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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.)

Benzinga · 03/17/2020 15:38

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

Down In The Dumps

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

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

Related Link:

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