Cautious Hold Rating on Neurogene Due to Regulatory Uncertainty and Data Quality Concerns for NGN-401

In a report released today, Jack Allen from Robert W. Baird downgraded Neurogene (NGNE – Research Report) to a Hold, with a price target of $24.00.

Jack Allen has given his Hold rating due to a combination of factors related to the regulatory path and data quality for Neurogene’s lead agent, NGN-401. The stock has seen a significant rise recently as investors became more optimistic about the possibility of a single-arm trial being sufficient for FDA approval. However, with new leadership at the FDA, there is an expectation that approval standards are becoming more stringent, leading to regulatory uncertainty.
Despite the recent positive momentum, Allen remains cautious due to the lack of robust data for NGN-401’s efficacy in treating Rett syndrome. The data available so far appears inconsistent, and the recent update from a competitor did not provide additional clarity or confidence in the regulatory path. Upcoming updates on trial plans and interim clinical data might influence the outlook, but for now, the uncertainties keep the rating at Hold.