HTX-011: Will the 3rd PDUFA be the 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). 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 our 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 (See Table 1 below). Last month, the FDA missed IV tramadol's PDUFA goal date of 4/12/21 and we still await the FDA's decision. Apparently there are 2 issues remaining for IV tramadol - label language and and a terminal sterilization CMC issue. This is not too different from the HTX-011 situation and likely with the same group at the FDA. This is IV tramadol's second PDUFA and HTX-011's third (Table 1). IV tramadol is on a Class 1 resubmission review, which should be simpler than HTX-011's class 2, but that also only gave the FDA 2 months before IV tramadol's PDUFA date, whereas they have had 6 months with HTX-011. Would the FDA issue a decision on HTX-011 while IV tramadol? We don't know of a statutory reason why that is not possible, especially since the FDA has had HTX-011's resubmitted NDA for 3 more months.
If HTX-011 is approved, a big issue with respect to HRTX's stock price, in addition to the market's thoughts on launching a new drug into the pandemic, is the market's perception of the precise wording of the label that is approved by the FDA. HTX-011's label will likely have the typical heart-attack, stroke warning of NSAID's since one of the ingredients, Meloxicam, is an NSAID (See warning on Meloxicam label, which is not that different than warnings on over-the-counter NSAIDs in our reading). This hopefully won't spook the market. Will the label mention the ability of HTX-011 to eliminate the need for opioids in many post-surgical patients when combined with over-the-counter pain medicines? Will it cover all post-surgical indications or just some/all of those where HRTX has clinical data - hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation? These details will be important to investors.
Plus, HRTX's delay in getting FDA has allowed their competition, especially Exparel, to continue to be entrenched in the market. See much more about competition in our HTX-011 IQ Card (HERE). Thus, a broad label is even more important than it was 2 years ago when HTX-011 received its first CRL.
It's down to the wire for HTX-011 again. Hopefully, this 3rd PDUFA will be a charm as we are investors in HRTX and have been riding this out since before HTX-011's first CRL. More importantly, for U.S. healthcare, an approval of HTX-011 will give physician's and patients an opportunity to use less/no opioids in many post-surgical pain management settings.
Table 1
#HTX011, #HRTX, #FBIO, #ATXI, #pain, #postsurgical, #postsurgery