이번주 제약-바이오 주요 일정 20201108
이번주 제약-바이오의 임상시험 결과 발표, 신약 승인, 실적 발표 일정입니다.
지난주 제약-바이오 섹터의 주요 이벤트들은 아래 포스팅에 정리.
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 목 - 11/9 월 American College of Rheumatology, or ACR, Convergence 2020
◈ 11/9 월 - 11/10 화 Credit Suisse 29th Annual Virtual Healthcare Conference
◈ 11/9 월 - 11/14 토 35th Annual Meeting of The Society for Immunotherapy of Cancer, or SITC
◈ 11/13 금 - 11/15 일 American Academy of Ophthalmology, or AAO, 2020 Virtual meeting
◈ 11/13 금 - 11/16 월 American Association for the Study of Liver Diseases, or AASLD, The Liver Meeting, Digital Experience
◈ 11/13 금 - 11/17 화 American Heart Association, or AHA, Scientific Sessions 2020
PDUFA
◈ Supernus Pharmaceuticals Inc (SUPN): 11/8 일. SPN-812, 주의력 결핍 장애 (ADHD)
◈ Sanofi SA (SNY): 11/14 토. sutimlimab, 저온응집병 (cold agglutinin disease)
SITC 발표 (11/9 월 - 11/14 토)
◈ Gossamer Bio Inc (GOSS): 고형암 대상 GB1275 + Keytruda 병용 임상 1/2상 KEYNOTE-A36 잠정 데이터
◈ Corvus Pharmaceuticals Inc (CRVS): COVID-19 대상 CPI-006 임상 1상
◈ 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 1/2a상 GEN-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 목 - 11/9 월)
◈ 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 2상
AASLD 결과 발표 (11/13 금 - 11/16 월)
◈ 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 3상 MAESTRO 초기 결과 / NAFLD 대상 resmetirom의 임상 3상 MAESTRO-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): NAFLD와 NASH 대상 namodenoson의 임상 2상 결과
AHA 결과 발표 (11/13 금 - 11/17 화)
◈ Cytokinetics Inc (CYTK), Amgen Inc (AMGN): 급성 심부전에 대한 omecamtiv mecarbil의 임상 3상 GALACTIC-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) | 2020말 | |
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 | 4Q후 or 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 | 11월 | |
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 2/3상 | 코로나-19 | 9월 | |
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 | 2020말 | |
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-line은 4분기) | 섬유근통 (Fibromyalgia) | 9월 | |
Uniqure NV | QURE | AMT-061 | Phase 3 HOPE-B 26주 데이터 | Hemophilia B | 2020말 | |
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 | 2020말/2021초 |
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 | 3회 CRL 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 | Tagrisso의 EGFR 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 말 | 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 | 2020말 | 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 | 2020-11말 | 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 | 2020말 | TBIO | COVID-19 vaccine | |||
Translate Bio Inc | TBIO | mRNA vaccine | Phase 1b | 2020말 | SNY | COVID-19 vaccine | |||
Vaxart Inc | VXRT | VXA-CoV2-1 | Phase 1 | 2020-10-13 |
출처
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