Week Ahead In Biotech: FDA To Decide On Emergency Use Of Pfizer's COVID Vaccine, Hematology Conference Presentations Pick Up Pace
Week Ahead In Biotech: FDA To Decide On Emergency Use Of Pfizer's COVID Vaccine, Hematology Conference Presentations Pick Up Pace
Biotech stocks headed higher in the week ended Dec. 5 as broader market optimism pervaded into the sector. The sector also continued to get support from vaccine-related positive news flow.
随着更广泛的市场乐观情绪弥漫到生物科技股中,截至12月5日的一周,生物科技股走高。该部门还继续从疫苗相关的积极消息流中获得支持。
The biggest headline of the week was the first-ever emergency-use authorization of a coronavirus vaccine candidate. The U.K. became the first country to conditionally approve a vaccine, as the nation's regulator gave its nod to Pfizer Inc. (NYSE:PFE) and BioNTech SE – ADR (NASDAQ:BNTX) for their mRNA vaccine, BNT162b2. The timeline for authorizations elsewhere has also been set.
Moderna Inc (NASDAQ:MRNA) reported at the start of the week positive primary efficacy and safety data, and also filed for emergency use authorization with the U.S. Food and Drug Administration.
Moderna(纳斯达克:MRNA3)在本周初报告了积极的主要疗效和安全性数据,并向美国食品和药物管理局申请了紧急使用授权。
Meanwhile, Novavax, Inc. (NASDAQ:NVAX) hinted at a delay in the U.S. leg of the Phase 3 study of its vaccine candidate. And Inovio Pharmaceuticals Inc (NASDAQ:INO), which also is working on a vaccine, added a new contract development and manufacturing organization (CDMO) to its consortium of partners.
The two FDA decisions slated for the week led to positive results, with the agency approving Vanda Pharmaceuticals Inc.'s (NASDAQ:VNDA) sleep disorder drug and BioCryst Pharmaceuticals, Inc.'s (NASDAQ:BCRX) treatment for hereditary angioedema.
The week also witnessed multiple presentations at the virtual American Society of Hematology annual meeting.
这一周还见证了在虚拟的美国血液学会年会上的多场演讲。
Four biotechs made their Wall Street debuts this week, raising a combined $782.5 billion in gross proceeds from initial public offerings.
四家生物技术公司本周在华尔街首次亮相,从首次公开募股(IPO)中总共筹集了7825亿美元的资金。
Here are the key catalysts for the upcoming week:
以下是即将到来的一周的关键催化剂:
FDA Meeting On Pfizer-BioNTech Vaccine
FDA召开辉瑞-BioNtech疫苗会议
The FDA's Vaccines and Related Biological Products Advisory Committee will meet Dec. 10 (Thursday) in an open session to discuss emergency use authorization of the vaccine developed by Pfizer and BioNTech. This is one of the most highly anticipated points in the timeline of this unfolding COVID-19 vaccine saga. It could determine whether some Americans start getting vaccines as soon as the next day. Vaccinations are set to begin in the U.K. on Tuesday.
FDA的疫苗和相关生物制品咨询委员会将于12月10日(星期四)举行公开会议,讨论辉瑞和BioNTech开发的疫苗的紧急使用授权。这是这部正在上演的新冠肺炎疫苗传奇故事中最受期待的时间点之一。这可能决定一些美国人是否最早在第二天开始接种疫苗。英国将于周二开始接种疫苗。
Conferences
会议
American Epilepsy Society, or AES, Annual Meeting (virtual event): Dec. 4-8
62nd American Society of Hematology, or ASH, Annual Meeting and Exposition virtual event: Dec. 5-8
San Antonio Breast Cancer Symposium, or SABCS, being held virtually: December 8-11
ESMO Immuno-oncology Virtual Congress: Dec. 9-12
美国癫痫学会年会(虚拟活动):12月4日至8日
第62届美国血液学会年会和博览会虚拟活动:12月5日至8日
圣安东尼奥乳腺癌研讨会,或SABCS,将于12月8日至11日举行
ESMO免疫肿瘤学虚拟大会:12月9日至12日
Clinical Readouts/Presentations
临床读数/演示
Sarepta Therapeutics Inc (NASDAQ:SRPT) will present on Monday interim data from the MOMENTUM study, a multiple-ascending dose clinical trial of SRP-5051, for the treatment of Duchenne muscular dystrophy.
Sarepta治疗公司(纳斯达克:SRPT)将于周一公布Momentum研究的中期数据,这是SRP-5051的多剂量递增剂量临床试验,用于治疗Duchenne肌营养不良症。
ASH Conference Presentations
ASH大会演讲
Sunday
星期天
Erytech Pharma SA (NASDAQ:ERYP): results of Phase 2 trial of eryaspase in acute lymphoblastic leukemia patients
艾瑞泰克制药公司(纳斯达克:ERYP):急性淋巴细胞性白血病患者使用赤霉素酶的第二阶段试验结果
Imara Inc (NASDAQ:IMRA): data from the ongoing IMR-687 Phase 2a open label extension clinical trial in adult patients with sickle cell disease
Imara Inc.(纳斯达克:伊姆拉):正在进行的IMR-687阶段2a开放标签延伸临床试验在成人镰状细胞疾病患者中的数据
Blueprint Medicines Corp (NASDAQ:BPMC): Overall survival data in patients with advanced systemic mastocytosis receiving avapritinib in the Phase I EXPLORER study
蓝图医药公司(纳斯达克:BPMC):在I期探索性研究中,接受Avapritinib治疗的晚期系统性肥大细胞增多症患者的总体生存数据
Protagonist Therapeutics Inc (NASDAQ:PTGX): updated results from the Phase 2 proof-of-concept study of PTG-300 in polycythemia vera
主人公治疗公司(纳斯达克:PTGX):PTG-300治疗真性红细胞增多症第二阶段概念验证研究的最新结果
Xencor Inc (NASDAQ:XNCR): Updated results from Phase 1 studies of vibecotamab in acute myeloid leukemia
Xencor Inc.(纳斯达克:XNCR):Vibecotamab治疗急性髓系白血病1期研究的最新结果
Rocket Pharmaceuticals Inc (NASDAQ:RCKT): Phase 1 study of lentiviral mediated gene therapy for pyruvate kinase deficiency
火箭制药公司(纳斯达克:RCKT):慢病毒介导的丙酮酸激酶缺乏症基因治疗的第一阶段研究
Beigene Ltd (NASDAQ:BGNE): initial results from the MAGNOLIA Phase 2 trial of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma
百济神州有限公司(纳斯达克:BGNE):Zanubrutinib治疗复发/难治性边缘带淋巴瘤患者的白玉兰2期试验的初步结果
MacroGenics Inc (NASDAQ:MGNX): Phase 1/2 data for flotetuzumab in primary induction failure and early relapse acute myeloid leukemia
宏基基因公司(纳斯达克:MGNX):在初次诱导失败和早期复发的急性髓系白血病中,FLOTITUZUMAB的1/2期数据
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) & Crispr Therapeutics AG (NASDAQ:CRSP): results from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9 gene-editing therapy CTX001 in patients with sickle cell disease and beta thalassemia.
ADC Therapeutics SA (NYSE:ADCT): preliminary results of a Phase 2 study of camidanlumab tesirine (Cami), an antibody-drug conjugate, in patients with relapsed or refractory Hodgkin lymphoma; interim results of loncastuximab tesirine combined with ibrutinib in relapsed/refractory diffuse large B-cell lymphoma
ADC治疗公司(纽约证券交易所:ADCT):对复发或难治性霍奇金淋巴瘤患者进行的抗体-药物结合物喜树单抗替西林(CAMI)2期研究的初步结果;联合伊布鲁替尼治疗复发/难治性弥漫性大B细胞淋巴瘤的中期结果
Syndax Pharmaceuticals Inc (NASDAQ:SNDX): updated data from the Phase 1 trial of axatilimab, its anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease
Syndax制药公司(纳斯达克:SNDX):抗CSF-1R单抗Axatilimab在慢性移植物抗宿主病患者中的1期试验的最新数据
CTI BioPharma Corp (NASDAQ:CTIC): results from the Phase 1/2 study of pacritinib in graft-versus-host disease
CTI BioPharma公司(纳斯达克:CTIC):帕利替尼治疗移植物抗宿主病的1/2期研究结果
Aptose Biosciences Inc (NASDAQ:APTO): data from the Phase 1a/b dose escalation study of CG-806 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or Non-Hodgkin's Lymphomas
Aptose Biosciences Inc.(纳斯达克:APTO):CG-806在复发或难治性慢性淋巴细胞白血病/小淋巴细胞性淋巴瘤或非霍奇金淋巴瘤患者中的1a/b期剂量递增研究数据
Johnson & Johnson (NYSE:JNJ) & Halozyme Therapeutics, Inc. (NASDAQ:HALO): primary data from the Phase 3 APOLLO study of subcutaneous daratumumab in combination with pomalidomide and dexamethasone in patients with multiple myeloma who have received one or more prior lines of therapy
Humanigen Inc (NASDAQ:HGEN): results from the Phase 1/2 multi-center study of lenzilumab and axicabtagene ciloleucel in patients with relapsed or refractory large B cell lymphoma
Humanigen Inc.(纳斯达克:HGEN):复发性或难治性大B细胞淋巴瘤患者使用lenzilumab和axicabagene cilolucel进行1/2期多中心研究的结果
Imv Inc (NASDAQ:IMV): updated data from phase 2 SPiReL study evaluating IMV's T cell therapy - DPX-Survivac - in combination with Merck & Co., Inc.'s (NYSE:MRK) Keytruda in patients with relapsed / refractory diffuse large B cell lymphoma
Related Link: What Pfizer, BioNTech Investors Need To Know About COVID-19 Vaccine With Conditional UK Approval
Monday
星期一
Bluebird bio Inc (NASDAQ:BLUE): updated results from patients in Group C of the Phase 1/2 HGB-206 study of lentiGlobin for sickle cell disease gene therapy
蓝鸟生物公司(纳斯达克:蓝色):来自第1/2期HGB-206期LentiGlobin用于镰状细胞病基因治疗的C组患者的最新结果
Rocket Pharmaceuticals: Phase 1/2 study of lentiviral-mediated ex-vivo gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I and updated results from global clinical studies of RP-L102 in Fanconi anemia
火箭制药:慢病毒介导的针对患有严重白细胞黏附缺陷的儿童患者的体外基因治疗的1/2期研究-I和全球范可尼贫血RP-L102临床研究的最新结果
Beigene: data from the Phase 2 study of zanubrutinib in patients with Waldenström macroglobulinemia as well as Phase 2 study of zanubrutinib in patients with relapsed/refractory B-cell malignancies
百济神州:扎努布替尼对沃尔登斯特伦巨球蛋白血症患者的第2期研究数据以及扎努布替尼对复发/难治性B细胞肿瘤患者的第2期研究
Sutro Biopharma Inc (NASDAQ:STRO): additional Phase 1 dose-escalation data for STRO-001 in patients with B-cell non-Hodgkin lymphoma
Sutro Biophma Inc.(纳斯达克:Stro):B细胞非霍奇金淋巴瘤患者STRO-001的额外第一阶段剂量递增数据
Precigen Inc (NASDAQ:PGEN): initial Phase 1 data for PRGN-3006 in myelodysplastic syndromes and acute myeloid leukemia
Precigen Inc.(纳斯达克:PGEN):PRGN-3006在骨髓增生异常综合征和急性髓系白血病中的初始1期数据
Forma Therapeutics Holdings Inc (NASDAQ:FMTX): data from the Phase 1 study of FT-4202 in patients with Sickle Cell Disease
Forma治疗控股公司(纳斯达克:FMTX):来自镰状细胞病患者FT-4202一期研究的数据
Autolus Therapeutics PLC (NASDAQ:AUTL): longer term follow-up data for AUTO1 in acute lymphoblastic leukemia, and updated Phase 2 data and longer-term follow up data for AUTO3 in diffuse large B cell lymphoma
Autolus Treeutics PLC(纳斯达克:AUTL):AUTO1在急性淋巴细胞白血病中的长期随访数据,以及AUT03在弥漫性大B细胞淋巴瘤中的最新2期数据和长期随访数据
Curis, Inc. (NASDAQ:CRIS): results (pharmacokinetics and activity) from the Phase 1 study of CA-4948 in patient with relapsed or refractory hematologic malignancies, and results from the Phase 1 open-label dose escalation trial evaluating CA-4948 in patients with acute myelogenous leukemia or myelodysplastic syndrome
库里斯股份有限公司(纳斯达克:CRIS):CA-4948在复发或难治性血液系统恶性肿瘤患者中的第一阶段研究结果,以及评估CA-4948在急性髓细胞白血病或骨髓增生异常综合征患者中的第一阶段开放剂量递增试验的结果(药代动力学和活性)
TG Therapeutics Inc common stock (NASDAQ:TGTX): results from the Phase 3 UNITY-CLL study of umbralisib plus ublituximab in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia, and results from the Phase 2 global UNITY-NHL trial that is evaluating umbralisib in patients with relapsed or refractory indolent non-Hodgkin's lymphoma
TG治疗公司普通股(纳斯达克:TGTX):来自治疗初治和复发/难治性慢性淋巴细胞白血病患者的umbralisib加ublituximab的3期unity-CLL研究结果,以及正在评估umbralisib用于复发或难治性惰性非霍奇金淋巴瘤患者的2期全球unity-NHL试验的结果
Agios Pharmaceuticals Inc (NASDAQ:AGIO): Phase 1 multiple ascending dose study data for mitapivat in subjects with sickle cell disease
Agios制药公司(纳斯达克:阿吉奥):镰状细胞病受试者中米他匹特的第一阶段多次递增剂量研究数据
Orchard Therapeutics PLC – ADR (NASDAQ:ORTX): data from the first patient treated in the proof-of-concept study of OTL-201, an investigational ex vivo autologous hematopoietic stem cell gene therapy being studied for the treatment of mucopolysaccharidosis type IIIA
果园治疗公司-ADR(纳斯达克:ORTX):数据来自在OTL-201概念验证研究中治疗的第一名患者,这是一种正在研究的体外自体造血干细胞基因疗法,用于治疗IIIA型粘多糖病
Trillium Therapeutics Inc (NASDAQ:TRIL): updates from Phase 1 dose escalation and expansion study of TTI-621, a biologic targeting CD47, in patients with relapsed or refractory hematologic malignancies
延龄治疗公司(纳斯达克:Tril):针对复发或难治性血液系统恶性肿瘤患者的生物靶向CD47的TTI-621的第一阶段剂量升级和扩大研究的最新进展
Allovir Inc (NASDAQ:ALVR): results from a Phase 2 study of ALVR106 for treating severe, drug-refractory viral infections in patients following hematopoietic stem cell transplantation
阿洛维公司(纳斯达克:ALVR):ALVR106治疗造血干细胞移植后严重、耐药病毒感染患者的第二阶段研究结果
GlycoMimetics Inc (NASDAQ:GLYC) and Pfizer: Phase 3 data for rivipansel in vaso-occlusive crisis of sickle cell disease
GlycoMimtics公司(纳斯达克:糖类)和辉瑞:利福平在镰状细胞病血管闭塞危象中的3期数据
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Fortress Biotech (NASDAQ:FBIO): Phase 2 dose selection study data for CAEL-101 in patients with AL amyloidosis
Oncternal Therapeutics Inc (NASDAQ:ONCT): data update for patients with mantle cell lymphoma and chronic lymphocytic leukemia, treated with cirmtuzumab plus ibrutinib in a Phase 1/2 study
Onctal Treeutics Inc.(纳斯达克:ONCT):套细胞淋巴瘤和慢性淋巴细胞白血病患者的数据更新,在1/2期研究中使用Cirmtuzumab加ibrutinib治疗
Tuesday
星期二
Uniqure NV (NASDAQ:QURE): first data from the Phase 3 HOPE-B gene therapy trial evaluating efficacy and safety of Etranacogene Dezaparvovec, a AAV5-Padua hFIX variant and codenamed AMT-061, in adults with severe or moderate-severe hemophilia B treated irrespective of pre-existing anti-capsid neutralizing antibodies (11:45 am ET)
UnQure NV(纳斯达克:Qure):来自第三阶段HOPE-B基因治疗试验的第一个数据,评估了Etranacogene Dezparvovec,一种AAV5-Padua hFIX变体,代号为AMT-061,在患有严重或中-重度血友病B的成年人中接受治疗,而不考虑先前存在的抗衣壳中和抗体(美国东部时间上午11:45)
SABCS Presentations
SABCS演讲
Infinity Pharmaceuticals Inc. (NASDAQ:INFI) and Arcus Biosciences Inc (NYSE:RCUS): Efficacy and safety of Arcus' etrumadenant + pegylated liposomal doxorubicin ± Infinity's eganelisib in participants with metastatic ovarian and triple negative breast cancer (Wednesday, 2 a.m. ET)
Infinity Pharma: Poster presentation on initial Phase 2 data from the study evaluating a triple combo of Infinity's eganelisib, Roche Holdings AG's Basel ADR Common Stock (OTC:RHHBY) Tecentriq and Bristol-Myers Squibb Co (NYSE:BMY) chemotherapy medication Arabaxane as first-line therapy for locally advanced or metastatic triple-negative breast cancer (Wednesday, 2 a.m. ET)
Evelo Biosciences Inc (NASDAQ:EVLO): Poster presentation of additional data from Phase 1/2 trial of EDP1503 in triple-negative breast cancer
Evelo生物科学公司(纳斯达克:EVLO):EDP1503在三阴性乳腺癌的1/2期试验的额外数据海报展示
Athenex Inc (NASDAQ:ATNX): Phase 2 data for oral Paclitaxel and Encequidar in the treatment of cutaneous angiosarcoma, the breast angiosarcoma group
Athenex Inc.(纳斯达克:ATNX):口服紫杉醇和恩奎达治疗皮肤血管肉瘤的2期数据,乳腺血管肉瘤组
Incyte Corporation (NASDAQ:INCY) & Oncolytics Biotech, Inc. (NASDAQ:ONCY): poster presentation of phase 2 data for Incyte's retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer (Wednesday, 9 a.m. ET)
Oncolytics Biotech: Phase 2 study to assess overall response rate by inducing an inflammatory phenotype in metastatic breast cancer with the oncolytic reovirus pelareorep in combination with anti-PD-L1 avelumab and paclitaxel
溶瘤生物技术:通过溶瘤呼肠孤病毒联合抗PD-L1阿维卢单抗和紫杉醇诱导转移性乳腺癌炎症表型来评估总体应答率的第二阶段研究
G1 Therapeutics Inc (NASDAQ:GTHX): final analysis of Phase 2 data for trilaciclib in combination of gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer (Wednesday, 10 a.m. to 11:15 a.m.)
G1治疗公司(纳斯达克:GTHX):转移性三阴性乳腺癌患者联合吉西他滨/卡铂治疗的Triaciclib第二阶段数据的最终分析(星期三,上午10点)至上午11:15)
Puma Biotechnology Inc (NASDAQ:PBYI): Latest findings from the breast cancer cohort in the SUMMIT Phase 2 study of 'basket' trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, HR-positive, metastatic breast cancer; Final overall survival analysis from the phase 3 study of neratinib in patients with HER2-positive early-stage breast cancer (both on Wednesday)
彪马生物技术公司(纳斯达克:PBYI):奈拉替尼+曲妥珠单抗+弗维斯特治疗HER2突变、HR阳性、转移性乳腺癌的顶峰第二阶段试验中乳腺癌队列的最新发现;NER2阳性早期乳腺癌患者第三阶段研究的最终总体生存分析(均在周三)
ESMO Presentations
ESMO演示文稿
Innate Pharma SA (NASDAQ:IPHA): updated results from a Phase 2 study investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (Wednesday)
先天医药公司(纳斯达克:IPHA):研究Monalizumab和西妥昔单抗联合治疗复发或转移性头颈部鳞状细胞癌患者的第二阶段研究的最新结果(周三)
Earnings
收益
译文内容由第三方软件翻译。