SIGA Tech则收涨11.07%，CorMedix涨11.70%，Pacira Pharmaceuticals涨14.71%。 | D 名称 ÷ | | 最新 ⇒ | 醫學 → | 磨促 ⇒ | 涨跌幅 ⇒ | 交易量 | 看涨 P | 时间 ÷ | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ■ | 트 Pacira Pharmaceuticals | 26.28 | 27.64 | 25.51 | +14.71% | 3.7M | ■日 | 03:59:59 0 | | D | | | | | | | | | | | = CorMedix | 6.780 | 7.700 | 6.695 | +11.70% | 3.95M | 印刷台 | 03:59:59 0 | | D | SIGA Tech | 5.920 | 6.400 | 5.590 | +11.07% | 1.15M | ■■合 | 03:28:20 G | | L | 三 阿玛琳 | 0.430 | 0.460 | 0.396 | +5.34% | 3.05M | 图图 ...

Core Viewpoint - Sanofi's investigational BTK inhibitor tolebrutinib has received priority review from the FDA for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), with a final decision expected by September 28, 2025 [1][2]. Group 1: Regulatory Filing and Studies - The FDA's acceptance of the filing is based on data from three late-stage studies, including one focused on nrSPMS and two on relapsing MS (RMS), demonstrating that tolebrutinib delayed disability progression compared to placebo [2]. - A similar regulatory filing is under review by the EMA, also supported by the same studies [2]. Group 2: Unique Treatment Potential - Tolebrutinib is positioned as the first and only brain-penetrant BTK inhibitor for both nrSPMS and RMS, targeting smoldering neuroinflammation, which is crucial for addressing disability accumulation in MS [3]. - Currently, there are no approved therapies for nrSPMS, highlighting a significant unmet need that tolebrutinib could potentially fulfill [4]. Group 3: Stock Performance and Future Studies - Year-to-date, Sanofi's shares have increased by 16%, outperforming the industry average growth of 6% [7]. - Sanofi is also evaluating tolebrutinib in a phase III study for primary progressive MS, with data expected in the second half of 2025 [8]. Group 4: Previous Clinical Holds - In 2022, the FDA placed a partial clinical hold on Sanofi's phase III studies for tolebrutinib due to cases of drug-induced liver injury observed in participants [9]. - The studies for myasthenia gravis (MG) indications were eventually discontinued after evaluating the competitive treatment landscape [10].

Core Viewpoint - Elevation Oncology's shares dropped over 40% following disappointing phase I study results for its lead drug EO-3021, which showed an objective response rate of only 22.2% in patients with advanced gastric and gastroesophageal junction cancers [1][2]. Company Developments - Following the poor study results, Elevation Oncology has decided to halt further clinical development of EO-3021 and will focus on a new solid tumor candidate, EO-1022, with an IND filing expected next year [2]. - The company is now without any pipeline candidates in clinical development, contributing to the significant decline in share price [2]. - Elevation Oncology plans to reduce its workforce by 70% as part of a restructuring effort to cut costs, which includes the departure of its Chief Medical Officer [5]. - The restructuring is expected to incur around $3 million in costs, primarily by the end of June [6]. Financial Performance - Year-to-date, Elevation Oncology's shares have decreased nearly 51%, contrasting with a 7% growth in the industry [3]. - The company has a cash balance of approximately $93 million as of the end of 2024, which is projected to last into the second half of 2026 following the restructuring [5].