We are certainly disappointed in the CRL for HTX-011, there is no doubt about that, but we would be buying todays weakness as we continue to believe HTX-011 will be approved. The FDA flagged CMC and non-clinical issues and it is a bit hard to know, at this time, exactly when the company will be able to re-file its NDA until HRTX meets with the FDA. With that said, we remain confident in HTX-011s approvability given its robust Phase 2/3 dataset, opioid sparing capability and the fact the FDA is not requiring any additional clinical work, which we view as a good sign. With the stock trading around ~$18, we think this is a significant buying opportunity for long-term investors given HTX-011s product profile and the size of the commercial opportunity. We lower our target price to $38 to reflect a delayed HTX-011 approval and launch. Reiterate Buy.
https://www.analystratings.com/articles/...stock-is-going-to-recover/ |
