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)

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

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 21)

• ALX Oncology Holdings Inc ALXO (IPOed Friday)
• Biofrontera AG BFRA
• Nkarta Inc NKTX
• Pandion Therapeutics Holdco LLC PAND (IPOed Friday)
• RENALYTIX AI ADR RNLX (IPOed Friday)
• Tricida Inc TCDA

Stocks In Focus

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

Aurinia Pharmaceuticals Inc 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 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 IQV.

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

Mesoblast limited 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 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. 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.

Offerings

CASI Pharmaceuticals Inc 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 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.

Earnings

Biogen (before the market open)