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.
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:
Disclosure: Very overweight position including some options
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