The Daily Biotech Pulse: Roche Obtains FDA Emergency Use Authorization For COVID-19 Test, Chembio Appoints New CEO, Inovio Slumps On Earnings - iShares Biotechnology ETF (NASDAQ:IBB), Inovio Pharmaceuticals (NASDAQ:INO), Roche Holding (OTC:RHHBY)

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs March 12.)

Masimo Corporation MASI

Down In The Dumps

(Biotech stocks that hit 52-week lows March 12.)

Abbott Laboratories ABT
ABIOMED, Inc. ABMD
Acasti Pharma Inc ACST
Accelerate Diagnostics Inc AXDX
AcelRx Pharmaceuticals Inc ACRX
Achieve Life Sciences Inc ACHV
Acorda Therapeutics Inc ACOR
Adamas Pharmaceuticals Inc ADMS
Adamis Pharmaceuticals Corp ADM
Adaptive Biotechnologies Corp ADPT
ADDEX THERAPEUT/ADR ADXN
ADMA Biologics Inc ADMA
Aeglea Bio Therapeutics Inc AGLE
Aerie Pharmaceuticals Inc AERI
AEterna Zentaris Inc. AEZS
Affimed NV AFMD
Aileron Therapeutics Inc ALRN
Aimmune Therapeutics Inc AIMT
Akari Therapeutics PLC AKTX
Akcea Therapeutics Inc AKCA
Akero Therapeutics Inc AKRO
Akers Biosciences Inc AKER
Akorn, Inc. AKRX
Albireo Pharma Inc ALBO
Alcon AG ALC
Aldeyra Therapeutics Inc ALDX
Alexion Pharmaceuticals, Inc. ALXN
Alkermes Plc ALKS
Allena Pharmaceuticals Inc ALNA
Allogene Therapeutics Inc ALLO
AMAG Pharmaceuticals, Inc. AMAG
Amarin Corporation plc AMRN
Amicus Therapeutics, Inc. FOLD
Amphastar Pharmaceuticals Inc AMPH
ANCHIANO THERAP/S ADR ANCN
AngioDynamics, Inc. ANGO
ANI Pharmaceuticals Inc Common Stock ANIP
Anixa Biosciences Inc ANIX
AnPac Bio-Medical Science Co Ltd – ADR ANPC
Applied DNA Sciences Inc APDN
Aptevo Therapeutics Inc APVO
Aptinyx Inc APTX
Aquestive Therapeutics Inc AQST
Aravive Inc ARAV
Arca Biopharma Inc ABIO
Arena Pharmaceuticals, Inc. ARNA
Artelo Biosciences Inc ARTL
Atara Biotherapeutics Inc ATRA
Athenex Inc ATNX
Atossa Therapeutics Inc ATOS
aTyr Pharma Inc LIFE
Auris Medical Holding Ltd EARS
Autolus Therapeutics Ltd – ADR AUTL
Avanos Medical Inc AVNS
AVEO Pharmaceuticals, Inc. (AVEO
AxoGen, Inc Common Stock AXGN
Axovant Gene Therapies Ltd AXGT
AzurRx BioPharma Inc AZRX
Bausch Health Companies Inc BHC
Beam Therapeutics Inc BEAM
Bellicum Pharmaceuticals Inc BLCM
BENITEC BIOPHAR/S ADR BNTC
Bio-Path Holdings Inc BPTH
BIO-TECHNE Corp TECH
BioDelivery Sciences International, Inc. BDSI
Biohaven Pharmaceutical Holding Co Ltd BHVN
BioLife Solutions Inc BLFS
BIOLINERX LTD/S ADR BLRX
BioNano Genomics Inc BNGO
BioSig Technologies Inc BSGM
BioTelemetry Inc BEAT
Black Diamond Therapeutics Inc BDTX
bluebird bio Inc BLUE
Blueprint Medicines Corp BPMC
Boston Scientific Corporation BSX
Capricor Therapeutics Inc CAPR
Cara Therapeutics Inc CARA
Cardiovascular Systems Inc CSII
CareDx Inc CDNA
CASI Pharmaceuticals Inc CASI
Catabasis Pharmaceuticals Inc CATB
Catalyst Biosciences Inc CBIO
Celcuity Inc CELC
Celldex Therapeutics, Inc. CLDX
Cellect Biotechnology Ltd – ADR APOP
CELYAD SA/ADR CYAD
Cerecor Inc CERC
Champions Oncology Inc CSBR
Checkpoint Therapeutics Inc CKPT
Chembio Diagnostics Inc CEMI
Chiasma Inc CHMA
CNS Pharmaceuticals Inc CNSP
Codexis, Inc. CDXS
Corbus Pharmaceuticals Holdings Inc CRBP
Corvus Pharmaceuticals Inc CRVS
Crinetics Pharmaceuticals Inc CRNX
Curis, Inc. CRIS
CytomX Therapeutics Inc CTMX
DBV TECHNOLOGIE/S ADR DBVT
DelMar Pharmaceuticals Inc DMPI
Denali Therapeutics Inc DNLI
Dynavax Technologies Corporation DVAX
Eagle Pharmaceuticals Inc EGRX
Edap Tms SA EDAP
Edesa Biotech Inc EDSA
Editas Medicine Inc EDIT
Ekso Bionics Holdings Inc EKSO
Eiger Biopharmaceuticals Inc EIGR
Elanco Animal Health Inc ELAN
Eloxx Pharmaceuticals Inc ELOX
Enlivex Therapeutics Ltd ENLV
Enochian Biosciences Inc ENOB
Entasis Therapeutics Holdings Inc ETTX
Eton Pharmaceuticals Inc ETON
Evelo Biosciences Inc EVLO
Evogene Ltd EVGN
Evolus Inc EOLS
EXACT Sciences Corporation EXAS
Exicure Inc XCUR
Eyenovia Inc EYEN
Eyepoint Pharmaceuticals Inc EYPT
FibroGen Inc FGEN
Five Prime Therapeutics Inc FPRX
Forward Pharma A/S FWP
FSD Pharma Inc HUGE
G1 Therapeutics Inc GTHX
Galectin Therapeutics Inc. Common Stock GALT
Galmed Pharmaceuticals Ltd GLMD
Genocea Biosciences Inc GNCA
Geron Corporation GERN
Glaukos Corp GKOS
GlaxoSmithKline plc GSK
Globus Medical Inc GMED
GlycoMimetics Inc GLYC
Gossamer Bio Inc GOSS
Grifols SA - ADR ADR Class B GRFS
Gritstone Oncology Inc GRTS
GW Pharmaceuticals PLC- ADR GWPH
Hepion Pharmaceuticals Inc HEPA
Heron Therapeutics Inc HRTX
Hologic, Inc. HOLX
Ideaya Biosciences Inc IDYA
Idera Pharmaceuticals Inc IDRA
Illumina, Inc. ILMN
ImmuCell Corporation ICCC
Immunomedics, Inc. (NASDAQ: IMMU
Incyte Corporation (NASDAQ: INCY
INmune Bio Inc (NASDAQ: INMB
INNATE PHARMA S/S ADR (NASDAQ: IPHA
Innovate Biopharmaceuticals Inc (NASDAQ: INNT
Intec Pharma Ltd (NASDAQ: NTEC
Integra Lifesciences Holdings Corp IART
Ionis Pharmaceuticals Inc IONS
Invivo Therapeutics Holdings Corp (NASDAQ: NVIV
Jaguar Health Inc JAGX
Jazz Pharmaceuticals PLC JAZZ
Johnson & Johnson JNJ
Kaleido Biosciences Inc KLDO
Kalvista Pharmaceuticals Inc KALV
Kamada Ltd. KMDA
KemPharm Inc KMPH
KITOV PHARMA LT/S ADR KTOV
Kura Oncology Inc KURA
Laboratory Corp. of America Holdings LH
Lantheus Holdings Inc LNTH
LeMaitre Vascular Inc LMAT
Ligand Pharmaceuticals Inc. LGND
LogicBio Therapeutics Inc LOGC
MacroGenics Inc MGNX
Madrigal Pharmaceuticals Inc MDGL
Magenta Therapeutics Inc MGTA
MannKind Corporation MNKD
TapImmune Inc. common stock MRKR
MediciNova, Inc. MNOV
Medigus Ltd. MDGS
Mediwound Ltd MDWD
MEI Pharma Inc MEIP
MeiraGTx Holdings PLC MGTX
Menlo Therapeutics Inc MNLO
Meridian Bioscience, Inc. VIVO
Merrimack Pharmaceuticals Inc MACK
Midatech Pharma PLC-ADR MTP
Misonix Inc MSON
Moleculin Biotech Inc MBRX
Monopar Therapeutics Inc MNPR
Mustang Bio Inc MBIO
Mylan NV MYL
Myriad Genetics, Inc. MYGN
Nabriva Therapeutics PLC – ADR NBRV
Nektar Therapeutics NKTR
Neos Therapeutics Inc NEOS
Neovasc Inc NVCN
Neurometrix Inc NURO
NewLink Genetics Corp NLNK
Novartis AG NVS
Novus Therapeutics Inc NVUS
NuVasive, Inc. NUVA
Obalon Therapeutics Inc OBLN
Obseva SA OBSV
OncoSec Medical Inc ONCS
Opiant Pharmaceuticals Inc OPNT
OraSure Technologies, Inc. OSUR
Orthofix Medical Inc OFIX
Orchard Therapeutics PLC – ADR ORTX
Oxford Immunotec Global PLC OXFD
Pacific Biosciences of California PACB
Pacira Biosciences Inc PCRX
Passage Bio Inc PASG
PDS Biotechnology Corp PDSB
Pfizer Inc. PFE
PhaseBio Pharmaceuticals Inc PHAS
Phio Pharmaceuticals Corp PHIO
Pieris Pharmaceuticals Inc PIRS
Pluristem Therapeutics Inc. PSTI
Plus Therapeutics Inc PSTV
Polarityte Inc PTE
Portola Pharmaceuticals Inc PTLA
PPD Inc PPD
PRA Health Sciences Inc PRAH
Precigen Inc PGEN
Precipio Inc PRPO
Precision BioSciences Inc DTIL
Progenics Pharmaceuticals, Inc. PGNX
Psychemedics Corp. PMD
Pulse Biosciences Inc PLSE
Radius Health Inc RDUS
Regenxbio Inc RGNX
Revolution Medicines Inc RVMD
Rhythm Pharmaceuticals Inc RYTM
Rigel Pharmaceuticals, Inc. RIGL
Rubius Therapeutics Inc RUBY
SAGE Therapeutics Inc SAGE
Salarius Pharmaceuticals Inc SLRX
Sangamo Therapeutics Inc SGMO
SCYNEXIS Inc SCYX
Seelos Therapeutics Inc SEEL
Sellas Life Sciences Group Inc SLS
Seneca Biopharma Inc SNCA
Sesen Bio Inc SESN
Shockwave Medical Inc SWAV
SI-Bone Inc SIBN
Solid Biosciences Inc SLDB
Spectrum Pharmaceuticals, Inc. SPPI
Spero Therapeutics Inc SPRO
Spring Bank Pharmaceuticals Inc SBPH
Stealth BioTherapeutics Corp MITO
Stemline Therapeutics Inc STML
Stoke Therapeutics Inc STOK
Supernus Pharmaceuticals Inc SUPN
SurModics, Inc. SRDX
Sutro Biopharma Inc STRO
Synlogic Inc SYBX
T2 Biosystems Inc TTOO
TAIWAN LIPOSOME/S ADR TLC
Takeda Pharmaceutical Co Ltd TAK
Tcr2 Therapeutics Inc TCRR
TELA Bio Inc TELA
Teligent Inc (NEW JERSEY) TLGT
Tenax Therapeutics Inc TENX
Tetraphase Pharmaceuticals Inc TTPH
TFF Pharmaceuticals Inc TFFP
TherapeuticsMD Inc TXMD
Therapix Biosciences Ltd – ADR TRPX
Theratechnologies Inc THTX
TRACON Pharmaceuticals Inc TCON
Trevi Therapeutics Inc TRVI
Unity Biotechnology Inc UBX
Unum Therapeutics Inc UMRX
Urogen Pharma Ltd URGN
Varian Medical Systems, Inc. VAR
Veracyte Inc VCYT
Vericel Corp VCEL
Verrica Pharmaceuticals Inc VRCA
Viking Therapeutics Inc VKTX
Viveve Medical Inc VIVE
VIVUS, Inc. VVUS
Voyager Therapeutics Inc VYGR
Xencor Inc XNCR
Xenetic Biosciences Inc XBIO
X T L Biopharmaceuticals Ltd XTLB
Y-mAbs Therapeutics, Inc YMAB
Zimmer Biomet Holdings Inc ZBH
ZIOPHARM Oncology Inc. ZIOP
Zosano Pharma Corp ZSAN
Zynerba Pharmaceuticals Inc ZYNE

Stocks In Focus

Roche's Coronavirus Test Granted Emergency Use Authorization By FDA

Roche Holdings AG Basel ADR RHHBY said the FDA has issued an Emergency Use Authorization for the cobas SARS-CoV-2 Test, which is intended for the qualitative detection of the virus that causes COVID-19 disease in nasopharyngeal and oropharyngeal swab samples collected from patients who meet the clinical and/or epidemiological criteria for testing.

The CE-IVD test is also available in markets that accept the CE mark, the company said.

Bio-Rad Launches SARS-CoV-2 Standard To Validate Assays

Bio-Rad Laboratories, Inc. Class A Common Stock BIO said it has launched a SARS-CoV-2 Standard through its Exact Diagnostics product line to support laboratory assay validation of testing for COVID-19. This, according to the company, will help labs validate their COVID-19 assay results and accelerate access to testing.

Lilly, AbCellera To Partner For COVID-19 Treatment

AbCellera, a privately held company developing therapeutic antibodies, and Eli Lilly And Co LLY said they have entered into an agreement to co-develop antibody products for treating COVID-19. AbCellera will leverage its rapid pandemic response platform, while Lilly will provide its global capabilities for rapid development, manufacturing and distribution.

AbCellera said it has identified 500 unique fully human antibody sequences following the screening of over 5 million immune cells, while looking for ones that produced functional antibodies in the blood sample from one of the first U.S. patients who recovered.

Chembio Appoints Industry Veteran Richard Eberly As CEO

Chembio Diagnostics Inc CEMI appointed diagnostics industry veteran Richard Eberly as president and CEO effective March 16. He will take over from Gail Page, who had been serving as interim CEO since January.

Separately, the company said its total fourth-quarter net revenues fell 11.8% year-over-year to $6.9 million and the net loss per share widened from 20 cents to 23 cents, while analysts expected a loss of 24 cents per share.

The stock was trading 17.86% higher at $3.30 in Friday's premarket session.

RA Medical Appoints Will MacGuire as CEO

RA Medical Systems Inc RMED announced the appointment of Will MacGuire as CEO and a member of the board effective March 30. MacGuire will take over the reins from Andrew Jackson, which had occupied the post on an interim basis since August 2019. Jackson, meanwhile, will remain as CFO.

Earnings

Inovio Pharmaceuticals Inc INO, which is developing a vaccine against SARS-CoV-2, reported revenue of $279,000 for the fourth quarter compared to $2.5 million in the year-ago quarter. The net loss per share widened from 34 cents to 38 cents, while analysts expected a loss of 24 cents per share.

The stock was slipping 19.79% to $7.62 in the premarket session.

Synlogic Inc's SYBX net loss narrowed from 48 cents per share in the fourth quarter of 2018 to 37 cents per share in the fourth quarter of 2019. Analysts had estimated a loss of 44 cents per share for the quarter.

The stock rose 7.91% to $1.50 in after-hours trading.

Bellicum Pharmaceuticals Inc BLCM said its fourth-quarter revenues climbed from $300,000 in 2018 to $5.1 million in 2019. The net loss per share narrowed from $6.72 to $5.82, which was wider than the $4-per-share loss estimated by analysts.

The stock plunged 15.23% to $5.01 in after-hours trading.

Lineage Cell Therapeutics Inc's LCTX fourth quarter revenues increased from $800,000 in 2018 to $1.2 million in 2019. The net loss per share narrowed notably from 35 cents to 3 cents, while analysts had estimated a loss of 5 cents per share.

The stock gained 7.34% to 73 cents in after-hours trading.

Nabriva Therapeutics PLC – ADR NBRV reported a net loss of 29 cents per share on revenues of $300,000 for the fourth quarter of 2019. In the year ago quarter, revenues were $800,000 and the net loss per share was 46 cents. The bottom-line result was better than the consensus loss estimate of 33 cents per share.

The stock lost 11.76% to 90 cents in after-hours trading.

Ocular Therapeutix Inc's OCUL fourth-quarter net product revenues increased from $504,000 in 2018 to $2.26 million in 2019, but the loss widened from 42 cents per share to 53 cents per share. Analysts had called for a loss of 45 cents per share for the quarter.

The stock moved up 7.93% to $4.63 in after-hours trading

On The Radar

Earnings

PLx Pharma Inc PLXP (before the market open)
Achieve Life Sciences Inc ACHV (before the market open)
Neos Therapeutics Inc NEOS (before the market open)

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