Thanks @Jimbowe for posting this, it was the first I'd heard of them. Just going to post some of the text here, since I need to read it a few times myself. I still don't fully grasp the dual tracking advantages and risks. Any comments?

Regulatory Milestone Achieved: FDA Pre-IND Meeting LTR Pharma has completed a successful pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA), marking a critical step in the SPONTAN development program. The FDA broadly endorsed LTR’s non-clinical (toxicology) and CMC (Chemistry, Manufacturing and Controls) development plans.

The meeting resulted in alignment on a streamlined clinical development path, including one pivotal safety and efficacy trial and a multi-dose pharmacokinetic (PK) study which will reinforce SPONTAN’s labelling and commercial positioning providing LTR with a clear guideline to gain approval in the US.

LTR Pharma's experienced team will work closely with Aptar Pharma and other CROs to leverage their extensive expertise and established FDA relationships to efficiently complete the required studies ahead of the planned New Drug Application (NDA) submission.

The team also plans to investigate the ability to use additional clinical trial data for the US with other regulatory submissions in key global markets.

Accelerating U.S. Market Entry with Roxus® 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. 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.*

This strategic initiative enables early market entry while SPONTAN progresses through FDA approval. Roxus is being developed with a pharmaceutical partner in Australia, with testing underway to establish stability and shelf-life. Completion is expected in the coming two quarters, with a potential US release in the first half of 2026CY.

This approach provides LTR with valuable patient and prescriber insights, informs pricing strategy, and builds early commercial traction in the world’s largest healthcare market.