Welcome to our dedicated page for Vanda Pharma news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharma stock.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) is a biopharmaceutical company whose news flow centers on FDA interactions, clinical trial results, product approvals, and financial performance. Recent press releases describe Vanda as a global biopharmaceutical company focused on therapies for high unmet medical needs, with commercial products including HETLIOZ, Fanapt, PONVORY, and NEREUS (tradipitant).
On this VNDA news page, readers can follow company announcements about regulatory milestones, such as FDA approvals, decision letters, and Biologics License Application or New Drug Application submissions. Examples include the FDA approval of NEREUS for the prevention of vomiting induced by motion, the submission of a BLA for imsidolimab in generalized pustular psoriasis, and updates on the collaborative framework with the FDA for HETLIOZ and tradipitant.
Investors and followers can also track clinical development updates, including topline data from randomized studies of tradipitant in GLP-1 agonist–induced nausea and vomiting, Phase 3 results in motion sickness, and long-term maintenance data for imsidolimab in generalized pustular psoriasis. Vanda’s news often highlights how these data support ongoing or planned regulatory submissions and potential new indications.
In addition, Vanda regularly issues financial and corporate communications, such as quarterly earnings releases, guidance updates, and notices of participation in investor conferences like the J.P. Morgan Healthcare Conference and the Stifel Healthcare Conference. These items provide context on product sales for Fanapt, HETLIOZ, and PONVORY, as well as commentary on commercial strategy and pipeline priorities.
By monitoring this VNDA news feed, readers can see how Vanda’s commercial performance, regulatory decisions, and clinical trial outcomes evolve over time across sleep-wake disorders, psychiatric illness, motion sickness, inflammatory skin disease, and treatment-related nausea and vomiting.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced results from a Phase II clinical study of VQW-765, a novel alpha 7 nicotinic acetylcholine receptor partial agonist, aimed at treating acute performance anxiety. In the study with 230 participants, VQW-765 demonstrated lower stress levels compared to placebo, particularly among female participants, who experienced significant effects. This study marks the first evidence of an α7-nAChR agonist's efficacy for performance anxiety. The drug's side effect profile resembled that of placebo, supporting its potential as a treatment option.
Vanda Pharmaceuticals Inc. (VNDA) announced its participation in upcoming investor conferences in November 2022. The company will present at the Stifel 2022 Healthcare Conference on November 15 at 10:20 a.m. Eastern Time, and at the Jefferies 2022 London Healthcare Conference on November 17 at 12:20 p.m. Greenwich Mean Time (7:20 a.m. Eastern Time). Live access to these presentations will be available on Vanda's corporate website, with archived versions accessible for about 30 days.
Vanda Pharmaceuticals reported Q3 2022 total revenues of $65.3 million, down 7% from $70.1 million in Q3 2021. HETLIOZ® sales fell by 9% to $41.3 million, while Fanapt® saw a 2% decline to $24.0 million. The company also experienced a net income drop to $3.3 million compared to $7.8 million in Q3 2021. Total revenues for the first nine months were $189.9 million, a 5% decrease year-over-year. Vanda aims to submit an NDA for tradipitant in Q1 2023 and expects a strong cash position of $454.8 million by year-end.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) will release its third quarter 2022 financial results on November 2, 2022, after market close. A conference call to discuss these results will occur at 4:30 PM ET on the same day. Interested participants can join by dialing 1-800-715-9871 (domestic) or 1-646-307-1963 (international) using passcode 5456289. A replay of the call will be available from 8:30 PM ET on November 2 until November 9, 2022.
Vanda Pharmaceuticals (Nasdaq: VNDA) announced that the FDA granted Orphan Drug Designation for VPO-227, a treatment for cholera. Despite low U.S. incidence, cholera poses significant global health risks, causing 21,000 to 143,000 deaths annually. VPO-227 blocks the CFTR ion channel, a key player in cholera-induced fluid loss. This designation offers benefits like tax credits and marketing exclusivity. Vanda plans to submit an Investigational New Drug (IND) application in 2023, exploiting the FDA's Tropical Disease Priority Review Voucher Program.
Vanda Pharmaceuticals (Nasdaq: VNDA) and OliPass Corporation have announced a collaboration to develop antisense oligonucleotide (ASO) therapeutics using OliPass' modified peptide nucleic acids. This partnership aims to enhance gene expression modulation in diseases with genetic underpinnings. Vanda has identified two ASO targets validated in disease models, focusing on a rare orphan condition and immuno-oncological diseases. The collaboration seeks to advance preclinical findings to clinical testing, leveraging OliPass' OPNA technology for improved therapeutic delivery.
Vanda Pharmaceuticals (NASDAQ: VNDA) will participate in the H.C. Wainwright Global Investment Conference in New York City on September 14, 2022, at 8:30 a.m. Eastern Time. Investors can access the live corporate presentation on Vanda's official website. The company is focused on developing innovative therapies for high unmet medical needs. An archived version of the presentation will be available for approximately 30 days after the conference.
On September 7, 2022, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced the opportunity for an FDA hearing regarding its Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) aimed at treating jet lag disorder. This follows a Complete Response Letter from the FDA received on August 19, 2019. Vanda submitted a hearing request on July 1, 2022, disputing the FDA's findings on the efficacy of their studies. The company remains committed to gaining approval for HETLIOZ® to address an unmet medical need.
Vanda Pharmaceuticals Inc. (VNDA) announced Q2 2022 revenues of $64.4 million, a 5% decline from Q2 2021. Net product sales for HETLIOZ® were $41.2 million (-7%), and Fanapt® sales were $23.2 million (-1%). The company reported a net income of $2.6 million, down from $9.7 million in Q2 2021. For the year-to-date, total revenues of $124.6 million also reflect a 5% decrease. Vanda expects total revenues for 2022 to range from $240 million to $280 million.
Vanda Pharmaceuticals (Nasdaq: VNDA) plans to release its second quarter 2022 financial results on August 3, 2022, after market close. A conference call to discuss the results will be held at 4:30 PM ET on the same day. Investors can access the call via phone or through Vanda's website, where a replay will be available from 8:30 PM ET on August 3 until 8:30 PM ET on August 10. Vanda focuses on developing therapies to meet significant medical needs.