Welcome to our dedicated page for Soleno Therapeutics news (Ticker: SLNO), a resource for investors and traders seeking the latest updates and insights on Soleno Therapeutics stock.
News about Soleno Therapeutics, Inc. (NASDAQ: SLNO) centers on its work as a biopharmaceutical company developing and commercializing novel therapeutics for rare diseases, with a primary focus on Prader-Willi syndrome (PWS) and hyperphagia. Company press releases highlight clinical, regulatory, commercial, and corporate developments related to its first commercial product, VYKAT XR (diazoxide choline) extended-release tablets.
Readers following SLNO news can find updates on VYKAT XR, a once-daily oral treatment indicated for hyperphagia in adults and pediatric patients 4 years of age and older with PWS. News items include details of the Phase 3 clinical program, such as the randomized withdrawal study published in the Journal of Clinical Endocrinology and Metabolism, which Soleno reports supported FDA approval as the first treatment for hyperphagia in people living with PWS.
Soleno’s news flow also covers financial results and launch metrics for VYKAT XR, including product revenue from U.S. sales, patient start forms, prescriber adoption, coverage levels, and commentary on achieving profitability and positive cash flow. Investors can track announcements about preliminary and full-quarter results, conference call schedules, and corporate presentations.
Additional news topics include capital allocation and corporate actions, such as the Board-authorized $100 million accelerated share repurchase agreement, amendments to loan facilities, and Board and Audit Committee changes. The company also issues communications on safety and regulatory matters, including an 8-K describing a serious adverse event reported in the FDA’s FAERS database and Soleno’s assessment of that case.
For those monitoring SLNO, this news stream provides insight into Soleno’s rare disease strategy, the commercial trajectory of VYKAT XR in PWS, and key corporate and regulatory milestones disclosed through press releases and SEC-referenced communications.
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Soleno Therapeutics (NASDAQ: SLNO) announced that Jennifer Fulk will become Chief Financial Officer, succeeding James Mackaness who will retire by the end of Q1 2026 and serve as a consultant through year-end to support the transition.
Mrs. Fulk brings over two decades of public company finance experience, including 15 years at Eli Lilly and recent CFO roles; leadership is timed with the U.S. rollout of VYKAT™ XR and ongoing regulatory efforts in the EU and other territories.
Soleno (NASDAQ: SLNO) reported fourth-quarter 2025 product revenue of $91.7M and full-year product revenue of $190.4M from the U.S. launch of VYKAT XR. The company achieved profitability with $20.9M net income for 2025 and ended the year with $506.1M in cash and marketable securities.
Launch metrics through Dec 31, 2025: 1,250 patient start forms, 859 active patients, 630 unique prescribers, and coverage for over 185 million lives. The company invested $100M in an accelerated share repurchase program.
Soleno Therapeutics (NASDAQ: SLNO) will report fourth quarter and full-year 2025 financial results after market close on Wednesday, February 25, 2026.
The company will host a conference call and webcast at 4:30 PM ET to discuss results and operational highlights. A live dial-in, international line, conference ID 55257, and a webcast link will be provided. A replay will be available for 30 days on the company's website.
Soleno Therapeutics (NASDAQ: SLNO) will participate in three investor conferences in Feb–Mar 2026: Guggenheim Emerging Outlook: Biotech Summit, Oppenheimer 36th Annual Healthcare Life Sciences Conference, and TD Cowen 46th Annual Health Care Conference.
Presentations are scheduled Feb 12 (11:30 AM ET, fireside chat), Feb 26 (10:00 AM ET, company presentation) and Mar 4 (9:50 AM ET, fireside chat). Webcasts and replays will be available in the company’s Investors section at www.soleno.life.
Soleno Therapeutics (NASDAQ: SLNO) reported preliminary unaudited fourth-quarter and full-year 2025 results tied to the U.S. launch of VYKAT XR. Full-year 2025 net revenue is expected to be $189M–$191M, with fourth-quarter net revenue of $90M–$92M. Since launch through Dec 31, 2025 the company recorded 1,250 patient start forms (207 in Q4), representing ~12.5% of the U.S. addressable market, and 630 unique prescribers (136 new in Q4). Discontinuation due to adverse events was ~12%. Coverage exceeds 185 million lives (~60%). The company reported profitability and positive cash flow and year-end cash and marketable securities of ~$500M after a $100M accelerated share repurchase. Final audited results are expected in late February 2026.
Soleno Therapeutics (NASDAQ: SLNO) announced publication in the Journal of Clinical Endocrinology and Metabolism of results from a 16-week randomized withdrawal study (C602-RWP) of VYKAT XR (diazoxide choline extended-release) in people ≥4 years with hyperphagia in Prader-Willi syndrome (PWS).
The study randomized 77 participants (VYKAT XR n=38; placebo n=39). Withdrawal to placebo produced statistically significant worsening in hyperphagia (HQ-CT, P=0.0022). Placebo participants gained more weight (LS mean difference -1.6 kg; 95% CI -3.1, -0.1) and had larger BMI z-score increases (LS mean difference -0.09; 95% CI -0.17, -0.01). No serious adverse events occurred in the VYKAT XR arm.
Soleno Therapeutics (NASDAQ: SLNO) announced the passing of William G. “Bill” Harris on Dec. 3, 2025. Mr. Harris served on Soleno’s Board since June 2014 and was Chairman of the Audit Committee. The company praised his decades of biopharmaceutical finance experience and extended condolences to his family. Long-serving director Andrew Sinclair is expected to assume the Audit Committee chair and qualifies as an audit committee financial expert under SEC and Nasdaq rules.
Soleno Therapeutics (NASDAQ: SLNO) announced that Anish Bhatnagar, M.D., Chief Executive Officer will participate in a fireside chat at the Piper Sandler 37th Healthcare Conference on Thursday, December 4, 2025 at 9:00 AM ET.
A live audio webcast and replay will be available in the Investors section of the company website at www.soleno.life.
Soleno Therapeutics (NASDAQ: SLNO) entered an $100 million Accelerated Share Repurchase (ASR) with Jefferies on Nov 11, 2025, with an initial payment of $100 million and an initial delivery of ~1,511,553 shares based on the Nov 10, 2025 close. The final repurchased share count will be adjusted by the volume-weighted average price during the ASR term. The company said the ASR supports confidence after achieving profitability in Q3 2025. The ASR is expected to complete in Q1 2026.