EnsoData has announced a collaboration with Takeda to jointly develop and validate AI-based polysomnography (PSG) algorithms to support more accurate and scalable diagnosis of narcolepsy type 1 (NT1). Upon successful validation and regulatory clearance, EnsoData will pursue the clinical availability and release of AI algorithms to enable future access, use, […]
Sleep Pharmaceuticals
Positive Topline Results from Second Phase 3 Trial of First OSA Pill
Apnimed, Inc. has announced positive topline results from its second pivotal Phase 3 clinical trial of Apnimed’s lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight […]
Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1
Alkermes plc today announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly referred to as ALKS 2680, is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in phase 2 development as […]
Nxera Pharma Receives $4.8M Milestone Payment from Centessa for ORX142 Trial
Nxera Pharma Co., Ltd. today announces that it will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals pursuant to its research collaboration with Centessa. The milestones were achieved as Centessa initiated clinical development of ORX142, its second novel orexin receptor 2 (OX2R) agonist, following the recent clearance of an […]
Avadel’s LUMRYZ Approval Upheld in Court
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the “Appeals Court”) affirmed a prior decision of the U.S. District Court for the District of Columbia (the “District […]
Harmony Strengthens Patent With ANDA Settlement
Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]
Avadel’s LUMRYZ Receives FDA Orphan Drug Designation for Idiopathic Hypersomnia
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may […]
Avadel Pharmaceuticals Presents New Data on LUMRYZ ER at SLEEP 2025
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 […]
Axsome Therapeutics Settles SUNOSI Patent Litigation with Hetero Labs Ltd.
Axsome Therapeutics, Inc. a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which […]
Apnimed Announces SynAIRgy Phase 3 Results
Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed’s lead […]













