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

Volatility is the name of the game in profitable trading, and it's all the more relavant in the biotech space, which is subject to many make-or-break catalytic events.

This apart, usual market-moving events such as initial public offerings, quiet period expiration dates, follow-on offerings, earnings announcements, pre-announcements, executive appointments, M&A and analyst notes could also move stocks in a big way.

A recent example of how volatile the biotech space is the huge move in Tetraphase Pharmaceuticals Inc TTPH on Feb. 13 after it failed to ace a late-stage trial that evaluated its lead antibiotic product candidate eravacycline for advanced urinary tract injection.

The stock was cut in half in the session, closing down more than 60 percent at $2.15.

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

PDUFA Action Days

PDUFA, or prescription drug user fee act, is the deadline by which the FDA has to make its verdict regarding the approvability or non-approvability of a drug or device. The timeframe from the time of the acceptance of a new drug application, or NDA, or biologic license application, or BLA, to the approval is 10 months for a standard review and six months for a priority review.

Friday, Feb. 23, 2018

KemPharm Inc KMPH's abuse-deterrent product candidate meant for short-term management of acute pain KP201/APAP is knocking the FDA altar after a failed attempt. The PDUFA date for the NDA for KP201/APAP is Feb. 23.

See Also: Foundation Medicine Set For 'Material Upside,' Cowen Says In Bullish Initiation

AICP Review

Dynavax Technologies Corporation DVAX's hepatitis B vaccine Heplisav B, which was twice rejected by the FDA was finally approved in November 2017. The vaccine will be up before the Advisory Committee On Immunization Practices, or AICP, on Feb. 21.

Vaccines have to go through the Center for Disease Control And Prevention's, or CDC, ACIP after the FDA approval. With respect to Heplisav B, the committee will decide on whether it's to be added to its adult vaccination schedule.

Clinical Trial Results Schedule

Biotech companies don't usually give an exact date for the release of clinical trial results, unless it's a presentation at a conference, and indicate the schedule by giving the month or quarter or part of the year.

We have included for the week those companies, which have given a February timeline but are yet to release the results.

• Aimmune Therapeutics Inc AIMT - Top-line data from a Phase 3 trial initiated in January 2017 for its peanut allergy treatment candidate AR 101
• Novavax, Inc. NVAX - full Phase 1/2 data for its influenza vaccine NanoFlu is awaited
• Sierra Oncology Inc SRRA - Update on Phase 1 trials of its advanced solid tumors or Non-Hodgkin's lymphoma treatment candidate.

Earnings

Monday Feb. 19

• Genomic Health, Inc. GHDX - 7 cents/$88.90 Mln

Tuesday, Feb. 20

• Halozyme Therapeutics, Inc. HALO - 72 cents/$165.19 Mln
• Medtronic plc. Ordinary Shares MDT - $1.17/$7.20 Bln

Wednesday, Feb. 21

• Insulet Corporation PODD - loss of 8 cents per share/$125.15 Mln
• Ligand Pharmaceuticals Inc. LGND - $1.14/$47.82 Mln
• The Medicines Company MDCO - loss of $1.28 per share/$22.67 Mln
• Momenta Pharmaceuticals, Inc. MNTA - loss of 31 cents per share/$66.59 Mln
• Portola Pharmaceuticals Inc PTLA - loss of $1.36 per share/$6.2 Mln

Thursday, Feb. 22

• BioMarin Pharmaceutical Inc. BMRN – loss of 24 cents per share/$357.49 Mln
• Emergent Biosolutions Inc EBS – 70 cents/$188.95 Mln.
• EXACT Sciences Corporation EXAS - loss of 24 cents per share/$85.09 Mln.

Friday, Feb. 23

• Insmed Incorporated INSM - loss of 64 cents per share

IPO

Genprex, a developer of gene-based nanoparticle therapies to treat cancer originally filed an S-1 in 2017 for a "best efforts" offering. As opposed to a "firm commitment" offering, a "best efforts" offering is one in which underwriting institutions do their best efforts to sell the offering to the public but do not buy the shares outright, or guarantee that the issuing company receives a definite amount of money.

The company modified the offering to a firm commitment offering. The company is likely to price the IPO this month, according to Renaissance Capital. The company expects to offer 1.3 million shares at $5, raising $6.5 million.

Conference Schedule

• American Academy of Dermatology, or AAD, Annual Meeting – Feb. 16-20