Soleno’s rare disease drug off to brisk start following FDA nod

Soleno Therapeutics Inc. (NASDAQ: SLNO) marked a major breakthrough in the first quarter of 2025 with US regulatory approval for VYKAT XR, the first treatment available for hyperphagia—a chronic and life-threatening symptom—in patients with Prader-Willi syndrome (PWS). The extended-release tablet, formerly known as DCCR, was cleared by the FDA on March 26 for use in patients aged four and older. PWS is a rare genetic disorder that severely impacts appetite regulation and metabolism.

This is the first FDA approval for Soleno and the late-March approval meant VYKAT XR did not generate revenue in Q1. However, in its first-quarter earnings update, Soleno reported early momentum for VYKAT XR following its US launch on April 14. Between the launch and May 6, the company received 268 patient start forms and prescriptions from 131 different healthcare providers—signals of a strong initial uptake. The company plans to seek marketing approval in Europe with an EMA filing in the second quarter.

The second quarter will provide the first meaningful snapshot of VYKAT XR’s revenue potential. Consensus estimates from Visible Alpha forecast $4 million in Q2 sales, rising to $61.4 million for the full year. Annual revenue is estimated to climb to $268 million in 2026. Notably, analysts view the absence of a boxed warning, or patient exclusions based on severity of hyperphagia as a positive signal for broader market adoption. Sales are projected to reach $1.1 billion by 2029, with peak global sales forecast at $2 billion by 2032—before generic competition is expected to erode exclusivity.