核心观点 - 公司是一家临床阶段生物技术公司，专注于利用其专有的生成性磷酸化蛋白质组学AP3平台发现和开发精准药物 [1] - 公司主要候选药物ACR-368在治疗子宫内膜癌的注册意向2b期试验中取得进展，并正在评估与超低剂量吉西他滨联用的方案 [2][5] - 公司第二个临床阶段资产ACR-2316的1期试验显示出初步临床活性，包括肿瘤缩小和确认的部分缓解 [2][5] - 公司现金状况稳健，截至2025年9月30日拥有1.344亿美元现金及等价物，预计可支撑运营至2027年第二季度 [1][10] 研发管线进展 - ACR-368（CHK1和CHK2抑制剂）：针对既往接受过铂类化疗和免疫检查点抑制剂治疗的复发性高级别子宫内膜癌患者的多中心注册意向2b期试验持续取得进展 [3][5] - 研究第三组（不要求治疗前活检进行生物标志物评估）的患者入组和给药正在进行中，该组旨在评估ACR-368与超低剂量吉西他滨联用，作为肿瘤增敏剂，用于既往治疗线数有限的子宫内膜癌患者 [5] - ACR-2316（WEE1/PKMYT1抑制剂）：在针对AP3优先实体瘤类型的1期单药剂量递增试验中，观察到初步临床活性，包括肿瘤缩小和跨多个实体瘤类型的确认部分缓解 [4][5] - 在临床前癌症异种移植模型中，ACR-2316诱导了完全消退，而基准WEE1抑制剂或PKMYT1抑制剂在最大耐受/可制剂剂量下仅导致疾病稳定 [5] 专有技术平台 - 生成性磷酸化蛋白质组学AP3平台能够以无偏见的方式解读和量化完整细胞内化合物特异性、药物调节的通路活性水平 [1][11] - 在AACR-NCI-EORTC会议上展示的数据表明，公司的AP3生成式AI模型KaiSR能够准确预测并扩展对可操作全局通路活性状态的无偏见理解，从而实现新治疗靶点的识别和化合物对整个细胞内蛋白质信号网络影响的评估 [6] - AP3平台超越了传统药物发现以及当前基于AI的靶点中心药物发现的局限性，通过细胞内蛋白质网络分析快速设计具有理想通路效应的差异化化合物 [11] 财务业绩与现金状况 - 2025年第三季度净亏损为1820万美元，较2024年同期的2240万美元净亏损有所收窄 [8] - 2025年第三季度研发费用为1360万美元，低于2024年同期的1890万美元，差异主要由当期计划内和已发生里程碑付款减少，以及ACR-368临床试验中优先关注子宫内膜癌而非其他肿瘤类型所驱动 [9] - 2025年第三季度一般及行政费用为600万美元，与2024年同期的630万美元基本一致 [10] - 截至2025年9月30日，公司拥有现金、现金等价物和投资共计1.344亿美元，预计足以支撑运营支出和资本支出需求至2027年第二季度 [1][10] 近期里程碑与未来计划 - 计划在2025年下半年提供ACR-368注册意向试验和验证性试验设计的更新 [13] - 计划在2025年下半年报告ACR-2316的1期临床研究的初步临床数据 [13] - 计划在2025年推进一个新的潜在首创细胞周期药物发现项目（针对未公开靶点）至开发候选物提名阶段 [13] - ACR-2316的1期试验正在推进，前三个剂量递增队列的患者入组已完成，在DL1和DL2观察到药物靶点结合，在DL3观察到肿瘤缩小的初步临床活性 [14]

Closed financing of up to $50 million; initial tranche of $30 million provides runway through 2027 Hosted key opinion leader event highlighting the important role of the Aryl Hydrocarbon Receptor (AhR) in intestinal inflammation, the unmet medical need in ulcerative colitis, and the potential clinical utility of EQ504, a novel oral AhR modulator EQ504 Phase 1 clinical study initiation planned for mid-2026 LA JOLLA, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biot ...

J.P. Morgan, Goldman Sachs & Co. LLC, Leerink Partners, TD Cowen and Cantor are acting as book-running managers of the offering. The offering was made only by means of a prospectus supplement and the accompanying prospectus, copies of which may be obtained from the offices of the following: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, c/o Prospectus Depa ...

Accessibility StatementSkip Navigation Company preparing to initiate comprehensive Phase 3 program for chronic cough in patients with idiopathic pulmonary fibrosis in first half of 2026 Company ended the third quarter of 2025 with $194.9 million in cash, cash equivalents and marketable securities with expected cash runway into 2028 Management to host a conference call and webcast today at 4:30 p.m. EST NEW HAVEN, Conn., Nov. 13, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical- sta ...

Accessibility StatementSkip Navigation "PAPZIMEOS represents a monumental shift in how we care for adults with RRP," said Dr. Simon R. Best, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine. "For the first time, we can offer adult patients a safe and effective treatment that addresses the underlying disease rather than repeatedly managing symptoms through endless surgeries. The durable patient outcomes from the pivotal trial are nothing short of re ...

100% LLDAS response rate observed in patients with SLE who received Descartes-08 in Phase 2 open-label trial reaching Month 3 follow-up (n=3) Disease remission reported as DORIS response seen in 2 out of 3 patients reaching Month 3 follow-up (n=3) Descartes-08 in SLE patients was observed to have a favorable safety profile supporting outpatient administration without the need for lymphodepleting chemotherapy Myositis seamless adaptive clinical trial design provides potential opportunity for a single pivota ...

财务业绩 - 2025年第三季度净销售额为500万美元，较去年同期450万美元增长10% [2] - 总运营费用降至400万美元，较去年同期690万美元下降42% [3] - 实现运营收入100万美元，去年同期为运营亏损240万美元 [4] - 归属于普通股东的净亏损为170万美元，较去年同期净亏损240万美元有所收窄，每股净亏损从0.02美元改善至0.01美元 [5] - 截至2025年9月30日，受限现金为84万美元，较2024年12月31日的74万美元有所增加 [6][14] 业务运营与战略 - 销售额增长得益于销售团队努力、社交媒体举措及夏季媒体宣传，同时PHEXX产品批发平均成本自2025年1月1日起上调以及SOLOSEC产品完整季度销售也贡献了增长 [2] - 运营费用改善290万美元，主要由于一般及行政费用减少100万美元，以及因Rush专利到期导致或有特许权负债会计估计变更产生一次性收益190万美元 [3] - 公司正推进生产成本降低策略，目标将PHEXX和SOLOSEC的制造成本降低约50%，以提升单位利润并进入价格敏感的全球市场 [11] 产品与研发进展 - PHEXX是一种激素免费、按需使用的处方避孕阴道凝胶，SOLOSEC是一种用于治疗细菌性阴道病和滴虫病的单剂量口服抗生素 [12] - 2025年第三季度，SOLOSEC已根据2025年6月与Pharma 1签订的许可和供应协议向阿拉伯联合酋长国提交上市申请 [11] - 一项由美国国立卫生研究院资助的第四阶段临床试验正在进行患者招募，该研究评估单剂量SOLOSEC versus 七天多剂量甲硝唑治疗滴虫感染的有效性和成本效益 [11] 公司治理与事件 - 在2025年10月20日特别股东大会上，股东未批准与Aditxt的合并交易，公司据此行使权利终止了合并协议 [11]

DARE to PLAY™ Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product RevenuePositive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued EnrollmentMultiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal ContraceptionFour Commercially Available Solutions for Women Expected Over the Next Two Years In addition to DARE to PLAY™ Sildenafil Cream, Commercialization of DARE to RESTORE™ Vaginal Probi ...

Multiple Late-Stage Data Readouts Reinforce Telitacicept’s Broad Potential Across Autoimmune DiseasesExpansion of Executive Leadership and Board Strengthens Global Development Capabilities Expected gross proceeds of $115 million raised in the November 2025 underwritten public offering, including the underwriters’ full exercise of the option to purchase additional shares BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoi ...

In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), fewer disease progressions and deaths than projected have been observed as of November 6, 2025. Based on 2:1 randomization with twice as many patients in the ELI-002 7P treatment arm compared to the observation arm, Elicio believes the lower-than-projected number of disease progressions and deaths may reflect a favorable impact on disease-free survival (“DFS”); event-driven primary DFS a ...