Vanda Pharma Stock Price, News & Analysis

Vanda Pharmaceuticals (Nasdaq: VNDA) has requested FDA Commissioner Martin Makary to review a recent decision regarding generic versions of Hetlioz®. The review petition follows outgoing CDER Director Jacqueline Corrigan-Curay's decision to uphold the approval of two generic versions of the drug, despite Vanda's 2023 citizen petitions challenging these approvals.

The controversy centers on bioequivalence studies that Vanda claims are flawed, specifically noting that the studies were conducted only on Indian male subjects and showed concerning data inconsistencies, including exposure levels more than double those of Hetlioz®. Vanda argues this reflects an institutional bias toward approving generic drugs regardless of evidence standards.

Vanda Pharmaceuticals (Nasdaq: VNDA) has achieved a significant legal victory against the FDA in its pursuit to get HETLIOZ® (tasimelteon) approved for treating jet lag disorder. The U.S. Court of Appeals for the D.C. Circuit has overturned the FDA's denial of Vanda's supplemental New Drug Application (sNDA), which was originally submitted in October 2018.

The Court ruled that the FDA failed to properly consider Vanda's evidence, noting that the company provided "specific, reasoned, and rooted in evidence" expert views. Clinical trials demonstrated statistically significant improvement in primary endpoints for treating sleep disturbance. The case has been remanded to the FDA, which must now either approve the sNDA or grant Vanda a hearing.

This landmark decision sets a precedent requiring the FDA to meaningfully engage with evidence presented by drug innovators, potentially transforming the regulatory landscape for pharmaceutical companies.

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 (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.