Novartis FDA Review Date Pushes Cryoport Shares

This morning the FDA posted a note on their website that they would be having a panel review of Novartis’ CAR-T therapy CTL019 (tisagenlecleucel-T) on July 12th. They will also be presenting their internal review documentation on July 10th for review prior to the panel discussion. These dates are well ahead of the guaranteed dates given out when Novartis filed.

This is a significant event not only for Novartis, but even more so for our Tailwinds Select Portfolio member Cryoport. This is shown by the trading in their respective shares today, with Novartis holding on to a $.01 gain while Cryoport is up $.19 or 5.3%. This is obviously a huge move for CYRX. Why is this event of such significance for this little company? A few reasons…

~ Cryoport is the shipping agent for CTL019. If it gets approval, this will amount to significant revenue to CYRX at very high margins.
~ Accelerated review can lead one to believe this drug is very well received by the healthcare community. Which, if true, could equate into higher revenue potential for CYRX. Perhaps as much as $20M per annum.
~ As the first CAR-T drug, CTL019 is setting a precedent for the whole market of CAR-T therapies. CYRX is the shipper of choice here and, if the FDA is accelerating approvals of all these therapies, we could see a major ramp in Cryoport revenue both quicker and higher than previously forecasted.

The bottom line here is that CAR-T therapies are coming sooner than expected and will likely be bigger than expected. Cryoport is the best play on this space as they are the most levered to the success of regenerative medicines and will benefit from a large number of approvals, without the risk associated with some of these drugs not making it through clinical studies.