Welcome to our dedicated page for Vanda Pharma news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharma stock.
Vanda Pharmaceuticals Inc. (VNDA) is a biopharmaceutical innovator developing therapies for complex medical conditions with limited treatment options. This news hub provides investors and healthcare professionals with essential updates on the company's clinical advancements, regulatory milestones, and strategic initiatives.
Access real-time information about VNDA's sleep-wake disorder treatments, psychiatric therapies, and neurology pipeline. Our curated collection includes FDA decision updates, clinical trial results, financial earnings reports, and partnership announcements – all critical for understanding the company's market position.
Bookmark this page for streamlined tracking of Vanda's progress in antisense oligonucleotide research and commercialization efforts. Regular updates ensure you stay informed about HETLIOZ developments, Fanapt market performance, and emerging therapies in the company's clinical pipeline.
Vanda Pharmaceuticals (Nasdaq: VNDA) reported Q2 2025 financial results, with total net product sales reaching $52.6 million, a 4% increase year-over-year. Fanapt® showed strong performance with net sales of $29.3 million, up 27% YoY, while HETLIOZ® and PONVORY® sales declined. The company reported a net loss of $27.2 million for Q2 2025.
Key regulatory milestones include Bysanti™ NDA acceptance for bipolar I disorder and schizophrenia (PDUFA date: February 21, 2026), Tradipitant NDA for motion sickness (PDUFA date: December 30, 2025), and planned Imsidolimab BLA submission for GPP in 2025. The company maintains its 2025 guidance of $210-250 million in total revenues.
Vanda Pharmaceuticals (Nasdaq: VNDA) has scheduled its second quarter 2025 financial results announcement for July 31, 2025, before market opening. The company will host a conference call at 8:00 AM ET on the same day to discuss the quarterly results and corporate activities.
Investors can participate by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 9430387. The call will be simultaneously webcast on www.vandapharma.com. A replay will be available from 11:00 AM ET until August 7, 2025, at 11:59 PM ET.
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 (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.