Shares of Soleno Therapeutics (SLNO 3.93%) were skyrocketing 39.8% higher as of 10:51 a.m. ET on Monday. The huge gain came after the clinical-stage biopharmaceutical company announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to diazoxide choline for treating adults and children ages 4 and older with Prader-Willi syndrome (PWS) who have hyperphagia (abnormally high appetite).
PWS is a rare genetic disorder that causes individuals to constantly eat because they don't feel full. It occurs in 1 in every 15,000 live births. Soleno reported positive top-line results in September 2023 from a late-stage study evaluating diazoxide choline in treating PWS.
Why Breakthrough Therapy Designation is a big deal for Soleno
The FDA only grants Breakthrough Therapy Designation to drugs that target a serious condition when preliminary clinical data shows the drug could offer a significant clinical benefit over currently available therapies. This designation is a big deal for Soleno because it means the FDA will expedite the review of diazoxide choline.
Soleno is busy getting its regulatory submission ready. It expects to file for FDA approval of diazoxide choline in mid-2024.
Is Soleno Therapeutics stock a buy?
There's no guarantee Soleno will win FDA approval for diazoxide choline, but its chances look pretty good at this point. I think this biotech stock remains a good pick for aggressive investors. Wall Street agrees, with the consensus 12-month price target for Soleno reflecting an upside potential of nearly 23%.
