Join our daily newsletter At The Bell to receive exclusive market insights
LTR Pharma (ASX:LTP) has unveiled its latest grand plan to further expand into the U.S. market – with a product called Roxus it says taps into “personalised healthcare.”
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.
But markets haven’t liked the news: Shares were down -6.3% heading in early afternoon trades on Wednesday. That could be because of confusion around what Roxus is, as opposed to LTR Pharma’s flagship drug SPONTAN, and whether or not Roxus will require years of clinical trials.
“LTR Pharma is advancing a dual-track US market strategy with the introduction of our new product, Roxus, a vardenafil-based nasal spray targeting the growing personalised healthcare sector,” LTR wrote on Wednesday.
Of course, its existing nasal-spray-based erection drug, SPONTAN, is also a vardenafil-based nasal spray. So you can understand investor confusion.
LTR Pharma ultimately appears to be trying to get Roxus onto the market through a secondary method that could, by any reasonable person’s interpretation of Wednesday’s announcement, shortcut through the FDA process and hit U.S. shelves before SPONTAN gets full approval.
“Roxus will be delivered via the 503(a)-compounding pharmacy pathway, part of the broader US compounding pharmacy market—currently valued at over US$6 billion and projected to reach US$10 billion by 2033,” LTR wrote.
The Section 503(a) pathway is a highly technical regulatory instrument covering compounding pharmacies in the U.S.
Ultimately, whether or not LTR Pharma can get Roxus to market quicker than SPONTAN remains to be seen for investors – but the confusion around launching two identical products under two different names through different pathways into the U.S. market has been enough to cause some risk-off sentiment, likely explaining the drop in shares on Wednesday.
“The response to SPONTAN, both clinically and scientifically, affirms the value of our innovative delivery method,” LTR Pharma Exec Chair Lee Rodne said.
More market news
51st State: What is Trump’s endgame with tariffs – and what will it mean for Canada?
Meet GeoGeorge: The HotCopper poster so accurate he got hired as an analyst
“We’re building a robust, multi-market commercial model that maximises short-term returns and long-term potential. First US sales are targeted for early 2026, with a strong foundation already in place.”
That kind of corporate buzzspeak might also be turning off investors looking for a more solid infodump.
LTP last traded at 45cps.
Join the discussion: See what HotCopper users are saying about LTR Pharma 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.
