BTD Decision for NNZ-2591 Could Land Anytime Now As of May 19, we’re officially entering the most critical period in the wait for a potential Breakthrough Therapy Designation (BTD) for Neuren’s NNZ-2591 in Phelan-McDermid syndrome (PMS).The FDA meeting was held on April 8, 2025.The 60-day deadline for a BTD response would fall around June 7–9.The FDA can respond at any time within this window — and if granted, Neuren will likely release the news through an ASX announcement without warning.Given the positive tone in the FDA Minutes Letter published on May 13 and the confirmed Phase 3 readiness (Phase 3 = Phase 2), many investors believe a BTD request has already been submitted right after the April meeting.A BTD would act as a “stamp of clinical and commercial potential” and could be the ultimate catalyst — especially before the PMS Phase 3 trial officially begins. The AGM on May 23 might provide further clues or set the scene.We’re in the final 3 weeks of the BTD window. Every day counts now...
Key Milestones: x FDA confirmed Phase 3 design for PMS (May 17) - BTD likely submitted post-April meeting - AGM on May 23 – potential catalyst or hints - BTD can be announced ANY DAY NOW - Phase 3 trial for NNZ-2591 in PMS expected mid-year
NEU Price at posting:
$12.63 Sentiment: Hold Disclosure: Held
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