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The Week Ahead In Biotech: Novavax Coronavirus Vaccine Readout, FDA Decisions And More Earnings

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The Week Ahead In Biotech: Novavax Coronavirus Vaccine Readout, FDA Decisions And More Earnings

Biotech stocks came under pressure in the week ended July 31 amid mixed earnings from the sector and some adverse clinical readouts.

COVID-19 news flow continued to pour in, with big pharma tie-ups flaunting positive tidings. In the biggest ever coronavirus funding deal, the Sanofi SA (NASDAQ: SNYGlaxoSmithKline plc (NYSE: GSKwon a joint $2.1 billion U.S. federal funding award.

Here're the key catalysts for the unfolding week:

Conferences

72nd National Hemophilia Foundation's Annual Bleeding Disorders Meeting 2020 (virtual meeting): Aug. 1-8

PDUFA Dates

FDA is scheduled to rule on DBV TECHNOLOGIE/S' ADR (NASDAQ: DBVT) Viaskin peanut allergy patch Wednesday. However, cancellation of the Adcom meeting scheduled May 15 has poured cold water on the prospects of an approval coming through.

Trevena Inc (NASDAQ: TRVN) has a tryst with the FDA Friday, with respect to the NDA for its pain drug oleceridine, which was once rejected by the agency on the premise of inadequacy of clinical data.

FDA is also due to rule on Eagle Pharmaceuticals Inc's (NASDAQ: EGRX) exertional heat stroke drug ryanodex Saturday. The original PDUFA date was pushed back a month as the FDA finds it hard to keep up with scheduling commitments due to COVID-19.

Clinical Readouts

BioSig Technologies Inc's (NASDAQ: BSGM) CEO Kenneth Londoner, will present at the Proactive Investors One2One Virtual Event Tuesday an update on Phase 2 clinical study of merimepodib in combination with remdesivir in adult patients with advanced COVID-19.

Novavax, Inc. (NASDAQ: NVAX) is scheduled to announce in the first week of August preliminary Phase 1 data for NVX-CoV2373, its investigational vaccine against SARS-CoV-2.

Earnings

Monday

Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (before the market open)
Minerva Neurosciences Inc (NASDAQ: NERV) (before the market open)
Pacific Biosciences of California Inc (NASDAQ: PACB) (after the close)
SI-Bone Inc (NASDAQ: SIBN) (after the close)
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) (after the close)
DURECT Corporation (NASDAQ: DRRX) (after the close)
Penumbra Inc (NYSE: PEN) (after the close)
Revance Therapeutics Inc (NASDAQ: RVNC) (after the close)

Tuesday

Haemonetics Corporation (NYSE: HAE) (before the market open)
Incyte Corporation (NASDAQ: INCY) (before the market open)
Karyopharm Therapeutics Inc (NASDAQ: KPTI) (before the market open)
Intersect ENT Inc (NASDAQ: XENT) (before the market open)
Oxford Immunotec Global PLC (NASDAQ: OXFD) (before the market open)
Epizyme Inc (NASDAQ: EPZM) (before the market open)
Neuronetics Inc (NASDAQ: STIM) (before the market open)
Mallinckrodt PLC (NYSE: MNK) (before the market open)
Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open)
Zimmer Biomet Holdings Inc (NYSE: ZBH) (before the market open)
Strongbridge Biopharma plc (NASDAQ: SBBP) (before the market open)
BIO-TECHNE Corp (NASDAQ: TECH) (before the market open)
Avanos Medical Inc (NYSE: AVNS) (before the market open)
Amarin Corporation plc (NASDAQ: AMRN) (before the market open)
Aquestive Therapeutics Inc (NASDAQ: AQST) (after the close)
Akcea Therapeutics Inc (NASDAQ: AKCA) (after the close)
Acorda Therapeutics Inc (NASDAQ: ACOR) (after the close) (after the close)
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close)
Corcept Therapeutics Incorporated (NASDAQ: CORT) (after the close)
Xencor Inc (NASDAQ: XNCR) (after the close)
Vapotherm Inc (NYSE: VAPO) (after the close)
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the close)
NuVasive, Inc. (NASDAQ: NUVA) (after the close)
Qiagen NV (NYSE: QGEN) (after the close)
Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the close)
Fulgent Genetics Inc (NASDAQ: FLGT) (after the close)
Enanta Pharmaceuticals Inc (NASDAQ: ENTA) (after the close)
Otonomy Inc (NASDAQ: OTIC) (after the close)
Inspire Medical Systems Inc (NYSE: INSP) (after the close)
Myokardia Inc (NASDAQ: MYOK) (after the close)
Curis, Inc. (NASDAQ: CRIS) (after the close)
CareDx Inc (NASDAQ: CDNA) (after the close)
Cardiovascular Systems Inc (NASDAQ: CSII) (after the close)
Cytosorbents Corp (NASDAQ: CTSO) (after the close)
GenMark Diagnostics, Inc (NASDAQ: GNMK) (after the close)
Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) (after the close)
Cerus Corporation (NASDAQ: CERS) (after the close)
Inspire Medical Systems Inc (NYSE: INSP) (after the close)

See also: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates

Wednesday

Constellation Pharmaceuticals Inc (NASDAQ: CNST) (before the market open)
Vericel Corp (NASDAQ: VCEL) (before the market open)
Oyster Point Pharma Inc (NASDAQ: OYST) (before the market open)
Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) (before the market open)
PPD Inc (NASDAQ: PPD) (before the market open)
Horizon Therapeutics PLC (NASDAQ: HZNP) (before the market open)
Moderna Inc (NASDAQ: MRNA) (before the market open)
Ionis Pharmaceuticals Inc (NASDAQ: IONS) (before the market open)
Regeneron Pharmaceuticals Inc (NASDAQ: REGN) (before the market open)
Harvard Bioscience, Inc. (NASDAQ: HBIO) (before the market open)
IVERIC bio Inc (NASDAQ: ISEE) (before the market open)
Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI) (before the market open)
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (before the market open)
Allogene Therapeutics Inc (NASDAQ: ALLO (before the market open)
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA (after the close)
ADMA Biologics Inc (NASDAQ: ADMA) (after the close)
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (after the close)
AxoGen, Inc Common Stock (NASDAQ: AXGN) (after the close)
Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) (after the close)
Global Blood Therapeutics Inc (NASDAQ: GBT) (after the close)
Transenterix Inc (NYSE: TRXC) (after the close)
Kindred Biosciences Inc (NASDAQ: KIN) (after the close)
ResMed Inc. (NYSE: RMD) (after the close)
Silk Road Medical Inc (NASDAQ: SILK) (after the close)
Tricida Inc (NASDAQ: TCDA) (after the close)
SurModics, Inc. (NASDAQ: SRDX) (after the close)
Immunomedics, Inc. (NASDAQ: IMMU) (after the close)
PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
Sangamo Therapeutics Inc (NASDAQ: SGMO) (after the close)
TRACON Pharmaceuticals Inc (NASDAQ: TCON) (after the close)
Lyra Therapeutics Inc (NASDAQ: LYRA) (after the close)
Miragen Therapeutics Inc (NASDAQ: MGEN) (after the close)
Zogenix, Inc. (NASDAQ: ZGNX) (after the close)
Sarepta Therapeutics Inc (NASDAQ: SRPT) (after the close)
Natera Inc (NASDAQ: NTRA) (after the close)
OraSure Technologies, Inc. (NASDAQ: OSUR) (after the close)
Orthopediatrics Corp (NASDAQ: KIDS) (after the close)
G1 Therapeutics Inc (NASDAQ: GTHX) (after the close)
Globus Medical Inc (NYSE: GMED) (after the close)
TransMedics Group Inc (NASDAQ: TMDX) (after the close)
Nevro Corp (NYSE: NVRO) (after the close)
Collegium Pharmaceutical Inc (NASDAQ: COLL) (after the close)
Endo International PLC (NASDAQ: ENDP) (after the close)

Thursday

Polarityte Inc (NASDAQ: PTE) (before the market open)
Mylan NV (NASDAQ: MYL) (before the market open)
Menlo Therapeutics Inc (NASDAQ: MNLO) (before the market open)
Mediwound Ltd (NASDAQ: MDWD) (before the market open)
Synlogic Inc (NASDAQ: SYBX) (before the market open)
Zoetis Inc (NYSE: ZTS) (before the market open)
TherapeuticsMD Inc (NASDAQ: TXMD) (before the market open)
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (before the market open)
Syneos Health Inc (NASDAQ: SYNH) (before the market open)
Orthofix Medical Inc (NASDAQ: OFIX) (before the market open)
Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) (before the market open)
Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) (before the market open)
Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
Athenex Inc (NASDAQ: ATNX) (before the market open)
Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
Bristol-Myers Squibb Co (NYSE: BMY) (before the market open)
Agenus Inc (NASDAQ: AGEN) (before the market open)
ABIOMED, Inc. (NASDAQ: ABMD) (before the market open)
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open)
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (before the market open)
Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
PDL BioPharma Inc (NASDAQ: PDLI) (after the close)
Syndax Pharmaceuticals Inc (NASDAQ: SNDX) (after the close)Regenxbio Inc
Dynavax Technologies Corporation (NASDAQ: DVAX) (after the close)
Accelerate Diagnostics Inc (NASDAQ: AXDX) (after the close)
Adamas Pharmaceuticals Inc (NASDAQ: ADMS) (after the close)
Achieve Life Sciences Inc (NASDAQ: ACHV) (after the close)
Acceleron Pharma Inc (NASDAQ: XLRN) (after the close)
Coherus Biosciences Inc (NASDAQ: CHRS) (after the close)
Puma Biotechnology Inc (NASDAQ: PBYI) (after the close)
Axonics Modulation Technologies Inc (NASDAQ: AXNX) (after the close)
Theravance Biopharma Inc (NASDAQ: TBPH) (after the close)
Iovance Biotherapeutics Inc (NASDAQ: IOVA) (after the close)
Glaukos Corp (NYSE: GKOS) (after the close)
CytomX Therapeutics Inc (NASDAQ: CTMX) (after the close)
Cytokinetics, Inc. (NASDAQ: CYTK) (after the close)
Insulet Corporation (NASDAQ: PODD) (after the close)
Chembio Diagnostics Inc (NASDAQ: CEMI) (after the close)
Exelixis, Inc. (NASDAQ: EXEL) (after the close)
Editas Medicine Inc (NASDAQ: EDIT) (after the close)
FibroGen, Inc. (NASDAQ: FGEN) (after the close)
Guardant Health Inc (NASDAQ: GH) (after the close)
GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the close)
PRA Health Sciences Inc (NASDAQ: PRAH) (after the close)
Illumina, Inc. (NASDAQ: ILMN) (after the close)
Insmed Incorporated (NASDAQ: INSM) (after the close)
Pfenex Inc (NYSE: PFNX) (after the close)
ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) (after the close)
Spero Therapeutics Inc (NASDAQ: SPRO) (after the close)
NovaBay Pharmaceuticals, Inc. (NYSE: NBY) (after the close)
Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the close)
Nektar Therapeutics (NASDAQ: NKTR) (after the close)

Friday

Arbutus Biopharma Corp (NASDAQ: ABUS) (before the market open)
Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open)
Ocular Therapeutix Inc (NASDAQ: OCUL) (before the market open)

IPO Quiet Period Expiry

Poseida Therapeutics, Inc. (NASDAQ: PSTX)
Nkarta Inc (NASDAQ: NKTX)

Related Link: Gilead Analysts Downplay Q2 Miss Amid Remdesivir's COVID-19 Opportunity

 

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