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{"aggregator_url":"https://www.sec.gov {"aggregator_url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt","as_of":"2026-04-08T02:28:02.401723+00:00","canonical_url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt","company":"SOLENO THERAPEUTICS INC","enrichment":{"aggregator_url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt","article_chars":5000,"article_truncated":true,"blocked_reason":null,"candidate_id":"sc_a6fb6d6a6a901f80","canonical_host":"sec.gov","canonical_is_aggregator":false,"canonical_url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt","content_type":"text/plain","enriched_at":"2026-04-08T03:28:28.474235+00:00","extraction_method":"heuristic","fetched_description":"","fetched_title":"8-K","final_url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt","html_truncated":false,"paywall_likely":false,"publisher_domain":"sec.gov","publisher_resolution":"canonical_url","requested_url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt","source_event_id":"evt_7ab165a50b30","source_quality":"high","status_code":200,"version":"signal_enrichment_v2"},"form_type":"8-K","fp":"c531d4b3c9fcbcee","kind":"sec_filing","published_at":"20260407","publisher_domain":"sec.gov","signal_understanding":{"analysis_basis":"article","claim_confidence":0.86,"dates_mentioned":["2026-04-07","mid-2026","2026-04-08T02:28:02.401723+00:00"],"entities":[{"asset_class":"equity","name":"Soleno Therapeutics, Inc.","relevance":"high","symbol":"SLNO","type":"issuer"},{"asset_class":"other","name":"European Medicines Agency (EMA)","relevance":"high","symbol":"","type":"regulator"},{"asset_class":"other","name":"VIOKAT prolonged-release tablets (diazoxide choline)","relevance":"high","symbol":"","type":"product"},{"asset_class":"other","name":"VYKAT XR","relevance":"high","symbol":"","type":"product_brand"},{"asset_class":"other","name":"Prader-Willi syndrome (PWS)","relevance":"medium","symbol":"","type":"indication"}],"event_type":"regulation","information_gaps":["What specific business/strategic considerations drove the withdrawal is not detailed beyond that general statement.","No information is provided on whether any alternative regulatory pathway/timeline is planned.","No financial impact, cost, or guidance changes are disclosed in the provided text.","No prior-state details beyond the statement that the application had been under review with a decision expected in mid-2026 are included, so the exact delta vs prior known state is limited to 'withdrawn vs previously under review.'"],"key_facts":["Filing is a Form 8-K (Current Report).","Date of report / earliest event reported: April 7, 2026.","The Company reported it voluntarily withdrew its marketing authorization application (MAA) for VIOKAT prolonged-release tablets (diazoxide choline).","VIOKAT is marketed in the U.S. as VYKAT XR.","The product is described as a medicinal product for treatment of adults and children aged 4 years and older with Prader-Willi syndrome (PWS) who experience hyperphagia.","The Company previously announced the application was under review by the EMA, with a decision expected in mid-2026.","The Company states the decision to withdraw the MAA is based on business and strategic considerations.","The Company states withdrawal preserves the ability to re-engage with regulators at a later date should there be an appropriate pathway to progress the program."],"numeric_claims":[],"primary_claim":"On April 7, 2026, Soleno Therapeutics voluntarily withdrew its EMA marketing authorization application for VIOKAT prolonged-release tablets (diazoxide choline).","relevance_score":0.72,"sentiment":"mixed","source_quality":"high","summary":"Soleno Therapeutics, Inc. filed a Form 8-K reporting that it voluntarily withdrew its EMA marketing authorization application for VIOKAT prolonged-release tablets (diazoxide choline), marketed in the U.S. as VYKAT XR. The company states the withdrawal is based on business and strategic considerations and preserves the ability to re-engage later.","topics":["SEC filing","8-K","EMA marketing authorization application withdrawal","VIOKAT/VYKAT XR","Prader-Willi syndrome","strategic/business considerations"]},"source":"sec_edgar","source_domain":"sec.gov","summary":"Form 8-K \u00b7 SOLENO THERAPEUTICS INC \u00b7 Filed 20260407","ticker":"SLNO","tickers":["SLNO"],"title":"SLNO filed 8-K","url":"https://www.sec.gov/Archives/edgar/data/1484565/0001193125-26-144511.txt"}... |