FDA Approval Propels Soleno Therapeutics’ Stock Surge
Soleno Therapeutics (SLNO) secured a significant milestone with the approval of its extended-release drug, Vykat XR, designed to treat excessive hunger caused by Prader-Willi syndrome, a rare genetic disorder. This breakthrough approval led to a surge in Soleno’s stock, marking a critical achievement for the company.
The newly approved medication is expected to be available for patients aged four and above starting in April. RBC Capital Markets analyst Brian Abrahams highlighted the arduous journey Soleno underwent to demonstrate the drug’s effectiveness. The company had to conduct trials where patients were removed from the treatment to observe the return of extreme hunger symptoms, reinforcing Vykat XR’s impact. Following the announcement, Soleno’s stock soared by 37.6%, closing at 67.39 on Thursday, surpassing its buy point of 60.92 after a period of consolidation.
Addressing Prader-Willi Syndrome With A Costly Solution
Prader-Willi syndrome, affecting approximately 12,000 individuals in the U.S., is characterized by a persistent feeling of hunger along with mental, behavioral, and physical complications. Soleno plans to price Vykat XR at an annual cost of $486,000 for patients weighing between 40 and 65 kilograms, positioning the drug as a high-cost but potentially life-changing treatment.
While the approval was somewhat anticipated, Abrahams noted that Soleno’s path included challenges and mixed clinical data. The success of Vykat XR suggests the FDA is maintaining flexibility when working with companies developing treatments for orphan diseases, a category that includes rare conditions affecting small patient populations.
Aardvark Therapeutics Faces Setback Despite Future Prospects
Despite Soleno’s success, Abrahams believes Aardvark Therapeutics (AARD) may develop a superior alternative. Aardvark is currently testing ARD-101, a drug that may offer a better balance of benefits and risks compared to Vykat XR. Clinical trials for Soleno’s treatment raised concerns about potential side effects, such as hyperglycemia and excessive hair growth, which could discourage female patients from opting for the drug. Abrahams suggested that Vykat XR and ARD-101 could ultimately be used in combination to enhance treatment outcomes.
Initially, Aardvark’s stock reacted positively to Soleno’s approval, but by the end of the trading session, shares had dropped 5.5%, closing at 8.90. While Aardvark’s potential breakthrough remains in development, the market’s response highlights the uncertainty surrounding future competition in treatments for Prader-Willi syndrome.
