Welcome to our dedicated page for Vanda Pharmaceuticals news (Ticker: VNDA), a resource for investors and traders seeking the latest updates and insights on Vanda Pharmaceuticals stock.
Vanda Pharmaceuticals Inc., traded under the symbol VNDA on Nasdaq, is a specialty biopharmaceutical company dedicated to the development and commercialization of innovative therapies. Vanda's primary focus is on addressing high unmet medical needs to improve the lives of patients. The company's commercial portfolio includes HETLIOZ for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome, and Fanapt for schizophrenia. Recently added to its portfolio is PONVORY, a treatment for multiple sclerosis.
Other promising products in Vanda's pipeline include VHX-896, ASO Molecules, VQW-765, Tradipitant (in clinical studies for gastroparesis and motion sickness), and VTR-297. Vanda's robust R&D efforts are highlighted by substantial advancements, such as the initiation of clinical programs in conditions like depression, psoriasis, ulcerative colitis, and pediatric insomnia.
In recent financial news, Vanda reported a net loss of $4.1 million for Q1 2024, a shift from a net income of $3.3 million in Q1 2023. Despite this, the company maintains a strong cash position and expects significant growth from upcoming milestones, including the launch of Fanapt in acute bipolar I disorder and PONVORY in multiple sclerosis.
Recently, Vanda made headlines with the FDA approval of tradipitant for preventing vomiting induced by motion sickness, and the commencement of a comprehensive marketing program for PONVORY following its acquisition from a Johnson & Johnson company. Additional corporate activities involve evaluating unsolicited acquisition proposals, indicating a strategic interest in Vanda’s innovative portfolio.
For more detailed information, investors can visit www.vandapharma.com and follow Vanda on social media platforms.
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced an update regarding its appeal in the HETLIOZ® ANDA litigation. The company appealed a ruling from December 13, 2022, by the United States District Court for Delaware to the Federal Circuit. A temporary injunction has been granted, preventing Teva Pharmaceuticals and Apotex from entering the market until at least January 6, 2023. Vanda seeks to extend this injunction while the appeal is considered, critical for protecting its HETLIOZ® market position.
Vanda Pharmaceuticals (Nasdaq: VNDA) has announced its response to a ruling in the HETLIOZ® ANDA Litigation. The court ruled that Teva and Apotex did not infringe on Vanda's patents related to HETLIOZ® (tasimelteon) and declared several of Vanda's patent claims invalid. Vanda plans to appeal the decision and will seek a stay on the market entry of Teva and Apotex during the appeal process. The litigation is limited to the U.S., and HETLIOZ® remains approved in the EU, unaffected by this ruling.
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.
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