Mental or Behavioral Dysfunction

FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

2 weeks ago talkbio0Tagged Circadian Rhythms, Clinical Trial Design, collaborative framework agreement, decision letter, expansion, Hetlioz, jet lag disorder, Labels (device), NDA, phase advance protocol, Rejection, Sleep Disorders, Supplement, tasimelteon, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute

Biohaven’s BHV-7000 Ion Channel Drug Fails Phase 2 Trial in Major Depressive Disorder

3 weeks ago talkbio0Tagged BHV-7000, Biohaven, Depressive disorder, Kv7 activator, psychiatric trials

Biohaven; BHV-7000; major depressive disorder; phase 2 failure; Kv7 activator; psychiatric trials

Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at CTAD Conference

2 months ago talkbio0Tagged access program, Alzheimer 's disease, Clinical Trials, Cognition Therapeutics, CTAD, Lewy bodies, Neurodegenerative Disorders, Phase 3 clinical trial, Presenile dementia, sigma-2 receptor, Zervimesine

Cognition Therapeutics; Zervimesine; CT1812; Phase 3 clinical trial; Alzheimer’s disease; Clinical Trials on Alzheimer’s Disease (CTAD); neurodegenerative diseases; sigma-2 receptor; dementia with Lewy bodies; expanded access program

Novo Nordisk’s Semaglutide Misses Key Goals in Closely-Watched Alzheimer’s Disease Phase 3 Trials

2 months ago talkbio0Tagged Alzheimer 's disease, Biological Markers, Clinical trial failure, EVOKE trial, Glucagon-Like Peptide 1, Mental deterioration, Novo Nordisk, Phase 3, Rybelsus, semaglutide

Novo Nordisk; semaglutide; Alzheimer’s disease; EVOKE trial; EVOKE+ trial; clinical trial failure; Rybelsus; GLP-1 drugs; phase 3; biomarkers; cognitive decline

Alkermes Ups Bid for Avadel Amid Lundbeck’s Competing Offer in Narcolepsy Drug Takeover Battle

2 months ago talkbio0Tagged Acquisition, Alkermes, Avadel Pharmaceuticals, bidding war, contingent value right, LUMRYZ, Lundbeck, M&A, Narcolepsy, Pharma, Primary Hypersomnia

Alkermes; Avadel Pharmaceuticals; Lundbeck; bidding war; Lumryz; narcolepsy; acquisition; contingent value right; pharma M&A; idiopathic hypersomnia

Bright Minds Biosciences Expands Scientific Advisory Board to Include Renowned Experts in Prader-Willi Syndrome (PWS)

2 months ago talkbio0Tagged BMB-101, BMB-105, Bright Minds Biosciences, Clinical Trials, Neurodevelopmental Disorders, Prader-Willi Syndrome, PWS, Scientific Advisory Board

Bright Minds Biosciences; Scientific Advisory Board; Prader-Willi Syndrome; PWS; BMB-101; BMB-105; clinical trials; neurodevelopmental disorders

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

2 months ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

Alkermes Pushes Narcolepsy Program to Phase III With Highly Competitive Mid-Stage Data

2 months ago talkbio0Tagged alixorexton, Alkermes, clinical endpoints, Narcolepsy, Orexin Receptor Agonist, Phase 2 Clinical Trials, Phase 3 Clinical Trials, Sleep Disorders, Wakefulness

Alkermes; alixorexton; narcolepsy; Phase II trial; Phase III clinical trial; orexin 2 receptor agonist; wakefulness; sleep disorder; clinical endpoints

Neurocrine’s Phase 2 Depression Drug Fails Primary Endpoint in Major Takeda-Licensed Study

2 months ago talkbio0Tagged Biosciences, Clinical Trials, depression drug, Depressive disorder, Drug licensing, NBI-1070770, Neurocrine, pharmaceutical setbacks, Phase 2 Failure, psychiatry pipeline, Takeda

Neurocrine Biosciences; Takeda; NBI-1070770; Phase 2 failure; major depressive disorder; depression drug; psychiatry pipeline; clinical trial results; drug licensing; pharmaceutical setbacks

BMS Battles Deeply Ingrained Prescribing Habits in Schizophrenia as Cobenfy Misses Q3 Estimates

3 months ago talkbio0Tagged Alzheimer 's disease, Antipsychotic Agents, Cobenfy, Dopamine D2 Receptor, Drug Kinetics, drug market, earnings, Myers Squibb, prescribing habits, Psychotic Disorders, Schizophrenia, Trimonthly, Uptake

Bristol Myers Squibb; Cobenfy; schizophrenia; prescribing habits; dopamine D2 receptor; novel mechanism of action; quarterly earnings; drug market uptake; Alzheimer’s disease psychosis; atypical antipsychotics