REDWOOD CITY, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the appointment of Jennifer Fulk as Chief Financial Officer, succeeding James Mackaness, who announced that he will be retiring from the Company by the end of the first quarter. Mr. Mackaness will serve as a consultant to Soleno through the end of the year to ensure a smooth transition. Mrs. Fu ...

Soleno Therapeutics (NasdaqCM:SLNO) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsAnish Bhatnagar - Chairman and CEOBrian Ritchie - Managing DirectorBrian Skorney - Managing Director of BiotechnologyJim Mackaness - CFOKhalil Fenina - Equity Research Associate of BiotechnologyMeredith Manning - Chief Commercial OfficerMoritz Reiterer - Biotechnology Equity Research AssociateShannon Duffy - Biotech Equity Research AssociateConference Call ParticipantsDerek Archila - Managing Director ...

Soleno Therapeutics (NasdaqCM:SLNO) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsAnish Bhatnagar - Chairman and CEOBrian Ritchie - Managing DirectorBrian Skorney - Managing Director of BiotechnologyJim Mackaness - CFOKhalil Fenina - Equity Research Associate of BiotechnologyMeredith Manning - Chief Commercial OfficerMoritz Reiterer - Biotechnology Equity Research AssociateRam Selvaraju - Managing Director of Healthcare Equity ResearchShannon Duffy - Biotech Equity Research Associa ...

Soleno Therapeutics (NasdaqCM:SLNO) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Speaker1Good afternoon, thank you for standing by. Welcome to Soleno Therapeutics' fourth quarter and full year 2025 financial and operating results conference call and webcast. Currently, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. As a reminder, today's webcast is being recorded. I would now like to introduce Brian Ritchie of LifeSci Advisors. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No.: 001-36593 Soleno Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 77-0523891 (State or other Jurisdiction ...

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKAT™ XR (diazoxide choline) extended-release tablets. Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights Revenue, net, from the sale of VYKAT XR for the th ...

Core Viewpoint - Soleno Therapeutics (NASDAQ:SLNO) is identified as a promising biotechnology stock with significant upside potential, supported by positive analyst ratings and strong sales performance. Group 1: Analyst Ratings and Price Targets - Ram Selvaraju from H.C. Wainwright increased the price target for Soleno Therapeutics from $110 to $120, indicating an upside potential of nearly 211% and reaffirming a Buy rating [1] - Wells Fargo analyst Derek Archila maintained an Overweight rating and raised the price target from $106 to $114, suggesting a revised upside potential of 195% [3] Group 2: Financial Performance and Product Development - The fourth-quarter earnings for Vykat extended-release exceeded expectations, although new PSFs did not meet targets; management aims for approximately 250 new starts per quarter, excluding seasonal effects [4] - Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases, with its leading product being Diazoxide Choline Extended-Release tablets, VYKAT XR, which began commercialization in April 2025 following FDA approval [5]

Core Viewpoint - Soleno Therapeutics is currently not providing full-year guidance as it seeks to better understand its business dynamics, but management indicates that guidance may be offered in the future when more comfortable with the data [1] Group 1: Company Overview - Soleno Therapeutics is a commercial-stage company focused on rare diseases, specifically with an approved product for Prader-Willi syndrome (PWS), which is characterized by hyperphagia [3][18] - The company has been marketing its product for approximately three quarters [3] Group 2: Launch and Market Dynamics - The company expects to capture about 10% of the total addressable market (TAM), translating to approximately 1,000 start forms over a 9 to 12-month period, with variability from quarter to quarter [2][6] - The first-quarter report will be the last to disclose start-form metrics, after which the focus will shift to revenue and active patient reporting [2][6] Group 3: Reimbursement and Coverage - Reimbursement has exceeded expectations, with coverage through nearly 48 Medicaid programs and Medicare being a strong payer [5][14] - The prescriber base has grown to over 600, although many prescribers are new to PWS and require education on the drug [15] Group 4: Patient Conversion and Revenue - Start forms typically convert to active patients within 30 to 45 days, with a single-digit cancellation rate and overall discontinuation around 15% to 20% [6][8] - Revenue is primarily driven by active paid patients, adherence, wholesale acquisition cost (WAC), and gross-to-net dynamics [8] Group 5: International Regulatory Progress - The company is progressing with its European regulatory review, expecting Day 180 questions by the end of February for a patient pool of approximately 9,500 in the EU4 plus the UK [5][16] - Soleno is building its European team and is considering direct market engagement while also exploring partnerships [16] Group 6: Future Plans and Capital Deployment - Capital deployment priorities include supporting U.S. and international launches, pursuing additional indications for its product, and evaluating inorganic growth opportunities, though significant deals are not anticipated in the short term [17]

Summary of Soleno Therapeutics Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM:SLNO) - **Industry**: Rare Disease Biopharmaceuticals - **Product**: First approved treatment for Prader-Willi syndrome (PWS), a genetic disorder characterized by hyperphagia, with no prior treatments available [5][38] Key Points and Arguments Market Position and Growth Expectations - Soleno currently holds approximately **10%** of the total addressable market (TAM) with a target of reaching another **10%** over the next **9-12 months**, equating to about **250 Start Forms** per quarter [7][12] - The company anticipates moving from Start Forms to traditional metrics of revenue and active patients after the first quarter of 2026 [10] - The expectation is that the holiday variability seen in the previous quarter will not recur, as there are no major holidays in the current quarter [8] Patient Flow and Revenue Generation - The process for Start Forms involves a **30-45 day** assessment period through their specialty pharmacy partner, Panther, with a small percentage of forms being canceled [14] - The discontinuation rate for patients is expected to stabilize between **15%-20%**, which is considered healthy for a rare disease context [15][24] - Active patient revenue is driven by a combination of paid and free patients, with adherence impacting overall revenue [17][18] Financial Guidance and Revenue Trends - Soleno is not providing full-year guidance for 2026 as the business is still maturing [11] - The company expects a **seasonal increase** in Gross to Net discounts in the first quarter due to resets in copay and potential changes in patient coverage [20][21] - The overall discontinuation rate as of the fourth quarter was approximately **15%**, with **12%** being adverse event-related [23] Clinical and Market Insights - Adverse events (AEs) reported in the real-world setting are consistent with those observed in clinical trials, primarily non-serious [26] - Most patients are titrating to their prescribed doses, with a few exceptions due to comorbidities [27][28] - The average wholesale acquisition cost (WAC) is currently in the **$500,000s**, with expectations of gradual increases over the next few years [31][32] Market Expansion and Reimbursement - Soleno has coverage for approximately **185 million lives**, with expectations for this number to increase as reimbursement policies improve [42] - The company is experiencing a favorable reimbursement environment, with no significant issues reported regarding prior authorizations [44] - There is a growing number of prescribers, with over **600** currently, which exceeds initial expectations [41] International Opportunities - The company is preparing for potential CHMP approval in Europe, with an estimated patient population of **9,500** in the EU and UK [47] - Soleno is considering launching the product independently in Europe while also exploring partnership opportunities [49] Capital Deployment Strategy - Soleno plans to focus on sustaining the success of its launch and exploring other indications, while also considering inorganic growth opportunities [50] Additional Important Insights - The company acknowledges the challenges of educating prescribers unfamiliar with PWS and the drug, which is crucial for improving treatment outcomes [45] - There is a noted social aspect influencing patient adherence and return to treatment, as positive patient experiences are shared within the community [34] This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting Soleno Therapeutics' current market position, growth expectations, and operational strategies in the rare disease sector.

Core Viewpoint - Soleno Therapeutics, Inc. is set to report its fourth quarter and full-year 2025 financial results on February 25, 2026, along with operational highlights, followed by a conference call to discuss these results and business updates [1]. Group 1: Financial Reporting - The financial results will be announced after the close of U.S. financial markets on February 25, 2026 [1]. - A conference call and webcast will take place at 4:30 PM Eastern Time to discuss the results [1][2]. Group 2: Company Overview - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [3]. - The company's first commercial product is VYKAT XR (diazoxide choline) extended-release tablets, which is a once-daily oral treatment for hyperphagia in individuals with Prader-Willi syndrome aged 4 years and older [3].