Iloperidone

Vanda Pharmaceuticals' Q3 2024 10-Q filing shows total revenues up to $47.7M, driven by PONVORY® and Fanapt® sales. Fanapt® sales rose 12% to $23.9M, HETLIOZ® up 2% to $17.9M, and PONVORY® contributed $5.9M. Despite increased R&D and SG&A expenses, the company reported a net loss of $5.3M. Cash and equivalents totaled $376.3M. Vanda continues to focus on product development and commercialization.

Vanda Pharmaceuticals reports Q3 2024 revenue of $47.7 million, up 23% YoY. Financial guidance for 2024 is revised upwards. Fanapt® launch in bipolar I disorder sees new patient starts increase by over 90% YoY. Fanapt® long-acting injectable program to start in Q4 2024. Milsaperidone NDA for schizophrenia and bipolar I disorder expected in early 2025. PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024. PONVORY® IND applications for psoriasis and ulcerative colitis expected in Q4 2024. Tradipitant NDA for motion sickness to be submitted in Q4 2024.

Schizophrenia clinical trial pipeline features 55+ companies and 60+ drugs, with key players like Sumitomo Pharma America, Boehringer Ingelheim, and Reviva Pharmaceuticals advancing novel therapies. Recent milestones include Reviva's Phase III RECOVER trial data, Luye Pharma Group's IND approval for LY03020, and Teva's positive SOLARIS trial results. DelveInsight's report provides comprehensive global coverage and insights into the schizophrenia pipeline.

Bristol Myers Squibb receives FDA approval for Cobenfy, a new antipsychotic drug for schizophrenia, the first in decades. Cobenfy, also known as KarXT, lacks warnings about increased mortality in elderly patients and common side effects like weight gain and movement disorders. Bristol Myers expects $2.5 billion in U.S. sales by 2030 and plans to launch the drug at $1,850 a month. The approval is based on studies showing significant symptom reduction, targeting cholinergic receptors instead of dopamine. Cobenfy's side effects include vomiting and nausea, and it is not recommended for patients with urinary retention or severe kidney/liver disease.

The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.

Vanda Pharmaceuticals' stock rose 1.8% since April, lagging the S&P 500's 7% gain. Fanapt, approved for bipolar 1 disorder, faces market challenges due to lack of differentiation from generic antipsychotics. Upcoming catalysts include FDA decisions on tradipitant for gastroparesis and motion sickness, and a Phase I study for a CFTR inhibitor to treat cholera. Vanda's cash position is strong, but its product pipeline is weak, with potential revenue declines from Hetlioz and Fanapt due to generic competition. The company rejected takeover bids, emphasizing the need for strategic cash management.