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The Daily Biotech Pulse: Aurinia's Kidney Inflammation Drug Filing Accepted For Review, Intuitive Surgical's Q2 Beat

The Daily Biotech Pulse: Aurinia's Kidney Inflammation Drug Filing Accepted For Review, Intuitive Surgical's Q2 Beat

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 21)

  • Assembly Biosciences Inc (NASDAQ: ASMB)
  • Bio-Rad Laboratories, Inc. (NYSE: BIO)
  • Beigene Ltd (NASDAQ: BGNE)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)
  • Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI)
  • Catalent Inc (NYSE: CTLT)
  • CTI BioPharma Corp (NASDAQ: CTIC)
  • Heat Biologics Inc (NASDAQ: HTBX)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)
  • Immunomedics, Inc. (NASDAQ: IMMU)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Natera Inc (NASDAQ: NTRA)
  • Novo Nordisk A/S (NYSE: NVO)
  • Opko Health Inc. (NASDAQ: OPK)(moved in reaction to an announcement it will offer COVID-19 diagnostics testing to the NFL)
  • ResMed Inc. (NYSE: RMD)
  • Retrophin Inc (NASDAQ: RTRX)
  • Trevena Inc (NASDAQ: TRVN)
  • Twist Bioscience Corp (NASDAQ: TWST)
  • Veracyte Inc (NASDAQ: VCYT)
  • West Pharmaceutical Services Inc. (NYSE: WST)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 21)

  • ALX Oncology Holdings Inc (NASDAQ: ALXO) (IPOed Friday)
  • Biofrontera AG (NASDAQ: BFRA)
  • Nkarta Inc (NASDAQ: NKTX)
  • Pandion Therapeutics Holdco LLC (NASDAQ: PAND) (IPOed Friday)
  • Tricida Inc (NASDAQ: TCDA)

Stocks In Focus

Aurinia Announces FDA Acceptance of NDA For Kidney Inflammation Drug With Priority Review

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) said the FDA has accepted the filing of its NDA for voclosporin, as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus. The FDA has granted Priority Review for the application, and has assigned a PDUFA target action date of Jan. 22, 2021.

The stock advanced 9.12% to $15.80 in after-hours trading.

Biogen Appoints Iqvia Executive as New CFO

Biogen Inc (NASDAQ: BIIB) announced the appointment of Michael McDonnell as EVP and CFO, effective Aug. 15, replacing the incumbent Jeffrey Capello. McDonnell is currently serving as CFO of Iqvia Holdings Inc (NYSE: IQV).

FDA To Hold an Adcom Review of Mesoblast's BLA For Acute GvHD Drug

Mesoblast limited (NASDAQ: MESO) said the Oncologic Drugs Advisory Committee of the FDA has scheduled a meeting Aug. 13 to review data supporting its BLA for the approval of Ryoncil for the treatment of steroid-refractory acute graft versus host disease in children.

The BLA has a PDUFA action date of Sept. 30.

Boston Scientific Announces FDA Nod For Device to Reduce Risk of Stroke

Boston Scientific Corporation (NYSE: BSX) said it has received FDA approval for the WATCHMAN FLX Left Atrial Appendage Closure Device.

The device is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage.

The company said it is planning an immediate limited commercial launch in the U.S.

In pre-market trading Wednesday, the stock was adding 2.05% to $38.25.

Intuitive Surgical Q2 Beats Estimates

Intuitive Surgical, Inc. (NASDAQ: ISRG) reported a 22% decline in second-quarter revenues to $852 million, while its non-GAAP net income per share fell from $3.25 to $1.11. Analysts, on average, had estimated earnings of 63 cents per share on revenues of $664.96 million.


CASI Pharmaceuticals Inc (NASDAQ: CASI) said it has commenced an underwritten public offering to issue shares of its common stock. All of the shares of common stock in the offering will be sold by the company.

The stock was slipping 9.42% to $2.02 in pre-market trading Wednesday.

On The Radar

Clinical Readouts

Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) said it will present an overview of its Zygel development program in Fragile X syndrome and additional caregiver-reported data from its 14-week pivotal CONNECT-FX trial during the 17th NFXF International Fragile X Conference Research Roundup. The presentation is scheduled to take place at 3:45 pm ET. The company reported results from the study on June 30, showing the study did not meet the primary and secondary endpoints.


Biogen (before the market open)


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