AlphaMedix
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Press Release: ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors
Globenewswire· 2025-10-20 06:30
Core Insights - New data from the ALPHAMEDIX-02 phase 2 study supports the first-in-class potential of AlphaMedix (212Pb-DOTAMTATE) for treating advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [1][5][10] - The study demonstrated significant efficacy in both radioligand therapy (RLT)-naïve and RLT-exposed patients, indicating its potential to address unmet medical needs in this challenging cancer type [2][5][10] Study Overview - ALPHAMEDIX-02 is a phase 2, open-label, multicenter study assessing the efficacy and safety of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs, including cohorts for RLT-naïve and RLT-exposed patients [3][12] - The primary efficacy endpoint was the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS) [3][12] Efficacy Results - In the RLT-naïve cohort (n=35), the ORR was 60.0% per investigator assessment and 57.1% per independent assessment, with a disease control rate (DCR) of 94.3% [4][6] - In the RLT-exposed cohort (n=26), the ORR was 34.6% per investigator assessment and 19.2% per independent assessment, with a DCR of 96.2% [6] - The 36-month PFS rate for RLT-naïve patients was 72.3%, while the 18-month PFS rate for RLT-exposed patients was 82.6% [6] Safety Profile - AlphaMedix exhibited a similar safety profile across both cohorts, with 85.7% of RLT-naïve patients and 84.6% of RLT-exposed patients completing all four doses [6][10] - Treatment-emergent adverse events (TEAEs) were reported in all patients, with grade ≥3 TEAEs occurring in 42.3% of RLT-exposed and 54.3% of RLT-naïve patients, primarily involving lymphocyte count decrease [6][10] Future Development - The positive results from the ALPHAMEDIX-02 study will inform further discussions with health authorities and support the planning of an international phase 3 study [10][11] - Sanofi has entered an exclusive licensing agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix, indicating strong commercial interest and potential market impact [11]
有色金属海外季报:Orano2024年收入同比增长23%至58.74亿欧元,归属于母公司所有者的净利润同比增长192%
HUAXI Securities· 2025-03-03 10:05
Investment Rating - The report recommends a "Buy" rating for the industry, predicting that the industry index will outperform the Shanghai Composite Index by 10% or more in the next six months [22]. Core Insights - Orano's revenue for 2024 reached €5.874 billion, representing a year-on-year growth of 23% from €4.775 billion in 2023 [2]. - The net profit attributable to the parent company increased significantly by 192% to €633 million in 2024, compared to €217 million in 2023 [9]. - The backlog of orders reached €9.069 billion, with 42% coming from outside France, indicating a strong market position [1]. Financial Performance Summary 1) Order Backlog - Total order backlog increased to €35.9 billion by the end of 2024, up from €30.8 billion at the end of 2023, with €1.3 billion attributed to market revaluation and currency effects [1]. 2) Revenue Breakdown - Mining revenue was €1.502 billion, a 13.9% increase year-on-year, driven by rising uranium prices [2]. - Front-end revenue remained stable at €1.307 billion, with positive price effects offsetting lower volume effects [2]. - Back-end revenue surged to €3.027 billion, a 41.8% increase, primarily due to a one-time contract with a Japanese utility [2]. 3) Operating Profit - Operating profit for 2024 was €1.085 billion, an increase of €450 million from 2023 [4]. - The mining segment's operating profit decreased to €122 million, reflecting challenges in Niger [7]. - The front-end segment's operating profit rose to €425 million, while the back-end segment's operating profit increased significantly to €616 million [7]. 4) Adjusted Net Profit - Adjusted net profit attributable to the parent company was €597 million in 2024, up from €22 million in 2023 [8]. 5) Cash Flow and Debt - EBITDA for Orano was €2.067 billion, a substantial increase from €1.228 billion in 2023, with an EBITDA margin rising from 25.7% to 35.2% [10]. - As of December 31, 2024, Orano had €1.3 billion in cash and €780 million in net debt, down from €1.48 billion in 2023 [14]. 6) Future Outlook - For 2025, Orano aims for revenues close to €5 billion, with an EBITDA margin between 23% and 25% and positive net cash flow [18].