company Overview - Gain Therapeutics is engaged in the discovery and development of allosteric therapies, with GT-02287 currently in a Phase 1b clinical trial for Parkinson's disease [2] - The company has additional potential applications for GT-02287 in treating Gaucher's disease, dementia with Lewy bodies, and Alzheimer's disease [2] - Gain has multiple undisclosed preclinical assets targeting lysosomal storage disorders, metabolic diseases, and solid tumors [2] Presentation Details - The oral presentation is scheduled for June 5, 2025, at 11:20 p.m. EST, presented by Dr. Jonas Hannestad, Chief Medical Officer of Gain Therapeutics [2]

SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna, will present at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025, at 3:45 p.m. ET in New York. A live webcast of the presentation will be available here and in the investors section of the company’s w ...

SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025, at 2:35 p.m. ET. A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In ...

GAITHERSBURG, Md., May 29, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference: Fireside Chat Date: Wednesday, June 4, 2025 Time: 2:00 – 2:30 p.m. Eastern Time (ET) Location:            New York, NY Goldman Sachs 46th Annual Global Healthcare Conference: Presentation Date: Wednesday, June 11, 2025 Time: 2:00 – 2:35 p.m. ET Location: Miami Bea ...

SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- LPL Financial LLC (Nasdaq:LPLA) today announced that Matt Audette, President and Chief Financial Officer, will present at the William Blair Growth Stock Conference on June 4. The presentation takes place at 11 a.m. ET. A live audio webcast of the presentation will be accessible at investor.lpl.com, with a replay available on the website after the presentation. Contacts Investor Relationsinvestor.relations@lplfinancial.com Media Relationsmedia.relations@lplfinancia ...

SEATTLE, May 28, 2025 (GLOBE NEWSWIRE) -- Trupanion, Inc. (Nasdaq: TRUP), a leader in medical insurance for cats and dogs, announced today that Margi Tooth, Chief Executive Officer and President, will present at the William Blair 45th Annual Growth Stock Conference on Tuesday, June 3, 2025, at 3:20 p.m. CT and will participate in meetings with investors throughout the day. Contact: The presentation will be webcast live and can be accessed on Trupanion's Investor Relations website at http://investors.trupani ...

WEST CHESTER, Pa., May 28, 2025 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica" or "the Company") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica Pharmaceuticals, will present at the Jefferies Global Healthcare Conference in New York City. Jefferies Global Healthcare Conference, June 3-5, 2025 Event details: Date: Wednesday, J ...