Weekly Biotech Review/Biotech 일정

이번주 제약-바이오 주요 일정 20201108

약 장 수 2020. 11. 9. 07:09
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이번주 제약-바이오의 임상시험 결과 발표, 신약 승인, 실적 발표 일정입니다.

 

약장수 텔레그램 채널

 

지난주 제약-바이오 섹터의 주요 이벤트들은 아래 포스팅에 정리.

오늘 아침 제약-바이오 주요 소식 20201102

오늘 아침 제약-바이오 주요 소식 20201103

오늘 아침 제약-바이오 주요 소식 20201104

오늘 아침 제약-바이오 주요 소식 20201105

오늘 아침 제약-바이오 주요 소식 20201106

 

날자/시간은 모두 미국 현지 시간.

 

 

학회/투자자 미팅

이번주 – 다음주에 걸쳐 면역항암제 학회 SITC, 간 학회 AASLD 등 중요한 학회가 많이 있음.

11/5 - 11/9 American College of Rheumatology, or ACR, Convergence 2020

11/9 - 11/10 Credit Suisse 29th Annual Virtual Healthcare Conference

11/9 - 11/14 35th Annual Meeting of The Society for Immunotherapy of Cancer, or SITC

11/13 - 11/15 American Academy of Ophthalmology, or AAO, 2020 Virtual meeting

11/13 - 11/16 American Association for the Study of Liver Diseases, or AASLD, The Liver Meeting, Digital Experience

11/13 - 11/17 American Heart Association, or AHA, Scientific Sessions 2020

 

 

PDUFA

Supernus Pharmaceuticals Inc (SUPN): 11/8 . SPN-812, 주의력 결핍 장애 (ADHD)

Sanofi SA (SNY): 11/14 . sutimlimab, 저온응집병 (cold agglutinin disease)

 

 

SITC 발표 (11/9 - 11/14 )

Gossamer Bio Inc (GOSS): 고형암 대상 GB1275 + Keytruda 병용 임상 1/2KEYNOTE-A36 잠정 데이터

Corvus Pharmaceuticals Inc (CRVS): COVID-19 대상 CPI-006 임상 1

I-Mab ADR (IMAB): lemzoparlimab (TJC4, CD47) 결과

Iovance Biotherapeutics Inc (IOVA): 두경부암 대상 LN-145 + Keytruda 임상 2상 중간 결과

MacroGenics Inc (MGNX): HER2 양성 암 대상 tebotelimab + margetuximab 병용 임상 1상 업데이트

Genocea Biosciences Inc (GNCA): 고형암 대상 GEN-009 (neoantigen vaccine) + PD-1 checkpoint inhibitors 임상 1/2aGEN-009-101

 

기타 SITC 발표 기업들

Fate Therapeutics Inc (FATE)

Celldex Therapeutics Inc(CLDX)

Amgen Inc (AMGN)

Leap Therapeutics Inc (LPTX)

Arcus Biosciences Inc (RCUS)

Nektar Therapeutics (NKTR)

OncoSec Medical Inc (ONCS)

Repligen Corporation (RGEN)

Checkmate Pharmaceuticals Inc (CMPI)

Agenus Inc (AGEN)

Curis Inc (CRIS)

Adaptimmune Therapeutics PLC ADR (ADAP)

Xencor Inc (XNCR)

ALX Oncology Holdings Inc (ALXO)

Spring Bank Pharmaceuticals Inc (SBPH)

BioNTech SE ADR (BNTX)

Genmab 10 Sponsored ADR (GMAB)

Imv Inc (IMV)

Cue Biopharma Inc (CUE)

Advaxis Inc (ADXS)

 

 

ACR 결과 발표 (11/5 - 11/9 )

Navidea Biopharmaceuticals Inc (NAVB): 류마티스성 관절염에 대한 NAV3-31 임상 2b상 두번째 중간 결과

Kiniksa Pharmaceuticals Ltd (KNSA): 거세포동맥염 (giant cell arteritis) 대상 mavrilimumab의 임상 2

 

 

AASLD 결과 발표 (11/13 - 11/16 )

NGM Biopharmaceuticals Inc (NGM): NASH 대상 aldafermin 임상 2상 코호트 4 24주차 결과

Metacrine Inc (MTCR): NASH 대상 MET409 임상 1b상 결과

Madrigal Pharmaceuticals Inc (MDGL): NASH 대상 resmetirom의 임상 3MAESTRO 초기 결과 / NAFLD 대상 resmetirom의 임상 3MAESTRO-NAFLD-1 오픈레이블 결과

89bio Inc (ETNB): NASH 대상 BIO89-100의 임상 1b/2a상 결과

CymaBay Therapeutics Inc (CBAY): NASH 대상 seladelpar의 임상 2상 결과

DURECT Corporation (DRRX): NASH 대상 DUR-928의 임상 1b상 결과

Can Fite Biopharma ADR (CANF): NAFLDNASH 대상 namodenoson의 임상 2상 결과

 

 

AHA 결과 발표 (11/13 - 11/17 )

Cytokinetics Inc (CYTK), Amgen Inc (AMGN): 급성 심부전에 대한 omecamtiv mecarbil의 임상 3GALACTIC-HFhe 결과

 

 

실적 발표

(월 장전) NEOS XERS ICPT MRSN MCRB REPH URGN PTE RUBY NSPR RETA TXMD BHVN SESN ITCI ALLK APYX

(월 장후) ATRA ATHX ARCT ARNA ADMP FBRX PLSE NBIX KIN CSTL PDLI EVFM CARA CASI OMER CCXI RVNC INFI MRKR NVAX FLGT MYGN ORGO RMTI CPRX

(화 장전) FULC SSKN ARPO ALT BNTX CRBP AFMD

(화 장후) ZGNX TXG ADPT CLSD VIE CTIC CRIS CLPT CPIX HTGM EYEN TCON LUMO SILK OSMT DTIL PASG GMDA

(수 장전) RPRX

(수 장후) ASND TEA CYCC TRVI OPGN SLRX

(목 장전) MYOV SLGL GLMD ADCT RDHL

(목 장후) ICCC APTX ARGX ACHV LIFE ALPN AYTU DARE DYAI ETON BNGO HSDT THMO RMED ONTX OPNT NARI

(금 장전) PLXP VIVO

 

아래는 어닝 위스퍼 실적 발표 일정

 

 

IPO Quiet Period 종료

ALGS KRBP OPT PRAX TARS CDAK

 

 

임상시험 결과 발표

회사명 심볼 후보물질 임상시험 적응증 예상 발표 협업
Acceleron Pharma Inc XLRN Stoatercept Phase 2 SPECTRA PHA
Aerie Pharmaceuticals Inc AERI Roclanda Mercury 3 topline Roclanda's intraocular pressure reducing performance compared to Ganfort 3Q
Aerpio Pharmaceuticals Inc ARPO Razuprotafib (AKB-9778) Phase 2 Open-angle glaucoma (OAG) 4Q
Akari Therapeutics PLC AKTX nomacopan 안약 아토피성 결막염 (atopic keratoconjunctivitis)
Aldeyra Therapeutics Inc ALDX Reproxalab Phase 3 Dry eye disease
Allogene Therapeutics Inc ALLO ALLO-715 Phase 1 UNIVERSAL Multiple Myeloma ASH 11/5
Amgen, Inc. AMGN AMG 510 Phase 2 단독 비소세포폐암 하반기
Anavex Life Sciences Corp AVXL ANAVEX 2-73 Phase 2 파킨슨병
Anavex Life Sciences Corp AVXL ANAVEX 2-73 Phase 2 Rett syndrome 4Q
Aprea Therapeutics Inc APRE APR-246 (eprenetapopt) and azacitidine Phase 2/3 TP53 mutant Myelodysplastic syndromes (MDS) 2020
Arcturus Therapeutics Holdings Inc ARCT ARCT-810 Phase 1 OTC deficiency 4Q
Arcus Biosciences Inc RCUS Domvanalimab (TIGIT) Phase 2 PD-L1 high NSCLC
Arcutis Biotherapeutics Inc ARQT ARQ-154 Phase 2b Scalp Psoriasis 4Q
Arena Pharmaceuticals, Inc. ARNA Etrasimod Phase 2 아토피성 피부염
Arvinas Inc ARVN ARV-471 Phase 1 ER+ HER2+ breast cancer
Atara Biotherapeutics Inc ATRA ATA 129 (tab-cel) Phase 3 ALLELE 중간결과 장기 이식 후 EB 바이러스 감염 (Epstein-Barr virus (EBV-PTLD) after solid organ transplant, SOT) 3Q
BioCryst Pharmaceuticals, Inc. BCRX Galidesivir Phase 1 Part 1 COVID-19 2020 3Q
BioLineRx ADR Representing 15 Ord Shs BLRX BL-8040 + Keytruda Phase 2a COMBAT/KEYNOTE-202 진행성 췌장암 2차 치료 PFS, OS 데이타
BioXcel Therapeutics Inc BTAI BXCL501 Phase 1/2b 노인성 치매 (geriatric dementia)에 의한 급성 흥분 4Q
Brainstorm Cell Therapeutics Inc BCLI NurOwn Phase 3 top-line Amytrophic lateral sclerosis (ALS) 11월말
Calithera Biosciences Inc CALA Telaglenastat (CB-839) + Cabozantinib Phase 2 CANTATA Renal cell carcinoma 4Qor 1Q21 EXEL
Calliditas Therapeutics Adr Rep 2 Ord Shs CALT Nefecon Phase 3 IgAN
Cellectis SA CLLS UCART22 Phase 1 BALLI-01 ASH 11/5
ChemoCentryx Inc CCXI Avacopan C3G
Chiasma Inc CHMA Mycapssa Phase 3 MPOWERED Maintenance treatment of adult acromegaly 11
Cortexyme Inc CRTX COR388 Phase 2/3 GAIN 중간결과 Alzheimer’s disease 4Q
Cyclerion Therapeutics Inc CYCN Olinciguat (IW-1701) Phase 2 STRONG-SCD Sickle Cell disease Late 3Q
Five Prime Therapeutics Inc FPRX FPT155 Phase 1a monotherapy
Forma Therapeutics Holdings Inc FMTX FT-4202 Phase 1 Sickle Cell Disease
Homology Medicines Inc FIXX HMI-102 Phase 1/2 페닐키토뇨증 Phenylketonuria (PKU) 3Q/4Q
Imagine All The People Inc IMTV IMA101 Phase 1/2 Solid tumors
Inhibrx Inc INBX INBRX-109 Phase 1 Chondrosarcoma
Inhibrx Inc INBX INBRX-106 Phase 1 OX40 monotherapy
Inovio Pharmaceuticals Inc INO INO-4800 임상 2/3 코로나-19 9
Johnson & Johnson JNJ 범용 인플루엔자 백신 VXRT
Johnson & Johnson JNJ M254 Phase 1/2 파트 B idiopathic thrombocytopenic purpura 3Q
Kalvista Pharmaceuticals Inc KALV KVD900 Phase 2 HAE 4Q
Karuna Therapeutics Inc KRTX KarXT Phase 1b 실험적으로 유도된 통증
Kiniksa Pharmaceuticals Ltd KNSA Rilonacept Phase 3 SEAL Recurring Pericarditis
Kura Oncology Inc KURA KO-539 (Menin inhibitor) Phase 1/2a ASH 11/5
Lyra Therapeutics Inc LYRA LYR-210 Phase 2 Chronic Rhinosinusitis
Magenta Therapeutics Inc MGTA MGTA-145 Phase 2 Stem cell mobilization
Mesoblast limited MESO MPC-06-ID Phase 3 만성 허리 통증 (Chronic low back pain) 2020년 중반
Mesoblast limited MESO MPC-150-IM Phase 3 Class 2/3 진행성 심부전 Heart failure 2020년 중반
Oncternal Therapeutics Inc ONCT cirmtuzumab (anti-ROR1) + Imbruvica Phase 1/2 맨틀 세포 림프종 (MCL), 만성 림프구성 림프종 (CML) ASH 11/5
Poseida Therapeutics, Inc. PSTX P-BCMA-101 Phase 2 Multiple Myeloma
Protagonist Therapeutics Inc PTGX PTG300 Phase 2 Polycythemia Vera
Protalix Biotherapeutics Inc PLX Pegunigalsidase alfa (PRX-102) Phase 3 BRIGHT Fabry disease 4Q
Rapt Therapeutics Inc RAPT FLX475 Phase 1/2 Solid tumors ESMO I/O
Rapt Therapeutics Inc RAPT RPT193 Phase 1b Atopic Dermatitis 2020
Replimune Group Inc REPL RP2 Phase 1
Rhythm Pharmaceuticals Inc RYTM Setmelanotide Phase 3 top-line Alstrom Syndrome 4Q
Rhythm Pharmaceuticals Inc RYTM Setmelanotide Phase 3 top-line Bardet-Biedl Syndrome 2021 1Q
Rocket Pharmaceuticals Inc RCKT RP-A501 Phase 1 Danon disease 4Q
Scholar Rock Holding Corp SRRK SRK-181 Phase 1 Solid tumors
Surface Oncology Inc SURF SRF617 Phase 1 Solid tumors
Surface Oncology Inc SURF SRF388 Phase 1 Solid tumors
TG Therapeutics Inc common stock TGTX U2 Phase 3 ULTIMATE I Multiple Sclerosis 하반기
Tonix Pharmaceuticals Holding Corp TNXP TNX-102 SL (Tonmya) 임상 3상 중간 결과 (top-line4분기) 섬유근통 (Fibromyalgia) 9
Uniqure NV QURE AMT-061 Phase 3 HOPE-B 26주 데이터 Hemophilia B 2020
Urovant Sciences Ltd UROV Vibegron Phase 2a IBS pain
Vaxart Inc VXRT 범용 인플루엔자 백신 JNJ
Y-mAbs Therapeutics, Inc YMAB GD2 x CD3 Phase 1 Solid tumors
Zymeworks Inc ZYME ZW49 Phase 1 HER2+ cancers 2020/2021

 

 

FDA 승인 심사 일정

회사명 심볼 프로젝트 AdCom PDUFA 종류 협업 비고
Spectrum Pharmaceuticals, Inc. SPPI SPI-2012 (ROLONTIS) for Chemotherapy-Induced Neutropenia 2020-10-24 신규 코로나-19로 인한 여행제한으로 제조시설 방문이 불가능한 관계로 연기
Biogen Inc BIIB Aducanumab for Alzheimer’s disease 2020-11-06 2021-03-07 신규 애드컴 반대 의견
Supernus Pharmaceuticals Inc SUPN SPN-812 (P301) for ADHD 2020-11-08 신규
Adamis Pharmaceuticals Corp ADMP ZIMHI (naloxone HCI Injection) for Opioid overdose 2020-11-15 확장
Alkermes Plc ALKS ALKS 3831 (olanzapine/samidorphan) for Schizophrenia, bipolar 2020-10-09 2020-11-15 신규 애드컴 효능 찬성 16-1 안전성 찬성 13-3 (1 기권)
Bristol-Myers Squibb Co BMY liso-cel (JCAR017) for r/r large B-cell lymphoma (TRANSCEND NHL-001) 2020-11-16 신규 Priority
Eiger Biopharmaceuticals Inc EIGR Lonafarnib for Hutchinson-Gilford Progeria Syndrome (HGPS) 2020-11-20 신규 Priority
Revance Therapeutics Inc RVNC DAXI (RT002) for Moderate to severe glabellar (frown) lines 2020-11-25 신규
Rhythm Pharmaceuticals Inc RYTM Setmelanotide for POMC deficiency obesity / Leptin Receptor Deficiency Obesity 2020-11-27 신규 Priority
Y-mAbs Therapeutics, Inc YMAB Naxitamab for Relapsed/Refractory High-Risk Neuroblastoma 2020-11-30 신규 Priority
Lipocine Inc LPCN Tlando for Men with low testosterone (Low T) 2020-11-30 신규 3CRL 후 재신청/PDUFA 8/28에서 11/30 주로 연기
BioCryst Pharmaceuticals, Inc. BCRX Berotralstat BCX7353 for Reduce or eliminate attacks in HAE patients 2020-12-03 신규
MacroGenics Inc MGNX Margetuximab for Metastatic breast cancer 2020-12-18 신규 ZLAB FDA AdCom 소집 없음
Zai Lab Ltd - ADR ZLAB Margetuximab for Metastatic breast cancer 2020-12-18 신규 MGNX FDA AdCom 소집 없음
Myovant Sciences Ltd MYOV Relugolix for Advanced prostate cancer 2020-12-20 신규 Priority Primary endpoint 충족. but 생존 데이터는 통계적 유의미성 확보 실패 (p = 0.84)
Urovant Sciences Ltd UROV Vibegron for Overactive bladder (OAB) 2020-12-26 신규
Osmotica Pharmaceuticals PLC OSMT Ontinua ER (arbaclofen) for Spasticity resulting from multiple sclerosis 2020-12-29 신규
Scpharmaceuticals Inc SCPH Furoscix for Heart failure 2020-12-30 신규
Alnylam Pharmaceuticals, Inc. ALNY Inclisiran 하반기 신규 NVS
AnaptysBio Inc ANAB Dostarlimab (Anti-PD-1) in endometrial cancer 하반기 신규 GSK
GlaxoSmithKline plc GSK Dostarlimab (Anti-PD-1) in endometrial cancer 하반기 신규 ANAB
GlaxoSmithKline plc GSK Trelegy Ellipta for COPD 하반기 확장 INVA, TBPH 9월초 AdCom 14-1 반대 표결
Innoviva Inc INVA Trelegy Ellipta for COPD 하반기 확장 GSK, TBPH 9월초 AdCom 14-1 반대 표결
Theravance Biopharma Inc TBPH Trelegy Ellipta for COPD 하반기 확장 GSK, INVA 9월초 AdCom 14-1 반대 표결
Johnson & Johnson JNJ Spravato 하반기 확장 Major depressive disorder with active suicidal ideation with intent (Aspire I and II)
Novartis AG NVS Inclisiran 하반기 신규 ALNY
Novartis AG NVS Xolair for Nasal polyps (Polyp 1 and 2) 하반기 확장 RHHBY
Roche Holdings AG Basel ADR Common Stock RHHBY Xolair for Nasal polyps (Polyp 1 and 2) 하반기 확장 NVX
Bristol-Myers Squibb Co BMY OPDIVO + CABOMETYX for RCC 2021-02-20 확장 Priority EXEL
Exelixis, Inc. EXEL OPDIVO + CABOMETYX for RCC 2021-02-20 확장 Priority BMY
AstraZeneca plc AZN TagrissoEGFR 돌연변이 비소세포폐암 애주반트 치료 2021-04-20 est 확장 Priority
Santen Pharmaceutical Co Ltd SNPHF 아토피 결막염 cyclosporine topical ophthalmic emulsion, 0.1% 2021-06-21
BioMarin Pharmaceutical Inc. BMRN 어린이 연골 무형성증 (Achondroplasia) 2021-08-20 신규

 

 

코로나-19 백신

회사명 심볼 후보물질 임상시험 시작 중간결과 기타 사항 협업 최종결과 적응증
Altimmune Inc ALT T-COVID 2020 4Q COVID-19
Altimmune Inc ALT AdCOVID Phase 1 2020 4Q COVID-19 vaccine, 비강
Arcturus Therapeutics Holdings Inc ARCT ARCT-021 LUNAR-COV19 Phase 1/2 2020 4Q COVID-19 vaccine
AstraZeneca plc AZN AZD1222 (ChAdOx1 nCoV-19) Phase 3 non-US trials 2020 4Q COVID-19 vaccine
AstraZeneca plc AZN AZD1222 (ChAdOx1 nCoV-19) Phase 3 US 2020/10/23 중단 후 재개 COVID-19 vaccine
BioNTech SE - ADR BNTX BNT162b2 Phase 2/3 2020-10 -> 11 PFE COVID-19 vaccine
CureVac BV CVAC CVnCoV Phase 1/2 2020 4Q (Ph1) COVID-19 vaccine
CureVac BV CVAC CVnCoV Phase 1/2 2020/9/29 (2a) 2020 4Q (Ph2a) COVID-19 vaccine
CureVac BV CVAC CVnCoV Phase 2b/3 2020 4Q COVID-19 vaccine
Dynavax Technologies Corporation DVAX CpG 1018 + Medicago vaccine Phase 1 2020-11 중순 COVID-19 vaccine
Dynavax Technologies Corporation DVAX CpG 1018 + Clover vaccine Phase 1 2020 COVID-19 vaccine
GlaxoSmithKline plc GSK Adjuvanted COVID-19 vaccine Phase 1/2 2020-09-04 2020-12 COVID-19 vaccine
GlaxoSmithKline plc GSK Adjuvanted COVID-19 vaccine Phase 3 2020-12 COVID-19 vaccine
Imv Inc IMV DPX-COVID-19 Phase 1/2 2020 COVID-19 vaccine
Inovio Pharmaceuticals Inc INO INO-4800 Phase 2/3 2020/9/29 부분 중단 COVID-19 vaccine
Johnson & Johnson JNJ JNJ-78436735 (Ad26.COV2-S) Phase 3 ENSEMBLE 2020-09-23 2020/10/23 중단 후 재개 COVID-19 vaccine
Moderna Inc MRNA mRNA-1273 Phase 2 COVID-19 vaccine
Moderna Inc MRNA mRNA-1273 Phase 3 2020-11 2020/10/22 모집 완료 COVID-19 vaccine
Novavax, Inc. NVAX NVX-CoV2373 Phase 3 2020-11 COVID-19 vaccine
Novavax, Inc. NVAX NVX-CoV2373 Phase 3 (UK) 2020-09-24 2020 4Q (Ph2) -> 2021 1Q COVID-19 vaccine
Pfizer Inc. PFE BNT162b2 Phase 2/3 2020-07-27 2020-10 BNTX COVID-19 vaccine
Sanofi SA SNY mRNA vaccine Phase 1b 2020 TBIO COVID-19 vaccine
Translate Bio Inc TBIO mRNA vaccine Phase 1b 2020 SNY COVID-19 vaccine
Vaxart Inc VXRT VXA-CoV2-1 Phase 1 2020-10-13

 

출처

https://www.benzinga.com/general/biotech/20/10/17942727/the-week-ahead-in-biotech-spectrum-pharma-fda-decision-biogen-and-abbott-earnings-cancer-conferen

https://www.evaluate.com

https://www.biopharmcatalyst.com

https://www.nyse.com/ipo-center/filings

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