$Bob's and Jbem's Bitchin' Bios

[tjguy]

$AUPH!

Excellent encouraging news on Aurinia out again yesterday after hours.

They met with the regulatory bodies in Europe and Japan and both groups said the one Phase III trial they will begin this quarter will be sufficient for approval in their respective areas! So, just one Phase 3 trial will cover all these areas!

This is great news and will make Aurinia much more attractive as a takeover candidate.

Upcoming catalysts:

April 22nd full release of Phase II data (the 48-week data) has been accepted for a late-breaking presentation at National Kidney Foundation (NKF) Spring Clinical Meeting taking place April 18-22 in Orlando, FL.

Q2: Begin the Phase III trial


Read all about it here: http://ir.auriniapharma.com/press-releases/detail/82

This is a very highly de-risked play and upon successful Phase 3 trial results are out and then an NDA is filed. Of course, approval will also greatly appreciate in price. A buy out could happen before approval for sure.

It's a longer term play, but it's a very safe play. It's hard to say how the stock price will hold up while waiting for results. It might drop a little or appreciate slowly the closer we get to the release date.

The possibility of a buyout/licensing always exists but probably increases after Phase III data is released.

From the press release:

The Phase III AURORA trial will be a global 52-week double-blind, placebo controlled study of approximately 320 patients. Patients will be randomized 1:1: to either of 23.7mg voclosporin BID and mycophenolate mofetil (MMF) or MMF and placebo, with both arms receiving a stringent oral corticosteroid taper. As in AURA, the study population will be comprised of patients with biopsy-proven active LN who will be evaluated on the primary efficacy endpoint of complete remission, or renal response, at 52 weeks, a composite which includes:

Urinary/protein creatinine ratio (UPCR) of ≤0.5mg/mg
Normal, stable renal function (≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of >20%)
Presence of sustained, low dose steroids (≤10mg prednisone from week 16-24)
No administration of rescue medications

“Based on the recent learnings from the positive AURA study at 48 weeks, we intend to use a UPCR of ≤0.5mg/mg and evaluate the primary endpoint at 52 weeks in AURORA,” added Richard M. Glickman, Aurinia’s Chief Executive Officer. “We are on track to initiating the global AURORA study this quarter and fulfilling our goal of improving the long-term outcomes for patients with this disease.”

Disclosure: Very overweight position including some options