The Daily Biotech Pulse: Johnson & Johnson Earnings, FDA Nod For Horizon Therapeutics, Slew Of Secondary Offerings

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 Jan. 21)

• Abbott Laboratories ABT
• Apellis Pharmaceuticals Inc APLS
• Aptose Biosciences Inc APTO
• AtriCure Inc. ATRC
• Bioanalytical Systems, Inc. BASI
• Bristol-Myers Squibb Co BMY
• Cardiovascular Systems Inc CSII
• ChemoCentryx Inc CCXI
• Cidara Therapeutics Inc CDTX
• Deciphera Pharmaceuticals Inc DCPH
• Epizyme Inc EPZM
• Frequency Therapeutics Inc FREQ
• GALAPAGOS NV/S ADR GLPG
• Horizon Therapeutics PLC HZNP
• Inspire Medical Systems Inc INSP
• Johnson & Johnson JNJ
• Medtronic PLC MDT (announced FDA approval for Micra AV, the smallest pacemaker with atrioventricular synchrony and also reported positive trial results for its DTM spinal cord stimulation)
• Masimo Corporation MASI
• Prevail Therapeutics Inc PRVL
• PTC Therapeutics, Inc. PTCT
• Repligen Corporation RGEN
• ResMed Inc. RMD
• Selecta Biosciences Inc SELB
• Soligenix, Inc. Common Stock SNGX
• Vertex Pharmaceuticals Incorporated VRTX
• Veru Inc VERU
• Zoetis Inc ZTS
• ZEALAND PHARMA/S ADR ZEAL
• Zymeworks Inc ZYME

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 22)

• Enanta Pharmaceuticals Inc ENTA
• Kura Oncology Inc KURA

Related Link: 7 Blockbuster Drugs Expected To Be Launched In 2020

Stocks In Focus

J&J Q4 EPS Beats Estimates By a Penny; Issues Muted FY20 Guidance

Johnson & Johnson's JNJ fourth-quarter sales rose 1.7% year-over-year to $20.75 billion and EPS slipped from $1.88 to $1.97. Pharmaceutical segment sales rose 4.4% compared to 2.1% growth for the consumer segment and a nearly flat performance by the medical device business.

The company expects operational sales of $85.8 million to $86.6 million and adjusted EPS of $8.95 to $9.10 for the fiscal year 2020. Analysts, on average, estimate EPS of $9.10 on sales of $85.48 million.

Supernus' NDA For ADHD Drug Accepted For Review

Supernus Pharmaceuticals Inc SUPN said the FDA has accepted for review its NDA for SPN-812, which is being evaluated for treating children and adolescents with attention deficit hyperactivity disorder. The FDA has set a PDUFA action date of Nov. 8 for the experimental drug.

The stock rose 1.26% to $25 in after-hours trading.

Horizon Therapeutics Thyroid Eye Disease Drug Approved by FDA

Horizon said the FDA has approved its TEPEZZA, a monoclonal antibody and a targeted insulin-like growth factor-1 receptor inhibitor, for the treatment of Thyroid Eye Disease, or TED. TED is a progressive, vision-threatening rate autoimmune disease that is associated with eye bulging, diplopia, blurred vision, pain, inflammation and facial disfigurement.

It has to be administered once every three weeks for a total of eight infusions, the company said. The approval came ahead of the PDUFA action date of March 8.

The stock added 1.96% to $39 in after-hours trading.

Adaptive Biotech Expects Revenues Above Consensus, Announces Secondary Offering of 8M Shares

Adaptive Biotechnologies CorpADPT announced preliminary revenues for the full year 2019, expecting revenues of $84 million to $85 million, ahead of the $82.85-million consensus estimate. The company noted that clinical volumes grew 25% from the third quarter. The company, however, expects a wider loss for the fourth quarter due to investments in market development activities.

Separately, the company announced the commencement an underwritten public offering of 8 million shares of its common stock by certain selling shareholders.

The stock rose 0.52% to $26.94 in after-hours trading.

Offerings

Novavax, Inc. NVAX said in a filing it will sell up to $100 million shares of its common stock from time to time through B Riley FBR.

Shares slipped 11.41% to $8.70 in after-hours trading.

Adaptimmune Therapeutics PLC – ADR ADAP said it intends to sell ADSs in an underwritten public offering, with all the ADSs to be sold by the company. The company said it plans to use the net proceeds to advance the development of its immunotherapies into and through clinical trials as well as for general corporate purposes.

The stock shed 4.59% to $3.95 in after-hours trading.

Blueprint Medicines Corp BPMC commenced an underwritten public offering of $325 million worth of its common stock. All the shares are being offered by the company.

The stock fell 2.93% to $77.40 in after-hours trading.

Applied Therapeutics Inc APLT plans to offer 1.75 million shares of its common stock in an underwritten registered public offering. The company said it plans to use the net proceeds to advance its pipeline and preparing for potential commercial launches, among other things.

The stock moved down 2.79% to $47 in after-hours trading.

Beijing-based Zai Lab Ltd ZLAB has commenced an underwritten public offering of 5.5 million ADSs, each representing one ordinary share of the company.

SI-Bone Inc SIBN has commenced an underwritten public offering of 4.3 million shares of its common stock. Of the total shares offered, 1.81 million is being offering by selling stockholders and 2.49 million by the company.