Yesterday, Heron (HRTX) reported additional data for its opioid-free pain med candidate HTX-011 in a post-surgery setting. In the latest report-out 77% of bunionectomy patients remained opioid-free 72 hours post surgery when HTX-011 was administered with over-the-counter pain meds in the latest extension study from their prior successful Phase 3 program. Earlier this year, HRTX reported additional extension study data from a hernia repair study where 90% of patients were opioid free 72 hours post surgery with the combination of HTX-011 plus over-the-counter meds.
HTX-011 is under priority review by the FDA with a target PDUFA data of April 30, 2018. HRTX has been lagging the stock price run up of many small/mid biopharma companies this year. Its current market cap of about $2 billion seems attractive given the potential market for HRTX and prior clinical results. Of course, there is always risk with a PDUFA review related to manufacturing and quality control. If the FDA approves HTX-011 and gives it a broad label related to post-operative surgery, investors could be rewarded in the near-term. Either way, HTX-011 appears to be an important future pain med in the fight against the current opioid epidemic.