Weekly Biotech Review/Biotech 일정
이번주 제약-바이오 주요 일정 20201025
약 장 수
2020. 10. 26. 05:05
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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
◈ 10/22 목 - 10/25 일 American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting
◈ 10/24 토 - 10/25 일 EORTC-NCI-AACR Annual, or ENA 2020, Symposium on Molecular Targets and Cancer Therapeutics
◈ 10/24 토 - 10/28 수 ASTRO Annual Meeting 2020
◈ 10/27 화 - 10/29 목 Macrophage-directed Therapies Summit
◈ 10/27 화 - 10/30 금 American Society of Human Genetics, or ASHG, Virtual Meeting 2020
◈ 10/28 수 Cantor Fitzgerald "Key Considerations for Gene Therapy Manufacturing and Platforms" virtual panel
◈ 10/29 목 B. Riley Securities Liver Disease Therapeutics Day
◈ 10/29 목 - 10/31토 European Academy Dermatology and Venereology, or EADV, Virtual 29th Congress
PDUFA
◈ Kala Pharmaceuticals Inc (KALA): 10/30 금. Eysuvis (loteprednol etabonate ophthalmic suspension, 0.25%), 안구건조증
◈ Merck & Co., Inc. (MRK): 10/30 금. Keytruda, 호지킨 림프종
임상시험 결과 발표
◈ Applied Therapeutics Inc (APLT): 10/26 월. ASHG 미팅. AT-007, 갈락토스 혈증 (Galactosemia)
◈ Jazz Pharmaceuticals PLC (JAZZ): 10/26 월 4:30PM. Xywav oral solution 업데이트
◈ Retrophin Inc (RTRX), Ligand Pharmaceuticals (LGND): ASN Kidney Week 2020. 임상 2상 DUET, sparsentan, 국소 분절 사구체 경화증 (focal segmental glomerulosclerosis)
◈ Galera Therapeutics Inc (NASDAQ: GRTX): 10/27 화. ASTRO 미팅. 임상 1b/2a상 avasopasem manganese (GC4419) + stereotactic body radiation therapy, 췌장암
◈ Concert Pharmaceuticals Inc (CNCE): 10/29 목. EADV Virtual Congress. CTP-543, 원형 탈모증
◈ Axovant Gene Therapies Ltd (AXGT): 10/30 금. Parkinson's disease R&D day. 임상2상 SUNRISE-PD 코호트 2. AXO-Lenti-PD 유전자 치료. 파킨슨병.
◈ Pfizer Inc (PFE), BioNTech SE (BNTX): 10월. 임상 2/3상 코로나-19 백신 후보 BNT162b2
◈ Dynavax Technologies Corporation (DVAX): 10월. 임상 1상 Medicago 코로나-19 백신 + CpG 1018 애쥬반트
실적 발표
◈ (월 장전) HCA MEDP
◈ (화 장전) PFE LLY NVS MRK LH NEO
◈ (화 장후) DXCM MASI RARE OMCL
◈ (수 장전) ANTM IART UTHR PPD BSX
◈ (수 장후) GILD TDOC LVGO AMGN ALIM TARO VNDA GMED MMSI PEN VKTX
◈ (목 장전) MRNA EVLO BAX BPMC ALXN AGEN ABMD PCRX PLX INSM NVCR SYNH XTNT CNST ALKS
◈ (목 장후) OPK VRTX AXGN BEAT PTCT ILMN NTUS LMAT RMD NUVA BIO QDEL EXAS CERS CDNA
◈ (금 장전) LGND ABBV
아래는 어닝 위스퍼 실적 발표 일정
IPO Quiet Period 종료
◈ Pulmonx Corp (LUNG)
◈ Oncorus Inc (ONCR)
◈ Immunome Inc (IMNM)
◈ C4 Therapeutics Inc (CCCC)
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 | ||
| 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 | |
| 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 | 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) | 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 | ||
| 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 | |
| Mirati Therapeutics Inc | MRTX | MRTX849 | Phase 1/2 KRYSTAL | 고형암: NSCLC/CRC 단독요법 | 10/24-25 EORTC-NCI-AACR | |
| 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
| 심볼 | 프로젝트 | AdCom | PDUFA | 종류 | 협업 | 비고 |
| NVO | Somapacitan/NN8640 (Once-weekly long-acting recombinant growth hormone) in adult-onset growth hormone deficiency | 3분기 | 신규 | |||
| SPPI | SPI-2012 (ROLONTIS) for Chemotherapy-Induced Neutropenia | 2020-10-24 | 신규 | |||
| KALA | EYSUVIS (KPI-121) 0.25% for Dry eye disease | 2020-10-30 | 신규 | CRL 2019/8/8 | ||
| SUPN | SPN-812 (P301) for ADHD | 2020-11-08 | 신규 | |||
| ADMP | ZIMHI (naloxone HCI Injection) for Opioid overdose | 2020-11-15 | 확장 | |||
| EIGR | Lonafarnib for Hutchinson-Gilford Progeria Syndrome (HGPS) | 2020-11-20 | 신규 Priority | |||
| RVNC | DAXI (RT002) for Moderate to severe glabellar (frown) lines | 2020-11-25 | 신규 | |||
| RYTM | Setmelanotide for POMC deficiency obesity / Leptin Receptor Deficiency Obesity | 2020-11-27 | 신규 Priority | |||
| YMAB | Naxitamab for Relapsed/Refractory High-Risk Neuroblastoma | 2020-11-30 | 신규 Priority | |||
| BCRX | Berotralstat BCX7353 for Reduce or eliminate attacks in HAE patients | 2020-12-03 | 신규 | |||
| MGNX | Margetuximab for Metastatic breast cancer | 2020-12-18 | 신규 | ZLAB | FDA AdCom 소집 없음 | |
| ZLAB | Margetuximab for Metastatic breast cancer | 2020-12-18 | 신규 | MGNX | FDA AdCom 소집 없음 | |
| MYOV | Relugolix for Advanced prostate cancer | 2020-12-20 | 신규 Priority | Primary endpoint 충족. but 생존 데이터는 통계적 유의미성 확보 실패 (p = 0.84) | ||
| UROV | Vibegron for Overactive bladder (OAB) | 2020-12-26 | 신규 | |||
| OSMT | Ontinua ER (arbaclofen) for Spasticity resulting from multiple sclerosis | 2020-12-29 | 신규 | |||
| SCPH | Furoscix for Heart failure | 2020-12-30 | 신규 | |||
| LPCN | Tlando for Men with low testosterone (Low T) | 미정 | 신규 | 3회 CRL 후 재신청/PDUFA 8/28에서 연기. 날자 미정 | ||
| ALNY | Inclisiran | 하반기 | 신규 | NVS | ||
| ANAB | Dostarlimab (Anti-PD-1) in endometrial cancer | 하반기 | 신규 | GSK | ||
| GSK | Dostarlimab (Anti-PD-1) in endometrial cancer | 하반기 | 신규 | ANAB | ||
| GSK | Trelegy Ellipta for COPD | 하반기 | 확장 | INVA, TBPH | 9월초 AdCom 14-1 반대 표결 | |
| INVA | Trelegy Ellipta for COPD | 하반기 | 확장 | GSK, TBPH | 9월초 AdCom 14-1 반대 표결 | |
| TBPH | Trelegy Ellipta for COPD | 하반기 | 확장 | GSK, INVA | 9월초 AdCom 14-1 반대 표결 | |
| JNJ | Spravato | 하반기 | 확장 | Major depressive disorder with active suicidal ideation with intent (Aspire I and II) | ||
| NVS | Inclisiran | 하반기 | 신규 | ALNY | ||
| NVS | Xolair for Nasal polyps (Polyp 1 and 2) | 하반기 | 확장 | RHHBY | ||
| RHHBY | Xolair for Nasal polyps (Polyp 1 and 2) | 하반기 | 확장 | NVX | ||
| BMY | OPDIVO + CABOMETYX for RCC | 2021-02-20 | 확장 Priority | EXEL | ||
| EXEL | OPDIVO + CABOMETYX for RCC | 2021-02-20 | 확장 Priority | BMY | ||
| BIIB | Aducanumab for Alzheimer’s disease | 2020-11-06 | 2021-03-07 | 신규 | ||
| AZN | Tagrisso의 EGFR 돌연변이 비소세포폐암 애주반트 치료 | 2021-04-20 est | 확장 Priority |
코로나-19 백신
| 회사명 | 심볼 | 후보물질 | 임상시험 | 시작 | 중간결과 | 기타 사항 | 협업 |
| Altimmune Inc | ALT | T-COVID | 2020 4Q | ||||
| Altimmune Inc | ALT | AdCOVID | Phase 1 | 2020 4Q | |||
| Arcturus Therapeutics Holdings Inc | ARCT | ARCT-021 LUNAR-COV19 | Phase 1/2 | 2020 4Q | |||
| AstraZeneca plc | AZN | AZD1222 (ChAdOx1 nCoV-19) | Phase 3 non-US trials | 2020 4Q | |||
| AstraZeneca plc | AZN | AZD1222 (ChAdOx1 nCoV-19) | Phase 3 US | 2020/10/23 중단 후 재개 | |||
| BioNTech SE - ADR | BNTX | BNT162b2 | Phase 2/3 | 2020-10 | PFE | ||
| CureVac BV | CVAC | CVnCoV | Phase 1/2 | 2020 4Q (Ph1) | |||
| CureVac BV | CVAC | CVnCoV | Phase 1/2 | 2020/9/29 (2a) | 2020 4Q (Ph2a) | ||
| CureVac BV | CVAC | CVnCoV | Phase 2b/3 | 2020 4Q | |||
| Dynavax Technologies Corporation | DVAX | CpG 1018 + Medicago vaccine | Phase 1 | 2020-10 | |||
| GlaxoSmithKline plc | GSK | Adjuvanted COVID-19 vaccine | Phase 1/2 | 2020-09-04 | 2020-12 | ||
| GlaxoSmithKline plc | GSK | Adjuvanted COVID-19 vaccine | Phase 3 | 2020-12 | |||
| Imv Inc | IMV | DPX-COVID-19 | Phase 1/2 | 2020말 | |||
| Inovio Pharmaceuticals Inc | INO | INO-4800 | Phase 2/3 | 2020/9/29 부분 중단 | |||
| Johnson & Johnson | JNJ | JNJ-78436735 (Ad26.COV2-S) | Phase 3 ENSEMBLE | 2020-09-23 | 2020/10/23 중단 후 재개 | ||
| Moderna Inc | MRNA | mRNA-1273 | Phase 2 | ||||
| Moderna Inc | MRNA | mRNA-1273 | Phase 3 | 2020-11 | 2020/10/22 모집 완료 | ||
| Novavax, Inc. | NVAX | NVX-CoV2373 | Phase 2/3 | 2020 4Q (Ph2) | |||
| Novavax, Inc. | NVAX | NVX-CoV2373 | Phase 3 (UK) | 2020-09-24 | |||
| Pfizer Inc. | PFE | BNT162b2 | Phase 2/3 | 2020-07-27 | 2020-10 | BNTX | |
| Sanofi SA | SNY | mRNA vaccine | Phase 1b | 2020말 | TBIO | ||
| Translate Bio Inc | TBIO | mRNA vaccine | Phase 1b | 2020말 | SNY | ||
| Vaxart Inc | VXRT | VXA-CoV2-1 | Phase 1 | 2020-10-13 |
출처
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