Why Soleno Therapeutics Stock Is Up 9% Today

Soleno Therapeutics (SLNO 9.11%) had some good news to report on the regulatory front on Tuesday. Investors were encouraged by this, as evidenced by sending the biotech stock over 9% higher in price on the day. This performance was much better than those closely followed S&P 500 index, which closed down less than 1%.

Jump ahead in the review process?

Before the market opened that day, Soleno reported that the review division of the US Food and Drug Administration (FDA) had determined that there was no need for an advisory committee meeting on a crucial proposal from the company, at least for now. This is a new drug application (NDA) for the company’s diazoxide choline (DCCR) tablets for the treatment of the genetic disorder Prader-Willi Syndrome.

Soleno isn’t entirely clear about skipping this typical step in the NDA process; The regulator added that it would continue to consider the need for such a meeting while reviewing the request.

Either way, the FDA appears headed for a decision on DCCR in the very near future. The drug has been designated as a priority review by the healthcare industry regulator, with a target action date of December 27.

No guarantees, but…

These are not the only factors in favor of DCCR; in late April, the FDA granted the drug breakthrough therapy designation, a label that also tends to speed up the approval process. While an FDA approval is never guaranteed for any drug, no matter how solid its performance in the lab, the outlook for Soleno’s lead program looks excellent right now.