SAN DIEGO, July 09, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding Series A, Series B-1, Series C-1, Series D, Series E and Series F Warrants (the “Existing Warrants”) to purchase up to ...

[Applause] All right. So, today I'm going to talk to you about cancer and about three very important words. You have cancer.I remember those words sort of tumbling out of my mouth. They weren't elegantly polished in the way I had sort of learned in medical school, actually here at Duke, sitting in the building across the street. They didn't have any of the the poignant pauses that I had practiced in the mirror on my first day as a doctor at the University of Chicago.None of the elegance, just words. Sort of ...

Core Insights - Hoth Therapeutics' investigational candidate HT-001 achieved a 100% response rate in at least one primary efficacy endpoint in its ongoing Phase 2a clinical study for EGFR inhibitor-induced skin toxicities [2][7] - The company will host a Key Opinion Leader event to discuss the interim results and potential impact of HT-001 on supportive care standards for oncology patients [1] Clinical Trial Highlights - The Phase 2a trial (CLEER-001) demonstrated that 100% of enrolled patients achieved at least one primary endpoint of clinical dermatologic improvement [7][8] - Over 65% of patients reported reductions in pain and pruritus, with 0% requiring dose reduction or discontinuation of their EGFR inhibitor therapy [7][8] - HT-001 is a once-daily topical gel that targets neuroinflammatory pathways without causing immunosuppression or systemic toxicity [4] Mechanism of Action - HT-001 is formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA) that mitigates inflammatory pathways triggered by EGFR inhibition, particularly those driven by Substance P [4][5] - Preclinical data showed significant reductions in dermatitis and alopecia severity, as well as inflammatory markers in rat models co-treated with erlotinib [5][9] Regulatory and Development Pathway - HT-001 is being advanced under the 505(b)(2) regulatory pathway, which allows the use of existing safety data to expedite development [10] - The company is currently planning a Phase 2b/3 trial following the ongoing Phase 2a trial [13]

Nuvalent (NUVL) Update / Briefing June 24, 2025 08:00 AM ET Speaker0 Good morning, and welcome to New Zealand's conference call. At this time, all participants are in a listen only mode. There will be a question and answer session after the prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Alex Stalcom, CFO of Nuvalent. You may begin. Speaker1 Thank you all for joining us today. Earlier this morning we issued a press rele ...

Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025 In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial estimated durability of response of 78% at the 12-month landmark and 62% at the 1 ...

CAMBRIDGE, Mass., June 18, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Christy Oliger to its Board of Directors."Christy's proven success in delivering new therapies to patients living with cancer strengthens our Board as we evolve from a development-stage company toward potential commercialization," said James Porter, Ph.D., C ...

Regeneron Pharmaceuticals (REGN) FY 2025 Annual General Meeting June 13, 2025 10:30 AM ET Speaker0 Good morning, and welcome to the twenty twenty five Annual Shareholder Meeting of Regeneron Pharmaceuticals. The meeting will begin after the following message. Speaker1 At Regeneron, we've always pursued bold science to drive our purpose, transforming lives through groundbreaking innovation. That principle is just as strong today as it was when the company was founded. Speaker2 We committed to not just treati ...

An updated edition of the April 16, 2025, article.The global cancer treatment market is transforming rapidly, driven by an increasing demand for more effective, less toxic therapies. As per the American Cancer Society, the United States alone is expected to see 2,041,910 new cancer cases and 618,120 cancer-related deaths in 2025. While advances in early detection and treatment have contributed to a decline in mortality rates for certain cancers, the overall rise in cancer incidence continues to push global ...

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 ...