Company Overview - Soleno Therapeutics, Inc. (NASDAQ: SLNO) specializes in rare diseases, particularly focusing on Prader-Willi Syndrome (PWS) hyperphagia, a condition characterized by insatiable hunger that significantly impacts patients' quality of life [1]. Drug Candidate - The company’s leading drug candidate, DCCR, has shown effectiveness in reducing hunger associated with PWS, addressing a critical unmet medical need as there are currently no approved treatments for this condition [1].

Company Overview - Soleno Therapeutics (SLNO) shares increased by 9.1% on Tuesday and an additional 4.1% in after-market trading following a positive regulatory update regarding its new drug application (NDA) for DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi syndrome (PWS) [1] - The FDA's Review Division indicated that an advisory committee meeting is not currently necessary for the DCCR NDA, although the need for one may be reassessed during the review process [2] Product Details - DCCR is a proprietary, once-daily extended-release formulation containing diazoxide choline, which is not yet approved for PWS but is used for treating certain rare diseases [3] - The NDA for DCCR is under the FDA's Priority Review pathway, which shortens the review period to four months, with a final decision expected by December 27, 2024 [3] Market Context - Approximately one in every 15,000 newborns is affected by PWS, with hyperphagia being the most common symptom, leading to serious long-term health issues [5] - There are currently no approved treatments addressing hyperphagia or other aspects of PWS, highlighting a significant unmet medical need [6] Competitive Landscape - Acadia Pharmaceuticals has introduced a new candidate, carbetocin nasal spray, for treating hyperphagia associated with PWS, which was acquired through the purchase of Levo Therapeutics [6] - A previous study indicated that carbetocin showed a statistically significant reduction in hyperphagia-related behaviors, leading to the initiation of a pivotal phase III study by Acadia in late 2023 [7] Regulatory Designations - Soleno has secured extensive patent protection for the use of diazoxide, diazoxide choline, and DCCR in PWS patients, with DCCR receiving Breakthrough, Fast Track, and Orphan Drug designations from the FDA [4]

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Core Insights - Soleno Therapeutics (SLNO) experienced a stock price increase of 9.11%, significantly outperforming the S&P 500 index, which gained less than 1% [1] Regulatory Developments - The FDA announced that it will not require an advisory committee meeting for the New Drug Application (NDA) for diazoxide choline (DCCR) tablets, aimed at treating Prader-Willi Syndrome, indicating a potentially smoother approval process [2] - The FDA's decision regarding the drug is expected by December 27, benefiting from priority review status and breakthrough-therapy designation [2] Financial Analysis - The current stock price of Soleno Therapeutics is $51.97, reflecting recent price appreciation [3] - Despite the positive stock performance, there are warning signs such as insider selling and a low Piotroski F-Score, which typically indicates poor business operations [3] - The company maintains strong financial health with sufficient cash to cover its debt, contributing to a stable financial situation [3] Valuation Insights - Soleno's GF Value cannot be evaluated due to insufficient data [4] - The stock is near its three-year high, and the potential for expedited FDA approval presents a consideration for investors to balance regulatory news against existing financial risks and warning signs [4]

Core Insights - Soleno Therapeutics is nearing FDA approval for its Prader-Willi treatment, leading to a stock price increase of over 9% [1] - The FDA has determined that an advisory committee meeting is not currently needed for Soleno's new drug application for diazoxide choline (DCCR) [2] - The FDA is expected to make a decision on DCCR by December 27, as it has been designated for priority review [3] - DCCR has received breakthrough therapy designation from the FDA, which may expedite the approval process [4]

PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ("Soleno") (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in indi ...

Core Points - Soleno Therapeutics has submitted a New Drug Application (NDA) to the FDA for DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi syndrome (PWS) in individuals aged four years and older who experience hyperphagia [12] - The FDA has 60 days to determine if the NDA will be accepted for review, with Soleno requesting Priority Review, which would target a six-month review period post-acceptance [2] Company Overview - Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [12] - The company has established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline, and DCCR in individuals with PWS [9] Product Information - DCCR is a proprietary extended-release dosage form of diazoxide choline, administered once daily, and has been used in other rare diseases but is not yet approved for PWS [9] - The development program for DCCR is supported by data from five completed Phase 1 clinical studies and three Phase 2 studies, including one involving individuals with PWS [9] Disease Context - Prader-Willi syndrome is estimated to occur in one in every 15,000 live births, characterized by hyperphagia, behavioral problems, cognitive disabilities, and other serious health issues [5] - There are currently no approved therapies to address the hyperphagia and other symptoms associated with PWS, highlighting the unmet medical need [5]

Core Viewpoint - The submission of the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets to the FDA represents a significant advancement for Soleno Therapeutics and individuals with Prader-Willi syndrome (PWS) [1][6]. Group 1: Company Overview - Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [10]. - The company has submitted an NDA for DCCR, which is a once-daily oral tablet aimed at treating PWS [10]. Group 2: Product Information - DCCR is designed to treat hyperphagia, a life-threatening symptom of PWS, and has received Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation for PWS in both the U.S. and E.U. [7][9]. - The development program for DCCR is supported by data from five completed Phase 1 clinical studies and three completed Phase 2 clinical studies, including one involving individuals with PWS [9]. Group 3: Market Context - PWS occurs in approximately 1 in every 15,000 live births, with hyperphagia being the hallmark symptom that severely impacts the quality of life for affected individuals and their families [8]. - There are currently no approved therapies to address the hyperphagia, metabolic, cognitive, or behavioral aspects of PWS [8].

The independent members of the Board of Directors of Soleno approved the grant of non-qualified stock options to purchase 247,200 shares of common stock to eight employees as an inducement for them entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company's lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral table ...

Core Points - Soleno Therapeutics, Inc. is set to join the Russell 3000® Index effective July 1, 2024, marking a significant milestone for the company [1][2] - The inclusion in the Russell indexes reflects the progress made in advancing its lead candidate DCCR (diazoxide choline) extended-release tablets through clinical development [2] - The Russell US Indexes reconstitution captures the 4,000 largest US stocks ranked by total market capitalization, with membership in the Russell 3000® Index providing automatic inclusion in the Russell 1000® or Russell 2000® Indexes [2] Company Overview - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases, with its lead candidate DCCR aimed at treating Prader-Willi syndrome (PWS) [4] - DCCR has recently completed its Phase 3 development program to support a planned NDA submission [4] Industry Context - Russell indexes are widely utilized by investment managers and institutional investors for index funds and as benchmarks for active investment strategies, with approximately $10.5 trillion in assets benchmarked against these indexes as of December 2023 [3]