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 (VNDA) reported Q4 and full-year 2021 results, showcasing total net product sales of $68.0 million in Q4 and $268.7 million for the year, reflecting increases of 1% and 8%, respectively. HETLIOZ® sales were $44.1 million in Q4, while Fanapt® reached $24.0 million. Net income for Q4 decreased to $7.1 million from $8.2 million in Q4 2020, but annual net income rose to $33.2 million from $23.3 million. Vanda anticipates 2022 revenue guidance of $240 to $280 million. A Phase III study of tradipitant did not meet its primary endpoint, prompting further analysis.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) is set to release its fourth quarter and full year 2021 financial results on February 23, 2022, after market close. A conference call will occur at 4:30 PM ET on the same day, where management will discuss the results and corporate activities. Investors can participate by calling 1-866-688-9426 (domestic) or 1-409-216-0816 (international) using passcode 5373895. A replay of the call will be available from 7:30 PM ET the same day until March 2, 2022.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced disappointing results from the Phase III study of tradipitant for treating gastroparesis, as it failed to meet its primary endpoint on nausea reduction. However, exploratory analyses suggest that the drug may have significant benefits when accounting for certain patient factors. Tradipitant demonstrated a similar safety profile to placebo, with diarrhea as the most common side effect. Vanda plans further data analysis and intends to pursue regulatory submissions, emphasizing their commitment to addressing unmet medical needs in gastroparesis.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced a License Agreement with MSN Pharmaceuticals and Impax Laboratories to resolve patent litigation over the generic version of its drug HETLIOZ (tasimelteon). The agreement allows MSN and Impax to market their version of HETLIOZ in the U.S. starting March 13, 2035, or July 27, 2035, if Vanda obtains pediatric exclusivity. The settlement includes a release of all claims from the litigation and is pending review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced its participation in significant investor conferences this November, including the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, and the Jefferies 2021 London Healthcare Conference on November 18-19, 2021. A corporate presentation will be available at the Stifel conference, while an on-demand fireside chat will be accessible for the Jefferies event. Investors can access presentations via Vanda's website, with archived content available for 30 days post-event.
Vanda Pharmaceuticals (VNDA) reported strong financial growth in Q3 2021, with total product sales of $70.1 million, a 16% increase from $60.3 million in Q3 2020. HETLIOZ® sales rose 15% to $45.6 million, while Fanapt® sales climbed 18% to $24.5 million. Net income reached $7.8 million, up from $5.9 million year-over-year. However, Vanda revised its HETLIOZ® sales guidance downward due to escalating reimbursement challenges, now estimating $170 to $190 million for 2021. The company anticipates results from a pivotal Phase III study on tradipitant in gastroparesis by year-end.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will announce its third quarter 2021 financial results on November 3, 2021, after market close. A conference call will follow at 4:30 PM ET, where management will discuss the results and corporate activities. Investors can join the call by dialing 1-866-688-9426 domestically or 1-409-216-0816 internationally, with passcode 5961858. The call will also be accessible via Vanda's website and available for replay starting at 7:30 PM ET on the same day until November 10, 2021.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced its participation in Evercore ISI's Catalyst Day on October 18, 2021. CEO Mihael H. Polymeropoulos will engage in a virtual fireside chat at 1:30 PM ET. Vanda Pharmaceuticals focuses on developing innovative therapies for unmet medical needs. For further details, visit www.vandapharma.com.
Vanda Pharmaceuticals Inc. (VNDA) announced its participation in the Citi 16th Annual BioPharma Virtual Conference from September 8 to September 10, 2021. The company's management will conduct investor meetings during the event. Vanda has also updated its corporate presentation, available on its website under the Investors tab. Vanda Pharmaceuticals is dedicated to developing innovative therapies to meet significant medical needs.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced the closure of enrollment in the ODYSSEY study, which aimed to compare tradipitant and placebo in hospitalized COVID-19 pneumonia patients. The study was terminated after meeting pre-defined futility criteria, suggesting it was unlikely to achieve its primary endpoint of treatment efficacy. A total of 153 patients were enrolled against a goal of 324. Despite this, Vanda will proceed with genetic analysis to explore susceptibility factors related to severe pneumonia in COVID-19 patients.