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.
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.
Soleno Therapeutics (NASDAQ: SLNO) reported third quarter 2025 results and a U.S. launch update for VYKAT XR on November 4, 2025. Key highlights: Q3 product revenue $66.0M, net income $26.0M for the quarter, and $556.1M in cash, cash equivalents and marketable securities as of September 30, 2025 (includes $230M gross proceeds raised in July). From FDA approval on March 26, 2025 through Sept 30, 2025: 1,043 patient start forms, 764 active patients, and 494 unique prescribers. Q3 product revenue rose >100% sequentially vs Q2. Company noted contingent consideration fair value of $19.5M tied to commercial milestones.
Soleno Therapeutics (NASDAQ: SLNO) announced participation in three investor conferences in November 2025 with dates, times, formats, and webcast availability.
Events: Guggenheim Securities Healthcare Innovation Conference on Nov 11, 2025 at 9:00 AM ET (fireside chat); Stifel 2025 Healthcare Conference on Nov 12, 2025 at 8:40 AM ET (fireside chat); and Jefferies London Healthcare Conference on Nov 18, 2025 at 5:00 PM GMT (presentation). Replays will be posted in the investor section at www.soleno.life.
Soleno Therapeutics (NASDAQ: SLNO) will report third quarter 2025 financial results and operational highlights after the U.S. market close on Tuesday, November 4, 2025.
The company will host a live conference call and webcast at 4:30 PM Eastern Time on that date. Dial-in numbers are 1-800-717-1738 (U.S.) and 1-646-307-1865 (international) with Conference ID 48794. A webcast will be available on the company website and replayable for 30 days.
Soleno Therapeutics (NASDAQ: SLNO) announced the appointment of biopharmaceutical finance executive Mark W. Hahn to its Board of Directors and as a member of its Audit Committee, increasing the Board to seven members.
Mr. Hahn brings nearly 30 years of CFO-level experience across life sciences companies, including roles that covered product launches, financings and M&A. His background includes serving as CFO of Verona Pharma through its phase 3 program and launch and its acquisition by Merck for approximately $10 billion (Oct 2025), and as CFO of Dova Pharmaceuticals through its sale for up to $915 million (Nov 2019). Soleno noted the hire aligns with its ongoing commercial launch of VYKAT™ XR and named Mr. Hahn as Audit Committee member.
Soleno Therapeutics (NASDAQ: SLNO), a biopharmaceutical company focused on rare disease therapeutics, has announced its participation in five major healthcare investor conferences during September 2025.
The company will present at the Cantor Global Healthcare Conference (Sept 3), Wells Fargo Healthcare Conference (Sept 4), H.C. Wainwright Global Investment Conference (Sept 8), Baird Global Healthcare Conference (Sept 9), and Bernstein Healthcare Forum (Sept 25). All presentations will be in fireside chat format.
Webcasts for the Cantor and Wells Fargo events will be available for replay on Soleno's website.
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