Week Ahead In Pharmaceuticals: 4 Stocks To Watch

临床试验结果推动股价暴涨暴跌,本周值得关注的四支股票

2019-02-26 07:20:00 RTTNews

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Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost their stock price while unfavorable results can send the stocks plummeting. Achieve Life Sciences Inc. (ACHV) rose as much as 145% to $4.54 in intraday trading on February 22, before settling down at $3.30, up 82.32%, at the close of the trading, thanks to encouraging phase I/II multi-dose, pharmacokinetic and pharmacodynamics data of Cytisinicline in smokers. Zosano Pharma Corporation (ZSAN) jumped more than 170% on February 21, to close the day's trading at $6.00, following favorable results from its long-term safety study for Qtrypta, in which patients treated migraine attacks over a one year period. Just like clinical trial results, regulatory events like FDA panel recommendations and FDA decision can also make or break the pharma/biotech stocks. Karyopharm Therapeutics Inc. (KPTI) cratered over 40% on February 22, as FDA staff concluded that there is only limited efficacy and significant toxicity in relapsed refractory multiple myeloma patients treated with Selinexor. An FDA panel is slated to review Selinexor on February 26. Let's look at some of the upcoming week's clinical trial and regulatory catalysts. 1. Bausch Health Companies Inc. (BHC) The FDA decision on Bausch Health's New Drug Application for its sub-micron Loteprednol etabonate ophthalmic gel, 0.38% is expected on February 25. This product, which has a reduced concentration and reduced dosing frequency compared to existing formulations of Loteprednol etabonate, is proposed for the treatment of post-operative inflammation and pain following ocular surgery. The Company's Loteprednol etabonate ophthalmic suspension 0.5% is approved under brand name Lotemax and is used to treat swelling and redness caused by certain eye conditions or surgery. BHC has traded in a range of $17.20 to $28.45 in the last 1 year. The stock closed Friday's trading at $23.75, up 1.02%. 2. Karyopharm Therapeutics Inc. (KPTI) An FDA panel is scheduled to review Karyopharm Therapeutics Inc.'s (KPTI) multiple myeloma drug candidate Selinexor on February 26. The Company is seeking approval of Selinexor as a new treatment for patients with penta-refractory multiple myeloma. The briefing documents posted by the FDA staff ahead of the panel meeting don't look good. It reads as "Given the limited efficacy and significant toxicity demonstrated in this population, it is unclear whether treatment with selinexor-dexamethasone provides a clinically meaningful benefit that outweighs the risks of treatment". The briefing documents are used as the basis for discussion by the FDA panel members.The FDA decision on Selinexor is expected on April 6, 2019. KPTI has traded in a range of $4.65 to $21.71 in the last 1 year. The stock closed Friday's trading at $ $5.07, down 43.48%. 3. Sarepta Therapeutics Inc. (SRPT) Sarepta is a commercial-stage biopharmaceutical company focused on developing precision genetic medicine to treat rare neuromuscular diseases, primarily Duchenne muscular dystrophy. The Company's drug EXONDYS was granted accelerated approval in the U.S. for Duchenne muscular dystrophy in September 2016, despite an FDA panel recommending against its approval. The approval of EXONDYS is considered one of the controversial decisions. The Company has a number of investigational gene therapies in its pipeline - one of which is MYO-101 to treat patients with Limb-Girdle Muscular Dystrophy Type 2E (beta-sarcoglycanopathy). Watch out for... Results from the first 3-patient cohort of phase I/IIa gene transfer clinical trial of MYO-101 to treat patients with Limb-Girdle Muscular Dystrophy Type 2E (beta-sarcoglycanopathy) are expected to be announced on February 27. SRPT has traded in a range of $59.51 to $176.50 in the last 1 year. The stock closed Friday's trading at $139.98, up 2.52%. 4. Heat Biologics Inc. (HTBX) Heat Biologics is a biopharmaceutical company developing immunotherapies against cancer. The Company's lead drug candidate is HS-110, which is being evaluated in combination with Bristol-Myers Squibb Co.'s (BMY) Opdivo, for the treatment of advanced non-small cell lung cancer in a phase II trial. Watch out for... New interim data from the phase II study of HS-110 in advanced non-small cell lung cancer is scheduled to be presented at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on February 28. HTBX has traded in a range of $0.95 to $4.30 in the last 1 year. The stock closed Friday's trading at $1.37, up 0.74%. For comments and feedback contact: editorial@rttnews.com Business News
临床试验是生物技术/制药公司的主要催化剂,因为积极的研究数据可以提高他们的股票价格,而不利的结果可能导致股票暴跌。 2月22日,在盘中交易中,达美生命科学公司( ACHV )股价上涨145%,至4.54美元,收盘时收于3.30美元,上涨82.32%,这得益于鼓励烟民使用 Cytisiniline 的 I / II 多剂量、药代动力学和药效学数据。 佐萨诺制药公司( ZosanoPharma Corporation , ZSAN )股价在2月21日飙升逾170%,收于6.00美元,此前该公司对 Qtrypta 的长期安全性研究取得了良好的结果,该研究对一年内治疗偏头痛的患者进行了治疗。 就像临床试验结果一样,像 FDA 专家小组的建议和 FDA 的决定这样的监管事件也可以制造或破坏制药/生物技术的股票。 2月22日, Karyopharm Therapeutics Inc ( KPTI )暴跌40%以上, FDA 的工作人员得出结论,在塞来诺治疗的复发难治性多发性骨髓瘤患者中,疗效有限,毒性显著。FDA 将于2月26日对 Selinelor 进行审查。 让我们来看看即将到来的一周的临床试验和监管催化剂。 1。Bausch Health Company Inc .( BHC ) FDA 对博施健康的新药申请其亚微米洛替普列醇非骨酸盐眼用凝胶的决定,预计2月25日0.38%。 本产品与现有的依替巴膦酸洛替芬酯制剂相比,浓度降低,剂量频率降低,可用于术后眼科手术后的炎症和疼痛的治疗。 本公司的洛替芬醇 etbonate 眼用混悬液0.5%以品牌名 Lotemax 批准上市,用于治疗某些眼病或手术引起的肿胀和红肿。 BHC 在过去一年的交易价格在17.20美元到28.45美元之间。该股上周五收于23.75美元,上涨1.02%. 2。Karyopharm Therapeutics Inc .( KPTI ) FDA 的一个小组计划在2月26日审查 KaryopharmTherapeutics Inc .的多发性骨髓瘤药物候选药物 Selinelor 。 该公司正在寻求批准塞力诺作为治疗五难治性多发性骨髓瘤的新疗法。 FDA 工作人员在小组会议之前发布的简报文件看起来不太好。它的意思是“鉴于这一人群的疗效和毒性有限,目前尚不清楚使用硒-地塞米松治疗是否提供了临床上有意义的益处,超过了治疗的风险”。 简报文件是 FDA 专家小组讨论的基础。FDA 对塞力诺的决定预计在2019年4月6日做出。 过去一年里, KPI 的交易价格在4.65美元到21.71美元之间。该股上周五收于5.07美元,下跌43.48%. 3。Sarepta Therapeutics Inc .( SRPT ) Sarepta 是一家商业阶段的生物制药公司,专注于开发精准基因药物,治疗罕见的神经肌肉疾病,主要是 Duchenne 肌营养不良。 该公司的药物 EXONDYS 于2016年9月在美国获得了杜兴氏肌营养不良症的加速批准,尽管 FDA 小组建议不予批准。批准 EXONDYS 被认为是有争议的决定之一。 该公司在其管道中有多个研究基因疗法-其中一个是 MYO-101治疗 Limb-Girdle 肌肉萎缩型2E (β-肌肉型)患者。 请注意。。。 首批3例 I / IIa 期基因转移临床试验的结果 MYO-101用于治疗 Limb-Girdle 肌肉萎缩型2E (β-肉瘤)患者,预计将于2月27日公布。 SRPT 在过去一年的交易价格在59.51美元到176.50美元之间。该股上周五收于139.98美元,上涨2.52%. 4。热生物技术公司( HTBX ) 热生物学公司是一家生物制药公司,开发免疫治疗癌症。 该公司的主要候选药物是 HS-110,目前正在与百时美施贵宝公司( BMY )的 Opdivo 联合进行评估,用于在二期试验中治疗晚期非小细胞肺癌。 请注意。。。 来自 HS-110晚期非小细胞肺癌 II 期研究的新的中期数据将于2月28日在2019年 ASCO-SITC 临床免疫肿瘤研讨会上发表。 HTBX 过去一年的交易价格在0.95美元至4.30美元之间。该股上周五收于1.37美元,上涨0.74%. 有关意见和反馈,请联系: edition @ rttnews.com 商业新闻

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