이번주 제약-바이오 주요 일정 20200802

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PDUFA

• DBV Technologies (DBVT): (8/5 수) 땅콩 알러지 - Viaskin 패치
• Trevena Inc (TRVN): (8/7 금) 수술후 통증 - Oliceridine 
• Eagle Pharmaceuticals Inc (EGRX): (8/8 토) 열사병 (exertional heat stroke) - ryanodex

 

 

임상시험 결과 발표

 

• BioSig Technologies Inc (BSGM): (8/4 화) 코로나-19에 대한 merimepodib, remdesivir 병용 임상 2상
• Novavax, Inc (NVAX): (8월 첫주) NVX-CoV2373 코로나-19 백신 후보물질 임상 1상

 

 

실적발표       

 

• 8/3 월 장전: LGND NERV
• 8/3 월 장후: PACB SIBN NBIX DRRX PEN RVNC
• 8/4 화 장전: HAE INCY KPTI XENT OXFD EPZM STIM MNK EVFM ZBH SBBP TECH AVNS AMRN
• 8/4 화 장후: AQST AKCA ACOR BMRN CORT XNCR VAPO RIGL NUVA QGEN JAZZ FLGT ENTA OTIC INSP MYOK CDNA CSII CTSO GNMK DCPH CERS INSP 
• 8/5 수 장전: CNST VCEL OYST EYPT PPD HZNP MRNA IONS REGN HBIO ISEE BCLI BDSI ALLO
• 8/5 수 장후: ARNA ADMA ACAD AXGN ARWR GBT TRXC KIN RMD SILK TCDA SRDX IMMU PTCT SGMO TCON LYRA MGEN ZGNX SRPT NTRA OSUR KIDS GTHX GMED TMDX NVRO COLL ENDP
• 8/6 목 장전: PTE MYL MNLO MDWD SYBX ZTS TXMD IRWD SYNH OFIX ELOX DRNA ALNY ATNX AMRX BMY AGEN ABMD BCRX AMAG GLMD 
• 8/6 목 장후: PDLI SNDX DVAX AXDX ADMS ACHV XLRN CHRS PBYI AXNX TBPH IOVA GKOS CTMX CYTK PODD CEMI EXEL EDIT FGEN GH GWPH PRAH ILMN INSM PFNX ZIOP SPRO NBY OPNT NKTR 
• 8/7 금 장전: ABUS VIVO OCUL

 

IPO Quiet Period 만료

• Poseida Therapeutics Inc (PSTX) 
• Nkarta Inc (NKTX)

※ Quiet Period: 한마디로 엠바고 기간. 이 기간이 해제되기 전까지는 공식적인 애널리스트 의견이 나올 수 없음. IPO를 위한 서류를 SEC에 제출한 이후 40일간.

 

 

2020년 중반 발표 예정인 임상시험 결과들

 

Spectrum Pharmaceuticals, Inc. (SPPI): HER2 양성 비소세포폐암에 대한 poziotinib의 임상 2상 ZENITH20  

Intra-Cellular Therapies Inc (ITCI): 양극성 우울증에 대한 lumateperone 보조치료의 임상 3상 

BioXcel Therapeutics Inc (BTAI): 노인성 치매 (geriatric dementia)에 의한 급성 흥분에 대한 BXCL501의 임상 1/2b상 

Alnylam Pharmaceuticals, Inc. (ALNY): 1형 원발성 옥살산뇨증 (primary hyperoxaluria type 1, PH1)에 대한 lumasiran이 임상 3상 ILLUMINATE-B 

Karuna Therapeutics Inc (KRTX): 실험적으로 유도된 통증에 대한 KarXT의 임상 1b상 

Akari Therapeutics PLC (AKTX): 아토피성 결막염 (atopic keratoconjunctivitis)에 대한 nomacopan 안약의 중간 결과 

Seres Therapeutics Inc (MCRB): C. difficile 감염에 대한 SER-109의 임상 3상  

Mesoblast (MESO): 진행성 심부전에 대한 Revascor의 임상 3상  

Akebia Therapeutics Inc (AKBA): 신장투석 비의존적 만성 신부전 환자의 결핵에 대한 vadadustat의 임상 3상 

Anavex Life Sciences Corp (AVXL): 파킨슨병에 대한 ANAVEX 2-73의 임상 2상 

BIOLINERX LTD/S ADR (BLRX): 진행성 췌장암에 대한 BL-8040 + Keytruda 2a 2차 치료의 임상 2a상 COMBAT/KEYNOTE-202의 PFS, OS 데이타 

Arcus Biosciences Inc (RCUS): AB928의 여러 암종에 대한 임상 1b상 병용 잠정 데이타 

Homology Medicines Inc (FIXX): 페닐키토뇨증 (phenylketonuria, PKU)에 대한 윶자 치료제의 임상 1/2상 pheNIX 추가 데이타 

Vaxart Inc (VXRT), Johnson & Johnson (JNJ): 범용 인플루엔자 백신 후보물질 데이타  

Albireo Pharma Inc (ALBO): 진행성 가족성 간내 담즙정체증 1형 (progressive familial intrahepatic cholestasis Odevixibat)에 대한 Odevixibat의 임상3상 PEDFIC 1/ NASH, NAFLD에 대한 elobixibat의 임상 3상 

resTORbio, Inc. (TORC): 파킨슨병에 대한 RTB101 + sirolimus의 임상1b/2a 전체 코호트 데이타 

 

 

8월로 예정된 FDA 승인 심사 일정

출처

• https://www.benzinga.com/general/biotech/20/08/16888527/the-week-ahead-in-biotech-novavax-coronavirus-vaccine-readout-fda-decisions-and-more-earnings
• https://www.benzinga.com/general/biotech/20/07/16778963/the-week-ahead-in-biotech-spotlight-on-gw-pharma-ultragenyx-fda-decisions-pfizer-earnings
• 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