이번주 제약-바이오 주요 일정 20201018
Weekly Biotech Review/Biotech 일정
2020. 10. 19. 03:03
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이번주 제약-바이오의 임상시험 결과 발표, 신약 승인, 실적 발표 일정 및 올해말 예정된 임상시험 결과 발표 및 신약 승인 일정입니다.
지난주 제약-바이오 섹터의 주요 이벤트들은 아래 포스팅에 정리.
날자/시간은 모두 미국 현지 시간.
학회/투자자 미팅
◈ 10/18 일 - 10/21 수 American College of Chest Physicians' CHEST Annual Meeting 2020
◈ 10/20 화 - 10/23 금 The Prostate Cancer Foundation's 27th Annual Scientific Retreat
◈ 10/20 화 - 10/25 일 IDWeek 2020: Oct. 20-25
◈ 10/22 목 - 10/25 일 American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting
◈ 10/24 토 - 10/25 일 32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium
PDUFA
◈ Zosano Pharma Corp (ZSAN): 10/20 화. Qtrypta, 편두통. 9/30에 DRL을 받음.
◈ Spectrum Pharmaceuticals Inc (SPPI): 10/24 토. SPI-2012 (ROLONTIS), 화학항암치료로 인한 호증구 감소증
임상시험 결과 발표
◈ Pfizer Inc (PFE): ID Week 2020발표. 폐렴쌍구균, 수막구균 백신 임상 2상 최종 결과
◈ Alnylam Pharmaceuticals Inc (ALNY): ASN 발표. primary hyperoxaluria type 1에 대한 lumasiran의 임상 3상 ILLUMINATE-B 결과 발표
◈ Omeros Corporation (OMER): 10/22 목. 조혈모세포이식에 의한 혈전미세혈관병에 대한 narsoplimab의 pivotal 임상시험 결과 발표
◈ Mustang Bio Inc (MBIO), Fortress Biotech (FBIO): 10/23 금. PSCA양성 전이성 거세 저항성 전립선암에 대한 CAR-T 치료제 MB-105의 임상 1상 결과 발표.
EORTC-NCI-AACR
◈ Cyclacel Pharmaceuticals Inc (CYCC): 10/24 토. 진행암에 대한 fadraciclib (CYC065)의 임상 1상 안전성, PK, PD 데이터.
◈ Revolution Medicines Inc (RVMD): 10/24 토. 고형암에 대한 RMC-4630 + cobimetinib 병용 임상 1/2상 중간 결과.
◈ Aileron Therapeutics Inc (ALRN): 10/24 토. p53 돌연변이 양성 소세포폐암 topotecan 화학치료전 부작용 방지를 위한 ALRN-6924 전처리에 대한 임상 1b상.
◈ Turning Point Therapeutics Inc (TPTX): 10/24 토. MET 돌연변이 양성 고형암에 대한 TPX-0022 임상 1상 안전성, PK, 초기 효능 데이터.
◈ Syros Pharmaceuticals Inc (SYRS): 10/24 토. 고형암에 대한 SY-5609 용량 증가 임상 1상 초기 데이터.
SYRS 2.07%
◈ Mirati Therapeutics Inc (MRTX): 10/24 토. 비소세포폐암, 대장암에 대한 MRTX849 임상 1/2상 KRYSTAL 단독요법 데이터.
실적 발표
◈ 11/20 화 장전: LGND
◈ 11/21 수 장전: ABT BIIB TMO
◈ 11/21 수 장후: EW ALGN
◈ 11/22 목 장전: DGX NURO WST
◈ 11/22 목 장후: PSTV
아래는 어닝 위스퍼 실적 발표 일정
IPO Quiet Period 종료
◈ Taysha Gene Therapies Inc (TSHA)
◈ Prelude Therapeutics Inc (PRLD)
◈ PMV Pharmaceuticals Inc (PMVP)
◈ Orphazyme A S ADR (ORPH)
2020년 4분기 발표 예정 임상시험 결과
| 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 | ||
| Altimmune Inc | ALT | T-COVID | COVID-19 | 4Q | ||
| 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-021 | Phase ½ | COVID-19 vaccine | 4Q | |
| 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 | ||
| AstraZeneca plc | AZN | AZD1222 (ChAdOx1 nCoV-19) | Phase 3 non-US trials | COVID-19 vaccine | 4Q | |
| 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 | |
| Aurinia Pharmaceuticals Inc | AUPH | Voclosporin ophthalmic solution (VOS) | Phase 2/3 AUDREY | Dry eye syndrome | 4Q | |
| Axovant Gene Therapies Ltd | AXGT | AXO-Lenti-PD | Phase 2 SUNRISE | |||
| BioCryst Pharmaceuticals, Inc. | BCRX | Galidesivir | Phase 1 Part 1 | COVID-19 | 3Q | |
| BioLineRx ADR Representing 15 Ord Shs | BLRX | BL-8040 + Keytruda | Phase 2a COMBAT/KEYNOTE-202 | 진행성 췌장암 2차 치료 PFS, OS 데이타 | ||
| BioNTech SE - ADR | BNTX | BNT162b2 | Phase 2/3 | COVID-19 vaccine | 10월 | PFE |
| 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) | 11월 | |
| 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 | ||
| Catabasis Pharmaceuticals Inc | CATB | Edasalonexent (CAT-1004) | Phase 3 | Duchenne muscular dystrophy (DMD) | 4Q | |
| ChemoCentryx Inc | CCXI | Avacopan | Phase 3 | C3G | ||
| ChemoCentryx Inc | CCXI | Avacopan | Phase 2b | Hidradenitis Suppurativa | 4Q초 | |
| Corbus Pharmaceuticals Holdings Inc | CRBP | lenabasum | Phase 2b | 낭포성 섬유증 | 3Q | |
| 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 | |
| Cytokinetics, Inc. | CYTK | Omecamtiv mecarbil | Phase 3 GALACTIC-HF top-line | Acute heart failure | 4Q AHA (11/13) | AMGN |
| Five Prime Therapeutics Inc | FPRX | FPT155 | Phase 1a monotherapy | |||
| Forma Therapeutics Holdings Inc | FMTX | FT-4202 | Phase 1 | Sickle Cell Disease | ||
| Forma Therapeutics Holdings Inc | FMTX | FT-4202 | Phase 2 | AML | ||
| 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 | ||
| Karyopharm Therapeutics Inc | KPTI | Selinexor | Phase 3 SEAL | |||
| Kiniksa Pharmaceuticals Ltd | KNSA | Rilonacept | Phase 3 SEAL | Recurring Pericarditis | ||
| Kiniksa Pharmaceuticals Ltd | KNSA | Mavrilimumab | Phase 2 | Giant Cell Arteritis | ||
| Kura Oncology Inc | KURA | KO-539 (Menin inhibitor) | Phase 1/2a | ASH | ||
| Lyra Therapeutics Inc | LYRA | LYR-210 | Phase 2 | Chronic Rhinosinusitis | ||
| Magenta Therapeutics Inc | MGTA | MGTA-145 | Phase 2 | Stem cell mobilization | ||
| Mirati Therapeutics Inc | MRTX | MRTX849 | Phase 1/2 KRYSTAL | 고형암: NSCLC/CRC 단독요법 | 10/24-25 EORTC-NCI-AACR | |
| 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 | |
| Moderna Inc | MRNA | mRNA-1273 | Phase 2 | COVID-19 vaccine | ||
| Moderna Inc | MRNA | mRNA-1273 | Phase 3 | COVID-19 vaccine | 4Q | |
| Pfizer Inc. | PFE | BNT162b2 | Phase 2/3 | COVID-19 vaccine | 10월 | BNTX |
| 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 | |||
| Revolution Medicines | RVMD | RMC-4630 + cobimetinib | Phase 1b/2 | Solid tumors | 10/24-25 EORTC-NCI-AACR | |
| 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 | ||
| Scholar Rock Holding Corp | SRRK | SRK-015 | Phase 2 TOPAZ | SMA | 4Q | |
| 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 |
| Novo Nordisk A/S | NVO | Somapacitan/NN8640 (Once-weekly long-acting recombinant growth hormone) in adult-onset growth hormone deficiency | 3분기 | 신규 | |||
| Zosano Pharma Corp | ZSAN | Qtrypta (M207) for Migraine | 2020-10-20 | 신규 | DRL 2020/9/30 | ||
| Spectrum Pharmaceuticals, Inc. | SPPI | SPI-2012 (ROLONTIS) for Chemotherapy-Induced Neutropenia | 2020-10-24 | 신규 | |||
| Kala Pharmaceuticals Inc | KALA | EYSUVIS (KPI-121) 0.25% for Dry eye disease | 2020-10-30 | 신규 | CRL 2019/8/8 | ||
| 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 | |||
| 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 | |||
| 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 | |||
| Biogen Inc | BIIB | Aducanumab for Alzheimer’s disease | 2020-11-06 | 2021-03-07 | 신규 | ||
| Lipocine Inc | LPCN | Tlando for Men with low testosterone (Low T) | 미정 | 신규 | 3회 CRL 후 재신청/PDUFA 8/28에서 연기. 날자 미정 | ||
| 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 |
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