The Daily Biotech Pulse: Breakthrough Device Designation For Neuronetics, AbbVie Receives European Label Expansion, AstraZeneca Flunks Late-Stage Study

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit hit 52-week highs March 5.)

• Arcus Biosciences Inc RCUS
• Arcturus Therapeutics Ltd ARCT
• BioMarin Pharmaceutical Inc. BMRN
• Centogene NV CNTG
• Cue Biopharma Inc CUE
• Forty Seven Inc FTSV
• Inovio Pharmaceuticals Inc INO
• Molecular Templates Inc MTEM
• Natera Inc NTRA
• Ocular Therapeutix Inc OCUL (Piper Sandler lifted the price target for the shares from $7 to $11)
• Quest Diagnostics Inc DGX (announced plans to launch a COVID-19 test service)
• Regeneron Pharmaceuticals Inc REGN
• Syndax Pharmaceuticals Inc SNDX
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech stocks that hit 52-week lows March 5.)

• Aldeyra Therapeutics Inc ALDX
• AngioDynamics, Inc. ANGO
• ANI Pharmaceuticals Inc Common Stock ANIP
• Aytu Bioscience Inc AYTU
• Celcuity Inc CELC
• Chembio Diagnostics Inc CEMI
• Eagle Pharmaceuticals Inc EGRX
• Eiger Biopharmaceuticals Inc EIGR
• Enlivex Therapeutics Ltd ENLV
• Evogene Ltd EVGN
• EXACT Sciences Corporation EXAS
• Glaukos Corp GKOS
• Lantheus Holdings Inc LNTH
• Mylan NV MYL
• Neurometrix Inc NURO
• Organogenesis Holdings Inc ORGO
• Orthofix Medical Inc OFIX
• Passage Bio Inc PASG (went public last week)
• Polarityte Inc PTE
• STRATA Skin Sciences Inc SSKN
• SurModics, Inc. SRDX (reacted to first-quarter results)
• T2 Biosystems Inc TTOO
• Xeris Pharmaceuticals Inc XERS

See also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Stocks In Focus

AstraZeneca's Imfinzi Flunks Late-Stage Study In Advanced Bladder Cancer

AstraZeneca plc AZN said a late stage trial that evaluated Imfinzi and Imfinzi plus tremelimumab in unresectable, Stage IV bladder cancer did not meet the primary endpoints of improving overall survival versus standard-of-care chemotherapy for Imfinzi monotherapy in patients whose tumor cells and/or tumor-infiltrating immune cells express high levels of PD-L1, or for Imfinzi plus tremelimumab in patients regardless of their PD-L1 expression.

In premarket trading, the shares were slipping 1.65% to $47.58.

AbbVie Gets Label Expansion For Shorter-Duration Maviret Course In Hepatitis C

AbbVie Inc ABBV said the European Commission has approved a change to the marketing authorization for Maviret to shorten once-daily treatment duration from 12 weeks to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C patients with genotype 3 infection.

"A shorter treatment duration means that more patients with HCV can be treated with an 8-week course of MAVIRET in the absence of initial tests to determine their genotype or degree of fibrosis or cirrhosis," Janet Hammond, vice president of generic medicines and the virology therapeutic area at AbbVie, said in a statement. 

Maviret is a collaboration with Enanta Pharmaceuticals Inc ENTA.

Neuronetics System Receives Breakthrough Device Designation 

Neuronetics Inc STIM said the FDA granted Breakthrough Device Designation for its NeuroStar Advanced Therapy System for the treatment of bipolar depression.

NeuroStar Advanced Therapy, according to the company, is the market leader in transcranial magnetic stimulation, a non-invasive form of neuromodulation, and has been approved for unipolar major depression.

The stock was trading 40.22% higher at $3.80 at the time of publication in Friday's premarket session. 

Silk Road Medical Shares Uplist To Nasdaq Global Select Market

Silk Road Medical Inc SILK said its common stock has been approved for uplisting to the Nasdaq Global Select Market and will continue to trade under its current ticker symbol, "SILK." The company went public in April 2019.

Earnings

Oncology-focused biopharma Arcus Biosciences' fourth-quarter revenue rose from $1.6 million in 2018 to $9.8 million in 2019. The net loss per share widened from 28 cents to 38 cents, which was narrower than the consensus loss estimate of 51 cents per share. Cash, cash equivalents and investments in marketable securities stood at $188.3 million as of Dec. 31, 2019 compared with $259.7 million as of Dec. 31, 2018.

In premarket trading Friday, Arcus shares were rising 4.06% to $20.

Enzo Biochem, Inc.'s ENZ fiscal second-quarter revenue edged up from $19.3 million in 2019 to $19.4 million in 2020. The non-GAAP loss narrowed from 18 cents per share to 12 cents per share.

The shares were ripping 50.44% higher to $3.40 in Friday's premarket session. 

Eton Pharmaceuticals Inc ETON reported revenue of $500,000 and a loss of 15 cents per share for the fourth quarter of 2019 versus no revenue and a loss of $2.24 per share one year ago.

Eton shares were advancing 6.12% to $5.90 in premarket trading Friday.

BioNano Genomics Inc BNGO reported a decline in its fourth-quarter revenue from $4 million in 2018 to $2.8 million in 2019. 

The net loss widened from $6.41 million to $7.9 million. As of Dec. 31, 2019, the company had cash and cash equivalents of $17.3 million compared to $16.5 million at the end of fiscal year 2018.

In premarket trading Friday, BioNano shares were down 24.78% at 85 cents.

On The Radar

Earnings

• Bio-Path Holdings Inc BPTH (before the market open)
• Digirad Corporation DRAD (before the market open)
• Milestone Pharmaceuticals Inc MIST (before the market open)

Related Link: How The COVID-19 Outbreak Is Benefiting Biotech Investors