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 (NASDAQ: MASI)

Down In The Dumps

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

• Abbott Laboratories (NYSE: ABT)

• ABIOMED, Inc. (NASDAQ: ABMD)

• Acasti Pharma Inc (NASDAQ: ACST)

• Accelerate Diagnostics Inc (NASDAQ: AXDX)

• AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)

• Achieve Life Sciences Inc (NASDAQ: ACHV)

• Acorda Therapeutics Inc (NASDAQ: ACOR)

• Adamas Pharmaceuticals Inc (NASDAQ: ADMS)

• Adamis Pharmaceuticals Corp (NASDAQ: ADM)

• Adaptive Biotechnologies Corp (NASDAQ: ADPT)

• ADDEX THERAPEUT/ADR (NASDAQ: ADXN)

• ADMA Biologics Inc (NASDAQ: ADMA)

• Aeglea Bio Therapeutics Inc (NASDAQ: AGLE)

• Aerie Pharmaceuticals Inc (NASDAQ: AERI)

• AEterna Zentaris Inc. (NASDAQ: AEZS)

• Affimed NV (NASDAQ: AFMD)

• Aileron Therapeutics Inc (NASDAQ: ALRN)

• Aimmune Therapeutics Inc (NASDAQ: AIMT)

• Akari Therapeutics PLC (NASDAQ: AKTX)

• Akcea Therapeutics Inc (NASDAQ: AKCA)

• Akero Therapeutics Inc (NASDAQ: AKRO)

• Akers Biosciences Inc (NASDAQ: AKER)

• Akorn, Inc. (NASDAQ: AKRX)

• Albireo Pharma Inc (NASDAQ: ALBO)

• Alcon AG (NYSE: ALC)

• Aldeyra Therapeutics Inc (NASDAQ: ALDX)

• Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)

• Alkermes Plc (NASDAQ: ALKS)

• Allena Pharmaceuticals Inc (NASDAQ: ALNA)

• Allogene Therapeutics Inc (NASDAQ: ALLO)

• AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)

• Amarin Corporation plc (NASDAQ: AMRN)

• Amicus Therapeutics, Inc. (NASDAQ: FOLD)

• Amphastar Pharmaceuticals Inc (NASDAQ: AMPH)

• ANCHIANO THERAP/S ADR (NASDAQ: ANCN)

• AngioDynamics, Inc. (NASDAQ: ANGO)

• ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)

• Anixa Biosciences Inc (NASDAQ: ANIX)

• AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ: ANPC)

• Applied DNA Sciences Inc (NASDAQ: APDN)

• Aptevo Therapeutics Inc (NASDAQ: APVO)

• Aptinyx Inc (NASDAQ: APTX)

• Aquestive Therapeutics Inc (NASDAQ: AQST)

• Aravive Inc (NASDAQ: ARAV)

• Arca Biopharma Inc (NASDAQ: ABIO)

• Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)

• Artelo Biosciences Inc (NASDAQ: ARTL)

• Atara Biotherapeutics Inc (NASDAQ: ATRA)

• Athenex Inc (NASDAQ: ATNX)

• Atossa Therapeutics Inc (NASDAQ: ATOS)

• aTyr Pharma Inc (NASDAQ: LIFE)

• Auris Medical Holding Ltd (NASDAQ: EARS)

• Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)

• Avanos Medical Inc (NYSE: AVNS)

• AVEO Pharmaceuticals, Inc. ((NASDAQ: AVEO)

• AxoGen, Inc Common Stock (NASDAQ: AXGN)

• Axovant Gene Therapies Ltd (NASDAQ: AXGT)

• AzurRx BioPharma Inc (NASDAQ: AZRX)

• Bausch Health Companies Inc (NYSE: BHC)

• Beam Therapeutics Inc (NASDAQ: BEAM)

• Bellicum Pharmaceuticals Inc (NASDAQ: BLCM)

• BENITEC BIOPHAR/S ADR (NASDAQ: BNTC)

• Bio-Path Holdings Inc (NASDAQ: BPTH)

• BIO-TECHNE Corp (NASDAQ: TECH)

• BioDelivery Sciences International, Inc. (NASDAQ: BDSI)

• Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)

• BioLife Solutions Inc (NASDAQ: BLFS)

• BIOLINERX LTD/S ADR (NASDAQ: BLRX)

• BioNano Genomics Inc (NASDAQ: BNGO)

• BioSig Technologies Inc (NASDAQ: BSGM)

• BioTelemetry Inc (NASDAQ: BEAT)

• Black Diamond Therapeutics Inc (NASDAQ: BDTX)

• bluebird bio Inc (NASDAQ: BLUE)

• Blueprint Medicines Corp (NASDAQ: BPMC)

• Boston Scientific Corporation (NYSE: BSX)

• Capricor Therapeutics Inc (NASDAQ: CAPR)

• Cara Therapeutics Inc (NASDAQ: CARA)

• Cardiovascular Systems Inc (NASDAQ: CSII)

• CareDx Inc (NASDAQ: CDNA)

• CASI Pharmaceuticals Inc (NASDAQ: CASI)

• Catabasis Pharmaceuticals Inc (NASDAQ: CATB)

• Catalyst Biosciences Inc (NASDAQ: CBIO)

• Celcuity Inc (NASDAQ: CELC)

• Celldex Therapeutics, Inc. (NASDAQ: CLDX)

• Cellect Biotechnology Ltd – ADR (NASDAQ: APOP)

• CELYAD SA/ADR (NASDAQ: CYAD)

• Cerecor Inc (NASDAQ: CERC)

• Champions Oncology Inc (NASDAQ: CSBR)

• Checkpoint Therapeutics Inc (NASDAQ: CKPT)

• Chembio Diagnostics Inc (NASDAQ: CEMI)

• Chiasma Inc (NASDAQ: CHMA)

• CNS Pharmaceuticals Inc (NASDAQ: CNSP)

• Codexis, Inc. (NASDAQ: CDXS)

• Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)

• Corvus Pharmaceuticals Inc (NASDAQ: CRVS)

• Crinetics Pharmaceuticals Inc (NASDAQ: CRNX)

• Curis, Inc. (NASDAQ: CRIS)

• CytomX Therapeutics Inc (NASDAQ: CTMX)

• DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT)

• DelMar Pharmaceuticals Inc (NASDAQ: DMPI)

• Denali Therapeutics Inc (NASDAQ: DNLI)

• Dynavax Technologies Corporation (NASDAQ: DVAX)

• Eagle Pharmaceuticals Inc (NASDAQ: EGRX)

• Edap Tms SA (NASDAQ: EDAP)

• Edesa Biotech Inc (NASDAQ: EDSA)

• Editas Medicine Inc (NASDAQ: EDIT)

• Ekso Bionics Holdings Inc (NASDAQ: EKSO)

• Eiger Biopharmaceuticals Inc (NASDAQ: EIGR)

• Elanco Animal Health Inc (NYSE: ELAN)

• Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)

• Enlivex Therapeutics Ltd (NASDAQ: ENLV)

• Enochian Biosciences Inc (NASDAQ: ENOB)

• Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)

• Eton Pharmaceuticals Inc (NASDAQ: ETON)

• Evelo Biosciences Inc (NASDAQ: EVLO)

• Evogene Ltd (NASDAQ: EVGN)

• Evolus Inc (NASDAQ: EOLS)

• EXACT Sciences Corporation (NASDAQ: EXAS)

• Exicure Inc (NASDAQ: XCUR)

• Eyenovia Inc (NASDAQ: EYEN)

• Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)

• FibroGen Inc (NASDAQ: FGEN)

• Five Prime Therapeutics Inc (NASDAQ: FPRX)

• Forward Pharma A/S (NASDAQ: FWP)

• FSD Pharma Inc (NASDAQ: HUGE)

• G1 Therapeutics Inc (NASDAQ: GTHX)

• Galectin Therapeutics Inc. Common Stock (NASDAQ: GALT)

• Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)

• Genocea Biosciences Inc (NASDAQ: GNCA)

• Geron Corporation (NASDAQ: GERN)

• Glaukos Corp (NYSE: GKOS)

• GlaxoSmithKline plc (NYSE: GSK)

• Globus Medical Inc (NYSE: GMED)

• GlycoMimetics Inc (NASDAQ: GLYC)

• Gossamer Bio Inc (NASDAQ: GOSS)

• Grifols SA - ADR ADR Class B (NASDAQ: GRFS)

• Gritstone Oncology Inc (NASDAQ: GRTS)

• GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)

• Hepion Pharmaceuticals Inc (NASDAQ: HEPA)

• Heron Therapeutics Inc (NASDAQ: HRTX)

• Hologic, Inc. (NASDAQ: HOLX)

• Ideaya Biosciences Inc (NASDAQ: IDYA)

• Idera Pharmaceuticals Inc (NASDAQ: IDRA)

• Illumina, Inc. (NASDAQ: ILMN)

• ImmuCell Corporation (NASDAQ: 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 (NASDAQ: IART)

• Ionis Pharmaceuticals Inc (NASDAQ: IONS)

• Invivo Therapeutics Holdings Corp (NASDAQ: NVIV

• Jaguar Health Inc (NASDAQ: JAGX)

• Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)

• Johnson & Johnson (NYSE: JNJ)

• Kaleido Biosciences Inc (NASDAQ: KLDO)

• Kalvista Pharmaceuticals Inc (NASDAQ: KALV)

• Kamada Ltd. (NASDAQ: KMDA)

• KemPharm Inc (NASDAQ: KMPH)

• KITOV PHARMA LT/S ADR (NASDAQ: KTOV)

• Kura Oncology Inc (NASDAQ: KURA)

• Laboratory Corp. of America Holdings (NYSE: LH)

• Lantheus Holdings Inc (NASDAQ: LNTH)

• LeMaitre Vascular Inc (NASDAQ: LMAT)

• Ligand Pharmaceuticals Inc. (NASDAQ: LGND)

• LogicBio Therapeutics Inc (NASDAQ: LOGC)

• MacroGenics Inc (NASDAQ: MGNX)

• Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)

• Magenta Therapeutics Inc (NASDAQ: MGTA)

• MannKind Corporation (NASDAQ: MNKD)

• TapImmune Inc. common stock (NASDAQ: MRKR)

• MediciNova, Inc. (NASDAQ: MNOV)

• Medigus Ltd. (NASDAQ: MDGS)

• Mediwound Ltd (NASDAQ: MDWD)

• MEI Pharma Inc (NASDAQ: MEIP)

• MeiraGTx Holdings PLC (NASDAQ: MGTX)

• Menlo Therapeutics Inc (NASDAQ: MNLO)

• Meridian Bioscience, Inc. (NASDAQ: VIVO)

• Merrimack Pharmaceuticals Inc (NASDAQ: MACK)

• Midatech Pharma PLC-ADR (NASDAQ: MTP)

• Misonix Inc (NASDAQ: MSON)

• Moleculin Biotech Inc (NASDAQ: MBRX)

• Monopar Therapeutics Inc (NASDAQ: MNPR)

• Mustang Bio Inc (NASDAQ: MBIO)

• Mylan NV (NASDAQ: MYL)

• Myriad Genetics, Inc. (NASDAQ: MYGN)

• Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)

• Nektar Therapeutics (NASDAQ: NKTR)

• Neos Therapeutics Inc (NASDAQ: NEOS)

• Neovasc Inc (NASDAQ: NVCN)

• Neurometrix Inc (NASDAQ: NURO)

• NewLink Genetics Corp (NASDAQ: NLNK)

• Novartis AG (NYSE: NVS)

• Novus Therapeutics Inc (NASDAQ: NVUS)

• NuVasive, Inc. (NASDAQ: NUVA)

• Obalon Therapeutics Inc (NASDAQ: OBLN)

• Obseva SA (NASDAQ: OBSV)

• OncoSec Medical Inc (NASDAQ: ONCS)

• Opiant Pharmaceuticals Inc (NASDAQ: OPNT)

• OraSure Technologies, Inc. (NASDAQ: OSUR)

• Orthofix Medical Inc (NASDAQ: OFIX)

• Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)

• Oxford Immunotec Global PLC (NASDAQ: OXFD)

• Pacific Biosciences of California (NASDAQ: PACB)

• Pacira Biosciences Inc (NASDAQ: PCRX)

• Passage Bio Inc (NASDAQ: PASG)

• PDS Biotechnology Corp (NASDAQ: PDSB)

• Pfizer Inc. (NYSE: PFE)

• PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS)

• Phio Pharmaceuticals Corp (NASDAQ: PHIO)

• Pieris Pharmaceuticals Inc (NASDAQ: PIRS)

• Pluristem Therapeutics Inc. (NASDAQ: PSTI)

• Plus Therapeutics Inc (NASDAQ: PSTV)

• Polarityte Inc (NASDAQ: PTE)

• Portola Pharmaceuticals Inc (NASDAQ: PTLA)

• PPD Inc (NASDAQ: PPD)

• PRA Health Sciences Inc (NASDAQ: PRAH)

• Precigen Inc (NASDAQ: PGEN)

• Precipio Inc (NASDAQ: PRPO)

• Precision BioSciences Inc (NASDAQ: DTIL)

• Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX)

• Psychemedics Corp. (NASDAQ: PMD)

• Pulse Biosciences Inc (NASDAQ: PLSE)

• Radius Health Inc (NASDAQ: RDUS)

• Regenxbio Inc (NASDAQ: RGNX)

• Revolution Medicines Inc (NASDAQ: RVMD)

• Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)

• Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)

• Rubius Therapeutics Inc (NASDAQ: RUBY)

• SAGE Therapeutics Inc (NASDAQ: SAGE)

• Salarius Pharmaceuticals Inc (NASDAQ: SLRX)

• Sangamo Therapeutics Inc (NASDAQ: SGMO)

• SCYNEXIS Inc (NASDAQ: SCYX)

• Seelos Therapeutics Inc (NASDAQ: SEEL)

• Sellas Life Sciences Group Inc (NASDAQ: SLS)

• Seneca Biopharma Inc (NASDAQ: SNCA)

• Sesen Bio Inc (NASDAQ: SESN)

• Shockwave Medical Inc (NASDAQ: SWAV)

• SI-Bone Inc (NASDAQ: SIBN)

• Solid Biosciences Inc (NASDAQ: SLDB)

• Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)

• Spero Therapeutics Inc (NASDAQ: SPRO)

• Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH)

• Stealth BioTherapeutics Corp (NASDAQ: MITO)

• Stemline Therapeutics Inc (NASDAQ: STML)

• Stoke Therapeutics Inc (NASDAQ: STOK)

• Supernus Pharmaceuticals Inc (NASDAQ: SUPN)

• SurModics, Inc. (NASDAQ: SRDX)

• Sutro Biopharma Inc (NASDAQ: STRO)

• Synlogic Inc (NASDAQ: SYBX)

• T2 Biosystems Inc (NASDAQ: TTOO)

• TAIWAN LIPOSOME/S ADR (NASDAQ: TLC)

• Takeda Pharmaceutical Co Ltd (NYSE: TAK)

• Tcr2 Therapeutics Inc (NASDAQ: TCRR)

• TELA Bio Inc (NASDAQ: TELA)

• Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)

• Tenax Therapeutics Inc (NASDAQ: TENX)

• Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)

• TFF Pharmaceuticals Inc (NASDAQ: TFFP)

• TherapeuticsMD Inc (NASDAQ: TXMD)

• Therapix Biosciences Ltd – ADR (NASDAQ: TRPX)

• Theratechnologies Inc (NASDAQ: THTX)

• TRACON Pharmaceuticals Inc (NASDAQ: TCON)

• Trevi Therapeutics Inc (NASDAQ: TRVI)

• Unity Biotechnology Inc (NASDAQ: UBX)

• Unum Therapeutics Inc (NASDAQ: UMRX)

• Urogen Pharma Ltd (NASDAQ: URGN)

• Varian Medical Systems, Inc. (NYSE: VAR)

• Veracyte Inc (NASDAQ: VCYT)

• Vericel Corp (NASDAQ: VCEL)

• Verrica Pharmaceuticals Inc (NASDAQ: VRCA)

• Viking Therapeutics Inc (NASDAQ: VKTX)

• Viveve Medical Inc (NASDAQ: VIVE)

• VIVUS, Inc. (NASDAQ: VVUS)

• Voyager Therapeutics Inc (NASDAQ: VYGR)

• Xencor Inc (NASDAQ: XNCR)

• Xenetic Biosciences Inc (NASDAQ: XBIO)

• X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)

• Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)

• Zimmer Biomet Holdings Inc (NYSE: ZBH)

• ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)

• Zosano Pharma Corp (NASDAQ: ZSAN)

• Zynerba Pharmaceuticals Inc (NASDAQ: 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 (OTC: 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 (NYSE: 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 (NYSE: 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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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.

View more earnings on IBB

Bellicum Pharmaceuticals Inc (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: PLXP) (before the market open)

• Achieve Life Sciences Inc (NASDAQ: ACHV) (before the market open)

• Neos Therapeutics Inc (NASDAQ: 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

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