SOLENO THERAPEUTICS INC
SLNO evidence brief
What we can confirm
What it means
What to watch
Prepared research question
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Traceable citations · Unknowns marked
BioSniper AI · SLNO
Soleno Therapeutics is a biopharmaceutical company focused on developing and commercializing VYKAT XR (diazoxide choline extended-release) for Prader-Willi syndrome, having achieved FDA approval and initial revenue in 2025.
Key risk: Single product revenue concentration
BioSniper Score
Based on 5 of 6 signals
Market Cap
$2.76B
Cash Runway
—
Lead Asset
dccr (BLA Filed)
Next Catalyst
—
Financial data as of Mar 31, 2026.
Tracking 2 pipeline candidates · 4 clinical trials · 1 FDA decision for SOLENO THERAPEUTICS INC.
Soleno Therapeutics is a biopharmaceutical company focused on developing and commercializing VYKAT XR (diazoxide choline extended-release) for Prader-Willi syndrome, having achieved FDA approval and initial revenue in 2025.
- Received FDA approval for VYKAT XR (diazoxide choline extended-release) for Prader-Willi syndrome in individuals four years and older with hyperphagia, with first prescriptions delivered in April 2025 [sec_mda · as of 2026-05-07].
- Reported net income of $31.4 million for the three months ended March 31, 2026, and cash & equivalents of $133.0 million as of March 31, 2026 [sec_mda · as of 2026-05-07].
- Achieved $100 million and $200 million cumulative revenue milestones in Q4 2025 and Q1 2026, respectively, triggering contingent payments [sec_mda · as of 2026-05-07].
- Entered into a merger agreement to become a wholly-owned subsidiary of Neurocrine, expected to close during the three months ending June 30, 2026 [sec_mda · as of 2026-05-07].
What works
- VYKAT XR is the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome, addressing a significant unmet medical need [sec_mda · as of 2026-05-07].
- The company achieved profitability in 2025, with net income of $31.4 million in Q1 2026, demonstrating commercial execution [sec_mda · as of 2026-05-07].
- Strong cash position of $133.0 million plus $396.0 million in marketable securities as of March 31, 2026, provides financial flexibility [sec_mda · as of 2026-05-07].
What to weigh
- The company had an accumulated deficit of $400.0 million as of March 31, 2026, reflecting historical losses prior to 2025 [sec_mda · as of 2026-05-07].
- The pending acquisition by Neurocrine introduces execution risk and uncertainty regarding the company's standalone future [sec_mda · as of 2026-05-07].
- Revenue concentration on a single product (VYKAT XR) exposes the company to commercial and competitive risks [sec_mda · as of 2026-02-25].
From the filings
Quoted directly from source documents.
FDA approval and initial commercialization of VYKAT XR
“With FDA approval of VYKAT XR and first prescriptions being delivered in April 2025, the Company began recognizing revenue and became profitable during 2025.”
SEC MD&A · May 7, 2026
Merger agreement with Neurocrine
“6 and is expected to close during the three months ending June 30, 2026, pursuant to the terms of the Merger Agreement, with the result being the Company becoming a wholly-owned subsidiary of Neurocrine.”
SEC MD&A · May 7, 2026
Cumulative revenue milestones achieved
“milestone of $100 million in cumulative revenue in our fourth quarter 2025 and subsequently paid $4.0 million during the three months ended March 31, 2026 and recorded $2.9 million for the remainder in accounts payable. We achieved the second and final commercial milestone of $200 million in cumulative revenue in our first quarter 2026.”
SEC MD&A · May 7, 2026
Risks & what to watch (4)›
Key risks
- Single product revenue concentration — VYKAT XR is the sole revenue-generating product; any commercial setback would materially impact financials [sec_mda · as of 2026-02-25].
- Pending acquisition execution risk — The merger with Neurocrine may face delays or regulatory hurdles, creating uncertainty for shareholders [sec_mda · as of 2026-05-07].
- Accumulated deficit and historical losses — Despite recent profitability, the company carries a $400M accumulated deficit, indicating past financial strain [sec_mda · as of 2026-05-07].
- Competitive and market risks — The rare disease market is competitive; changes in payer dynamics or new therapies could affect VYKAT XR uptake [sec_mda · as of 2026-02-25].
What to watch
- Closing of the merger with Neurocrine, expected by June 30, 2026 [sec_mda · as of 2026-05-07].
- Quarterly revenue growth and profitability trends for VYKAT XR [sec_mda · as of 2026-05-07].
- Any updates on regulatory or commercial milestones for VYKAT XR in additional indications or geographies [sec_mda · as of 2026-02-25].
Sources: SEC filings · SEC MD&A · Generated August 14, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
Profitable (positive operating cash flow)
D/E 0.23 · 2% dilution
Lead: Approved
2 candidates
No upcoming catalysts tracked
0 buys · 6 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
224
Total value held
$2.08B
| Holder | Shares | Value |
|---|---|---|
| janus henderson group plc | 7,247,163 | $242.6M |
| fmr llc | 5,788,410 | $193.8M |
| wellington management group llp | 4,426,781 | $148.2M |
| vanguard capital management llc | 4,306,436 | $144.2M |
| blackrock, inc. | 3,742,774 | $125.3M |
| state street corp | 2,680,802 | $89.8M |
| woodline partners lp | 2,224,208 | $74.5M |
| polar capital holdings plc | 1,698,855 | $56.9M |
| caption management, llc | 1,589,343 | $53.2M |
| susquehanna international group, llp | 1,567,977 | $52.5M |
Showing top 10 of 224 institutional holders of SOLENO THERAPEUTICS INC. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 17.9%
- Days to cover
- 1.0
- Shares short
- 6,526,389
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
SLNO short interestGovernance
Frequently asked questions
What is the AI investment thesis for SOLENO THERAPEUTICS INC?
Soleno Therapeutics is a biopharmaceutical company focused on developing and commercializing VYKAT XR (diazoxide choline extended-release) for Prader-Willi syndrome, having achieved FDA approval and initial revenue in 2025.
What is SOLENO THERAPEUTICS INC's lead drug candidate?
SOLENO THERAPEUTICS INC's most advanced tracked candidate is dccr (BLA Filed) for Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.
Who is the CEO of SOLENO THERAPEUTICS INC?
Dr. Anish Bhatnagar M.D. is the chief executive officer of SOLENO THERAPEUTICS INC (SLNO).
Where is SOLENO THERAPEUTICS INC headquartered?
SOLENO THERAPEUTICS INC (SLNO) is headquartered in Redwood City, CA, United States.
What therapeutic areas does SOLENO THERAPEUTICS INC focus on?
SOLENO THERAPEUTICS INC develops therapies across Rare Disease.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.