The short answer is the HTX-011 (ZYNRELEF) label language that was approved by the FDA. As we discussed in our prior posts on BPIQ.com, the precise label language (see below) was going to be important for HTX-011 and the market's reaction to its likely approval. Unlike FBIO/ATXI's surgical pain med IV tramadol, the FDA managed to hit their PDUFA goal date for HTX-011. Unfortunately, the FDA-approved label for HTX-011 (now ZYNRELEF) is limited to bunionectomy, open inguinal heriorrhaphy and total knee arthroplasty. HRTX was seeking a broad label, more similar to EXPAREL's label EXPAREL is marketed by PCRX. It's interesting that both HRTX and PCRX are down today on HTX-011's long-awaited approval.
For more details about HRTX's ZYNRELEF label and market vs. EXPAREL, as well as Amp Biotech Research's thoughts on the stock moving forward, read the full article on our BPIQ.com blog. If you are not a subscriber to BPIQ.com, just follow the links on our home page (30-day free trial with no credit card and no commitments).
