The Daily Biotech Pulse: Setback For DBV In Peanut Allergy Patch Review, Roche Starts Coronavirus Test Shipment, Regeneron Aims For 'Cocktail' COVID-19 Treatment - DBV Technologies (NASDAQ:DBVT), iShares Biotechnology ETF (NASDAQ:IBB), Roche Holding (OTC:RHHBY), Regeneron Pharmaceuticals (NASDAQ:REGN)

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

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)