Weekly Biotech Review/Biotech 일정
이번주 제약-바이오 주요 일정 20201004
약 장 수
2020. 10. 5. 04:02
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이번주 제약-바이오의 임상시험 결과 발표, 신약 승인, 실적 발표 일정 및 올해 중반으로 예정된 임상시험 결과 발표 및 신약 승인 일정입니다. 이번주에는 이벤트들이 비교적 많지 않습니다. 하단 표에 4분기로 예정된 일정들이 추가됐습니다.
날자/시간은 모두 미국 현지 시간입니다.
학회/투자자 미팅
이번주에도 근육, 심장, 세포 치료, 유전자 치료, 신경내분비 종양, 면역항암제 등의 학회가 많네요.
9/30 수 – 10/6 화 Heart Failure Society of America (HFSA), Virtual Annual Scientific Meeting 2020
10/4 일 – 10/9 금 American Neurological Association (ANA)
10/5 월 – 10/6 화 Virtual Jefferies Cell Therapy Summit
10/5 월 – 10/6 화 Chardan Virtual 4th Annual Genetic Medicines Conference
10/5 월 – 10/8 목 HIV Glasgow 2020
PDUFA
Fortress Biotech Inc (FBIO), Avenue Therapeutics Inc (ATXI): (10/10 토) tramadol 정맥주사,
건막류 수술 후 통증
AdCom
Alkermes Plc (ALKS) : (10/9금) olanzapine/samidorphan 경구용 태블릿, 조현병 & 양극성 장애 I
임상시험 결과 발표
Neurocrine Biosciences Inc. (NBIX): ANA 발표. 임상3상 Ongentys, 파킨슨병
Merck & Co. Inc. (MRK): HIV Glasgow 발표. 임상 2상 islatravir, 1/1b상 islatravir + MK-8507
2020년 4분기 발표 예정 임상시험 결과
| 회사명 | 심볼 | 후보물질 | 임상시험 | 적응증 | 예상 발표 |
| 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 |
| 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 | |
| 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 | |
| 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 |
| BioXcel Therapeutics Inc | BTAI | BXCL501 | Phase 1/2b | 노인성 치매 (geriatric dementia)에 의한 급성 흥분 | |
| Brainstorm Cell Therapeutics Inc | BCLI | NurOwn | Phase 3 top-line | Amytrophic lateral sclerosis (ALS) | 11월 |
| Calithera Biosciences Inc | CALA | Telaglenastat | Phase 2 CANTATA | ||
| 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 | |
| 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) |
| 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 | |||
| Kalvista Pharmaceuticals Inc | KALV | KVD900 | Phase 2 | HAE | |
| 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 | |
| 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 |
| Momenta Pharmaceuticals, Inc. | MNTA | M254 | Phase 1/2 파트 B | idiopathic thrombocytopenic purpura | 3Q |
| Pfizer Inc. | PFE | BNT162b2 | Phase 2/3 | COVID-19 vaccine | 10월 |
| 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 | |
| Scholar Rock Holding Corp | SRRK | SRK-181 | Phase 1 | Solid tumors | |
| Scholar Rock Holding Corp | SRRK | SRK-015 | Phase 2 TOPAZ | SMA | |
| 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 | |||
| 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 (11월까지): 첫 승인
| 회사명 | 심볼 | 프로젝트 | PDUFA | 예상매출 ($M) | 비고 |
| Lipocine | LPCN | Tlando for Men with low testosterone (Low T) | 수주후 | - | 3회 CRL 후 재신청/PDUFA 8/28에서 연기. 날자 미정 |
| Fortress Biotech Inc, Avenue Therapeutics Inc | FBIO, ATXI | Intravenous (IV) tramadol for Postoperative pain following bunionectomy surgery |
10/10 | ||
| Zosano Pharma Corporation | ZSAN | Qtrypta (M207) for Migraine | 10/20 | DRL 2020/9/30 | |
| Spectrum Pharmaceuticals Inc | SPPI | SPI-2012 (ROLONTIS) for Chemotherapy-Induced Neutropenia | 10/24 | ||
| Kala Pharmaceuticals Inc | KALA | EYSUVIS (KPI-121) 0.25% for Dry eye disease | 10/30 | CRL 2019/8/8 | |
| Supernus Pharmaceuticals Inc | SUPN | SPN-812 (P301) for ADHD | 11/8 | ||
| Eiger BioPharmaceuticals Inc | EIGR | Lonafarnib for Hutchinson-Gilford Progeria Syndrome (HGPS) | 11/20 Priority | ||
| Revance Therapeutics Inc | RVNC | DAXI (RT002) for Moderate to severe glabellar (frown) lines | 11/25 | ||
| Rhythm Pharmaceuticals Inc | RYTM | Setmelanotide for POMC deficiency obesity / Leptin Receptor Deficiency Obesity | 11/27 Priority | ||
| Y-mAbs Therapeutics Inc | YMAB | Naxitamab for Relapsed/Refractory High-Risk Neuroblastoma | 11/30 Priority | ||
| Novo Nordisk | NVO | Somapacitan/NN8640 | 3분기 | 318 | Once-weekly long-acting recombinant growth hormone in adult-onset growth hormone deficiency |
| GSK/Anaptysbio | GSK/ANAB | Dostarlimab | 하반기 | 512 | Anti-PD-1 filed in endometrial cancer |
| Novartis/Alnylam | NVS/ALNY | Inclisiran | 하반기 | 2,010 |
FDA 승인 심사 일정 (11월까지): 적응증 확장
| 회사명 | 심볼 | 프로젝트 | PDUFA | 비고 |
| Adamis Pharmaceuticals Corporation | ADMP | ZIMHI (naloxone HCI Injection) for Opioid overdose | 11/15 | |
| Johnson & Johnson | JNJ | Spravato | 하반기 | Major depressive disorder with active suicidal ideation with intent (Aspire I and II) |
| GSK, Innoviva, Theravance | GSK, INVA, TBPH | Trelegy Ellipta | 하반기 | COPD, 9초 AdCom 14-1 반대 표결 |
| Novartis, Roche | NVS, RHHBY | Xolair | 하반기 | Nasal polyps (Polyp 1 and 2) |
출처
https://www.nasdaq.com/market-activity/ipos
https://www.nyse.com/ipo-center/filings
https://www.biopharmcatalyst.com/news/2020/phase-3-catalysts-to-watch-for-4q-biotech-week-in-review
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