Jan. 21, 2025 -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced today announced it has entered into agreements with certain holders of its existing warrants exercisable for 4,971,110 shares of its common stock, in the aggregate, to exercise outstanding warrants at a reduced exercise price of $0.751 per share, in exchange for new warr

January 21, 2025. Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. This decision allows for the initiation of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone. AUTs evaluate the use of the medicine under real-world conditions to identify any issues that

- Investigator-initiated trial (IIT) to be led by pioneers of cell therapy in B-cell mediated autoimmune disease, the Schett/Mackensen group at Friedrich-Alexander University Erlangen-Nürnberg - - Trial to evaluate and enhance clinical experience with CNTY-101 in patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis - Jan. 21, 2025 -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company d

2025年1月22日，乐普生物宣布将创新ADC新药MRG007的大中华区外全球权益授权给ArriVent Biopharma。 根据许可协议，ArriVent支付4700万美元预付款和近期里程碑金额，11.6亿美元的开发、注册和销售里程碑付款，以及高个位数至低双位数百分比的销售分成。 MRG007为一款潜在同类最佳的针对消化道肿瘤的ADC新药，预计2025年上半年递交首个IND申请，重点开发结直肠癌、胰腺癌和其他消化道恶性肿瘤适应症。 乐普生物经过多年布局，建立了持续迭代的ADC技术平台和极具竞争力的ADC管线，首发的EGFR ADC已经递交上市申请并获得突破疗法认证和优先审评资格。 2024年AACR会议上，乐普生物汇报了新一代ADC技术平台Hi-TOPi，包括在此基础上开发的GPC3 ADC新药MRG006的临床前研究数据。Hi-TOPi的设计特点包括：Linker在血液循环中高度稳定，在肿瘤细胞中高效释放毒素；Payload为新型TOP1抑制剂，具有更高的活性，因其并非Pgp的底物，因此具有克服耐药性的潜力；在临床前多种肿瘤PDX模型和CDX模型中表现出优异的疗效与安全性。

近日，信立泰宣布旗下子公司美国Salubris Biotherapeutics, Inc.（下称“Salubris Bio”）自主研发的用于治疗成人慢性心力衰竭的JK07在HFrEF（射血分数降低的心衰）和HFpEF（射血分数保留的心衰）患者的MRCT II期临床试验中获得积极的中期数据。 JK07（重组人神经调节蛋白1（NRG-1）-抗HER3抗体融合蛋白注射液）是具有全球知识产权的NRG-1融合抗体药物，是心衰领域首个进入临床开发阶段的抗体融合蛋白[1]、选择性ErbB4激动剂，拟开发适应症包括HFrEF和HFpEF。 JK07的II期临床研究中期分析，旨在评估JK07在低剂量组（0.045mg/kg）中多次给药的安全性，为启动高剂量组（0.09mg/kg）提供保障，根据方案“将进行描述性（无正式统计检验）期中分析”。根据中期分析结果，目前已启动高剂量组的患者入组。 JK07的II期临床试验为随机、双盲、安慰剂对照、剂量递增研究，旨在评估JK07在HFrEF和HFpEF患者中的安全性和有效性。试验计划纳入282例心衰患者，按照2:1的比例随机接受JK07或安慰剂治疗。本次中期

1. 2025年FDA首批！阿斯利康/第一三共TROP2 ADC在美国获批上市 1月18日，美国FDA宣布批准由阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）联合开发的抗体偶联药物（ADC）Datroway（datopotamab deruxtecan或Dato-DXd）上市，用于治疗无法切除或转移性激素受体（HR）阳性、HER2阴性的成年乳腺癌患者，这些患者曾接受过内分泌疗法和化疗。3期试验结果显示，Datroway相较于化疗，可将患者的疾病进展或死亡风险降低37%。根据阿斯利康新闻稿，这是Datroway首次在美国获批。美国FDA的批准主要基于TROPION-Breast01试验的结果。分析显示，Datroway治疗组的中位PFS为6.9个月（95% CI：5.7，7.4），化疗组为4.9个月（95% CI：4.2，5.5），风险比（HR）为0.63（95% CI：0.52，0.76），双侧p值<0.0001。Datroway治疗组的中位OS为18.6个月（95% CI：17.3，20.1），化疗组为18.3个月（95% CI：17.3，20.5

January 16, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces that Idorsia Pharmaceuticals has entered into a royalty monetization agreement with the R-Bridge Healthcare Fund in relation to AGAMREE® (vamorolone). Idorsia has also recently exercised outstanding warrants held in Santhera on a cashless basis, reinforcing its position as a major shareholder in the Company. Idorsia transfers rights to royalties and milestones for AGAMREE (vamorolone) to R-Bridge Healthcare Fund through a monetiz

January 15, 2025 -- Silexion Therapeutics Corp (NASDAQ: SLXN) (“Silexion Therapeutics” or the “Company”), a clinical-stage biotech developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the pricing of a public offering of an aggregate of 3,703,703 of the Company’s ordinary shares (or ordinary share equivalents) and warrants to purchase up to 3,703,703 ordinary shares at a combined public offering price of $1.35 per share (or per ordinary share equivalent) and accom

日前，Arrowhead Pharmaceuticals宣布，美国FDA已受理其在研RNAi疗法plozasiran用于治疗家族性乳糜微粒血症综合征（FCS）的新药申请（NDA）。该申请的PDUFA日期为2025年11月18日。Arrowhead同时计划在2025年向全球其他监管机构提交plozasiran治疗FCS患者的上市申请。 家族性乳糜微粒血症综合征是一种严重的罕见遗传病，可能由不同的单基因突变所引起。FCS患者具有极高的甘油三酯（TG）水平，通常超过880 mg/dL，进而导致各种严重的临床症状，包括急性和潜在致命的胰腺炎、慢性腹痛、糖尿病、肝脂肪变性和认知问题。目前，尚无疗法获美国FDA批准用于FCS的治疗。 此次NDA提交的依据主要包括在3期PALISADE研究中获得的积极结果，以及2期SUMMIT项目所提供的支持性验证数据。在PALISADE研究中，75名患有持续性乳糜微粒血症的患者，被随机分配接受每三个月一次皮下注射25 mg（n=26）或50 mg（n=24）的plozasiran或安慰剂（n=25）共12个月。基线时，患者的中位TG水平为2044 mg/dL。4

January 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98.3% sero-response rate one-year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old) which supported filing for potential label extension to this age group in the U.S.1,