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Celcuity Appoints Charles Romp to its Board of Directors
Globenewswire· 2026-02-12 21:05
Core Insights - Celcuity Inc. has appointed Charles (Chip) R. Romp to its Board of Directors, bringing over 25 years of experience in the pharmaceutical industry, particularly in oncology [1][2] - Mr. Romp's expertise in commercializing significant oncology drugs is expected to provide valuable insights as Celcuity advances its programs and prepares for the potential approval and launch of gedatolisib later this year [2][3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [3] - Celcuity is conducting several clinical trials, including a Phase 3 trial (VIKTORIA-1) for gedatolisib in combination with fulvestrant for HR+/HER2- advanced breast cancer, which has completed enrollment [3] - Another Phase 3 trial (VIKTORIA-2) is currently enrolling patients, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Leadership Experience - Mr. Romp is currently the CEO of Secura Bio and previously served as Executive Vice President, Commercial U.S., at Seagen, Inc., overseeing the entire commercial organization [2] - He has a history of managing the growth of key oncology products such as ADCETRIS, PADCEV, TUKYSA, and TIVDAK at Seagen [2] - Prior to Seagen, Mr. Romp held senior sales leadership positions at Genentech, responsible for oncology and immunology products [2]
Financial Markets React to JPMorgan Earnings, Pfizer’s Breast Cancer Breakthrough, and Global Developments
Stock Market News· 2025-10-14 11:08
Financial Performance - JPMorgan Chase & Co. reported Q3 2025 adjusted revenue of $47.12 billion, exceeding analyst estimates of $45.48 billion, with net income of $14.4 billion or $5.07 per share, up from $12.9 billion or $4.37 per share year-over-year [3][4][9] - Wells Fargo & Company reported a Q3 provision for credit losses of $681 million, significantly lower than the estimated $1.17 billion, with net income of $5.6 billion or $1.66 per diluted share, surpassing the expected EPS of $1.55 [10][11] Outlook and Projections - JPMorgan updated its full-year 2025 Net Interest Income (NII) forecast to approximately $95.8 billion, with Q4 NII projected around $25 billion [4][9] - Wells Fargo's total revenue for Q3 was $21.44 billion, exceeding the estimate of $21.19 billion, with corporate and investment banking revenue of $4.88 billion [11] Pharmaceutical Developments - Pfizer Inc. announced positive topline results from its Phase 3 HER2CLIMB-05 trial for TUKYSA (tucatinib) combination therapy, showing significant improvement in progression-free survival for HER2-positive metastatic breast cancer patients [6][7][9] Geopolitical and Market Dynamics - In Japan, political developments are unfolding as LDP leader Takaichi arranges meetings with opposition leaders amidst a changing political landscape [12] - In Germany, wholesale electricity prices have surged to €156 per megawatt hour, the highest since February, driven by low solar and wind output, with average wholesale prices in H1 2025 increasing by 37% to just under USD 100/MWh [13]
TUKYSA Combination Significantly Improves Progression-Free Survival as First-Line Maintenance in HER2+ Metastatic Breast Cancer in HER2CLIMB-05 Trial
Businesswire· 2025-10-14 10:45
Core Insights - Pfizer Inc. announced positive topline results from the Phase 3 HER2CLIMB-05 trial, demonstrating that TUKYSA (tucatinib) in combination with trastuzumab and pertuzumab significantly improves progression-free survival in patients with HER2+ metastatic breast cancer compared to placebo [1][2][3] Study Overview - HER2CLIMB-05 is a randomized, double-blind, placebo-controlled Phase 3 study evaluating TUKYSA versus placebo, both combined with trastuzumab and pertuzumab as maintenance therapy after chemotherapy [5][6] - The trial included 654 participants, with 326 receiving TUKYSA and 328 receiving placebo [6] Treatment Context - HER2+ breast cancer represents a challenging subtype, with a five-year survival rate of 41-47% for HER2+ metastatic breast cancer [2] - The standard of care for first-line maintenance treatment has not changed since 2012, and many patients experience disease progression within two years [2] Safety Profile - TUKYSA's safety profile in the trial was consistent with established profiles of the individual therapies, with tolerable side effects [1][3] - Serious adverse reactions occurred in 26% of patients receiving TUKYSA, with diarrhea being the most common [9][13] Future Implications - Pfizer aims to position TUKYSA as a key player in front-line treatment for HER2+ metastatic breast cancer, potentially benefiting a broader patient population [3] - Results from the HER2CLIMB-05 trial will be presented at future medical congresses and discussed with regulatory authorities [3]