GILD's KTE-X19 To Face FDA, NTEC Drops As NVS Walks Away, KZIA On Watch

GILD 的 KTE-X19面对 FDA , NTEC 随着 NVS 走开而下降, KZIA 正在观察

2019-12-12 12:28:22 RTTNews


Today's Daily Dose brings you news about Puma Biotech's SUMMIT basket trial results; TransEnterix' reverse stock split; Seattle Genetics' pivotal HER2CLIMB study and the latest update on Intec/Novartis deal. Read on… Kite, a Gilead Co. (GILD), has submitted a Biologics License Application to the FDA for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The Company plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. This product candidate is designated a Breakthrough Therapy by the FDA and Priority Medicines (PRIME) by the EMA for relapsed or refractory mantle cell lymphoma. GILD closed Wednesday's trading at $67.78, up 1.04%. Shares of Intec Pharma Ltd. (NTEC) declined 11% on Wednesday, following the termination of the Feasibility and Option agreement with Novartis (NVS) for the development of a custom-designed Accordion Pill (AP) for a proprietary Novartis compound. Despite the Accordion Pill having met the technical and pharmacokinetic (PK) clinical specifications set forth by Novartis, the agreement has been terminated as the program no longer meets Novartis' mid to long-term strategic goals. NTEC closed Wednesday's trading at $0.52, down 11.30%. Kazia Therapeutics Ltd.'s (KZIA) lead program, GDC-0084, has been selected to join GBM AGILE, an international, academic-led, multi-drug adaptive phase II / III study in glioblastoma. The study is expected to recruit up to 200 patients into the GDC-0084 arm, with recruitment expected to commence in the second or third quarter of the calendar year 2020. It is expected that data from GBM AGILE will be used to seek marketing approval for GDC-0084 from FDA and other regulatory agencies. GDC-0084 was licensed from Genentech in late 2016. KZIA closed Wednesday's trading at $4.42, up 3.51%. Puma Biotechnology Inc. (PBYI), on Wednesday, announced encouraging updated results from its phase II SUMMIT basket trial, which is evaluating Neratinib in patients who have solid tumors with activating HER2 or HER3 mutations. According to the Company, Neratinib in combination with Trastuzumab and Fulvestrant showed that for the 17 efficacy evaluable HER2-mutant, HR-positive breast cancer patients, 9 patients (53%) experienced a confirmed objective response, all of which were classified as partial responses, and 10 patients (59%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response has not been reached and the median progression-free survival was 9.8 months, added the Company. Neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX(r) (neratinib) tablets. The drug was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early-stage breast cancer in August 2018. PBYI closed Wednesday's trading at $8.69, up 2.36%. In after-hours, the stock gained another 3.80% to $9.02. Seattle Genetics Inc. (SGEN) plans to seek approval of Tucatinib for the treatment of patients with HER2-positive metastatic breast cancer in the U.S. and Europe by the first quarter of 2020. The pivotal clinical trial comparing Tucatinib in combination with Trastuzumab and Capecitabine against Trastuzumab and Capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with Trastuzumab, Pertuzumab, and T-DM1 has yielded encouraging results. In the trial, dubbed HER2CLIMB, the primary endpoint of progression-free survival showed that the addition of Tucatinib was superior to trastuzumab and capecitabine alone, with a 46 percent reduction in the risk of disease progression or death. Moreover, the addition of Tucatinib to the commonly used combination of Trastuzumab and Capecitabine improved overall survival, reducing the risk of death by 34 percent compared to trastuzumab and capecitabine alone. SGEN closed Wednesday's trading at $111.34, down 2.32%. TransEnterix Inc. (TRXC), a medical device company, is all set to effect a reverse stock split of one-for-thirteen, with the common stock beginning to trade on a split-adjusted basis when markets open on December 12, 2019. No fractional shares are issued in connection with the reverse stock split, the Company added. TRXC closed Wednesday's trading at $0.165, down 7.15%. For comments and feedback contact: Business News
今天的每日 Dose 给你带来了关于 Puma Biotech 公司 SUMMIT 一揽子试验结果的新闻; TransEnterix 的反向股票分割; Seattle Genetics 的关键 HER2CLIMB 研究和最新的 Intec / Novartis 交易。 阅读… Kite ,一家吉利德(Gilead)公司( GILD )已向 FDA 提交了一份 Biologics License Application for KTE-X19,一种研究嵌合抗原受体( CAR ) T 细胞疗法,用于治疗成人复发或难治性地幔细胞淋巴瘤。 本公司计划于2020年初在欧盟提交 KTE-X19上市许可申请。该产品候选者被 FDA 和优先药物( PRIME )指定为复发或难治性地幔细胞淋巴瘤的突破性治疗。 GILD 周三收于67.78美元,上涨1.04%. 在与诺华(Novartis)( Novartis )就开发一种定制的 Accordion 丸( AP )开发专有诺华化合物的可行性和期权协议终止后, Intic Pharma Ltd ( NTEC )股价周三下跌11%。 尽管 Accordion 丸符合诺华公司规定的技术和药代动力学( PK )临床规范,但由于该方案不再符合诺华(Novartis)公司中长期战略目标,该协议已终止。 NTEC 周三收于0.52美元,下跌11.30%. Kazia Therapeutics Ltd .的( KZIA )领导项目 GDC-0084已入选 GBM AGILE , GBM AGILE 是一项国际性、学术性、多药物适应性的胶质瘤 II / III 期研究。 这项研究预计将招募多达200名患者进入 GDC-0084部门,预计将于2020年第二或第三季度开始招募。 预计 GBM AGILE 的数据将用于寻求 FDA 和其他监管机构对 GDC-0084的市场批准。 GDC-0084于2016年末从基因泰克(Genentech)获得许可。 KZIA 周三收于4.42美元,上涨3.51%. Puma Biotechnology Inc .( PBYI )周三宣布,其第二期 SUMMIT 篮子试验令人鼓舞的最新结果。该试验正在对 HER2或 HER3突变激活实体肿瘤患者的 Neratinib 进行评估。 根据本公司的资料, Neratinib 联合 Trastuzumab 和 Fulvestrant 显示,对于17例疗效可评价的 HER2突变体, HR 阳性乳腺癌患者中,9例(53%)出现了明确的客观反应,均被归类为部分反应。10例(59%)有临床疗效(临床疗效定义为确认完全反应或部分反应或至少24周稳定疾病)。 该公司补充说,未达到平均反应时间,无进展生存期为9.8个月。 Neratinib 于2017年7月获得 FDA 批准,用于辅助曲妥珠单抗治疗后早期 HER2阳性乳腺癌成年患者的扩展辅助治疗,并在美国上市,作为 NERLYNX ( r )( enetinib )片剂。该药品于2018年8月获得欧盟委员会关于激素受体阳性 HER2阳性早期乳腺癌扩展辅助治疗的上市许可。 PBYI 周三收于8.69美元,上涨2.36%。盘后,该股又上涨3.80%,至9.02美元。 西雅图基因公司( SGEN )计划在2020年第一季度之前寻求 Tucatinib 批准用于治疗 HER2阳性转移性乳腺癌患者。 将 Tucatinib 与 Trastuzumab 和 Capectabine 联合应用于局部晚期不可切除或转移性 HER2阳性乳腺癌患者的关键临床试验与 Trastuzumab 、 Pertuzumab 和 T-DM1联合应用,取得了令人鼓舞的结果。 在这项名为 HER2CLIMB 的试验中,无进展生存期的主要终点显示 Tucatinib 的添加优于单独使用曲妥珠单抗和卡培他滨,疾病进展或死亡的风险降低了46%。 此外,在常用的曲妥珠单抗和卡培他滨联合使用中加入 Tucatinib 可提高整体生存率,与单纯曲妥珠单抗和卡培他滨相比,降低死亡风险34%。 SGEN 周三收于111.34美元,下跌2.32%。 医疗器械公司 TransEnterix Inc .( TRXC )均将实施一对十三的反向股票分割,普通股在2019年12月12日开市时开始按拆股调整后的价格交易。 本公司补充称,并无就反向股票分割发行零碎股份。 TRXC 周三收于0.165美元,下跌7.15%. 有关意见和反馈,请联系: edition @ 商业新闻