Join our daily newsletter At The Bell to receive exclusive market insights
Mesoblast (ASX:MSB) has seen its shares dip on Monday morning out the gate as some investors struggle to digest what exactly the recent receipt of feedback from the FDA means for the Australian company’s ambitions to see its stem cell product used to treat inflammatory back pain.
Listen to the HotCopper podcast for in-depth discussions and insights on all the biggest headlines from throughout the week. On Spotify, Apple, and more.
Pointing to chronic discogenic low back pain (CLBP) as its main target market, Mesoblast wrote on Monday: “Mesoblast is seeking FDA approval for rexlemestrocel-L based on reduction in CLBP through 12 months.”
“Comparing outcomes between rexlemestrocel-L and placebo from MSB-DR003 trial, the FDA acknowledged the effects on pain intensity appear to favor the active arm.”
“FDA also confirmed a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy and stated that the robust results on opioid reduction from at least one adequate and well-controlled trial could be included in the Clinical Studies section of product labelling.” That’s a lot of ‘coulds.’
In other words: Mesoblast has walked away from the FDA with a lot of promising language, but no ultimate approval. That adds some context to what Mesoblast named its Monday announcement: “FDA Confirms Path to Approval for CLBP” (emphasis is this finance journalist’s own.)
Curious, too, that the FDA informed Mesoblast, in other words, it may want to consider harping on about stem cells being an opioid-free medicine – that suggests, to anybody paying attention, Mesoblast may need to pander to RFK’s dubious agenda moving forward.
That’s just this Market Link journalist’s speculation, but if you think that’s impossible, I have an Arctic nation to sell you.
MSB last traded at $2.59/sh today.
Join the discussion: See what HotCopper users are saying about Mesoblast Ltd and be part of the conversations that move the markets.
The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.
