The Daily Biotech Pulse: Roche Obtains FDA Emergency Use Authorization For COVID-19 Test, Chembio Appoints New CEO, Inovio Slumps On Earnings

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

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

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)

Related Link: The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues