The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates
The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates
Biotech stock reversed course last week, dragged lower by the broader market weakness.
受大盤疲軟拖累,生物科技股上週逆轉走勢。
The week's news flow was headlined by Johnson & Johnson (NYSE:JNJ) kickstarting a Phase 3 trial of its coronavirus vaccine candidate.
A few clinical readouts released during the week triggered strong moves. Vaccinex Inc (NASDAQ:VCNX) and AC Immune SA (NASDAQ:ACIU) were among the worst decliners of the week, with the former reacting to a failed mid-stage trial of lead drug in Huntington's disease, while the latter plunged after an out-licensed Alzheimer's drug flunked a mid-stage trial.
Here are the key catalysts for the unfolding week.
以下是即將到來的一週的關鍵催化劑。
Conferences
會議
World Muscle Society, or WMS, 25: Virtual Congress: Sept. 28-Oct. 2
Annual Northeast Amyotrophic Lateral Sclerosis, or NEALS, meeting: Sept. 30- Oct. 1
Heart Failure Society of America, or HFSA, Virtual Annual Scientific Meeting 2020: Sept. 30-Oct. 6
virtual Jefferies Cell Therapy Summit: Oct. 5-6
Virtual Jefferies Gene Therapy/Editing Summit: Oct. 1-2
North American Neuroendocrine Tumor Society, or NANETS', Multidisciplinary NET Medical Virtual Symposium: Oct. 2-3
Virtual 7th Immunotherapy of Cancer Conference, or ITOC7: Oct. 2-3
EURETINA 2020 Virtual Meeting: Oct. 2-4
世界肌肉協會,或WMS,25:虛擬大會:9月28-10月2.
年度東北肌萎縮側索硬化症,或Neals,會議:9月。30-10月1日
美國心力衰竭協會,或HFSA,2020年虛擬年度科學會議:9月。30-10月6.
虛擬傑富瑞細胞治療峯會:10月5日至6日
虛擬傑富瑞基因治療/編輯峯會:10月1日至2日
北美神經內分泌腫瘤學會,多學科網絡醫學虛擬研討會:10月2-3日
第七屆虛擬癌症免疫治療會議(ITOC7):10月2日至3日
EURETINA 2020虛擬會議:10月2日至4日
PDUFA Dates
PDUFA日期
The FDA is set to rule on Aquestive Therapeutics Inc's (NASDAQ:AQST) NDA for libervant (AQST-203) in seizure clusters. (Sunday)
FDA將就以下問題做出裁決Aqutive Treateutics Inc.的(納斯達克:AQST)在癲癇羣中對利凡特(AQST-203)的NDA。(星期日)
The regulatory agency is also scheduled to give its verdict on Eton Pharmaceuticals Inc's (NASDAQ:ETON) NDA for Alkindi Sprinkle, which is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age. (Tuesday)
該監管機構還計劃對伊頓製藥公司(納斯達克:伊頓公學)阿爾金迪噴灑的NDA,這是一種正在被評估為兒童腎上腺功能不全的替代療法,包括從出生到17歲以下患者的先天性腎上腺增生。(星期二)
Mesoblast limited (NASDAQ:MESO) awaits FDA decision on its BLA for remestemcel-L (MSC-100-IV) in steroid-refractory acute graft versus host disease in children. (Wednesday)
有限的中胚層(納斯達克:中觀)等待FDA關於其用於治療兒童激素難治性急性移植物抗宿主病的MSC-100-IV的BLA的決定。(星期三)
Roche Holdings AG's Basel (OTC:RHHBY) regulatory application seeking label expansion for Xolair to be used for chronic rhinosinusitis with nasal polyps has a PDUFA timeline of Q3
羅氏控股公司的巴塞爾(場外交易:RHHBY)尋求Xolair用於慢性鼻竇炎鼻息肉的標籤擴展的監管申請的PDUFA時間表為第三季度
Clinical Readouts
臨牀讀數
Capricor Therapeutics Inc (NASDAQ:CAPR) is scheduled to present at the WMS Congress, novel data from its Phase 2 HOPE-2 clinical trial of lead asset CAP-1002, in boys and young men with Duchenne muscular dystrophy. (Thursday afternoon)
Capricor治療公司(納斯達克:CAPR)計劃在WMS大會上展示其在患有Duchenne肌營養不良症的男孩和年輕男性中進行的鉛資產CAP-1002的第二階段HOPE-2臨牀試驗的新數據。(星期四下午)
Xencor Inc (NASDAQ:XNCR) will present at the NANETS symposium initial data from its Phase 1 dose-escalation study of tidutamab in patients with neuroendocrine tumors. (Friday)
Xencor Inc.(納斯達克:XNCR)將在NANETS研討會上展示其在神經內分泌腫瘤患者中進行的替度他單抗第一階段劑量遞增研究的初始數據。(星期五)
Spring Bank Pharmaceuticals Inc (NASDAQ:SBPH) is dure to present at the ITOC7, Phase 1a/1b data for intravenous SB 11285 in solid tumors
春銀醫藥股份有限公司(納斯達克:SBPH)期間在ITOC7,1a/1b階段展示了實體腫瘤靜脈注射SB 11285數據
MeiraGTx Holdings PLC (NASDAQ:MGTX) will present at the EURETINA meeting nine-month results from the ongoing Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa. (Saturday)
MeiraGTx控股公司(納斯達克:MGTX)將在EURETINA會議上公佈正在進行的AAV-RPGR 1/2期臨牀試驗的9個月結果,AAV-RPGR是一種治療X連鎖視網膜色素變性的研究基因療法。(星期六)
At the EURETINA meeting, Apellis Pharmaceuticals Inc (NASDAQ:APLS) will make a late-breaker oral presentation, of post hoc analysis of the Phase 2 FILLY study investigating intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. (Saturday)
在EURETINA會議上阿佩利斯製藥公司(納斯達克:APL)將對玻璃體內聚乙二醇胺計劃治療繼發於年齡相關性黃斑變性的地理萎縮的第二階段FILLY研究的後期分析進行後期口頭陳述。(星期六)
Cytokinetics, Inc. (NASDAQ:CYTK) is due to present at the HFSA meeting new data from the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil and additional results thee completed Phase 2 clinical trial which evaluated omecamtiv mecarbil in patients with heart failure with reduced ejection fraction.
細胞動力學公司(納斯達克:細胞色素TK)將在HFSA會議上提交奧卡米夫美卡比利的第三階段事件驅動心血管結果臨牀試驗的新數據和其他結果,該第二階段臨牀試驗評估了奧卡米夫美卡比利在射血分數減少的心力衰竭患者中的療效。
Q3 Releases
第三季度發佈
Ovid Therapeutics Inc (NASDAQ:OVID): results from the Phase 2 ARCADE trial in CDKL5 deficiency disorder and Dup15q syndrome, results from Phase 2 ELEKTRA trial in patients with Dravet syndrome and Lennox-Gastaut syndrome, and updated data from the ENDYMION open-label extension study in developmental and epileptic encephalopathies
奧維德治療公司(納斯達克:奧維德):CDKL5缺乏症和Dup15q綜合徵的第二階段拱廊試驗結果,Dravet綜合徵和Lennox-Gastaut綜合徵患者的Elektra第二階段試驗結果,以及發育和癲癇腦病Endymion開放標記擴展研究的最新數據
Selecta Biosciences Inc (NASDAQ:SELB): topline data from the head-to-head COMPARE trial of once-monthly dose of SEL-212 (ImmTOR + pegadricase) compared to biweekly doses of pegloticase in tophaceous gout
SELECTA生物科學公司(納斯達克:SELB):每月一次的SEL-212(ImmTor+聚乙二酸乙二醇酯)與兩週一次的聚乙二醇酯治療痛風的頭對頭對照試驗的主要數據
Synthetic Biologics Inc (NYSE:SYN): interim futility analysis of Phase 2b investigator-sponsored clinical trial of SYN-010, intended to treat irritable bowel syndrome-constipation
合成生物製品公司(紐約證券交易所:同步):研究人員贊助的2b期臨牀試驗SYN-010用於治療腸易激綜合徵-便祕的中期無效性分析
Cyclerion Therapeutics Inc (NASDAQ:CYCN): top-line results from the Phase 2 STRONG-SCD study of olinciguat, in sickle cell disease (late Q3)
環素治療公司(納斯達克:中青網):在鐮狀細胞病中對奧利西瓜特進行第二階段強SCD研究的主要結果(第三季度末)
Atara Biotherapeutics Inc (NASDAQ:ATRA): interim analysis of the tab-cel Phase 3 study in Epstein-Barr virus and post-transplant lymphoproliferative disease after solid organ transplant
Atara生物治療公司(納斯達克:全反式維甲酸):實體器官移植後EB病毒和移植後淋巴增生性疾病的TAB-CEL 3期研究的中期分析
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY): topline results from the ILLUMINATE-B Phase 3 study of lumasiran in primary hyperoxaluria type 1 patients less than six years of age with preserved renal function
Alnylam製藥公司(納斯達克:ALNY):對6歲以下腎功能保留的原發性高草酸尿症1型患者進行的盧馬西蘭的LIGHTINE-B期3期研究的TOPLINE結果
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA): results from Part B of the Phase 1/2 study of M254 in idiopathic thrombocytopenic purpura
Momenta製藥公司(納斯達克:MNTA):M254治療特發性血小板減少性紫癜的1/2期研究的B部分結果
Myovant Sciences Ltd (NYSE:MYOV): Castration-resistance free survival data for relugolix in prostate cancer
邁奧萬特科技有限公司(紐約證券交易所:MYOV):前列腺癌患者瑞盧格雷的無去勢耐藥生存數據
Ascendis Pharma A/S (NASDAQ:ASND): six-month data from the open-label extension portion of the PaTH Forward Trial evaluating TransCon for hypoparathyroidism
阿森迪斯醫藥A/S(納斯達克:ASND):來自Path Forward試驗開放標籤擴展部分的六個月數據,評估甲狀旁腺功能減退症的Transcons
Corbus Pharmaceuticals Holdings Inc (ASDAQ: CRBP): topline results from the Phase 2b study of lenabasum for cystic fibrosis
Corbus製藥控股公司(ASDAQ:CRBP):Lenabasum治療囊性纖維化的2b期研究的TOPLINE結果
Aerie Pharmaceuticals Inc (NASDAQ:AERI): Mercury 3 topline readout, highlighting Roclanda's intraocular pressure reducing performance compared to Ganfort
艾瑞製藥公司(納斯達克:AIR):水星3背線讀數,突出了Roclanda與Ganfort相比的降低眼壓性能
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX): Part 1 of galidesivir trial in COVID-19 patients (end of Q3) and data from the Phase 1 study of BCX9930 in treatment-naïve Paroxysmal nocturnal hemoglobinuria in patients
BioCryst製藥公司(納斯達克:BCRX):新冠肺炎患者伽利西韋試驗的第一部分(第三季度末)和BCX9930治療幼稚陣發性睡眠性血紅蛋白尿患者的第一階段研究的數據
September Releases
9月發佈
Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP): interim analysis of results for Phase 3 RELIEF trial of TNX-102 SL for the management of Fibromyalgia
東尼克斯製藥控股公司(納斯達克:TNXP):治療纖維肌痛的TNX-102 SL 3期緩解試驗的中期結果分析
Coronavirus Vaccine Updates
冠狀病毒疫苗最新進展
Moderna Inc (NASDAQ:MRNA): interim Phase 2 efficacy data of RNA-m1273 (Q3)
Moderna(納斯達克:MRNA3):RNA-m1273中期第二階段療效數據(第三季度)
Inovio Pharmaceuticals Inc (NASDAQ:INO): commencement of Phase 2/3 study of INO-4800 DNA vaccine candidate (September)
Inovio製藥公司(納斯達克:伊諾):INO-4800候選DNA疫苗第2/3階段研究開始(9月)
Regeneron Pharmaceuticals Inc (NASDAQ:REGN): initial virology and biomarker data Phase 2/3 trial REGN-COV2, an antiviral antibody, in COVID-19 (September)
Regeneron製藥公司(納斯達克:註冊):初步病毒學和生物標記物數據2/3期試驗REGN-COV2,一種抗病毒抗體,在新冠肺炎(9月)
Earnings
收益
AngioDynamics, Inc. (NASDAQ:ANGO) (Tuesday, before the market open)
AngioDynamics,Inc.(納斯達克:安戈(星期二,開盤前)
IPOs
首次公開募股
Exton, Pennsylvania-based Immunome, Inc. has filed with the SEC a preliminary prospectus to offer 2.5 million shares of its common stock in an initial public offering, or IPO. The biopharma, which uses its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, said it expects to price the offering between $11 and $13. The company has applied for listing its shares on the Nasdaq under the ticker symbol IMNM.
總部位於賓夕法尼亞州埃克斯頓免疫組織公司已向美國證券交易委員會提交了初步招股説明書,擬在首次公開募股(IPO)中發行250萬股其普通股。這家生物製藥公司利用其專有的人類記憶B細胞平臺發現和開發一流的抗體療法。該公司表示,預計發行價在11美元至13美元之間。該公司已申請在納斯達克上市,股票代碼為IMNM。
Pulmonx Corporation, a commercial-stage MedTech company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease, has filed for a 6.67-million IPO at an estimated price range of $14-$16. The Redwood City, California-based company has applied for listing its shares on the Nasdaq under the ticker symbol LUNG.
普爾蒙克斯公司,這是一家商業階段的醫療科技公司,為患有嚴重肺氣腫的患者提供微創治療。該公司已提交667萬股IPO申請,預計發行價區間為14-16美元。這家總部位於加利福尼亞州雷德伍德城的公司已申請在納斯達克上市,股票代碼為LONG。
IPO Quiet Period Expiry
IPO靜默期到期
PainReform Ltd (NASDAQ:PRFX)
畫廊改革有限公司(納斯達克:PRFX)
譯文內容由第三人軟體翻譯。