Vanda Pharma (VNDA) Stock News

Vanda Pharmaceuticals (VNDA) has initiated dosing in a first-in-human trial of VCA-894A, an antisense oligonucleotide therapeutic, targeting a rare variant of the IGHMBP2 gene that causes Charcot-Marie-Tooth disease Type 2S (CMT2S). The trial focuses on a patient diagnosed at age 5 with CMT2S, an inherited neuromuscular disorder affecting less than 1 in 1,000,000 people worldwide. VCA-894A has shown promising results in preclinical studies, successfully restoring IGHMBP2 gene expression levels in an organ-on-a-chip neuromuscular junction system derived from patient cells. This personalized therapeutic approach represents a potential breakthrough in treating rare genetic disorders, which collectively affect over 300 million people globally.

Vanda Pharmaceuticals (NASDAQ: VNDA) announced its participation in the 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Scottsdale, Arizona, scheduled from May 27-30, 2025. Dr. Sean R. Chadwick from Clinical Development will present a poster titled "Pharmacokinetic Results of Single-Dose and Multiple-Dose Bioequivalence Studies of Milsaperidone and Iloperidone Immediate-Release Oral Tablets" during Poster Presentation Session II. The presentation, designated as Poster Number T19, will take place on May 27, 2025.

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.