SLNO
Soleno Therapeutics, Inc.49.50
-0.45-0.9%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Reaffirms launch, details seasonality.
Q&A reinforced VYKAT XR's durable launch, clarifying 1,000 more start forms over 9-12 months without quarterly boluses, despite Q1 gross-to-net hits from co-pay resets and plan switches. Patient weights exceed trial averages at >500 mg/kg, refills hold firm as doses optimize, and efficacy-driven discontinuations stay low. Peak U.S. penetration could surpass 40-50% given no rivals. GSD1 dosing aligns with PWS but offers tolerability edge from fewer comorbidities. Management sidestepped EU risks but expects Day 180 questions soon. Confident tone prevails; watch active patients and EU verdict.
Key Stats
Market Cap
2.66BP/E (TTM)
-Basic EPS (TTM)
-1.75Dividend Yield
0%Recent Filings
8-K
Soleno launches $100M ASR
Soleno Therapeutics entered an ASR agreement with Jefferies on November 10, 2025, to repurchase $100 million of common stock, receiving 1,511,553 shares initially with final delivery by Q1 2026 based on VWAP less discount. Lenders amended the Oxford loan facility to permit the ASR but rendered $50 million in Term C/D loans uncommitted, leaving $100 million uncommitted too. Buyback signals confidence. Final shares hinge on market price.
8-K
Solen appoints seasoned CFO Hahn
Soleno Therapeutics bolstered its Board on October 13, 2025, appointing Mark W. Hahn as an independent director and Audit Committee member, expanding the board to seven. Hahn's 30 years as a biopharma CFO, including steering Verona Pharma's $10 billion sale to Merck and Dova's $915 million acquisition by Sobi, positions him to guide Soleno's commercial rollout of VYKAT XR for Prader-Willi syndrome hyperphagia. This addition sharpens financial oversight amid the product's post-FDA approval launch. Hahn received 10,046 RSUs vesting over three years.
8-K
Unrelated patient death disclosed
Soleno Therapeutics disclosed a serious adverse event in the FDA's FAERS database involving a 17-year-old male patient with Prader-Willi Syndrome who died from a pulmonary embolus on September 10, 2025. Both the treating physician and Soleno assessed the death as unrelated to VYKAT XR treatment, citing the patient's comorbidities like obesity and thrombophlebitis. Prader-Willi patients face reduced life expectancy, averaging 29.5 years. Soleno will comment on future events only if directly linked to VYKAT XR.
8-K
VYKAT XR launch update
Soleno Therapeutics is sharing its August 2025 corporate presentation during investor meetings on August 18-19, highlighting VYKAT XR's FDA approval on March 26, 2025, as the first treatment for hyperphagia in Prader-Willi syndrome patients aged 4 and older. The drug's Phase 3 trials showed significant hyperphagia reduction, backed by over 440 person-years of safety data, while pro forma cash stands at $509.5 million to fund the ongoing U.S. launch, which has reached 646 start forms and 295 new prescribers by Q2 end. VYKAT XR targets a $2 billion U.S. market. Yet risks loom from forward-looking uncertainties.
8-K
VYKAT XR launch yields $32.7M revenue
Soleno Therapeutics launched VYKAT XR on April 14, 2025, for hyperphagia in Prader-Willi syndrome patients, generating $32.7 million in net product revenue during Q2 despite a $4.7 million net loss. The company secured 646 patient start forms from 295 prescribers, covering over 100 million lives, while R&D expenses dropped to $9.1 million from $12.3 million year-over-year amid the commercial shift. VYKAT XR transforms PWS care. Contingent liabilities rose to $18.9 million on early sales momentum.
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