Soleno Therapeutics (NASDAQ: SLNO) had some good news to report on the regulatory front on Tuesday. Investors were cheered by this as evidenced by their sending the biotech's stock more than 9% higher in price on the day. This performance was much better than that of the closely watched S&P 500 index, which closed up by less than 1%.
Skipping ahead in the review process?
Before market open that day, Soleno reported that the U.S. Food and Drug Administration's (FDA) review division determined there was no need for an advisory committee meeting on a crucial submission from the company, at least for now. This is a new drug application (NDA) for the company's diazoxide choline (DCCR) tablets aimed at the treatment of genetic disorder Prader-Willi Syndrome.
Soleno isn't entirely in the clear to skip this typical step in the NDA process; the regulator added that it would continue to consider the need for such a meeting while it reviews the application.
Either way, the FDA seems 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 this coming Dec. 27.
No guarantees, but...
These are not the only factors in DCCR's favor; in late April, the FDA granted the drug its breakthrough-therapy designation, a tag that also tends to hasten the approval process. While an FDA nod is never guaranteed for any medication, no matter how solid its performance in the lab, the prospects for Soleno's leading program look excellent at the moment.
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