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The Week Ahead In Biotech (Jan 23-29): Roche, Azurity FDA Decisions, J&J, Vertex Earnings, Samsara Vision IPO And More
The Week Ahead In Biotech (Jan 23-29): Roche, Azurity FDA Decisions, J&J, Vertex Earnings, Samsara Vision IPO And More
Biotech stocks pulled back yet again during the week ending Jan. 21, with the sector retreating along with the broader market. The news flow tapered off following the frenetic pace of the week that encompassed the JPM Healthcare conference.
On the M&A front, rare disease biopharma Zogenix, Inc. (NASDAQ:ZGNX) agreed to be acquired by Belgium's UCB SA (OTC:UCBJY) for about $1.8 billion.
Here are the key catalytic events biotech investors can look forward to in the unfolding week:
Conferences
B. Riley Virtual Oncology Conference: Jan. 27-28
PDUFA Dates
The Food and Drug Administration is scheduled to announce by Saturday, Jan. 29, its verdict on Azurity's new drug application for zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy. Azurity had purchased zonisamide oral suspension from Eton Pharmaceuticals, Inc.(NASDAQ:ETON).
Roche Holding AG (PNK: RHHBY) awaits approval for its biologic license application for faricimab as a treatment option for wet age-related macular degeneration and diabetic macular edema. The decision is expected by late January.
Clinical Readouts/Presentations
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) will present at the American Society of Clinical Oncology Plenary Series Session on Tuesday, results of the Phase 3 INTRIGUE study of Qinlock in second-line gastrointestinal stromal tumor. Zai Lab Limited (NASDAQ:ZLAB) has in-licensed the investigational asset for the Greater China region.
Cue Biopharma, Inc. (NASDAQ:CUE) will provide on Wednesday an update from its ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma.
Related Link: 23andMe Pivoting To Clinical Research: Could That Lead To A Turnaround For The Stock?
Earnings
Johnson & Johnson (NYSE:JNJ) (Tuesday, before the market open)
Abbott Laboratories (NYSE:ABT) (Wednesday, before the market open)
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) (Wednesday, after the close)
Edwards Lifesciences Corporation (NYSE:EW) (Wednesday, after the close)
ResMed Inc. (NYSE:RMD) (Thursday, after the close)
IPOs
IPO Pricing
New Jersey-based Samsara Vision, Inc. (NASDAQ:SMSA) has filed a preliminary prospectus with the SEC related to its proposed initial public offering of 4.17 million shares. The medical device that focuses on treatments for late-stage conditions of the retina expects the shares to be priced between $5 and $7. It has applied for listing its common stock on the Nasdaq under the ticker symbol SMSA.
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates
Biotech stocks pulled back yet again during the week ending Jan. 21, with the sector retreating along with the broader market. The news flow tapered off following the frenetic pace of the week that encompassed the JPM Healthcare conference.
生物科技股在截至1月21日的一周内再次回落,该板块与大盘一起回落。随着摩根大通医疗保健会议(JPM Healthcare Conference)一周的狂热节奏,新闻流量逐渐减少。
On the M&A front, rare disease biopharma Zogenix, Inc. (NASDAQ:ZGNX) agreed to be acquired by Belgium's UCB SA (OTC:UCBJY) for about $1.8 billion.
在并购方面,罕见病生物制药Zgenix,Inc.纳斯达克(Sequoia Capital:ZGNX)同意被比利时UCB SA(场外交易代码:UCBJY)约18亿美元。
Here are the key catalytic events biotech investors can look forward to in the unfolding week:
以下是生物技术投资者在即将展开的一周中可以期待的关键催化事件:
Conferences
会议
B. Riley Virtual Oncology Conference: Jan. 27-28
B.莱利虚拟肿瘤学会议:1月27日至28日
PDUFA Dates
PDUFA日期
The Food and Drug Administration is scheduled to announce by Saturday, Jan. 29, its verdict on Azurity's new drug application for zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy. Azurity had purchased zonisamide oral suspension from Eton Pharmaceuticals, Inc.(NASDAQ:ETON).
美国食品和药物管理局(Food and Drug Administration,简称FDA)定于1月29日(星期六)宣布对Azity申请唑尼沙胺口服混悬剂治疗癫痫患者部分癫痫发作的新药申请的裁决。阿齐蒂从以下公司购买了唑尼沙胺口服混悬剂伊顿公学制药公司(Eton PharmPharmticals,Inc.)(纳斯达克:伊顿公学)。
Roche Holding AG (PNK: RHHBY) awaits approval for its biologic license application for faricimab as a treatment option for wet age-related macular degeneration and diabetic macular edema. The decision is expected by late January.
罗氏控股公司PNK:RHHBY)正在等待其Faricimab作为治疗湿性老年性黄斑变性和糖尿病性黄斑水肿的生物许可申请的批准。这一决定预计将在1月下旬做出。
Clinical Readouts/Presentations
临床读数/演示文稿
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) will present at the American Society of Clinical Oncology Plenary Series Session on Tuesday, results of the Phase 3 INTRIGUE study of Qinlock in second-line gastrointestinal stromal tumor. Zai Lab Limited (NASDAQ:ZLAB) has in-licensed the investigational asset for the Greater China region.
Deciphera制药公司纳斯达克(Sequoia Capital)(纳斯达克代码:DCPH)将于周二在美国临床肿瘤学会全体会议上公布秦洛克治疗二线胃肠道间质瘤的3期耐人寻味研究结果。再鼎医药-SB纳斯达克(Sequoia Capital:ZLAB)已经为大中华区的调查资产授予了内部许可。
Cue Biopharma, Inc. (NASDAQ:CUE) will provide on Wednesday an update from its ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma.
Cue Biophma,Inc.纳斯达克公司(Temasek Holdings:CUE)将于周三提供其正在进行的CUE-101临床试验的最新情况。CUE-101是CUE-100系列中基于IL-2的主要候选药物产品,也是具有代表性的候选药物。CUE-101目前正在进行1b期临床试验,用于治疗HPV阳性的复发/转移性头颈部鳞状细胞癌。
Related Link: 23andMe Pivoting To Clinical Research: Could That Lead To A Turnaround For The Stock?
相关链接:23andMe转向临床研究:这能让股票扭亏为盈吗?
Earnings
收益
Johnson & Johnson (NYSE:JNJ) (Tuesday, before the market open)
Abbott Laboratories (NYSE:ABT) (Wednesday, before the market open)
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) (Wednesday, after the close)
Edwards Lifesciences Corporation (NYSE:EW) (Wednesday, after the close)
ResMed Inc. (NYSE:RMD) (Thursday, after the close)
强生(纽约证券交易所代码:JNJ)(周二,市场开盘前)
雅培(纽约证券交易所代码:ABT)(周三,市场开盘前)
Vertex制药公司(纳斯达克:VRTX)(周三收盘后)
爱德华兹生命科学公司(纽约证券交易所股票代码:EW)(周三收盘后)
ResMed Inc.(纽约证券交易所股票代码:RMD)(周四收盘后)
IPOs
首次公开募股(IPO)
IPO Pricing
IPO定价
New Jersey-based Samsara Vision, Inc. (NASDAQ:SMSA) has filed a preliminary prospectus with the SEC related to its proposed initial public offering of 4.17 million shares. The medical device that focuses on treatments for late-stage conditions of the retina expects the shares to be priced between $5 and $7. It has applied for listing its common stock on the Nasdaq under the ticker symbol SMSA.
总部位于新泽西州Samsara Vision,Inc.纳斯达克(Sequoia Capital:SMSA)已向美国证券交易委员会提交了一份初步招股说明书,涉及其拟发行417万股的首次公开募股(IPO)。这家专注于治疗视网膜晚期疾病的医疗设备预计发行价在5美元至7美元之间。该公司已申请将其普通股在纳斯达克上市,股票代码为SMSA。
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates
相关链接:生物技术投资者请注意:将您的日历标记为PDUFA日期为1月份
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
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