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The Daily Biotech Pulse: Pfizer's Eczema Drug Aces Latestage Study, Orphan Drug Designation For Dicerna, Dyadic's COVID-19 Connection

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The Daily Biotech Pulse: Pfizer's Eczema Drug Aces Latestage Study, Orphan Drug Designation For Dicerna, Dyadic's COVID-19 Connection

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week highs on March 18)

  • Biomerica, Inc. (NASDAQ: BMRA)( announced commencement of international shipment of rapid COVID-19 test)
  • BioNTech SE – ADR (NASDAQ: BNTX)
  • Imara Inc (NASDAQ: IMRA)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 18)

  • 89bio Inc (NASDAQ: ETNB)
  • AC Immune SA (NASDAQ: ACIU)
  • Acasti Pharma Inc (NASDAQ: ACST)
  • Accelerate Diagnostics Inc (NASDAQ: AXDX)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Adamis Pharmaceuticals Corp (NASDAQ: ADM)
  • Adial Pharmaceuticals Inc (NASDAQ: ADIL)
  • ADMA Biologics Inc (NASDAQ: ADMA)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO)
  • AEterna Zentaris Inc. (NASDAQ: AEZS)
  • Agenus Inc (NASDAQ: AGEN)
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO)
  • Aikido Pharma Inc (NASDAQ: AIKI)
  • Akorn, Inc. (NASDAQ: AKRX)
  • Alkermes Plc (NASDAQ: ALKS)
  • Allogene Therapeutics Inc (NASDAQ: ALLO)
  • Alterity Therapeutics Ltd (NASDAQ: ATHE)
  • AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
  • Amphastar Pharmaceuticals Inc (NASDAQ: AMPH)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • Anika Therapeutics Inc (NASDAQ: ANIK)
  • Anixa Biosciences Inc (NASDAQ: ANIX)
  • Antares Pharma Inc (NASDAQ: ATRS)
  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)
  • Aptinyx Inc (NASDAQ: APTX)
  • Arca Biopharma Inc (NASDAQ: ABIO)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • Aridis Pharmaceuticals Inc (NASDAQ: ARDS)
  • Assertio Therapeutics Inc (NASDAQ: ASRT)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • Athenex Inc (NASDAQ: ATNX)
  • Avanos Medical Inc (NYSE: AVNS)
  • Axonics Modulation Technologies Inc (NASDAQ: AXNX)
  • Axovant Gene Therapies Ltd (NASDAQ: AXGT)
  • Bausch Health Companies Inc (NYSE: BHC)
  • Bellerophon Therapeutics Inc (NASDAQ: BLPH)
  • BIO-TECHNE Corp (NASDAQ: TECH)
  • BioCardia Inc (NASDAQ: BCDA)
  • BioDelivery Sciences International, Inc. (NASDAQ: BDSI)
  • BIOFRONTERA AG/ADR (NASDAQ: BFRA)
  • BIOLASE Inc (NASDAQ: BIOL)
  • BIOLINERX LTD/S ADR (NASDAQ: BLRX)
  • BioNano Genomics Inc (NASDAQ: BNGO)
  • BioSig Technologies Inc (NASDAQ: BSGM)
  • BioSpecifics Technologies Corp. (NASDAQ: BSTC)
  • BioTelemetry Inc (NASDAQ: BEAT)
  • Black Diamond Therapeutics Inc (NASDAQ: BDTX)
  • Boston Scientific Corporation (NYSE: BSX)
  • BridgeBio Pharma Inc (NASDAQ: BBIO)
  • Cabaletta Bio Inc (NASDAQ: CABA)
  • Caladrius Biosciences Inc (NASDAQ: CLBS)
  • Cara Therapeutics Inc (NASDAQ: CARA)
  • CareDx Inc (NASDAQ: CDNA)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB)
  • Catalent Inc (NYSE: CTLT)
  • Catalyst Pharmaceuticals Inc (NASDAQ: CPRX)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • Cellectis SA (NASDAQ: CLLS)
  • CELYAD SA/ADR (NASDAQ: CYAD)
  • Chiasma Inc (NASDAQ: CHMA)
  • Chimerix Inc (NASDAQ: CMRX)
  • Coherus Biosciences Inc (NASDAQ: CHRS)
  • DelMar Pharmaceuticals Inc (NASDAQ: DMPI)
  • Dyadic International, Inc. (NASDAQ: DYAI)
  • Edesa Biotech Inc (NASDAQ: EDSA)
  • Elanco Animal Health Inc (NYSE: ELAN)
  • Enlivex Therapeutics Ltd (NASDAQ: ENLV)
  • Enzo Biochem, Inc. (NYSE: ENZ)
  • Erytech Pharma SA (NASDAQ: ERYP)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON)
  • Evogene Ltd (NASDAQ: EVGN)
  • 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)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Galera Therapeutics Inc (NASDAQ: GRTX)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)
  • Genocea Biosciences Inc (NASDAQ: GNCA)
  • Glaukos Corp (NYSE: GKOS)
  • Global Cord Blood Corp (NYSE: CO)
  • Global Blood Therapeutics Inc (NASDAQ: GBT)
  • GlycoMimetics Inc (NASDAQ: GLYC)
  • Gossamer Bio Inc (NASDAQ: GOSS)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Haemonetics Corporation (NYSE: HAE)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • Harvard Bioscience, Inc. (NASDAQ: HBIO)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)
  • Hepion Pharmaceuticals Inc (NASDAQ: HEPA)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Illumina, Inc. (NASDAQ: ILMN)
  • Immunovant Inc (NASDAQ: IMVT)
  • Incyte Corporation (NASDAQ: INCY)
  • Innovate Biopharmaceuticals Inc (NASDAQ: INNT)
  • Innoviva Inc (NASDAQ: INVA)
  • Insmed Incorporated (NASDAQ: INSM)
  • Inspire Medical Systems Inc (NYSE: INSP)
  • Intec Pharma Ltd (NASDAQ: NTEC)
  • Integra Lifesciences Holdings Corp (NASDAQ: IART
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Iterum Therapeutics PLC (NASDAQ: ITRM)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Kalvista Pharmaceuticals Inc (NASDAQ: KALV)
  • KemPharm Inc (NASDAQ: KMPH)
  • Kezar Life Sciences Inc (NASDAQ: KZR)
  • Kindred Biosciences Inc (NASDAQ: KIN)
  • Kura Oncology Inc (NASDAQ: KURA)
  • Laboratory Corp. of America Holdings (NYSE: LH)
  • Lantheus Holdings Inc (NASDAQ: LNTH)
  • Liminal BioSciences Inc (NASDAQ: LMNL)
  • Lipocine Inc (NASDAQ: LPCN)
  • MacroGenics Inc (NASDAQ: MGNX)
  • Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)
  • Mallinckrodt PLC (NYSE: MNK)
  • Medigus Ltd. (NASDAQ: MDGS)
  • Medtronic PLC (NYSE: MDT)
  • MEI Pharma Inc (NASDAQ: MEIP)
  • MeiraGTx Holdings PLC (NASDAQ: MGTX)
  • Menlo Therapeutics Inc (NASDAQ: MNLO)
  • MEREO BIOPHARMA/ADR (NASDAQ: MREO)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
  • Merus NV (NASDAQ: MRUS)
  • Midatech Pharma PLC-ADR (NASDAQ: MTP)
  • Milestone Pharmaceuticals Inc (NASDAQ: MIST)
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • Morphosys Ag (NASDAQ: MOR)
  • MYOS Corporation common stock (NASDAQ: MYOS)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Natera Inc (NASDAQ: NTRA)
  • Natus Medical Inc (NASDAQ: NTUS)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Neovasc Inc (NASDAQ: NVCN)
  • Neurometrix Inc (NASDAQ: NURO)
  • Neuronetics Inc (NASDAQ: STIM)
  • NewLink Genetics Corp (NASDAQ: NLNK)
  • Novus Therapeutics Inc (NASDAQ: NVUS)
  • NuVasive, Inc. (NASDAQ: NUVA)
  • Obalon Therapeutics Inc (NASDAQ: OBLN)
  • OptiNose Inc (NASDAQ: OPTN)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)
  • Organovo Holdings Inc (NASDAQ: ONVO)
  • Orthofix Medical Inc (NASDAQ: OFIX)
  • Otonomy Inc (NASDAQ: OTIC)
  • Oxford Immunotec Global PLC (NASDAQ: OXFD)
  • Outlook Therapeutics Inc (NASDAQ: OTLK)
  • Pacific Biosciences of California (NASDAQ: PACB)
  • Pacira Biosciences Inc (NASDAQ: PCRX)
  • Passage Bio Inc (NASDAQ: PASG)
  • PDS Biotechnology Corp (NASDAQ: PDSB)
  • PLx Pharma Inc (NASDAQ: PLXP)
  • Precipio Inc (NASDAQ: PRPO)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Quest Diagnostics Inc (NYSE: DGX)
  • Rapt Therapeutics Inc (NASDAQ: RAPT)
  • REDHILL BIOPHAR/S ADR (NASDAQ: RDHL)
  • Regenxbio Inc (NASDAQ: RGNX)
  • resTORbio, Inc. (NASDAQ: TORC)
  • Retrophin Inc (NASDAQ: RTRX)
  • Rexahn Pharmaceuticals, Inc. (NASDAQ: REXN)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
  • Rocket Pharmaceuticals Inc (NASDAQ: RCKT)
  • SAGE Therapeutics Inc (NASDAQ: SAGE)
  • Salarius Pharmaceuticals Inc NASDAQ: SLRX
  • SCYNEXIS Inc (NASDAQ: SCYX)
  • Seneca Biopharma Inc (NASDAQ: SNCA)
  • Shockwave Medical Inc (NASDAQ: SWAV)
  • SI-Bone Inc (NASDAQ: SIBN)
  • Sierra Oncology Inc (NASDAQ: SRRA)
  • Silk Road Medical Inc (NASDAQ: SILK)
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Stemline Therapeutics Inc (NASDAQ: STML)
  • STRATA Skin Sciences Inc (NASDAQ: SSKN)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN)
  • SurModics, Inc. (NASDAQ: SRDX)
  • Takeda Pharmaceutical Co Ltd (NYSE: TAK)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)
  • Tcr2 Therapeutics Inc (NASDAQ: TCRR)
  • TELA Bio Inc (NASDAQ: TELA)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • Therapix Biosciences Ltd – ADR (NASDAQ: TRPX)
  • Theratechnologies Inc (NASDAQ: THTX)
  • Titan Medical Inc. (NASDAQ: TMDI)
  • Trevena Inc (NASDAQ: TRVN)
  • Trevi Therapeutics Inc (NASDAQ: TRVI)
  • Tricida Inc (NASDAQ: TCDA)
  • Trinity Biotech plc (NASDAQ: TRIB)
  • TrovaGene Inc (NASDAQ: TROV)
  • Twist Bioscience Corp (NASDAQ: TWST)
  • Urogen Pharma Ltd (NASDAQ: URGN)
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)
  • Vascular Biogenics Ltd (NASDAQ: VBLT)
  • Veracyte Inc (NASDAQ: VCYT)
  • Vericel Corp (NASDAQ: VCEL)
  • VERONA PHARMA P/S ADR (NASDAQ: VRNA)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • VIVUS, Inc. (NASDAQ: VVUS)
  • X4 Pharmaceuticals Inc (NASDAQ: XFOR)
  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE)
  • Xeris Pharmaceuticals Inc (NASDAQ: XERS)
  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH)
  • Zoetis Inc (NYSE: ZTS)
  • Zogenix, Inc. (NASDAQ: ZGNX)

See Also: 8 Biotechs With Coronavirus Vaccines In Development

Stocks In Focus

Moleculin To Test Candidates For Coronavirus

Canada's WPD Pharma said its licensing partner Moleculin Biotech Inc (NASDAQ: MBRX) has entered into an agreement with a leading government funded research facility in the U.S. to conduct research on its patented portfolio of molecular inhibitors, including drug candidate, WP1122, for antiviral properties against a range of viruses, including Coronavirus.

In pre-market trading Thursday, Moleculin stock was rallying 134.49% to $1.10.

Roche's Genentech To Evaluate Drug For COVID-19 Pneumonia

Roche Holdings AG Basel ADR (OTC: RHHBY)'s Genentech unit said it is working with the BARDA to evaluate the safety and efficacy of Actemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.

The company said the global study is expected to begin enrolling as soon as possible in early April with 330 patients.

Novartis's Zolgensma Gets Japanese Regulatory Approval

Novartis AG (NYSE: NVS) said the Japanese Ministry of Health, Labor and Welfare approved its gene therapy Zolgensma for treating spinal muscular atrophy in patients aged under two.

Separately, the company said it is voluntarily recalling 100mg sandimmune and neural prescription drug blister packages due to the failure to meet child-resistant packaging requirement. If it is consumed by children, it exposes them to toxicity risk, the company said.

Separately, the company announced publication in the New England Journal of Medicine results of three pivotal Phase III clinical trials for inclisiran, a siRNA investigational agent for hyperlipidemia in adults, which showed achievement of primary endpoints and safety.

J&J Submits NDA For Multiple Sclerosis Drug

Johnson & Johnson (NYSE: JNJ)'s Janssen unit announced the submission of an NDA, seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis.

Bio-Rad's Real-Time qPCR Products Used by Labs For COVID-10 Screening

Bio-Rad Laboratories, Inc. (NYSE: BIO) said its Real-Time qPCR products are being used by testing laboratories globally to screen for COVID-19.

Dyadic's Platform to be Used By Israeli Research Institution to Develop COVID-19 Treatment

Participating in the 32nd Annual ROTH Conference, which was held virtually, Dyadic said the Israeli Institute For Biologic Research will explore the potential of Dyadic's industrially proven C1 gene expression platform to express gene sequences and targets developed by IIBR into both a rVaccine candidate and monoclonal antibodies for COVID-19 treatment

In pre-market trading, the stock was adding 25.19% to $3.23.

Qiagen's COVID-19 Test Gets CE Mark In Europe

Qiagen NV (NYSE: QGEN) said it has obtained CE marking for its newly-developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic to detect SARS-CoV-2.

Pfizer's Eczema Drug Aces Latestage Study

Pfizer Inc. (NYSE: PFE) said the Phase 3 JADE COMPARE study that evaluated the safety and efficacy of abrocitinib, an investigational oral once-daily Janus kinase 1 inhibitor, in adults with moderate to severe atopic dermatitis who were also on background topical therapy, met its co-primary efficacy endpoints.

"These data, along with other results from other pivotal trials, MONO-1 and MONO-2, will support filings with regulatory bodies, starting with the US Food and Drug Administration (FDA) planned for later this year," the company said.

Dicerna's Genetic Disorder Drug Gets Orphan Drug Designation

Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) said the FDA granted orphan drug designation to its DCR-A1AT for the treatment of alpha-1 antitrypsin deficiency - a genetic disorder that can cause lung and liver disease.

In pre-market trading, the stock was adding 4.09% to $14.

Earnings

Capricor Therapeutics Inc's (NASDAQ: CAPR) fourth-quarter net loss narrowed from $1.05 per share to 34 cents per share, in line with the consensus. As of Dec. 31, 2019, cash, cash equivalents and marketable securities totaled about $9.9 million, compared to approximately $7.3 million on Dec. 31, 2018.

In pre-market trading, the stock was slipping 5.36% to $1.18.

Acer Therapeutics Inc (NASDAQ: ACER) said its fourth-quarter loss per share narrowed from 85 cents to 51 cents, while analyst estimated a narrower loss of 48 cents per share. Cash and cash equivalents were $12.1 million as of Dec. 31, 2019, compared to $41.7 million as of Dec. 31, 2018. The company said it believes its cash position will suffice to fund operations till the end of 2020, excluding support for Edsivo development and precommercial activities, and the planned osanetant clinical trial.

Separately, the company said the Office of New Drugs of the FDA has denied its appeal of the Complete Response Letter for EDSIVO NDA.

In pre-market trading, the stock was slipping 5.94% to $1.90.

On The Radar

Earnings

Vascular Biogenics Ltd (before the market open)
Zai Lab Ltd (NASDAQ: ZLAB) (before the market open)
Hookipa Pharma Inc (NASDAQ: HOOK) (before the market open)
BIOLASE Inc (NASDAQ: BIOL) (before the market open)
Auris Medical Holding Ltd (NASDAQ: EARS) (after the close)
Curis, Inc. (NASDAQ: CRIS) (after the close)
Viveve Medical Inc (NASDAQ: VIVE) (after the close)

 

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