The Week Ahead In Biotech: Earnings, PDUFA Dates And More

The number of biotech stocks posting gains outstripped those recording losses for the week. Notable among the gainers for the week were Odonate Therapeutics Inc ODT — which reported its financial results Feb. 14 and has been rallying ever since — and ARMO Biosciences Inc ARMO, which priced its initial public offering Jan. 26 and saw its analyst quiet period expire Feb. 20.

Among the catalysts we outlined in the article for the week of Feb. 18: Dynavax Technologies Corporation DVAX got the nod from the CDC's Advisory Committee on Immunization Practices to add the hepatitis B vaccine HEPLISAV-B to its recommended product list. The Wednesday announcement triggered a nearly 5-percent intraday gain, although the stock gave much of it back by the close.

Here's a compilation of key biotech events to keep a tab on this week.

PDUFA Dates

Wednesday, Feb. 28

• Sorrento Therapeutics Inc SRNE's NDA for its lead product candidate ZTlido, a lidocaine patch for treating pain associated with post-herpetic neuralgia, will come up before the FDA. The candidate has failed to clear the FDA hurdle once and this is its second try.

See Also: 4 Reasons Behind BofA's Bullish Restorbio Initiation

Clinical Trial Results

• Asterias Biotherapeutics Inc AST: Six-month data from Cohort 3 and Cohort 4 testing its AST-OPCI for cervical spinal cord injuries.
• Heat Biologics Inc HTBX: Initial Phase 2 data for its non-small cell lung cancer candidate HS-110 along with Opdivo is due Feb. 28 at the company's analyst and investor event.
• Novavax, Inc. NVAX is awaiting full Phase 1/2 data for its NanoFlu vaccine. 
• Sierra Oncology Inc SRRA: An update on Phase 1 trials of its advanced solid tumors or Non-Hodgkin's lymphoma treatment candidate.

Earnings

Monday, Feb. 26

• Clovis Oncology Inc CLVS Q4 Estimates (EPS/Revenues): $1.30 loss/$20.32 million. 

Tuesday, Feb. 27

• ACADIA Pharmaceuticals Inc. ACAD: 58-cent loss/$44.32 million. 
• Acceleron Pharma Inc XLRN: 62-cent loss/$3.66 million. 
• FibroGen Inc FGEN ): 29-cent loss/$49.77 million. 
• Ionis Pharmaceuticals Inc IONS
• Jazz Pharmaceuticals plc - Ordinary Shares JAZZ
• Mallinckrodt PLC MNK:$1.70/$773.06 million. 

Wednesday, Feb. 28

• Amicus Therapeutics, Inc. FOLD: 29-cent loss/$14 million. 
• Horizon Pharma PLC HZNP: 22 cents/$264.62 million. 
• Mylan N.V. MYL: $1.41/$3.31 billion. 

Thursday, March 1

• Puma Biotechnology Inc PBYI: $1.98 loss/$20.01 million. 
• Nektar Therapeutics NKTR: 35-cent loss/$38.83 million. 
• Sarepta Therapeutics Inc SRPT: Loss of 32 cents/$55.3 million. 

<h3IPOs</h3

• Genprex is likely to price its IPO after making an S-1 filing in 2017. The developer of gene-based nanoparticle therapies to treat cancer is expected to offer 1.3 million shares at $5 each. 

Conferences/Symposiums

• 13th Annual Huntington Disease Therapeutics Conference, Feb. 26-March 1.