Vanda Pharmaceuticals Inc. develops and commercializes biopharmaceutical therapies, with company updates centered on prescription products and clinical or regulatory programs. Recurring news includes financial results, Fanapt sales trends, HETLIOZ commercialization, the U.S. availability of NEREUS (tradipitant) for prevention of vomiting induced by motion, and FDA approval of BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia.
Vanda news also covers development activity for imsidolimab in generalized pustular psoriasis, product-access and commercial-channel updates, investor conference participation, regulatory-policy statements, and corporate governance changes such as board appointments.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will release its third quarter 2020 financial results on October 28, 2020, after market close. A conference call will follow at 4:30 PM ET on the same day, where management will discuss the results and corporate activities. Participants can join by calling 1-866-688-9426 (domestic) or 1-409-216-0816 (international), using passcode 8971955. The call will be available for replay from 7:30 PM ET on October 28 until November 4, 2020.
Vanda Pharmaceuticals (VNDA) announced updates on its tradipitant program aimed at treating gastroparesis, stating that enrollment in its Phase III clinical trial is expected to complete by mid-2021. A publication on tradipitant’s efficacy in gastroparesis was accepted in Gastroenterology. The drug shows potential commercial prospects, given the estimated 6 million U.S. patients affected by the condition. Additionally, interim analysis indicates tradipitant may improve outcomes for COVID-19 pneumonia. Vanda is navigating FDA requirements for expanded safety data and is pursuing multiple therapeutic indications.
Vanda Pharmaceuticals (VNDA) announced promising interim results from the ODYSSEY study of tradipitant for COVID-19 pneumonia. The analysis revealed that patients receiving tradipitant showed accelerated clinical improvement by day 7 compared to those on placebo (HR=2.55, p=0.0375). While 57% of tradipitant patients improved, 50% of placebo patients did as well, with similar mortality rates of 14.2% and 16.6%, respectively. The study, involving 300 patients, is ongoing. Vanda plans to expand tradipitant's evaluation beyond COVID-19 pneumonia to include seasonal influenza pneumonia.
Vanda Pharmaceuticals (VNDA) reported Q2 2020 financial results, showing total revenues of $62.2 million, a 5% increase from $59.1 million in Q2 2019. HETLIOZ® net sales rose 10% to $41.6 million, while Fanapt® sales decreased 3% to $20.6 million. Cash and equivalents increased to $339.8 million. However, net income fell to $8.7 million from $11.5 million year-over-year, with diluted earnings per share at $0.16. Vanda provided updated revenue guidance for 2020, expecting total revenues of $240 to $260 million.
Vanda Pharmaceuticals (VNDA) announced that the FDA has accepted its applications for HETLIOZ for Smith-Magenis Syndrome (SMS), granting priority review. This includes a Supplemental New Drug Application (sNDA) for capsules and a New Drug Application (NDA) for a liquid formulation aimed at treating both adults and children with SMS. The FDA's decision deadline is set for December 1, 2020. Notably, there are currently no approved treatments for SMS, which affects approximately 15,000 individuals in the U.S.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will release its second quarter 2020 financial results on August 5, 2020, after market close. A conference call is scheduled for 4:30 PM ET the same day, where management will discuss the results and corporate activities. Investors can participate by calling 1-888-771-4371 domestically or 1-847-585-4405 internationally, using passcode 49854840. The call will also be streamed live and archived on Vanda's website.