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.

 

약장수 텔레그램 채널

 

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. 임상3Ongentys, 파킨슨병

Merck & Co. Inc. (MRK): HIV Glasgow 발표. 임상 2 islatravir, 1/1bislatravir + MK-8507

 

 

20204분기 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) 2020
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 10
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) 11
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 2/3 코로나-19 9
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 10
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 2020
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-line4분기) 섬유근통 (Fibromyalgia) 9
Uniqure NV QURE AMT-061 Phase 3 HOPE-B 26주 데이터 Hemophilia B 2020
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 2020/2021

 

 

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 - 3CRL 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, 9AdCom 14-1 반대 표결
Novartis, Roche NVS, RHHBY Xolair 하반기 Nasal polyps (Polyp 1 and 2)

 

 

출처

https://www.benzinga.com/general/biotech/20/10/17759230/the-week-ahead-in-biotech-avenues-fda-decision-alkermes-adcom-meeting-aziyo-biologics-ipo

https://www.evaluate.com/vantage/articles/events/company-events/go-or-no-go-valuable-drugs-set-fda-decisions?utm_campaign=Vantage%20Daily%20LIVE-2020-07-21T13:05:51.000+01:00&utm_medium=email&utm_source=vantagedaily&utm_content=a&mkt_tok=eyJpIjoiTlRKbE5ETmhaamt6TkRNeiIsInQiOiJlYitxaU1uZkI5VUZXV2JOOEtUbytUQVNZS3NXekRPWkFpM0JjSHhPb3N5UzVwemxPZTJ5RVRiOFBPUjh2QUFqcytEaUtFbzBqXC9IMWJrMytNemRWR2VWcXF4N3NOUnBSYWM2akR5WWZnWmFQdDZYOHlUN1hzcDIxNkY3c2o1THoifQ%3D%3D

https://www.biopharmcatalyst.com/news/2020/biotech-stock-catalysts-to-watch-in-august-biotech-week-in-review

https://www.biopharmcatalyst.com/news/2020/biotech-week-in-review-biotech-catalysts-likely-due-over-the-next-two-weeks

https://www.biopharmcatalyst.com/news/2020/phase-3-biotech-stock-catalysts-to-watch-in-september-biotech-week-in-review

https://www.nasdaq.com/market-activity/ipos

https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-august?utm_campaign=Vantage%20Daily%20LIVE-2020-08-20T09:46:21.000+01:00&utm_medium=email&utm_source=vantagedaily&utm_content=a&mkt_tok=eyJpIjoiWW1WbU5tUXlaVEEzTWpjeSIsInQiOiJKamdLZ0JjaVZkOTg3RTJTdFBObFphbUlrU2RYSFZzakZOaWZPMGMzQ1poWUJYYitoQVBhdXhXZURVWmVcL2t5eVF5dmFxanlcL3ZoaTNITXdiVmZXR05sXC9ucmkrNHN0TlBNVVNWeFBja1BKTENHSnphczh6UnRoNDdEV05UM3RzQiJ9

https://www.biopharmcatalyst.com/news/2020/phase-1-2-clinical-trial-readouts-to-watch-in-september-biotech-week-in-review

https://www.nyse.com/ipo-center/filings

https://www.biopharmcatalyst.com/news/2020/small-cap-biotech-stocks-with-pdufa-dates-through-to-november-biotech-week-in-review

https://www.biopharmcatalyst.com/news/2020/biotech-stock-catalysts-remaining-for-september-biotech-week-in-review

https://www.biopharmcatalyst.com/news/2020/phase-3-catalysts-to-watch-for-4q-biotech-week-in-review

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