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 SNY GlaxoSmithKline plc GSK won 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 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 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 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 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. 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. LGND (before the market open)
Minerva Neurosciences Inc NERV (before the market open)
Pacific Biosciences of California Inc PACB (after the close)
SI-Bone Inc SIBN (after the close)
Neurocrine Biosciences, Inc. NBIX (after the close)
DURECT Corporation DRRX (after the close)
Penumbra Inc PEN (after the close)
Revance Therapeutics Inc RVNC (after the close)

Tuesday

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

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

Wednesday

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

Thursday

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

Friday

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

IPO Quiet Period Expiry

• Poseida Therapeutics, Inc. PSTX
• Nkarta Inc NKTX

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