Soleno Pharma (SLNO) Pops 40% on FDA Approval
Shares of Soleno (SLNO) have gapped up and are rallying to new all-time highs today on news that the FDA approved its first commercial drug.
The company’s drug, extended-release tablets with the commercial name Vykat XR, used to treat abnormally strong hunger tied to Prader-Willi syndrome, should be available to patients ages four and older starting in early April.
We’ve been holding on to SLNO for over a year. We jumped in in January 2024. And it’s been a journey to say the least. Things were going well with the drug on track to be approved, then there was a delay as the FDA required that trial patients go off the drug to prove that their hunger would return.
I’d like to say I KNEW it would be approved eventually. But of course, FDA approvals are never a certainty, though this one seemed like an eventuality. Glad it came through.
Management says it will charge about $486K a year for patients that weigh 88 to 143 lbs. Dosing is based on weight. I believe that pricing is higher than expected.
Following approval, there have been a number of price target upgrades, and some notes on competition, with Aardvark (AARD), a recent IPO, getting a little attention given its drug candidate, ARD-101, is rumored to work as well with fewer side effects (it’s not approved, yet). Something to watch there.
Baird has taken its price target to 102 and Cantor Fitzgerald has gone to 123.
SLNO is trading up around 40% today to roughly 70. These new price targets imply a lot more upside.
The biggest near-term risk is that Soleno will raise equity to help support a commercial rollout. But the company finished 2025 with $380 million in cash and in February said that is enough to help them “execute their strategy.” An equity raise seems unlikely, though not out of the realm of possibilities. More money in the bank is always better.
Revenue estimates are just starting to be updated. Looks like the consensus is around $35 million this year and $232 million in 2025.
This is a nice win for us, though I’m not yet ready to take profits, yet. We’re up around 55%. Let’s continue to sit on SLNO and see what happens. HOLD HALF
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