The Daily Biotech Pulse: Setback For DBV In Peanut Allergy Patch Review, Roche Starts Coronavirus Test Shipment, Regeneron Aims For 'Cocktail' COVID-19 Treatment

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 16.)

  • BioNTech SE – ADR BNTX (announced efforts to develop a vaccine for COVID-19)
  • SUMMIT THERAPEU/S ADR SMMT

Down In The Dumps

(Biotech stocks that hit 52-week lows March 16.)

  • 89bio Inc ETNB
  • Abbott Laboratories ABT
  • Abeona Therapeutics Inc ABEO
  • ABIOMED, Inc. ABMD
  • AC Immune SA ACIU
  • Acasti Pharma Inc ACST
  • Accelerate Diagnostics Inc AXDX
  • AcelRx Pharmaceuticals Inc ACRX
  • Achieve Life Sciences Inc ACHV
  • Adamas Pharmaceuticals Inc ADMS
  • Adamis Pharmaceuticals Corp ADM
  • Adaptive Biotechnologies Corp ADPT
  • ADDEX THERAPEUT/ADR ADXN
  • Aeglea Bio Therapeutics Inc AGLE
  • Aerie Pharmaceuticals Inc AERI
  • AEterna Zentaris Inc. AEZS
  • Affimed NV AFMD
  • Aimmune Therapeutics Inc AIMT (announced potential slow uptake of its peanut allergy drug due to COVID-19)
  • Akari Therapeutics PLC AKTX
  • Akcea Therapeutics Inc AKCA
  • Akers Biosciences Inc AKER
  • Akorn, Inc. AKRX
  • Albireo Pharma Inc ALBO
  • Aldeyra Therapeutics Inc ALDX
  • Alexion Pharmaceuticals, Inc. ALXN
  • Alkermes Plc ALKS
  • Allena Pharmaceuticals Inc ALNA
  • Allogene Therapeutics Inc ALLO
  • Alterity Therapeutics Ltd ATH
  • AMAG Pharmaceuticals, Inc. AMAG
  • Amarin Corporation plc AMRN
  • Amicus Therapeutics, Inc. FOLD
  • Amphastar Pharmaceuticals Inc AMPH
  • Anavex Life Sciences Corp AVXL
  • ANCHIANO THERAP/S ADR ANCN
  • AngioDynamics, Inc. ANGO
  • Anika Therapeutics Inc ANIK
  • Antares Pharma Inc ATRS
  • Applied DNA Sciences Inc APDN
  • Applied Genetic Technologies Corp AGTC
  • Aptinyx Inc APTX
  • Aquestive Therapeutics Inc AQST
  • Aravive Inc ARAV
  • Arca Biopharma Inc ABIO
  • Arcutis Biotherapeutics Inc ARQT
  • Artelo Biosciences Inc ARTL
  • AstraZeneca plc AZN
  • Atara Biotherapeutics Inc ATRA
  • Athenex Inc ATNX
  • aTyr Pharma Inc LIFE
  • Auris Medical Holding Ltd EARS
  • Autolus Therapeutics Ltd – ADR AUTL
  • Avrobio Inc AVRO
  • AxoGen, Inc Common Stock AXGN
  • Axovant Gene Therapies Ltd AXGT
  • Bausch Health Companies Inc BHC
  • Baxter International Inc BAX
  • 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
  • BIOFRONTERA AG/ADR BFRA
  • Biohaven Pharmaceutical Holding Co Ltd BHVN
  • BioLife Solutions Inc BLFS
  • BIOLASE Inc BIOL
  • 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
  • BridgeBio Pharma Inc BBIO
  • Boston Scientific Corporation BSX
  • Cabaletta Bio Inc CABA
  • Cara Therapeutics Inc CARA
  • Cardiovascular Systems Inc CSII
  • Catabasis Pharmaceuticals Inc CATB
  • Celcuity Inc CELC
  • Celldex Therapeutics, Inc. CLDX
  • Cellectis SA CLLS
  • CELYAD SA/ADR CYAD
  • Cerecor Inc CERC
  • Cerus Corporation CERS
  • Champions Oncology Inc CSBR
  • Chembio Diagnostics Inc CEMI
  • China SXT Pharmaceuticals Inc SXTC
  • CNS Pharmaceuticals Inc CNSP
  • Coherus Biosciences Inc CHRS
  • Conatus Pharmaceuticals Inc CNAT
  • Corbus Pharmaceuticals Holdings Inc CRBP
  • Corvus Pharmaceuticals Inc CRVS
  • Crinetics Pharmaceuticals Inc CRNX
  • Crispr Therapeutics AG CRSP
  • CTI BioPharma Corp CTIC
  • Curis, Inc. CRIS
  • CytomX Therapeutics Inc CTMX
  • DBV TECHNOLOGIE/S ADR DBVT
  • Dynavax Technologies Corporation DVAX
  • Edap Tms SA EDAP
  • Edesa Biotech Inc EDSA
  • Editas Medicine Inc EDIT
  • Edwards Lifesciences Corp EW
  • Ekso Bionics Holdings Inc EKSO
  • Eiger Biopharmaceuticals Inc EIGR
  • Elanco Animal Health Inc ELAN
  • Eloxx Pharmaceuticals Inc ELOX
  • Enlivex Therapeutics Ltd ENLV
  • Esperion Therapeutics Inc ESPR
  • Evogene Ltd EVGN
  • Evolus Inc EOLS
  • EXACT Sciences Corporation EXAS
  • Exelixis, Inc. EXEL
  • Exicure Inc XCUR
  • Eyenovia Inc EYEN
  • Eyepoint Pharmaceuticals Inc EYPT
  • FibroGen Inc FGEN
  • Five Prime Therapeutics Inc FPRX
  • Flexion Therapeutics Inc (NASDAQ: FLXN
  • Fresenius Medical Care AG & Co. FMS
  • Fortress Biotech (NASDAQ: FBIO
  • FSD Pharma Inc HUGE
  • G1 Therapeutics Inc GTHX
  • Galera Therapeutics Inc GRTX
  • Gamida Cell Ltd GMDA
  • GENFIT S A/ADR GNFT
  • GENMAB A/S/S ADR GMAB
  • Genocea Biosciences Inc GNCA
  • Geron Corporation GERN
  • GlaxoSmithKline plc GSK
  • Globus Medical Inc GMED
  • GlycoMimetics Inc GLYC
  • Grifols SA - ADR ADR Class B GRFS
  • GW Pharmaceuticals PLC- ADR GWPH
  • Haemonetics Corporation HAE
  • Hepion Pharmaceuticals Inc HEPA
  • Heron Therapeutics Inc HRTX
  • Hologic, Inc. HOLX
  • Hookipa Pharma Inc HOOK
  • Hoth Therapeutics Inc HOTH
  • Idera Pharmaceuticals Inc IDRA
  • ImmuCell Corporation ICCC
  • Immunic Inc IMUX )
  • Immunomedics, Inc. IMMU
  • Imv Inc IMV
  • Incyte Corporation INCY
  • Infinity Pharmaceuticals Inc. INFI
  • INmune Bio Inc INMB
  • INNATE PHARMA S/S ADR IPHA
  • Innoviva Inc INVA
  • Intec Pharma Ltd NTEC
  • Integra Lifesciences Holdings Corp (NASDAQ: IART
  • Intellia Therapeutics Inc NTLA
  • Intercept Pharmaceuticals Inc ICPT
  • Intuitive Surgical, Inc. ISRG
  • Invivo Therapeutics Holdings Corp NVIV
  • Ionis Pharmaceuticals Inc IONS
  • Iterum Therapeutics PLC ITRM
  • Jazz Pharmaceuticals PLC JAZZ
  • Johnson & Johnson JNJ
  • Kalvista Pharmaceuticals Inc KALV
  • Kamada Ltd. KMDA
  • KemPharm Inc KMPH
  • Kindred Biosciences Inc KIN
  • Kura Oncology Inc KURA
  • Lantheus Holdings Inc LNTH
  • Ligand Pharmaceuticals Inc. LGND
  • MacroGenics Inc MGNX
  • Madrigal Pharmaceuticals Inc MDGL
  • Magenta Therapeutics Inc MGTA
  • MannKind Corporation MNKD
  • Mediwound Ltd MDWD
  • Medtronic PLC MDT
  • MEI Pharma Inc MEIP
  • MeiraGTx Holdings PLC MGTX
  • Menlo Therapeutics Inc MNLO
  • MEREO BIOPHARMA/ADR MREO
  • Mesoblast limited MESO
  • Microbot Medical Inc MBOT
  • Midatech Pharma PLC-ADR MTP
  • Milestone Pharmaceuticals Inc MIST
  • Miragen Therapeutics Inc MGEN
  • Misonix Inc MSON
  • Moleculin Biotech Inc MBRX
  • Monopar Therapeutics Inc MNPR
  • Morphic Holding Inc MORF
  • Morphosys Ag MOR
  • Mylan NV MYL
  • Myokardia Inc MYOK
  • 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
  • Obseva SA OBSV
  • Omeros Corporation OMER
  • OncoSec Medical Inc ONCS
  • Opiant Pharmaceuticals Inc OPNT
  • OptiNose Inc OPTN
  • Organovo Holdings Inc ONVO
  • Orthofix Medical Inc OFIX
  • Otonomy Inc OTIC
  • Oxford Immunotec Global PLC OXFD
  • Pacific Biosciences of California PACB
  • Pacira Biosciences Inc PCRX
  • Paratek Pharmaceuticals Inc PRTK
  • Passage Bio Inc PASG
  • PDS Biotechnology Corp PDSB
  • Pfizer Inc. PFE
  • PLx Pharma Inc PLXP
  • Portola Pharmaceuticals Inc PTLA
  • PRA Health Sciences Inc PRAH
  • Precision BioSciences Inc DTIL
  • Progenics Pharmaceuticals, Inc. PGNX
  • Predictive Oncology Inc POAI
  • Progenics Pharmaceuticals, Inc. PGNX
  • ProQR Therapeutics NV PRQR
  • Pulse Biosciences Inc PLSE
  • PTC Therapeutics, Inc. PTCT
  • Puma Biotechnology Inc PBYI
  • Quest Diagnostics Inc DGX
  • Radius Health Inc RDUS
  • Regenxbio Inc RGNX
  • Regulus Therapeutics Inc RGLS
  • Replimune Group Inc REPL
  • Revolution Medicines Inc RVMD
  • Rexahn Pharmaceuticals, Inc. REXN
  • Rhythm Pharmaceuticals Inc RYTM
  • Rocket Pharmaceuticals Inc RCKT
  • Rockwell Medical Inc RMTI
  • SAGE Therapeutics Inc SAGE
  • Sangamo Therapeutics Inc SGMO
  • Sanofi SA SNY
  • 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
  • Silk Road Medical Inc SILK
  • SI-Bone Inc SIBN
  • Sol Gel Technologies Ltd SLGL
  • 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
  • STRATA Skin Sciences Inc SSKN
  • Supernus Pharmaceuticals Inc SUPN
  • SurModics, Inc. SRDX
  • Sutro Biopharma Inc STRO
  • Synlogic Inc SYBX
  • Syros Pharmaceuticals Inc SYRS
  • T2 Biosystems Inc TTOO
  • Tandem Diabetes Care Inc TNDM
  • Takeda Pharmaceutical Co Ltd TAK
  • Taro Pharmaceutical Industries Ltd. TARO
  • TELA Bio Inc TELA
  • Tetraphase Pharmaceuticals Inc TTPH
  • Therapix Biosciences Ltd – ADR TRPX
  • Theratechnologies Inc THTX
  • TRACON Pharmaceuticals Inc TCON
  • Titan Medical Inc. TMDI
  • TrovaGene Inc TROV
  • Twist Bioscience Corp TWST
  • Ultragenyx Pharmaceutical Inc RARE
  • Urogen Pharma Ltd URGN
  • Vanda Pharmaceuticals Inc. VNDA
  • VERONA PHARMA P/S ADR VRNA
  • Viking Therapeutics Inc VKTX
  • Viveve Medical Inc VIVE
  • Voyager Therapeutics Inc VYGR
  • X4 Pharmaceuticals Inc XFOR
  • Xencor Inc XNCR
  • Xenetic Biosciences Inc XBIO
  • Xeris Pharmaceuticals Inc XERS
  • Y-mAbs Therapeutics, Inc YMAB
  • Zimmer Biomet Holdings Inc ZBH
  • ZIOPHARM Oncology Inc. ZIOP
  • Zosano Pharma Corp ZSAN
  • Zynerba Pharmaceuticals Inc ZYNE

See also: 8 Biotechs With Coronavirus Vaccines In Development

Stocks In Focus

FDA Questions Efficacy Of DBV's Investigational Peanut Allergy Skin Patch

DBV TECHNOLOGIE/S ADR DBVT said the FDA has identified questions regarding efficacy, including the impact of patch-site adhesion, with respect to its investigational peanut allergy skin patch Viaskin Peanut.

The FDA has decided not to hold an Allergenic Products Advisory Committee meeting May 15 to discuss the BLA as per the original schedule. 

Although the FDA communicated no change in the PDUFA review date of Aug. 5, the company said the additional information sought by the FDA amounts to a major amendment and could extend the target action date.

2.80 −2.46 (46.77%)

DBV shares were plunging 46.77% to $2.80 in Tuesday's premarket session, while Aimmune, which recently commercially launched a competing drug, was advancing 17.33% to $13.47. 

Pfizer, BioNTech Enter COVID-19 Vaccine Development Agreement

Pfizer and BioNTech confirmed they have agreed to a letter of intent regarding co-development and distribution of a potential mRNA-based coronavirus vaccine, BNT162, to prevent COVID-19 infection.

The collaboration takes effect immediately, the companies said. The companies also said they would finalize details of the agreement regarding financial terms, and all activities related to development, manufacturing and potential commercialization, over the next few weeks.

BioNTech shares were trading 52.4% higher at $60.96 at the time of publication, while Pfizer was adding 2.55% to $30.95. 

FDA Gives Emergency Use Authorization For LabCorp, Hologic's COVID-19 Tests

FDA announced the issuance of Emergency Use Authorization to Hologic for its Panther Fusion SARS-CoV-2 Assay as well as for LabCorp for its COVID-19 RT-PCR test.

In after-hours trading, LabCorp shares rose 3.77% to $126.50. Hologic was trading 7.75% higher at $34.75 in Tuesday's premarket session. 

Roche Begins COVID-19 Test Shipment

Roche Holdings AG Basel ADR RHHBY, which announced last week that it received the FDA's Emergency Use Authorization for its COVID-19 test, said it has begun shipment of the first allotment of its cobas SARS-CoV-2 test kits. The company expects the shipment to be completed this week.

The company also said it plans to ship an additional 400,000 tests per week to lab testing sites across the U.S.

Provention Bio To Temporarily Pause Patient Randomization In Diabetes Study

Provention Bio Inc PRVB announced a temporary pause in the randomization of patients with newly diagnosed Type 1 diabetes into its global Phase 3 study of PRV-031, citing caution to protect the parties involved in the wake of the COVID-19 pandemic.

The company, however, said it remains on track to complete its rolling submissions of a BLA to the FDA for the indication in the fourth quarter of 2020.

Co-Diagnostics Says New FDA Policy Will Help Aggressive US Expansion

Co-Diagnostics Inc CODX said a new policy the FDA released Monday regarding expediting the availability of COVID-19 diagnostics will allow the company to aggressively expand its presence in the U.S. Due to the change in the policy, the company's test kit will soon be available for use by and marketed to a wide array of U.S. laboratories without first requiring Emergency Use Authorization, according to Co-Diagnostics. 

In premarket trading Tuesday, Co-Diagnostics shares were rallying 45.21% to $13.20. 

Merck's Cough Drug Meets Goals In Late-Stage Study

Merck & Co., Inc. MRK said the Phase 3 study that evaluated its gefapixant for the treatment of refractory or unexplained chronic cough met the primary endpoints. The company said the trials will continue for long-term follow-up to collect additional safety data.

In premarket trading Tuesday, Merck shares were adding 0.97% to $70.60.

Regeneron On Tap To Select 2 Antibodies For COVID-19 Treatment Cocktail 

Regeneron Pharmaceuticals Inc REGN said it has isolated hundreds of virus-neutralizing, fully human antibodies from the company's VelocImmune mice, which have been genetically modified to have a human immune system. Regeneron said it has also isolated antibodies from humans who have recovered from COVID-19.

The company intends to select top two antibodies for a "cocktail" treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities.

In premarket trading Tuesday, Regeneron shares were rallying 10.8% to $488.50.

CareDx Launches Remote Monitoring Solutions For Transplant Patients

CareDx Inc CDNA announced the launch of RemoTraC, a solution enabling remote home-based monitoring of transplant patients.

The shares were soaring 16.08% to $18.99 in premarket trading Tuesday.

Mallinckrodt Completes Rolling NDA Submission For Kidney Failure Drug

Mallinckrodt PLC MNK said it has completed the rolling submission of an NDA for terlipressin, an investigational agent for treating hepatorenal syndrome type 1.

In premarket trading Tuesday, Mallinckrodt shares were rising 16.67% to $2.10.

Insmed Announces Japanese Regulatory Submission of Lung Disease Drug, Suspends Guidance

Insmed Incorporated INSM said it has submitted a NDA to Japan's Ministry of Health, Labour and Welfare for its investigational drug Arikayce for the treatment of patients with non-tuberculous mycobacterial lung disease caused by mycobacterium avium complex who did not sufficiently respond to prior treatment.

The company also said AstraZeneca has exercised the first option pursuant to their October 2016 license agreement, taking up sole responsibility to develop INS1007 up to and including Phase 2b clinical trials in chronic obstructive pulmonary disease or asthma.

The company also said it is suspending its previously issued 2020 revenue guidance due to the general uncertainty regarding the impact of COVID-19 on the ARIKAYCE patient population and their physicians

The stock rose 1.10% to $15.69 in after-hours trading.

Earnings

Catalyst Pharmaceuticals Inc CPRX reported total revenue of $30.12 million for the fourth quarter of 2019 compared to no revenue one year ago.

The company reversed to a profit of 7 cents per share from a loss of 14 cents per share in the fourth quarter of 2018. For 2020, the company forecast Firdapse net revenues of $135 million to $155 million, in line with the consensus estimate of $145.62 million.

The stock rose 6.90% to $2.79 in after-hours trading.

Fortress Biotech's fourth-quarter net revenue climbed 85% year-over-year to $11.1 million in 2019. The loss per share came in at 27 cents, narrower than the consensus loss estimate of 31 cents.

In after-hours trading, the stock advanced 9.65% to $1.25.

CorMedix Inc. CRMD reversed to a loss of 21 cents per share from a profit of 10 cents per share, with the widening reflecting a reversal of clinical expenses following a settlement agreement with its CRO in 2018.

Analysts had estimated a loss of 24 cents per share for the quarter. Revenue declined year-over-year from $26.52 million to $24.78 million.

The stock fell 5.32% to $2.85 in after-hours trading.

Athersys, Inc. ATHX said its fourth-quarter revenue declined from $1.5 million in 2018 to $300,000 in 2019. The net loss narrowed from 8 cents per share to 6 cents per share. The consensus estimate had called for a loss of 8 cents per share.

The stock rallied 12.71% to $1.33 in after-hours trading.

AVEO Pharmaceuticals, Inc. AVEO reported a loss of 28 cents per share on revenue of $764,000 for the fourth quarter of 2019. In the year-ago quarter, the loss was 35 cents per share and revenue was $1.48 million.

The stock slipped 7.59% to $2.80 in after-hours trading.

Transenterix Inc TRXC reported a sharp decline in its fourth-quarter revenue from $7.5 million in 2018 to $700,000 in 2019, reflecting a lack of system sales. The adjusted net loss per share widened from 89 cents to 83 cents. Analysts had estimated a loss of 62 cents per share.

The stock plunged 16.55% to 30 cents in after-hours trading.

On The Radar

PDUFA Date

The FDA is due to announce its verdict on epilepsy drug candidate EM-105, developed by Acuta Pharma as an adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures and generalized seizures of Lennox-Gastaut syndrome in patients 2 and older.

Eton Pharmaceuticals Inc ETON has acquired U.S. commercial rights to the drug. An additional validation study sought by the FDA in mid-February has cast a cloud on the approval coming through by the March 17 PDUFA date.

The company said in its earnings report March 5 it expects to receive a CRL, given the unlikelihood of the study to be completed in the second or the third quarter of 2020.

Earnings

  • DarioHealth Corp DRIO (before the market open)
  • STRATA Skin Sciences Inc SSKN (before the market open)
  • Baxter International Inc BAX (before the market open)
  • Cue Biopharma Inc CUE (after the close)

Related Link:

The Week Ahead In Biotech: COVID-19 Updates, Tapering Earnings Flow, Eton's Seizure Drug Review

Posted In: BiotechEarningsNewsGuidanceFDATrading Ideas

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