Weekly Biotech Review/Biotech 일정
이번주 제약-바이오 주요 일정 20201129
약 장 수
2020. 11. 30. 04:32
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이번주 제약-바이오의 임상시험 결과 발표, 신약 승인, 실적 발표 일정입니다.
이번주 주말부터 미국 혈액 학회 ASH가 열립니다.
지난주 제약-바이오 섹터의 주요 이벤트들은 아래 포스팅에 정리.
날자/시간은 모두 미국 현지 시간.
학회/투자자 미팅
◈ 11/30 월 - 12/3 목. Piper Sandler 32nd Annual Virtual Healthcare Conference
◈ 12/1 화 - 12/2 수. 3rd Annual Evercore ISI 2020 Virtual HealthCONx Conference
◈ 12/4 금 - 12/8 화. American Epilepsy Society, or AES, Annual Meeting (virtual event)
◈ 12/5 토 - 12/8 화. 62nd American Society of Hematology, or ASH, Annual Meeting and Exposition (virtual event)
PDUFA
◈ Vanda Pharmaceuticals Inc (VNDA): 12/1 화. HETLIOZ (tasimelteon) for Smith-Magenis Syndrome
◈ BioCryst Pharmaceuticals Inc (BCRX): 12/3 목. Berotralstat BCX7353 for Reduce or eliminate attacks in HAE patients
임상 시험 결과 발표
◈ Imv Inc (IMV): 12/3 KOL event에서 난소암에 대한 T-세포 치료 업데이트.
◈ Sutro Biopharma Inc (STRO): 12/3 KOL 미팅에서 난소암에 대한 항체-약물 접합체 (ADC) STRO-002의 임상 1상 결과 업데이트.
AES 미팅 (12/4 금 - 12/8 화)
◈ Xenon Pharmaceuticals Inc (XENE): 유아기 결여 간칠 (childhood absence epilepsy)에 대한 XEN007의 임상 2상 중간 결과.
◈ Ovid Therapeutics Inc (OVID), Takeda Pharmaceutical Co Ltd (TAK): 드라베 증후군, 레녹스-가스토 증후군에 대한 TAK-935/OV935의 임상 2상, 앵갤먼 증후군에 대한 OV101의 임상 3상.
ASH 미팅 (12/5 토 - 12/8 화)
◈ Mazeraski @Mazeraski 이라는 트위터리안이 미국 혈액 학회 ASH 2020의 발표 명단을 구글시트에 정리해놨음. 아래 링크 참조.
실적 발표
◈ (화 장후) VEEV
아래는 어닝 위스퍼 실적 발표 일정
임상시험 결과 발표
| 회사명 | 심볼 | 후보물질 | 임상시험 | 적응증 | 예상 발표 | 협업 |
| Aerie Pharmaceuticals Inc | AERI | Roclanda | Mercury 3 topline | Roclanda's intraocular pressure reducing performance compared to Ganfort | 2020 3Q | |
| Aerpio Pharmaceuticals Inc | ARPO | Razuprotafib (AKB-9778) | Phase 2 | Open-angle glaucoma (OAG) | 2020 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 2020-11-05 | |
| Amgen, Inc. | AMGN | AMG 510 | Phase 2 단독 | 비소세포폐암 | 2020 하반기 | |
| Anavex Life Sciences Corp | AVXL | ANAVEX 2-73 | Phase 2 | Rett syndrome | 2020 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 | 2020 4Q | |
| Arcus Biosciences Inc | RCUS | Domvanalimab (TIGIT) | Phase 2 | PD-L1 high NSCLC | ||
| 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) | 2020 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 | 2020 4Q | |
| Calithera Biosciences Inc | CALA | Telaglenastat (CB-839) + Cabozantinib | Phase 2 CANTATA | Renal cell carcinoma | 2020 4Q or 2021 1Q | EXEL |
| Cellectis SA | CLLS | UCART22 | Phase 1 BALLI-01 | ASH 2020-11-05 | ||
| ChemoCentryx Inc | CCXI | Avacopan | C3G | |||
| Cortexyme Inc | CRTX | COR388 | Phase 2/3 GAIN 중간결과 | Alzheimer’s disease | 2020 4Q | |
| Cyclerion Therapeutics Inc | CYCN | Olinciguat (IW-1701) | Phase 2 STRONG-SCD | Sickle Cell disease | 2020 3Q말 | |
| Five Prime Therapeutics Inc | FPRX | FPT155 | Phase 1a monotherapy | |||
| Forma Therapeutics Holdings Inc | FMTX | FT-4202 | Phase 1 | Sickle Cell Disease | ||
| Imagine All The People Inc | IMTV | IMA101 | Phase 1/2 | Solid tumors | ||
| Inhibrx Inc | INBX | INBRX-106 | Phase 1 | OX40 monotherapy | ||
| Inovio Pharmaceuticals Inc | INO | INO-4800 | 임상 2/3상 | 코로나-19 | 2020-9 | |
| Johnson & Johnson | JNJ | 범용 인플루엔자 백신 | VXRT | |||
| Johnson & Johnson | JNJ | M254 | Phase 1/2 파트 B | idiopathic thrombocytopenic purpura | 2020 3Q | |
| Kalvista Pharmaceuticals Inc | KALV | KVD900 | Phase 2 | HAE | 2020 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 2020-11-05 | ||
| 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) | 2020 중반 | |
| Mesoblast limited | MESO | MPC-150-IM | Phase 3 Class 2/3 | 진행성 심부전 Heart failure | 2020 중반 | |
| Oncternal Therapeutics Inc | ONCT | cirmtuzumab (anti-ROR1) + Imbruvica | Phase 1/2 | 맨틀 세포 림프종 (MCL), 만성 림프구성 림프종 (CML) | ASH 2020-11-05 | |
| 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 | 2020 4Q | |
| 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 | 2020 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 | 2020 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 | 2020 하반기 | |
| Tonix Pharmaceuticals Holding Corp | TNXP | TNX-102 SL (Tonmya) | 임상 3상 중간 결과 (top-line은 4분기) | 섬유근통 (Fibromyalgia) | 2020-9 | |
| 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 | 참고사항 |
| Spectrum Pharmaceuticals, Inc. | SPPI | SPI-2012 (ROLONTIS) for Chemotherapy-Induced Neutropenia | 2020-10-24 | 신규 | 2020-10-24 코로나-19로 인한 여행제한으로 제조시설 방문이 불가능한 관계로 연기 | ||
| Bristol-Myers Squibb Co | BMY | liso-cel (JCAR017) for r/r large B-cell lymphoma (TRANSCEND NHL-001) | 2020-11-16 | 신규 Priority | 2020-11-17 연기 (생산시설 방문 불가) | ||
| Revance Therapeutics Inc | RVNC | DAXI (RT002) for Moderate to severe glabellar (frown) lines | 2020-11-25 | 신규 | 2020-11-25 코로나-19로 인한 여행제한으로 제조시설 방문이 불가능한 관계로 연기 | ||
| 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 | ||
| Vanda Pharmaceuticals Inc. | VNDA | HETLIOZ (tasimelteon) for Smith-Magenis Syndrome | 2020-12-01 | 확장 Priority | |||
| BioCryst Pharmaceuticals, Inc. | BCRX | Berotralstat BCX7353 for Reduce or eliminate attacks in HAE patients | 2020-12-03 | 신규 | |||
| Pfizer Inc. | PFE | BNT162b2 for COVID-19 vaccine | 2020-12-10 | 신규 EUA | BNTX | ||
| BioNTech SE - ADR | BNTX | BNT162b2 for COVID-19 vaccine | 2020-12-10 | 신규 EUA | PFE | ||
| 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 | |
| AstraZeneca plc | AZN | Roxadustat for Anaemia in Chronic Kidney Disease | 2020-12-20 | 신규 | FGEN | ||
| FibroGen Inc | FGEN | Roxadustat for Anaemia in Chronic Kidney Disease | 2020-12-20 | 신규 | AZN | ||
| 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 | |||
| Athenex Inc | ATNX | Tirbanibulin ointment for Actinic keratosis | 2020-12-30 | 신규 | |||
| Scpharmaceuticals Inc | SCPH | Furoscix for Heart failure | 2020-12-30 | 신규 | |||
| Alnylam Pharmaceuticals, Inc. | ALNY | Inclisiran | 2020 하반기 | 신규 | NVS | ||
| AnaptysBio Inc | ANAB | Dostarlimab (Anti-PD-1) in endometrial cancer | 2020 하반기 | 신규 | GSK | ||
| GlaxoSmithKline plc | GSK | Dostarlimab (Anti-PD-1) in endometrial cancer | 2020 하반기 | 신규 | ANAB | ||
| GlaxoSmithKline plc | GSK | Trelegy Ellipta for COPD | 2020 하반기 | 확장 | INVA, TBPH | 9월초 AdCom 14-1 반대 표결 | |
| Innoviva Inc | INVA | Trelegy Ellipta for COPD | 2020 하반기 | 확장 | GSK, TBPH | 9월초 AdCom 14-1 반대 표결 | |
| Theravance Biopharma Inc | TBPH | Trelegy Ellipta for COPD | 2020 하반기 | 확장 | GSK, INVA | 9월초 AdCom 14-1 반대 표결 | |
| Johnson & Johnson | JNJ | Spravato | 2020 하반기 | 확장 | Major depressive disorder with active suicidal ideation with intent (Aspire I and II) | ||
| Novartis AG | NVS | Inclisiran | 2020 하반기 | 신규 | ALNY | ||
| Novartis AG | NVS | Xolair for Nasal polyps (Polyp 1 and 2) | 2020 하반기 | 확장 | RHHBY | ||
| Roche Holdings AG Basel ADR Common Stock | RHHBY | Xolair for Nasal polyps (Polyp 1 and 2) | 2020 하반기 | 확장 | NVX | ||
| CorMedix Inc. | CRMD | 카테터를 통한 감염, Defencath | No | 2021-01-14 | 신규 | ||
| 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 | ||
| Regeneron Pharmaceuticals Inc | REGN | Evinacumab for HofH | 2021-02-21 | 신규 Priority | |||
| Sarepta Therapeutics Inc | SRPT | casimersen (SRP-4045, AMONDYS 45) for DMD exon 45 skipping | No | 2021-02-25 | 신규 Priority | ||
| Regeneron Pharmaceuticals Inc | REGN | Libtayo for 1L locally advanced/metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 | 2021-02-28 | 확장 Priority | SNY | ||
| Regeneron Pharmaceuticals Inc | REGN | Libtayo for locally advanced or metastatic basal cell carcinoma (BCC) | 2021-03-03 | 확장 Priority | SNY | ||
| Biogen Inc | BIIB | Aducanumab for Alzheimer’s disease | 2020-11-06 | 2021-03-07 | 신규 | 애드컴 반대 의견 | |
| Regeneron Pharmaceuticals Inc | REGN | Praluent for HofH | 2021-04-04 | 확장 | SNY | ||
| AstraZeneca plc | AZN | Tagrisso의 EGFR 돌연변이 비소세포폐암 애주반트 치료 | 2021-04-20 est | 확장 Priority | |||
| Protalix Biotherapeutics Inc | PLX | 파브리병, pegunigalsidase alfa (PRX–102) | 2021-04-27 | 신규 Priority | Chiesi | 2021-01-27에서 3개월 연장 | |
| Apellis Pharmaceuticals Inc | APLS | pegcetacoplan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) | No | 2021-05-14 | 신규 Priority | ||
| ADC Therapeutics SA | ADCT | loncastuximab tesirine (Lonca) for DLBCL | 2021-05-21 | 신규 Priority | |||
| Kiniksa Pharmaceuticals Ltd | KNSA | 재발성 심낭염 recurrent pericarditis, Rilonacept | 2021-05-21 | 신규 Priority | |||
| Liminal BioSciences Inc | LMNL | 선천성 플라스미노젠 결핍증 (congenital plasminogen deficiency)에 대한 Ryplazim (plasminogen) | 2021-06-05 | 신규 | 2021-03-05에서 3개월 연장 | ||
| 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 |
| 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 | |||
| 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 + Clover vaccine | Phase 1 | 2020 말 | |||
| 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 | |||
| GlaxoSmithKline plc | GSK | Medicago CoVLP | Phase 2/3 | 2020-11-12 | |||
| 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 | ||
| Novavax, Inc. | NVAX | NVX-CoV2373 | Phase 3 | 2020-11말 | |||
| Novavax, Inc. | NVAX | NVX-CoV2373 | Phase 3 (UK) | 2020-09-24 | 2020 4Q (Ph2) -> 2021 1Q | ||
| 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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