이번주 제약-바이오 주요 일정 20201101

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이번주 제약-바이오의 임상시험 결과 발표, 신약 승인, 실적 발표 일정입니다.

 

이번주는 미국 대선 (11/3), FOMC (11/5)에 더해 중소형 바이오텍의 실적 발표가 몰려있는 주입니다. 중소형 바이오텍의 실적발표 = 파이프라인 업데이트라 바이오텍의 변동성은 시장 변동성보다 더 심할 것으로 보입니다.

 

더불어 바이오젠의 치매 치료제 후보물질 아두카누맙의 AdCom이 11/4로 잡혀있습니다. 바이오 산업군에서 비중이 큰 기업인 만큼 바이오 전체에 미치는 파급력도 클 것으로 보입니다. 바이오젠 기업으로 봐도 현재 상황이 안좋기 때문에 애드컴에서 반대 의견이 많으면 당분간 상당히 힘들 수 있습니다.

 

▶ 약장수 텔레그램 채널

 

지난주 제약-바이오 섹터의 주요 이벤트들은 아래 포스팅에 정리.

▶ 오늘 아침 제약-바이오 주요 소식 20201026

▶ 제약-바이오 주요 소식 20201027~1029

▶ 오늘 아침 제약-바이오 주요 소식 20201030

 

날자/시간은 모두 미국 현지 시간.

 

 

학회/투자자 미팅

◈ 11/1 일 - 11/5 목 International Cytokine and Interferon Society's Cytokines, or, ICIS, 2020 Conference

◈ 11/4 수 - 11/7 토 13th Clinical Trials on Alzheimer's Disease, or CTAD

 

 

AdCom

◈ Biogen Inc (BIIB): 11/4 수. aducanumab, 알츠하이머

 

 

임상시험 결과 발표

◈ Surface Oncology Inc (SURF): 11/1 일. ICIS congress 발표. 고형암에 대한 SRF388 전임상 결과.

◈ vTv Therapeutics Inc (VTVT): 11/4 수. CTAD 발표. 2형 당뇨병 환자의 알츠하이머병에 대한 azeliragon의 임상2상 Elevage.

◈ Bellerophon Therapeutics Inc (BLPH): 11/5 목. American Thoracic Society Interstitial Lung Disease Mini Symposia/2020 Pulmonary Fibrosis Foundation Meeting 발표. 폐고혈압 위험군 섬유성 간질성 폐질환 환자에 대한 INOpulse의 임상 2상.

◈ Cassava Sciences Inc (SAVA): 11/7 토. 알츠하이머병에 대한 sumifilam의 임상 2b상.

 

 

실적 발표

◈ (월 장전) HZNP ISEE EGRX XENT NERV STIM VCYT SNDX HALO ESPR UROV DRRX SIBN

◈ (월 장후) JAZZ KPTI PACB

◈ (화 장전) HUM BHC MCK CTLT INSP OXFD AVNS

◈ (화 장후) GWPH ACOR SUPN FPRX

◈ (수 장전) IONS HAE

◈ (수 장후) FLXN AQST ANIK ACAD AXNX TTOO OSUR HOLX OTIC SRDX SGMO PRAH CTSO LCTX PODD CYTK MNKD DMAC GTHX SPPI

(목 장전) AZN REGN AMRN BMY TEVA ZTS KIDS KURA SYBX ABUS ALNY ATNX ADAP ANIP ATRS AGIO XFOR SAGE NTLA KALA OPTN OFIX RDUS RGEN INCY EYPT CNCE CLVS VCEL PRVB HBIO BCRX BDSI INCY

◈ (목 장후) NVTA EDIT IOVA NVCN EBS BMRN EXEL YMAB ACRX AERI ADMS TRXC PRTK NKTR SPRO MSON TFFP XNCR OYST SRPT NTRA ICUI RIGL GH RTRX TNDM CEMI DRNA EXEL ENDP FGEN FLDM NVRO CTMX DVAX GERN CRMD CELC BLFS CLBS TBPH GBT CHRS ATRC XLRN ADMA OCUL IRWD SYRS ZIOP SRTS DCPH ELOX CHMA INMB CALA

◈ (금 장전) CVS IMGN AMRX ELAN AMRX ENDP GLPG MYL AMPH MTNB ZBH

 

아래는 어닝 위스퍼 실적 발표 일정

 

IPO Quiet Period 종료

◈ AZYO KRON SPRB

 

 

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
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)	11월말
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
ChemoCentryx Inc	CCXI	Avacopan	Phase 3	C3G
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
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
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
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
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

회사명	심볼	프로젝트	AdCom	PDUFA	종류	협업	비고
Spectrum Pharmaceuticals, Inc.	SPPI	SPI-2012 (ROLONTIS) for Chemotherapy-Induced Neutropenia	2020-10-24	신규	코로나-19로 인한 여행제한으로 제조시설 방문이 불가능한 관계로 연기
Biogen Inc	BIIB	Aducanumab for Alzheimer’s disease	2020-11-06	2021-03-07	신규
Supernus Pharmaceuticals Inc	SUPN	SPN-812 (P301) for ADHD	2020-11-08	신규
Adamis Pharmaceuticals Corp	ADMP	ZIMHI (naloxone HCI Injection) for Opioid overdose	2020-11-15	확장
Bristol-Myers Squibb Co	BMY	liso-cel (JCAR017) for r/r large B-cell lymphoma (TRANSCEND NHL-001)	2020-11-16	신규 Priority
Eiger Biopharmaceuticals Inc	EIGR	Lonafarnib for Hutchinson-Gilford Progeria Syndrome (HGPS)	2020-11-20	신규 Priority
Revance Therapeutics Inc	RVNC	DAXI (RT002) for Moderate to severe glabellar (frown) lines	2020-11-25	신규
Rhythm Pharmaceuticals Inc	RYTM	Setmelanotide for POMC deficiency obesity / Leptin Receptor Deficiency Obesity	2020-11-27	신규 Priority
Y-mAbs Therapeutics, Inc	YMAB	Naxitamab for Relapsed/Refractory High-Risk Neuroblastoma	2020-11-30	신규 Priority
BioCryst Pharmaceuticals, Inc.	BCRX	Berotralstat BCX7353 for Reduce or eliminate attacks in HAE patients	2020-12-03	신규
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
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
Scpharmaceuticals Inc	SCPH	Furoscix for Heart failure	2020-12-30	신규
Lipocine Inc	LPCN	Tlando for Men with low testosterone (Low T)	미정	신규	3회 CRL 후 재신청/PDUFA 8/28에서 연기. 날자 미정
Alnylam Pharmaceuticals, Inc.	ALNY	Inclisiran	하반기	신규	NVS
AnaptysBio Inc	ANAB	Dostarlimab (Anti-PD-1) in endometrial cancer	하반기	신규	GSK
GlaxoSmithKline plc	GSK	Dostarlimab (Anti-PD-1) in endometrial cancer	하반기	신규	ANAB
GlaxoSmithKline plc	GSK	Trelegy Ellipta for COPD	하반기	확장	INVA, TBPH	9월초 AdCom 14-1 반대 표결
Innoviva Inc	INVA	Trelegy Ellipta for COPD	하반기	확장	GSK, TBPH	9월초 AdCom 14-1 반대 표결
Theravance Biopharma Inc	TBPH	Trelegy Ellipta for COPD	하반기	확장	GSK, INVA	9월초 AdCom 14-1 반대 표결
Johnson & Johnson	JNJ	Spravato	하반기	확장	Major depressive disorder with active suicidal ideation with intent (Aspire I and II)
Novartis AG	NVS	Inclisiran	하반기	신규	ALNY
Novartis AG	NVS	Xolair for Nasal polyps (Polyp 1 and 2)	하반기	확장	RHHBY
Roche Holdings AG Basel ADR Common Stock	RHHBY	Xolair for Nasal polyps (Polyp 1 and 2)	하반기	확장	NVX
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
AstraZeneca plc	AZN	Tagrisso의 EGFR 돌연변이 비소세포폐암 애주반트 치료	2021-04-20 est	확장 Priority
Santen Pharmaceutical Co Ltd	SNPHF	아토피 결막염 cyclosporine topical ophthalmic emulsion, 0.1%	2021-06-21

 

 

코로나-19 백신

회사명	심볼	후보물질	임상시험	시작	중간결과	기타 사항	협업	최종결과	적응증
Altimmune Inc	ALT	T-COVID	2020 4Q	COVID-19
Altimmune Inc	ALT	AdCOVID	Phase 1	2020 4Q	COVID-19 vaccine, 비강
Arcturus Therapeutics Holdings Inc	ARCT	ARCT-021 LUNAR-COV19	Phase 1/2	2020 4Q	COVID-19 vaccine
AstraZeneca plc	AZN	AZD1222 (ChAdOx1 nCoV-19)	Phase 3 non-US trials	2020 4Q	COVID-19 vaccine
AstraZeneca plc	AZN	AZD1222 (ChAdOx1 nCoV-19)	Phase 3 US	2020/10/23 중단 후 재개	COVID-19 vaccine
BioNTech SE - ADR	BNTX	BNT162b2	Phase 2/3	2020-10 -> 11	PFE	COVID-19 vaccine
CureVac BV	CVAC	CVnCoV	Phase 1/2	2020 4Q (Ph1)	COVID-19 vaccine
CureVac BV	CVAC	CVnCoV	Phase 1/2	2020/9/29 (2a)	2020 4Q (Ph2a)	COVID-19 vaccine
CureVac BV	CVAC	CVnCoV	Phase 2b/3	2020 4Q	COVID-19 vaccine
Dynavax Technologies Corporation	DVAX	CpG 1018 + Medicago vaccine	Phase 1	2020-10	COVID-19 vaccine
GlaxoSmithKline plc	GSK	Adjuvanted COVID-19 vaccine	Phase 1/2	2020-09-04	2020-12	COVID-19 vaccine
GlaxoSmithKline plc	GSK	Adjuvanted COVID-19 vaccine	Phase 3	2020-12	COVID-19 vaccine
Imv Inc	IMV	DPX-COVID-19	Phase 1/2	2020말	COVID-19 vaccine
Inovio Pharmaceuticals Inc	INO	INO-4800	Phase 2/3	2020/9/29 부분 중단	COVID-19 vaccine
Johnson & Johnson	JNJ	JNJ-78436735 (Ad26.COV2-S)	Phase 3 ENSEMBLE	2020-09-23	2020/10/23 중단 후 재개	COVID-19 vaccine
Moderna Inc	MRNA	mRNA-1273	Phase 2	COVID-19 vaccine
Moderna Inc	MRNA	mRNA-1273	Phase 3	2020-11	2020/10/22 모집 완료	COVID-19 vaccine
Novavax, Inc.	NVAX	NVX-CoV2373	Phase 3	2020-11말	COVID-19 vaccine
Novavax, Inc.	NVAX	NVX-CoV2373	Phase 3 (UK)	2020-09-24	2020 4Q (Ph2) -> 2021 1Q	COVID-19 vaccine
Pfizer Inc.	PFE	BNT162b2	Phase 2/3	2020-07-27	2020-10	BNTX	COVID-19 vaccine
Sanofi SA	SNY	mRNA vaccine	Phase 1b	2020말	TBIO	COVID-19 vaccine
Translate Bio Inc	TBIO	mRNA vaccine	Phase 1b	2020말	SNY	COVID-19 vaccine
Vaxart Inc	VXRT	VXA-CoV2-1	Phase 1	2020-10-13

 

 

출처

https://www.benzinga.com/general/biotech/20/10/17942727/the-week-ahead-in-biotech-spectrum-pharma-fda-decision-biogen-and-abbott-earnings-cancer-conferen

https://www.evaluate.com

https://www.biopharmcatalyst.com

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