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Soleno Therapeutics, Inc. (SLNO) Targets EMA Approval as U.S. Launch of VYKAT XR Expands
Yahoo Finance· 2025-09-18 14:38
In this article, we will be taking a look at the 13 Most Oversold Healthcare Stocks So Far in 2025. Soleno Therapeutics, Inc. is one of them. Soleno Therapeutics, Inc. (NASDAQ:SLNO) tops our list for being one of the most oversold stocks. It is a clinical-stage biotech focused on rare diseases and has seen significant stock volatility in 2025 following the commercial launch of its lead product, VYKAT XR, the first FDA-approved treatment for hyperphagia in Prader-Willi Syndrome (PWS). The therapy addresses ...
SLNO Investor News: If You Have Suffered Losses in Soleno Therapeutics, Inc. (NASDAQ: SLNO), You Are Encouraged to Contact The Rosen Law Firm About Your Rights
Globenewswire· 2025-09-10 16:37
Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Soleno Therapeutics, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Investigation and Class Action - Shareholders who purchased Soleno Therapeutics securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to Soleno Therapeutics [2]. Group 2: Stock Performance and Concerns - On August 15, 2025, Soleno Therapeutics' stock fell 7.4% following a short report from Scorpion Capital that raised serious concerns about its treatment for Prader-Willi syndrome, VYKAT XR [3]. - The Scorpion Capital report highlighted personal safety issues and suggested that the drug might face withdrawal from the market or a significant decline in new prescriptions [3]. - The stock experienced an additional decline of 4.9% on the next trading day after the initial drop [3]. Group 3: Rosen Law Firm's Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been ranked in the top 4 for securities class action settlements since 2013 and recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4]. - Founding partner Laurence Rosen was recognized as a Titan of Plaintiffs' Bar by Law360 in 2020, and many attorneys at the firm have received accolades from Lawdragon and Super Lawyers [4].
Here’s Why Analysts are Bullish on Soleno Therapeutics (SLNO)
Yahoo Finance· 2025-09-10 04:59
Company Overview - Soleno Therapeutics, Inc. (NASDAQ:SLNO) is recognized as one of the best stocks to buy for the next three months according to hedge funds [1] - The company specializes in developing and commercializing novel treatments for rare diseases [3] Recent Developments - The company announced the commercial launch of VYKAT XR, the first FDA-approved treatment for hyperphagia in Prader-Willi Syndrome [2] - Since the approval, Soleno has received 646 patient start forms from 295 unique prescribers, covering over 100 million insured lives in the US [2] - Soleno is also pursuing marketing approval for VYKAT XR in the European Union through the European Medicines Agency [2] - The company has presented clinical data at major medical conferences to enhance awareness regarding the drug's safety and efficacy [2] Analyst Ratings - Analysts have shown a bullish outlook on the stock, with TD Cowen analyst Tyler Van Buren maintaining a Buy rating and a price target of $120 [3] - Oppenheimer's Leland Gershell also reiterated a Buy rating with a price target of $110 [3]
Rosen Law Firm Encourages Soleno Therapeutics, Inc. Investors to Inquire About Securities Class Action Investigation - SLNO
Prnewswire· 2025-09-05 18:49
Accessibility StatementSkip Navigation NEW YORK, Sept. 5, 2025 /PRNewswire/ -- Why:Â Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Soleno Therapeutics, Inc. (NASDAQ: SLNO) resulting from allegations that Soleno Therapeutics may have issued materially misleading business information to the investing public. So What: If you purchased Soleno Therapeutics securities you may be entitled to compensation without payment of ...
Soleno Therapeutics(SLNO) - 2025 FY - Earnings Call Transcript
2025-09-04 18:32
Financial Data and Key Metrics Changes - The company received FDA approval for its first drug, VYKAT XR, for Prader-Willi syndrome at the end of March, followed by a successful launch with 646 start forms and 295 prescribers in the first three months, exceeding expectations [4][10] - The discontinuation rate for adverse events was about 5.2%, which is consistent with the clinical trial population, indicating a surprisingly low rate compared to typical transitions from clinical to commercial settings [18][21] Business Line Data and Key Metrics Changes - The launch of VYKAT XR has shown strong initial uptake, with a significant number of prescribers and start forms, indicating a positive reception in the market [4][26] - The patient demographic has shifted, with a majority of new patients being between 4 and 26 years of age, and they are somewhat heavier than the clinical trial population, which may lead to more comorbidities [15][30] Market Data and Key Metrics Changes - The total addressable market (TAM) in the U.S. is estimated at 10,000 patients, with about 12,500 patients identified based on claims analysis [34] - In Europe, the prevalence of Prader-Willi syndrome is similar to that in the U.S., with an estimated 9,000 patients, and the company is expecting a year for approval following its filing in early May [38][39] Company Strategy and Development Direction - The company aims to maintain a strong commercial focus on the launch of VYKAT XR while exploring potential partnerships for European commercialization [41] - There is an emphasis on lifecycle management and patent protection, with several families of patents in place to extend the product's market exclusivity [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's safety profile and the ongoing education of healthcare providers regarding patient monitoring and titration [16][17] - The company anticipates a slow and steady increase in patient uptake over time, rather than exponential growth, as the market stabilizes [25][26] Other Important Information - The company has a strong cash position of over $500 million, which supports its operational and expansion plans [55][56] - There is ongoing development of marketing materials and educational resources for healthcare providers and families to ensure proper drug administration and monitoring [17] Q&A Session Summary Question: What are the early efficacy and safety observations from patients on VYKAT XR? - Management noted that while the safety profile remains similar to clinical trials, some patients with more comorbidities have experienced more severe side effects [6][7] Question: How is the physician community responding to the drug? - The embrace of the drug is evident, with a high number of prescribers and positive feedback from key opinion leaders [12] Question: What is the expected trajectory for the drug's launch? - Management indicated that while initial numbers are strong, they expect a more moderate growth rate moving forward [25][26] Question: What is the company's strategy regarding European commercialization? - The company is considering both self-commercialization and potential partnerships, with ongoing hiring and market development in Europe [41] Question: How does the company view the competitive landscape for Prader-Willi syndrome treatments? - Management believes there is room for multiple treatments in the market, as no single drug will work for all patients [44] Question: What is the company's approach to intellectual property and lifecycle management? - The company has multiple patent families in place and is actively pursuing additional options for IP protection [51][52]
Soleno Therapeutics(SLNO) - 2025 FY - Earnings Call Transcript
2025-09-04 18:30
Financial Data and Key Metrics Changes - Soleno Therapeutics received FDA approval for its first drug, VYKAT XR, for Prader-Willi syndrome at the end of March 2025, with a successful launch shortly thereafter [4] - In Q2, the company reported 646 start forms and 295 prescribers, exceeding expectations [4][10] - The discontinuation rate for adverse events was about 5.2%, which is consistent with the clinical trial population [18] Business Line Data and Key Metrics Changes - The launch of VYKAT XR has been successful, with a significant number of prescribers and start forms indicating strong initial uptake [4][10] - The patient population primarily consists of younger individuals aged 4 to 26, who are heavier than those in clinical trials, leading to potential challenges in monitoring [14][15] Market Data and Key Metrics Changes - The total addressable market (TAM) for Prader-Willi syndrome in the U.S. is estimated at 10,000 patients, with 12,500 patients identified based on claims analysis [36] - In Europe, the prevalence of Prader-Willi syndrome is similar to that in the U.S., with an estimated 9,000 patients across the EU4 plus the UK [40] Company Strategy and Development Direction - The company aims to maintain a strong commercial focus on the launch of VYKAT XR while exploring potential partnerships for European commercialization [43][55] - Soleno Therapeutics is open to exploring additional assets or mechanisms of action (MOAs) related to Prader-Willi syndrome in the future [54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's safety profile and the ongoing education of healthcare providers regarding monitoring and titration [16][17] - The company anticipates a slow and steady increase in patient uptake over time, rather than exponential growth [27][28] Other Important Information - The company has a robust intellectual property (IP) strategy, with multiple patent families and potential extensions into the late 2030s [52] - Management highlighted the importance of long-term safety data, which provides a competitive advantage over new entrants in the market [48][49] Q&A Session Summary Question: What is the launch trajectory for VYKAT XR? - Management indicated that while initial uptake has been strong, it is not sustainable at the same rate, and a moderate growth trajectory is expected [27][28] Question: How is the physician community responding to VYKAT XR? - The embrace of the drug is significant, with many prescribers being previously unknown to the company, indicating a broad acceptance [12] Question: What are the expectations for payer coverage and reauthorizations? - Currently, there have been no reauthorizations, and the focus will be on whether the drug is effective for patients [22][23] Question: What is the competitive landscape for Prader-Willi syndrome treatments? - Management believes there is room for multiple treatments in the market, as no single drug will work for everyone [44][45] Question: What is the company's strategy regarding commercialization in Europe? - The company is considering both self-commercialization and potential partnerships, with ongoing discussions in this area [43] Question: How does the company plan to manage its cash and commercial footprint? - The company is well-capitalized with over $500 million in cash, allowing for continued investment in the launch and potential expansion [56][57]
Soleno Therapeutics Provides Update on U.S. Launch of VYKAT(TM) XR and Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-06 20:01
Soleno used $12.6 million of cash in its operating activities during the three months ended June 30, 2025, and had $293.8 million of cash, cash equivalents and marketable securities as of the end of the quarter. Cash as of the end of the second quarter excludes $230 million of gross proceeds that the company raised in July through an underwritten offering of common stock. Product revenue, net was $32.7 million for the three months ended June 30, 2025. VYKAT XR had not been approved or commercially launched ...
Soleno Therapeutics Announces Pricing of $200 Million Public Offering of Common Stock
Globenewswire· 2025-07-10 13:07
Core Viewpoint - Soleno Therapeutics, Inc. has announced a public offering of 2,352,941 shares of common stock priced at $85.00 per share, aiming to raise approximately $200 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 2,352,941 shares, with an additional 30-day option for underwriters to purchase up to 352,941 more shares at the same price [1]. - The offering is expected to close on or about July 11, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds will primarily fund the commercialization of VYKAT XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Additional proceeds will support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3]. Group 3: Underwriters - Goldman Sachs & Co. LLC, Guggenheim Securities, TD Cowen, Cantor, and Oppenheimer & Co. are serving as joint book-running managers for the offering [2]. Group 4: Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product aimed at treating hyperphagia in individuals aged 4 and older with Prader-Willi syndrome [6].
Soleno Therapeutics Announces Two Presentations Featuring VYKAT(TM) XR in Prader-Willi Syndrome at ENDO 2025
Globenewswire· 2025-07-01 12:00
Core Insights - Soleno Therapeutics, Inc. announced the selection of two abstracts for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) regarding VYKAT™ XR (diazoxide choline) extended-release tablets, aimed at treating hyperphagia in individuals with Prader-Willi syndrome [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [10] - VYKAT XR was approved by the U.S. FDA on March 26, 2025, and is now available for patients in the U.S. [3] Product Information - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3] - The product's safety information includes contraindications for patients with known hypersensitivity to diazoxide or thiazides [4] Presentation Details - The first presentation at ENDO 2025 will focus on the glycemic outcomes of VYKAT XR in treating hyperphagia over four years [2] - The second presentation will characterize peripheral edema in individuals with Prader-Willi syndrome during long-term administration of VYKAT XR over 4.5 years [6] Health Implications - Prader-Willi syndrome is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [2] - The treatment with VYKAT XR aims to address the life-threatening aspects of hyperphagia and improve the quality of life for affected individuals [2]
Soleno Therapeutics Highlights New Data on VYKAT(TM) XR at the 2025 United in Hope: International Prader-Willi Syndrome Conference
Globenewswire· 2025-06-25 12:00
Core Insights - Soleno Therapeutics presented new data on VYKAT XR (diazoxide choline) extended-release tablets at the 2025 International Prader-Willi Syndrome Conference, highlighting its potential benefits for individuals with Prader-Willi Syndrome (PWS) [1][2] Group 1: Efficacy of VYKAT XR - VYKAT XR significantly reduces hyperphagia symptoms in PWS patients managed with strict food controls, showing statistically significant reductions in HQ-CT Total scores (p ≤ 0.0001) [5] - Participants in highly food-restricted environments benefited from VYKAT XR treatment similarly to those in less restricted environments, indicating broad applicability of the treatment [5] Group 2: Safety and Efficacy in Co-Morbid Conditions - 60% of study participants had evidence of pre-diabetes or diabetes (PD/DM) at baseline, with efficacy outcomes at Week 156 showing similar results for both PD/DM and normoglycemic groups (p<0.0001) [7] - Although a higher proportion of hyperglycemia-related adverse events were reported in the PD/DM group (42.7% vs 24.0%), these events were generally manageable, and treatment discontinuation rates were low (4.0% in PD/DM vs 6.0% in normoglycemic) [8][9] Group 3: Background on Prader-Willi Syndrome - Prader-Willi Syndrome is a rare genetic neurodevelopmental disorder affecting approximately 1 in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [10][11] - Hyperphagia in PWS can result in significant mortality and long-term co-morbidities such as diabetes, obesity, and cardiovascular disease [12] Group 4: Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in adults and pediatric patients aged 4 years and older with PWS [13][18]