Vanda Pharmaceuticals Inc. - VNDA STOCK NEWS

Vanda Pharmaceuticals (Nasdaq: VNDA) reported fourth quarter and full year 2020 results, achieving record commercial revenue of $67.7 million in Q4, an 11% increase year-over-year. HETLIOZ® sales rose 14% to $44.2 million, while Fanapt® sales increased 5% to $23.5 million. Despite a drop in annual net income to $23.3 million from $115.6 million in 2019, Vanda holds $367.7 million in cash. Looking ahead, the company projects 2021 revenues between $270-$300 million, with HETLIOZ® and Fanapt® sales expected to reach $180-$200 million and $90-$100 million, respectively.

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will release its fourth quarter and full year 2020 results on February 10, 2021, after market close. Management will discuss these results during a conference call at 4:30 PM ET on the same day, with participation details provided. A replay will be available until February 17, 2021. Vanda focuses on developing innovative therapies to address unmet medical needs and improve patient lives. For more information, visit www.vandapharma.com.

Vanda Pharmaceuticals (VNDA) announced FDA approval for HETLIOZ^® (tasimelteon) to treat nighttime sleep disturbances in patients with Smith-Magenis Syndrome (SMS). This marks HETLIOZ^® as the first medication approved for SMS, a rare disorder affecting sleep due to an inverted circadian rhythm. The approval is based on a placebo-controlled study showing efficacy in both adults and children. HETLIOZ^® capsules are available immediately, while the liquid formulation for children is expected in Q1 2021. Vanda aims to address significant sleep-related challenges for SMS patients.

Vanda Pharmaceuticals (Nasdaq: VNDA) reported Q3 2020 net product sales of $60.3 million, up 1% year-over-year. HETLIOZ® sales grew 5% to $39.6 million, while Fanapt® sales fell 6% to $20.7 million. Income before taxes decreased to $8.4 million from $12.3 million in Q3 2019. For the first nine months, revenue increased 9% to $180.5 million, with HETLIOZ® sales rising 12%. Cash reserves grew to $348.5 million. Upcoming FDA decisions include priority reviews for HETLIOZ® in treating Smith-Magenis Syndrome, with a target date of December 1, 2020.

Vanda Pharmaceuticals (NASDAQ: VNDA) announced FDA approval for its Investigational New Drug (IND) application for VSJ-110, a CFTR activator, aimed at treating allergic conjunctivitis. This milestone marks a key collaboration with UCSF and initiates a Phase II clinical study to assess VSJ-110's anti-inflammatory effects and its potential to increase tear production. With 16 million individuals in the U.S. affected by dry eye, this drug could address a significant unmet medical need. Results from the study are expected in 2021.

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.