Axatilimab的生物制品许可申请(BLA)获得FDA的优先审查:Axatilimab是一种针对慢性移植物抗宿主病(GVHD)的治疗药物,FDA已接受其BLA并授予优先审查地位,审批决定预计将在2024年8月28日前做出。
Revumenib的新药申请(NDA)提交给...查看全文
Syndax(SNDX)02-28 06:25
$Syndax制药(SNDX)$ S-8 Securities to be offered to employees in employee benefit plans Accession Number: 0001193125-24-048118 Act: 33 Size: 86 KB 网页链接查看全文
Syndax(SNDX)02-10 05:05
$Syndax制药(SNDX)$ 4 Statement of changes in beneficial ownership of securities Accession Number: 0001562180-24-001218 Size: 7 KB 网页链接查看全文
Syndax(SNDX)02-28 05:05
$Syndax制药(SNDX)$ 8-K Current report, items 2.02 and 9.01 Accession Number: 0000950170-24-021086 Act: 34 Size: 359 KB 网页链接查看全文
Syndax(SNDX)02-08 23:25
$Syndax制药(SNDX)$ SC 13G/A [Amend] Statement of acquisition of beneficial ownership by individuals Accession Number: 0000902219-24-000134 Act: 34 Size: 37 KB 网页链接查看全文
Syndax(SNDX)02-14 10:45
$Syndax制药(SNDX)$ SC 13G/A [Amend] Statement of acquisition of beneficial ownership by individuals Accession Number: 0000919574-24-001234 Act: 34 Size: 167 KB 网页链接查看全文
Syndax(SNDX)02-10 05:05
$Syndax制药(SNDX)$ 4 Statement of changes in beneficial ownership of securities Accession Number: 0001562180-24-001217 Size: 7 KB 网页链接查看全文
Syndax(SNDX)03-18 19:15
$Syndax制药(SNDX)$ 8-K Current report, items 5.02, 7.01, and 9.01 Accession Number: 0000950170-24-032514 Act: 34 Size: 469 KB 网页链接查看全文
Syndax(SNDX)04-03 04:05
$Syndax(SNDX)$ DEF 14A Other definitive proxy statements Accession Number: 0000950170-24-040099 Act: 34 Size: 6 MB 网页链接查看全文
起步龙耀路04-25 14:32
$Kura Oncology(KURA)$ 公司选择性menin抑制剂ziftomenib获FDA授予突破性疗法认定,用于治疗携带NPM1基因突变的复发/难治性急性髓系白血病(AML)患者。在Ⅰ期临床KOMET-007中,ziftomenib联合标准疗法一线治疗NPM1突变型和KMT2A重排型AML患者,达到了100%的完全缓解(CR)率;在难治/复发(R/R)...查看全文
确定性required03-25 20:06
$Syndax制药(SNDX)$ 在2024年预计将取得以下主要成果:
Axatilimab的生物制品许可申请(BLA)获得FDA的优先审查:Axatilimab是一种针对慢性移植物抗宿主病(GVHD)的治疗药物,FDA已接受其BLA并授予优先审查地位,审批决定预计将在2024年8月28日前做出。
Revumenib的新药申请(NDA)提交给...查看全文
chuminhua2023-10-03 12:05
10/2,Syndax Pharmaceuticals $Syndax制药(SNDX)$ 周一报告称,revumenib 的 I/II 期研究在某些急性白血病患者中实现了其主要目标,尽管结果低于投资者的预期,并且出现了安全信号。 一个独立的数据监测委员会建议提前停止 AUGMENT-101 试验,该公司表示计划在年底前向 FDA 申请这个口服 menin 抑...查看全文
产业链观察2023-10-02 17:31
#药闻简讯# $Syndax制药(SNDX)$ A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101) $Kura Oncology(KURA)$查看全文
陈岭谈药2023-07-30 08:57
继续为您梳理过去一周国内国际Top药闻:
一.国内药闻:
1.正大天晴曲妥珠单抗获批上市: 正大天晴宣布其研发的曲妥珠单抗生物类似药(TQ-B211,商品名:赛妥)获批上市,批准用于HER2阳性早期乳腺癌、转移性乳腺癌及转移性胃癌的治疗。该产品为继汉曲优(复宏汉霖)、安瑞泽(博锐生物)之...查看全文
产业链观察2023-07-26 01:35
#药闻简讯# 7月24日,$Syndax制药(SNDX)$ 和$因塞特医疗(INCY)$ 共同宣布,抗CSF-1R单抗axatilimab在既往接受过二线及以上治疗后疾病进展的慢性移植物抗宿主病(GVHD)成人和儿童患者中的II期AGAVE-201研究取得了积极的关键数据。
AGAVE-201研究是一项随机、开放标签的II期临床试验,共纳入241...查看全文
SeekingBiotech2023-07-24 22:03
SNDX and Incyte announced topline data from the pivotal AGAVE-201 trial of axatilimab in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy. The trial achieved its primary endpoint across all cohorts
$S...查看全文
不入流资讯2023-07-24 19:29
$Syndax制药(SNDX)$ Contango ORE tumbles 25% premarket on underwritten public offering
Contango ORE因承销的公开发行在盘前股价下跌25%。这是ChatGPT翻译的信息。查看全文
不入流资讯2023-07-24 19:28
$Syndax制药(SNDX)$ Syndax soars 30% premarket after trial primary endpoint Syndax在临床试验中主要终点达成后,盘前股价飙升30%。来自ChatGPT翻译查看全文
牛唐2023-06-14 15:55
医药板块速评(2022.06.12)
1、RNAi疗法赛道涨幅较少,哪些公司值得关注?
2、$Syndax制药(SNDX)催化剂在即,是否有配置机会?
3、$小鹏汽车(XPEV)$ 、$苹果(AAPL)$ 、$中概互联网指数ETF-KraneShares(KWEB)$ 等期权异动,后续走势如何看?查看全文
智通财经APP预告,2021年5月12日,港美股上市公司活动及香港重要财经会议信息情况如下: 00:00 AECOM(ACM.US) AECOM(ACM.US)2021年第一季度业绩电话会 网络转播 04:30 Syndax Pharmaceuticals Inc(SNDX.US) Syndax Pharmaceuticals Inc(... 网页链接
$Syndax制药(SNDX)$ EFFECT - Notice of Effectiveness Filed: 2019-09-10 AccNo: 9999999995-19-002056 Size: 1 KB 网页链接
$Syndax制药(SNDX)$ 424B5 - Prospectus [Rule 424(b)(5)] Filed: 2019-09-10 AccNo: 0001193125-19-242045 Size: 359 KB 网页链接
$Syndax制药(SNDX)$ S-3 - Registration statement under Securities Act of 1933 Filed: 2019-08-30 AccNo: 0001193125-19-235283 Size: 1 MB 网页链接
$Syndax制药(SNDX)$ 8-K - Current report Filed: 2019-08-07 AccNo: 0001564590-19-030050 Size: 277 KBItem 2.02: Results of Operations and Financial ConditionItem 9.01: Financial Statements and Exhibits 网页链接
$Syndax制药(SNDX)$ 10-Q - Quarterly report [Sections 13 or 15(d)] Filed: 2019-08-07 AccNo: 0001564590-19-030067 Size: 7 MB 网页链接
$Syndax制药(SNDX)$ S-8 - Securities to be offered to employees in employee benefit plans Filed: 2019-08-07 AccNo: 0001564590-19-030084 Size: 141 KB 网页链接
$Syndax制药(SNDX)$ 美东时间 2019-08-07 盘后 披露财报,预期EPS -0.44 网页链接
$Syndax制药(SNDX)$ 8-K - Current report Filed: 2019-07-08 AccNo: 0001564590-19-024625 Size: 28 KBItem 5.02: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers 网页链接
$Syndax制药(SNDX)$ 8-K - Current report Filed: 2019-06-11 AccNo: 0001564590-19-022241 Size: 36 KBItem 5.07: Submission of Matters to a Vote of Security Holders 网页链接
$Syndax制药(SNDX)$ 10-Q - Quarterly report [Sections 13 or 15(d)] Filed: 2019-05-08 AccNo: 0001564590-19-017318 Size: 6 MB 网页链接