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.
隨着更廣泛的市場樂觀情緒瀰漫到生物科技股中,截至12月5日的一週,生物科技股走高。該部門還繼續從疫苗相關的積極消息流中獲得支持。
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(納斯達克:MRNA3)在本週初報告了積極的主要療效和安全性數據,並向美國食品和藥物管理局申請了緊急使用授權。
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.
這一週還見證了在虛擬的美國血液學會年會上的多場演講。
Four biotechs made their Wall Street debuts this week, raising a combined $782.5 billion in gross proceeds from initial public offerings.
四家生物技術公司本週在華爾街首次亮相,從首次公開募股(IPO)中總共籌集了7825億美元的資金。
Here are the key catalysts for the upcoming week:
以下是即將到來的一週的關鍵催化劑:
FDA Meeting On Pfizer-BioNTech Vaccine
FDA召開輝瑞-BioNtech疫苗會議
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的疫苗和相關生物製品諮詢委員會將於12月10日(星期四)舉行公開會議,討論輝瑞和BioNTech開發的疫苗的緊急使用授權。這是這部正在上演的新冠肺炎疫苗傳奇故事中最受期待的時間點之一。這可能決定一些美國人是否最早在第二天開始接種疫苗。英國將於週二開始接種疫苗。
Conferences
會議
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
美國癲癇學會年會(虛擬活動):12月4日至8日
第62屆美國血液學會年會和博覽會虛擬活動:12月5日至8日
聖安東尼奧乳腺癌研討會,或SABCS,將於12月8日至11日舉行
ESMO免疫腫瘤學虛擬大會:12月9日至12日
Clinical Readouts/Presentations
臨牀讀數/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治療公司(納斯達克:SRPT)將於週一公佈Momentum研究的中期數據,這是SRP-5051的多劑量遞增劑量臨牀試驗,用於治療Duchenne肌營養不良症。
ASH Conference Presentations
ASH大會演講
Sunday
星期天
Erytech Pharma SA (NASDAQ:ERYP): results of Phase 2 trial of eryaspase in acute lymphoblastic leukemia patients
艾瑞泰克製藥公司(納斯達克:ERYP):急性淋巴細胞性白血病患者使用赤黴素酶的第二階段試驗結果
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.(納斯達克:伊姆拉):正在進行的IMR-687階段2a開放標籤延伸臨牀試驗在成人鐮狀細胞疾病患者中的數據
Blueprint Medicines Corp (NASDAQ:BPMC): Overall survival data in patients with advanced systemic mastocytosis receiving avapritinib in the Phase I EXPLORER study
藍圖醫藥公司(納斯達克:BPMC):在I期探索性研究中,接受Avapritinib治療的晚期系統性肥大細胞增多症患者的總體生存數據
Protagonist Therapeutics Inc (NASDAQ:PTGX): updated results from the Phase 2 proof-of-concept study of PTG-300 in polycythemia vera
主人公治療公司(納斯達克:PTGX):PTG-300治療真性紅細胞增多症第二階段概念驗證研究的最新結果
Xencor Inc (NASDAQ:XNCR): Updated results from Phase 1 studies of vibecotamab in acute myeloid leukemia
Xencor Inc.(納斯達克:XNCR):Vibecotamab治療急性髓系白血病1期研究的最新結果
Rocket Pharmaceuticals Inc (NASDAQ:RCKT): Phase 1 study of lentiviral mediated gene therapy for pyruvate kinase deficiency
火箭製藥公司(納斯達克:RCKT):慢病毒介導的丙酮酸激酶缺乏症基因治療的第一階段研究
Beigene Ltd (NASDAQ:BGNE): initial results from the MAGNOLIA Phase 2 trial of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma
百濟神州有限公司(納斯達克:BGNE):Zanubrutinib治療復發/難治性邊緣帶淋巴瘤患者的白玉蘭2期試驗的初步結果
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(納斯達克:MGNX):在初次誘導失敗和早期復發的急性髓系白血病中,FLOTITUZUMAB的1/2期數據
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治療公司(紐約證券交易所:ADCT):對復發或難治性霍奇金淋巴瘤患者進行的抗體-藥物結合物喜樹單抗替西林(CAMI)2期研究的初步結果;聯合伊布魯替尼治療復發/難治性瀰漫性大B細胞淋巴瘤的中期結果
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製藥公司(納斯達克:SNDX):抗CSF-1R單抗Axatilimab在慢性移植物抗宿主病患者中的1期試驗的最新數據
CTI BioPharma Corp (NASDAQ:CTIC): results from the Phase 1/2 study of pacritinib in graft-versus-host disease
CTI BioPharma公司(納斯達克:CTIC):帕利替尼治療移植物抗宿主病的1/2期研究結果
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.(納斯達克:APTO):CG-806在復發或難治性慢性淋巴細胞白血病/小淋巴細胞性淋巴瘤或非霍奇金淋巴瘤患者中的1a/b期劑量遞增研究數據
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.(納斯達克:HGEN):複發性或難治性大B細胞淋巴瘤患者使用lenzilumab和axicabagene cilolucel進行1/2期多中心研究的結果
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
藍鳥生物公司(納斯達克:藍色):來自第1/2期HGB-206期LentiGlobin用於鐮狀細胞病基因治療的C組患者的最新結果
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
火箭製藥:慢病毒介導的針對患有嚴重白細胞黏附缺陷的兒童患者的體外基因治療的1/2期研究-I和全球範可尼貧血RP-L102臨牀研究的最新結果
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
百濟神州:扎努布替尼對沃爾登斯特倫巨球蛋白血癥患者的第2期研究數據以及扎努布替尼對復發/難治性B細胞腫瘤患者的第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.(納斯達克:Stro):B細胞非霍奇金淋巴瘤患者STRO-001的額外第一階段劑量遞增數據
Precigen Inc (NASDAQ:PGEN): initial Phase 1 data for PRGN-3006 in myelodysplastic syndromes and acute myeloid leukemia
Precigen Inc.(納斯達克:PGEN):PRGN-3006在骨髓增生異常綜合徵和急性髓系白血病中的初始1期數據
Forma Therapeutics Holdings Inc (NASDAQ:FMTX): data from the Phase 1 study of FT-4202 in patients with Sickle Cell Disease
Forma治療控股公司(納斯達克:FMTX):來自鐮狀細胞病患者FT-4202一期研究的數據
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(納斯達克:AUTL):AUTO1在急性淋巴細胞白血病中的長期隨訪數據,以及AUT03在瀰漫性大B細胞淋巴瘤中的最新2期數據和長期隨訪數據
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
庫里斯股份有限公司(納斯達克:CRIS):CA-4948在復發或難治性血液系統惡性腫瘤患者中的第一階段研究結果,以及評估CA-4948在急性髓細胞白血病或骨髓增生異常綜合徵患者中的第一階段開放劑量遞增試驗的結果(藥代動力學和活性)
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治療公司普通股(納斯達克:TGTX):來自治療初治和復發/難治性慢性淋巴細胞白血病患者的umbralisib加ublituximab的3期unity-CLL研究結果,以及正在評估umbralisib用於復發或難治性惰性非霍奇金淋巴瘤患者的2期全球unity-NHL試驗的結果
Agios Pharmaceuticals Inc (NASDAQ:AGIO): Phase 1 multiple ascending dose study data for mitapivat in subjects with sickle cell disease
Agios製藥公司(納斯達克:阿吉奧):鐮狀細胞病受試者中米他匹特的第一階段多次遞增劑量研究數據
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
果園治療公司-ADR(納斯達克:ORTX):數據來自在OTL-201概念驗證研究中治療的第一名患者,這是一種正在研究的體外自體造血幹細胞基因療法,用於治療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
延齡治療公司(納斯達克:Tril):針對復發或難治性血液系統惡性腫瘤患者的生物靶向CD47的TTI-621的第一階段劑量升級和擴大研究的最新進展
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
阿洛維公司(納斯達克:ALVR):ALVR106治療造血幹細胞移植後嚴重、耐藥病毒感染患者的第二階段研究結果
GlycoMimetics Inc (NASDAQ:GLYC) and Pfizer: Phase 3 data for rivipansel in vaso-occlusive crisis of sickle cell disease
GlycoMimtics公司(納斯達克:糖類)和輝瑞:利福平在鐮狀細胞病血管閉塞危象中的3期數據
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.(納斯達克:ONCT):套細胞淋巴瘤和慢性淋巴細胞白血病患者的數據更新,在1/2期研究中使用Cirmtuzumab加ibrutinib治療
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(納斯達克:Qure):來自第三階段HOPE-B基因治療試驗的第一個數據,評估了Etranacogene Dezparvovec,一種AAV5-Padua hFIX變體,代號為AMT-061,在患有嚴重或中-重度血友病B的成年人中接受治療,而不考慮先前存在的抗衣殼中和抗體(美國東部時間上午11:45)
SABCS Presentations
SABCS演講
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生物科學公司(納斯達克:EVLO):EDP1503在三陰性乳腺癌的1/2期試驗的額外數據海報展示
Athenex Inc (NASDAQ:ATNX): Phase 2 data for oral Paclitaxel and Encequidar in the treatment of cutaneous angiosarcoma, the breast angiosarcoma group
Athenex Inc.(納斯達克:ATNX):口服紫杉醇和恩奎達治療皮膚血管肉瘤的2期數據,乳腺血管肉瘤組
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
溶瘤生物技術:通過溶瘤呼腸孤病毒聯合抗PD-L1阿維盧單抗和紫杉醇誘導轉移性乳腺癌炎症表型來評估總體應答率的第二階段研究
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治療公司(納斯達克:GTHX):轉移性三陰性乳腺癌患者聯合吉西他濱/卡鉑治療的Triaciclib第二階段數據的最終分析(星期三,上午10點)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)
彪馬生物技術公司(納斯達克:PBYI):奈拉替尼+曲妥珠單抗+弗維斯特治療HER2突變、HR陽性、轉移性乳腺癌的頂峯第二階段試驗中乳腺癌隊列的最新發現;NER2陽性早期乳腺癌患者第三階段研究的最終總體生存分析(均在週三)
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)
先天醫藥公司(納斯達克:IPHA):研究Monalizumab和西妥昔單抗聯合治療復發或轉移性頭頸部鱗狀細胞癌患者的第二階段研究的最新結果(週三)
Earnings
收益
譯文內容由第三人軟體翻譯。