Broker data is out for the 12/5 where we dropped 10%~
Largest seller is Morgans (who are mostly a retail broker) - on that day it was their biggest net sale across their network (50+ retail offices). They don't offically cover Neuren but their research is below par. The part highlighted (from 24th Feb) is egregious. Saying the designations are effectively worthless as a result is such poor analysis and they shouldn't put anything out if they aren't going to bother doing proper research.
NEU has announced the granting of FDA's Rare Pediatric Disease Designation (RPD) for both Pitt Hopkins (PH) and Angelman Syndrome (AS), both neurological disorders which emerge in early childhood and currently have no approved treatments.
These designations allow companies to apply for various incentives, including the highly-prized Priority Review Voucher (PRV) which awards RPD participants a voucher which can be used to accelerate the FDA's review process, or can opt to on-sell to another drug developer to use.
However, there remains uncertainty under current legislation where the PRV program was active up until September 2024 but has not since been reauthorised. The sunsetting of incentives currently only allows the awarding of the vouchers for approved designations up until late 2026, but seemingly not the qualifying tickets to entry which it continues to award.
Given the time it takes to run Ph3 pivotal trials along with the NDA submission process, the designations are effectively zombie designations with no material benefit unless US congress reauthorise the program.
A bill introduced in December 2024 (with bipartisan support) which would have extended the sunset date for another 4+ years ran into political challenges and ultimately stripped back many provisions which included the PRV extension. We note that congress has since passed several of the bills originally stripped out of the continuing resolutions, which gives some degree of hope for the program in the near-term. However, from our searches we cannot find any current commentary from the FDA or heard of this program being on the ticket for discussion at the congressional level at this stage.
NEU Price at posting:
$13.04 Sentiment: Buy Disclosure: Held
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