이번주 제약-바이오 주요 일정 20201011
지난주 제약-바이오는 마켓보다 크게 아웃퍼폼. XBI 8.96%, NBI 6.56%, XPH 9.35%.
지난주 제약-바이오 섹터의 주요 이벤트들은 아래 포스팅에 정리.
날자/시간은 모두 미국 현지 시간.
학회/투자자 미팅
10/11 일 – 10/13 화 United European Gastroenterology, or UEG Week
10/12 월 – 10/16 금 Cell & Gene Meeting on the Mesa 2020
10/12 월 – 10/23 금 Joint 49th Child Neurology Society Annual Meeting/16th International Child Neurology Congress
10/14 수 – 10/17 토 European Society for Immunodeficiencies, or ESID, 2020 Meeting
임상시험 결과 발표
Bristol-Myers Squibb (BMY): (11/12 월 8:00 EST) UEG Week 발표. 임상 3상 True North, Zeposia, 궤양성 대장염
Rocket Pharmaceuticals Inc. (RCKT): ESID meeting 발표. 임상 1/2상 PR-L201, leukocyte adhesion deficiency-I, 임상 1상 파트.
실적 발표
11/13 화 장전: J&J
11/13 화 장후: ENZ
11/14 수 장전: UNH
11/15 목 장전: BCLI, RHHBY
11/15 목 장후: ISRG
아래는 투자 등급 헬스케어 기업 실적 발표 일정 (출처: BoA)
IPO Quiet Period 종료
Metacrine Inc (MTCR), Dyne Therapeutics Inc (DYN), Athira Pharma Inc (ATHA), Outset Medical Inc (OM)
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 |
|
|
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 |
|
|
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 |
|
|
|
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 |
|
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 |
|
|
|
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 |
|
|
Matrix Service Co |
MTRX |
MRTX849 |
Phase 1/2 KRYSTAL |
고형암: NSCLC/CRC 단독요법 |
10/24-25 triple meeting |
|
|
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 |
|
|
|
|
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 (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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