The Daily Biotech Pulse: AbbVie, Allergan Agree On Divestments, Obalon Stops Obesity Balloon Sale, COVID-19 Updates

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 17)

• BioNTech SE – ADR BNTX
• Regeneron Pharmaceuticals Inc REGN ( Updated on its COVID-19 treatment development plan)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 17)

• Abeona Therapeutics Inc ABEO
• AC Immune SA ACIU
• Acasti Pharma Inc ACST
• Accelerate Diagnostics Inc AXDX
• Acorda Therapeutics Inc ACOR
• Adamis Pharmaceuticals Corp ADM
• ADDEX THERAPEUT/ADR ADXN
• ADMA Biologics Inc ADMA
• Aerie Pharmaceuticals Inc AERI
• Agenus Inc AGEN
• Aimmune Therapeutics Inc AIMT
• Aldeyra Therapeutics Inc ALDX
• Alkermes Plc ALKS
• Allogene Therapeutics Inc ALLO
• Alpine Immune Sciences Inc ALPN
• AngioDynamics, Inc. ANGO
• Anika Therapeutics Inc ANIK
• Antares Pharma Inc ATRS
• Apellis Pharmaceuticals Inc APLS
• Applied Genetic Technologies Corp AGTC
• Aptinyx Inc APTX
• Aridis Pharmaceuticals Inc ARDS
• Artelo Biosciences Inc ARTL
• Assertio Therapeutics Inc ASRT
• Atara Biotherapeutics Inc ATRA
• Athenex Inc ATNX
• Avrobio Inc AVRO
• Axonics Modulation Technologies Inc (NASDAQ: AXNX
• Bio-Path Holdings Inc BPTH
• Biocept Inc BIOC
• BioDelivery Sciences International, Inc. BDSI
• BIOFRONTERA AG/ADR BFRA
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• BIOLASE Inc BIOL
• Biomerica, Inc. BMRA
• BioTelemetry Inc BEAT
• bluebird bio Inc BLUE
• BridgeBio Pharma Inc BBIO
• CareDx Inc CDNA
• Catabasis Pharmaceuticals Inc CATB
• Catalent Inc CTLT
• Catalyst Pharmaceuticals Inc CPRX
• Celcuity Inc CELC
• Cerus Corporation CERS
• Chiasma Inc CHMA
• Coherus Biosciences Inc CHRS
• Conatus Pharmaceuticals Inc CNAT
• Corbus Pharmaceuticals Holdings Inc CRBP
• Crinetics Pharmaceuticals Inc CRNX
• DBV TECHNOLOGIE/S ADR DBVT
• Dynavax Technologies Corporation DVAX
• Edwards Lifesciences Corp EW
• Enanta Pharmaceuticals Inc ENTA
• Enzo Biochem, Inc. ENZ
• Erytech Pharma SA ERYP
• Evogene Ltd EVGN
• Evolus Inc EOLS
• EXACT Sciences Corporation EXAS
• Exelixis, Inc. EXEL
• Flexion Therapeutics Inc (NASDAQ: FLXN
• G1 Therapeutics Inc GTHX
• Galectin Therapeutics Inc. Common Stock GALT
• Galera Therapeutics Inc GRTX
• Glaukos Corp GKOS
• Gossamer Bio Inc GOSS
• Guardant Health Inc GH
• GW Pharmaceuticals PLC- ADR GWPH
• Haemonetics Corporation HAE
• Halozyme Therapeutics, Inc. HALO
• Hologic, Inc. HOLX
• Hoth Therapeutics Inc HOTH
• Ideaya Biosciences Inc IDYA
• Immunic Inc IMUX
• IMMURON LTD/S ADR IMRN
• Innoviva Inc INVA
• Insmed Incorporated INSM
• Inspire Medical Systems Inc INSP
• Intec Pharma Ltd NTEC
• Intercept Pharmaceuticals Inc ICPT
• Intuitive Surgical, Inc. ISRG
• Invivo Therapeutics Holdings Corp NVIV
• Jazz Pharmaceuticals PLC JAZZ
• Kindred Biosciences Inc KIN
• Kura Oncology Inc KURA
• Inspire Medical Systems Inc INSP
• Laboratory Corp. of America Holdings LH
• Lantheus Holdings Inc LNTH
• Ligand Pharmaceuticals Inc. LGND
• Madrigal Pharmaceuticals Inc MDGL
• Medigus Ltd. MDGS
• MeiraGTx Holdings PLC MGTX
• Merrimack Pharmaceuticals Inc MACK
• Mesoblast limited MESO
• Midatech Pharma PLC-ADR MTP
• Milestone Pharmaceuticals Inc MIST
• Miragen Therapeutics Inc MGEN
• Monopar Therapeutics Inc MNPR
• Morphic Holding Inc MORF
• Myriad Genetics, Inc. MYGN
• Natus Medical Inc NTUS
• Neovasc Inc NVCN
• Neurometrix Inc NURO
• Neuronetics Inc STIM
• NuVasive, Inc. NUVA
• OncoSec Medical Inc ONCS
• Oncternal Therapeutics Inc ONCT
• Orchard Therapeutics PLC – ADR ORTX
• Organovo Holdings Inc ONVO
• Orthofix Medical Inc OFIX
• Pacira Biosciences Inc PCRX
• PLx Pharma Inc PLXP
• Portola Pharmaceuticals Inc PTLA
• PRA Health Sciences Inc PRAH
• Precigen Inc PGEN
• Precipio Inc PRPO
• Precision BioSciences Inc DTIL
• Predictive Oncology Inc POAI
• Progenics Pharmaceuticals, Inc. PGNX
• PTC Therapeutics, Inc. PTCT
• Puma Biotechnology Inc PBYI
• Quest Diagnostics Inc DGX
• Retrophin Inc RTRX
• Revolution Medicines Inc RVMD
• Rigel Pharmaceuticals, Inc. RIGL
• Rocket Pharmaceuticals Inc RCKT
• Rubius Therapeutics Inc RUBY
• SAGE Therapeutics Inc SAGE
• Sesen Bio Inc SESN
• Shockwave Medical Inc SWAV
• SI-Bone Inc SIBN
• Spectrum Pharmaceuticals, Inc. SPPI
• Supernus Pharmaceuticals Inc SUPN
• Syros Pharmaceuticals Inc SYRS
• T2 Biosystems Inc TTOO
• Tandem Diabetes Care Inc TNDM
• Tcr2 Therapeutics Inc TCRR
• TELA Bio Inc TELA
• Tetraphase Pharmaceuticals Inc TTPH
• TherapeuticsMD Inc TXMD
• Titan Medical Inc. TMDI
• TrovaGene Inc TROV
• Twist Bioscience Corp TWST
• Ultragenyx Pharmaceutical Inc RARE
• Urogen Pharma Ltd URGN
• Vanda Pharmaceuticals Inc. VNDA
• Varian Medical Systems, Inc. VAR
• Vericel Corp VCEL
• Viking Therapeutics Inc VKTX
• X4 Pharmaceuticals Inc XFOR
• X T L Biopharmaceuticals Ltd XTLB
• Xencor Inc XNCR
• ZIOPHARM Oncology Inc. ZIOP
• Zynerba Pharmaceuticals Inc ZYNE

See Also: 8 Biotechs With Coronavirus Vaccines In Development

Stocks In Focus

Vaxart, Emergent Join Hands For Oral COVID-19 Vaccine, Clinical Trials to Begin In 2020

Vaxart Inc VXRT said it has entered into an agreement with Emergent Biosolutions Inc EBS, which will allow Emergent to deploy its molecule-to-market contract development and manufacturing services to develop and manufacture the former's oral vaccine candidate for COVID-19.

"We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign, and Emergent is a great partner to help in this endeavor," SAID Wouter Latoud, CEO of Vaxart.

Vaxart expects Emergent to produce bulk cGMP vaccine to allow it to initiate Phase 1 study in the second hand of 2020.

In pre-market trading Wednesday, Vaxart shares were rallying 23.32% to $2.38.

IMV Jumps Into The Fray For COVID-19 Vaccine

Imv Inc IMV said it's advancing the clinical development of a DPX-based vaccine candidate against COVID-19. It intends to develop its vaccine candidate DPX-COVID-19 in collaboration with lead investigators for the phase 1 clinical study

AbbVie, Allergan Agree To Divest Certain Assets To Consummate Proposed Merger

AbbVie Inc ABBV and Allergan plc AGN said they have entered into a consent decree agreement with the FTC staff regarding the former acquiring the latter. Under the agreement, the companies agreed to divest brazikumab, an investigational autoimmune disorder drug, to AstraZeneca plc AZN, and Zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, as well as Viokace, another pancreatic enzyme preparation, both to NESTLE S A/S ADR NSRGY.

The companies expect the deal to close in May 2020, compared to the initial deadline of early 2020.

In after-hours trading, shares of AbbVie slipped 1.47% to $71.95, while Allergan shares rose 1.84% to $175.

Addex To Delay Parkinson's Disease Drug Registrational Study, Release of Q4 Results

Addex has postponed the start of the registrational efficacy and safety study of dipraglurant to treat levodopa induced dyskinesia in patients with Parkinson's disease due to the COVID-19 pandemic. The company also announced delaying the release of its fourth quarter results till April 8.

Biomerica Begins International Shipments of COVID-19 Rapid Test

Biomerica said it has commenced shipping initial samples of its COVID-19 IgG/IgM Rapid Test – a finger prick test with results in 10 minutes – to countries outside of the U.S.

"Biomerica is positioned to begin filling large international orders of this disposable one-use tests within weeks, assuming international product shipping channels remain open and active," the company said. The company has also begun the application process with the FDA for Emergency Use Authorization for its COVID-19 test.

Qiagen To Ramp Up Production If COVID-19 Testing Reagents By 7 Times

Qiagen NV Qiagen NV QGEN said it plans to dramatically ramp global production capacity of RNA extraction kits used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

From its historical capacity of manufacturing RNA nucleic acid extraction reagents for 1.5 million patient tests on a monthly basis, Qiagen now plans to ramp production of reagents to support more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June.

Obalon To Halt Sale of Weight Loss System In California Due To COVID-19

Obalon Therapeutics Inc OBLN, which markets the first FDA-approved swallowable gas-filled intragastric balloon system for treating obesity, said it has temporarily suspended sale of the system at its existing retail treatment centers in San Diego and Orange County, California in the wake of the COVID-19 threat.

Earnings

Diffusion Pharmaceuticals Inc DFFN reported a narrowing of its fourth-quarter loss from $8.21 in 2018 to $1.76 in 2019. Cash and cash equivalents stood at $14.2 million as of Dec. 31, 2019, compared with $8 million at Dec. 31, 2018.

The stock jumped 22.46% to 35 cents in after-hours trading.

On The Radar

Clinical Readouts

Spectrum Pharmaceuticals, Inc. SPPI is due to present at the Annual Congress on Pulmonology & Respiratory Medicine, already-released Phase 2 data for Poziotinib in non-small cell lung cancer with exon 20 insertion mutation in EGFR or HER2.

Earnings

Brickell Biotech Inc BBI (after the close)
Cumberland Pharmaceuticals, Inc. CPIX (after the close)
Capricor Therapeutics Inc CAPR (after the close)
Turning Point Therapeutics Inc TPTX (after the close)
Osmotica Pharmaceuticals PLC OSMT (after the close)