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HTX-011: Will 3rd PDUFA be a Charm?

HRTX has a Big-Mover PDUFA goal date tomorrow, 5/12/21. We have written quite a bit about HRTX over the past years (e.g. see our Bull/Bear theses from 2020 HERE (BPIQ free-trial required)). HRTX stock was up about 6% yesterday on CEO, Barry Quart's, comment in their quarterly report: "We have no outstanding questions on the pending NDA and are currently in labelling discussions with the FDA, as we prepare for the anticipated commercial launch of HTX-011 in the U.S." But the FDA has already missed some PDUFA goal dates this year. Thus, even though HRTX's resubmitted NDA review appears to be down to label language, there is no assurance that the FDA will hit tomorrow's goal date. Furthermore, as we've commented on previously, the agreed-upon label language will be super important for the present valuation of HRTX's pain med.


It turns out that HRTX's situation is similar to another Big-Mover PDUFA on our April and May Big-Mover catalyst lists: FBIO/ATXI's IV tramadol for the management of pain. We still await the FDA's decision on that PDUFA, which had a goal date of 4/12/21. Read our detailed forum post on HTX-011's PDUFA with a detailed comparison of IV tramadol's current PDUFA and CRL history, with that of HTX-011. Plus, we discuss key label language considerations. To sign up for BPIQ's free trial, just go to BPIQ.com and follow the links.




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