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ATXI and FBIO's Upcoming PDUFA: Not for the faint of heart investor

Updated: Apr 13, 2021

FBIO founded ATXI to develop an intravenous version of Tramadol, a patented intravenous formulation of the commonly prescribed, approved generic pain therapeutic, called Ultram among other names. In our view, this PDUFA is an especially complex catalyst, only for experienced biopharma investors with significant time to dig into the facts:

First, ATXI actually is supposed to be acquired by Invagen (owns 33% of ATXI already, and Invagen was acquired by Cipla) if the FDA approves IV Tramadol by April 30, 2021 and the label has no REMS and is not limited to specific surgeries (and FBIO shareholders (majority shareholder of ATXI) will share in the proceeds of this acquisition);

Second, If IV, Tramadol is approved by April 30, 2021, has no REMs requirement, and the label is not limited to specific surgeries, litigation between ATXI, FBIO and Invagen appears a real possibility because Invagen has threatened that it will not go forward with its purchase of ATXI due to commercialization challenges caused by Covid;

Third, you've got the challenges of figuring out whether the market will positively respond to an approval here not only given the uncertainty with point 2, but is the data strong enough that IV, Tramadol will be successful enough to trigger payments to ATXI shareholders under the Invagen acquisition agreement; and

fourth: you have an opioid drug, which have not been well-received by the FDA in recent years, and trying to determine whether ATXI met the FDA's prior concerns in its CRL of October 2020.

Of course, there are positive elements of this drug candidate and PDUFA as well. But the above points give you a sense of the unique complexities of this PDUFA and these companies as they stand currently. We have lots more detailed facts about this PDUFA to help you in your analysis in our bull/bear thesis card at this link if you sign up for a free subscription (see below).

There are more PDUFAs coming this month (and upcoming months too of course). Find them easily with our catalyst database search, and find which of them the market sees as big-mover catalysts by signing up for our free 30-day trial, (quick and easy, no credit card required, and get you our intro $12 or $15/month subscription level if you want to continue). Just go to our home page at and follow the links.



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