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

Down In The Dumps

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

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