Vanda Pharmaceuticals Announces Participation in the Mizuho Neuro & Ophthalmology Summit 2025
WASHINGTON , May 16, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025 in New York City on Wednesday, May 21, 2025. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.
Vanda Pharmaceuticals (VNDA) Reports Q1 Loss, Tops Revenue Estimates
Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.50 per share versus the Zacks Consensus Estimate of a loss of $0.55. This compares to loss of $0.07 per share a year ago.
Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results
Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON , May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline.
Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026
WASHINGTON , May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application.
Vanda Pharmaceuticals to Announce First Quarter 2025 Financial Results on May 7, 2025
Conference Call and Webcast to Follow WASHINGTON , May 2, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2025 on Wednesday, May 7, 2025, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, May 7, 2025, during which management will discuss the first quarter 2025 financial results and other corporate activities.
FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA
WASHINGTON , April 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary, and reductions in force.
Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia
WASHINGTON , March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.
Vanda Pharmaceuticals, Inc. (VNDA) Q4 2024 Earnings Call Transcript
Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA ) Q4 2024 Earnings Conference Call February 13, 2025 4:30 PM ET Company Participants Kevin Moran - SVP, CFO & Treasurer Mihael Polymeropoulos - Founder, President, CEO & Chairman Conference Call Participants Charles Duncan - Cantor Fitzgerald Raghuram Selvaraju - H.C. Wainwright Andrew Tsai - Jefferies Operator Hello, and thank you for standing by.
Vanda Pharmaceuticals (VNDA) Reports Q4 Loss, Tops Revenue Estimates
Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.08 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.04 per share a year ago.
Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results
Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023 Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025 HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024 Tradipitant NDA for motion sickness submitted in Q4 2024 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON , Feb. 13, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2024. "Strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hetlioz and Ponvory.
Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2024 Financial Results on February 13, 2025
Conference Call and Webcast to Follow WASHINGTON , Feb. 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2024 on Thursday, February 13, 2025, after the market closes. Vanda will host a conference call at 4:30 PM ET on Thursday, February 13, 2025, during which management will discuss the fourth quarter and full year 2024 financial results and other corporate activities.
Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis
Highlights faulty FDA review WASHINGTON , Jan. 27, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provides an update on the tradipitant development program. Gastroparesis is a serious digestive disorder of the stomach.
