Vanda Pharma Stock Price, News & Analysis

Vanda Pharmaceuticals (Nasdaq: VNDA) announced its upcoming participation in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025. The event will take place in New York City on Wednesday, May 21, 2025. This conference provides an opportunity for Vanda to engage with investors and discuss their developments in the neurological and ophthalmological therapeutic areas.

Vanda Pharmaceuticals (VNDA) reported Q1 2025 financial results with total net product sales of $50.0 million, up 5% year-over-year. Fanapt showed strong growth with sales of $23.5 million (+14% YoY) and prescription growth reaching 2,000 weekly prescriptions. The company reported a net loss of $29.5 million, compared to $4.1 million in Q1 2024, partly due to a $15 million payment for imsidolimab licensing. Key regulatory milestones include FDA acceptance of NDAs for tradipitant (PDUFA: Dec 30, 2025) and Bysanti (PDUFA: Feb 21, 2026). Cash position stands at $340.9 million. The company maintains its 2025 revenue guidance of $210-250 million and expects year-end cash of $280-320 million.

Vanda Pharmaceuticals announced that the FDA has accepted their New Drug Application (NDA) for Bysanti™ (milsaperidone), with a target decision date of February 21, 2026. Bysanti is a new chemical entity discovered to be bioequivalent to iloperidone, targeting bipolar I manic and mixed episodes and schizophrenia. The drug's efficacy is supported by multiple clinical studies, including two for acute schizophrenia episodes, one for bipolar I disorder, and one for schizophrenia relapse prevention. Safety data includes thousands of patient studies and over 80,000 patient-year exposures. Bysanti is also being studied as a once-daily treatment for major depressive disorder, with results expected in 2026. If approved, the drug will receive 5-year regulatory data exclusivity, with patent applications potentially extending protection into the 2040s.

Vanda Pharmaceuticals (NASDAQ: VNDA) has scheduled its first quarter 2025 financial results announcement for Wednesday, May 7, 2025, after market close. The company will host a conference call at 4:30 PM ET the same day to discuss quarterly results and corporate activities. Investors can join via phone using the numbers 1-800-715-9871 (domestic) or 1-646-307-1963 (international) with passcode 9941754.

The call will be simultaneously broadcast and archived on www.vandapharma.com. A replay will be available from 8:30 PM ET on May 7 until 11:59 PM ET on May 14, 2025, accessible at 1-800-770-2030 (domestic) or 1-609-800-9909 (international) using the same passcode.

Vanda Pharmaceuticals (Nasdaq: VNDA) has announced that FDA bureaucrats are delaying a hearing request for tradipitant, a drug intended to treat gastroparesis. The FDA is attributing the minimum 6-month delay to recent staff reductions and newly appointed Commissioner Dr. Martin Makary.

Vanda disputes these claims, noting that Commissioner Makary confirmed the cuts did not affect scientists or reviewers. The company points out similar delays in previous cases, including six-month periods for Hetlioz hearing requests for both jet lag and insomnia applications.

The company highlights that FDA has denied every hearing request on new drug approvability for at least the past decade. Vanda's CEO, Dr. Mihael Polymeropoulos, calls for increased transparency and rational decision-making in the FDA approval process.

Vanda Pharmaceuticals (VNDA) announced its participation at the American Academy of Neurology (AAN) Annual Meeting in San Diego from April 5-9, 2025. The company will present a poster on April 9 showcasing data for VCA-894A, a novel therapeutic customized for a specific genetic mutation in Charcot-Marie-Tooth disease type 2S (CMT2S).

The presentation will highlight how VCA-894A demonstrated significant improvements in neuromuscular function using Hesperos' Human-on-a-Chip® model with patient-derived cells. Key improvements include reduced muscle fatigue and enhanced synaptic transmission between motor neurons and skeletal muscle myotubes.

The FDA has granted VCA-894A an orphan designation, and it is expected to be administered to the specific patient for whom it was developed. The experimental platform represents advancement in precision medicine, potentially enabling development of genetically-tailored treatments for unmet medical needs.

Vanda Pharmaceuticals (NASDAQ: VNDA) has submitted a New Drug Application (NDA) to the FDA for Bysanti™ (milsaperidone), targeting the treatments of acute bipolar I disorder and schizophrenia. The application is backed by multiple clinical studies evaluating the drug's efficacy and safety.

Bysanti™, a novel atypical antipsychotic, works by interacting with various neurotransmitter receptors including alpha-adrenergic, serotonin, and dopamine receptors in the brain. If approved, the drug could reach the US market by 2026, with potential exclusivity extending into the 2040s.

Additionally, Vanda has launched a Phase III clinical trial investigating Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results anticipated in 2026.

Vanda Pharmaceuticals (VNDA) has published research on a novel antisense oligonucleotide (ASO) therapeutic, VCA-894A, developed for treating a patient with Charcot-Marie-Tooth disease Type 2S (CMT2S). The treatment targets a specific variant of the IGHMBP2 gene.

CMT2S is an inherited neuromuscular disorder causing progressive muscle weakness and motor function loss, with a prevalence of less than 1 in 1,000,000 worldwide. VCA-894A has shown significant improvements in neuromuscular function in testing, including reduced muscle fatigue and improved synaptic transmission between motor neurons and skeletal muscle myotubes.

The FDA has granted VCA-894A an orphan designation, and it is expected to be administered to the specific patient for whom it was developed. The experimental platform represents a breakthrough in precision medicine, potentially enabling the development of personalized treatments for rare genetic diseases.

Vanda Pharmaceuticals (VNDA) reported Q4 2024 total revenues of $53.2 million, up 17% year-over-year, with Fanapt® sales reaching $26.6 million (+18% YoY). Full-year 2024 revenues totaled $198.8 million, a 3% increase from 2023. The company posted a Q4 net loss of $4.9 million and a full-year net loss of $18.9 million.

Looking ahead, Vanda projects 2025 revenue between $210-250 million and targets psychiatry portfolio revenue exceeding $750 million by 2030. Key regulatory milestones include MAA submissions for Fanapt® and HETLIOZ® in Q4 2024, upcoming BysantiTM NDA submission in Q1 2025, and imsidolimab BLA submission planned for 2025.

The company's cash position stands at $374.6 million as of December 31, 2024, representing a decrease of $13.6 million from year-end 2023.