News & Events zu Vanda Pharmaceuticals Inc (VNDA)VNDAVanda Pharmaceuticals Inc

Vanda Pharmaceuticals' Nereus Significantly Reduces GLP-1 Related Vomiting

Vanda Pharmaceuticals announced results from Study 3601, a Phase III randomized, placebo-controlled study evaluating Nereus, an oral neurokinin-1, or NK-1, receptor antagonist, for the prevention of vomiting associated with GLP-1 receptor agonist therapy. The study showed significant reduction in overall vomiting episodes and extreme vomiting episodes. Based on the totality of data from the Phase II and Phase III programs, Vanda intends to discuss the results with the FDA and is planning a supplemental new drug application, or sNDA, to support the use of Nereus for the prevention of vomiting associated with GLP-1 receptor agonist therapy. Nereus reduced the incidence of any vomiting. Vomiting occurred in 43.0% of Nereus-treated participants compared with 58.5% on placebo, a 27% relative reduction. The key secondary endpoint of any vomiting together with worst nausea greater than or equal to3 occurred in 33.1% of participants on Nereus versus 50.6% on placebo, a 35% relative reduction. Exploratory analyses examined higher-intensity vomiting patterns. The proportion of participants with frequent vomiting-defined as more than 2 episodes on more than one day-was 6.3% with Nereus versus 15.9% with placebo, a 60% relative reduction. The proportion with extreme vomiting was 2.8% with Nereus versus 14.6% with placebo, corresponding to an 81% relative reduction. These analyses are post hoc and are presented as supportive evidence of a reduction in higher-burden vomiting. A similar approximately 80% relative reduction in extreme vomiting was observed in the Phase II study. Almost all vomiting episodes in either group occurred by Day 2. Vomiting rates peaked on Day 1, and the absolute separation between Nereus and placebo was greatest on Days 1 and 2. After Day 2, few additional participants began vomiting. These observations indicate that early prevention-dosing prior to initiation or dose escalation and in the first days after dosing of the GLP-1 analog-is the most impactful window for reducing vomiting.

Vanda Pharmaceuticals VQW-765 Clinical Trial Fails to Meet Primary Endpoint

Vanda Pharmaceuticals provided an update on its clinical development program for VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor partial agonist. Vanda's Phase III clinical study, VP-VQW-765-3201, which evaluated VQW-765 for the on-demand treatment of acute anxiety in adults with social anxiety disorder, did not meet its primary endpoint. Study 3201 was a multicenter, randomized, double-blind, placebo-controlled Phase III study conducted at approximately 30 clinical sites in the U.S. The study randomized 546 adults 18 to 65 years of age with a current diagnosis of social anxiety disorder and elevated baseline scores on the Liebowitz Social Anxiety Scale and Public Speaking Anxiety Scale. Participants received a single oral dose of VQW-765 or placebo in a 1:1 ratio and were then challenged with a psychosocial stress test, the standardized Trier Social Stress Test. The TSST induces acute stress by having participants prepare (anticipation phase) and then deliver (performance phase) an interview-style presentation to a panel that gives no feedback or encouragement. The primary endpoint was the level of distress during the performance phase of the TSST in the female population, as measured by the Subjective Units of Distress Scale, on which participants rate their nervousness or distress from 0 to 100, with higher scores indicating greater distress. Female participants who received VQW-765 did not show a statistically significant difference from those who received placebo. The study also did not meet the key secondary endpoint of SUDS during the performance phase of the TSST in the full population. Study 3201 was designed to confirm the findings of Vanda's earlier Phase II clinical study, VP-VQW-765-2201 (Study 2201), in which participants with a history of performance anxiety who received VQW-765 reported numerically lower stress levels during the TSST than those who received placebo. The Phase III results did not confirm those findings. "We are disappointed that Study 3201 did not confirm the earlier Phase II findings2 for VQW-765 in patients with social anxiety disorder," said Mihael Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "We thank the participants, investigators and site staff who made this study possible." Given these results, the VQW-765 program is on hold pending further analysis of the full dataset.

Stock Futures Rise, Boeing Up 3%

Stock futures were higher after the Fed's preferred gauge showed core inflation at 3.0% in August, which was lighter than expected.In pre-market trading, S&P 500 futures were up 0.34%, Nasdaq futures were up 0.5%, and Dow futures were up 0.31%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Boeingup 3% after being selected to produce the U.S. Navy's F/A-XX Strike Fighter for over $20BAchieve Life Sciencesup 4% after Stifel initiated coverage with a Buy ratingGameStopup 2% after Chairman and CEO Ryan Cohen purchased $10.6M worth of sharesRobinhoodup 5% after unveiling Robinhood Agents and extending equities trading to 24-7Vandaup 4% after saying Hetlioz met its primary endpoint in a late-stage trial for adults with Delayed Sleep-Wake Phase DisorderDOWN AFTER EARNINGS -Cal-Mainedown 7%Concentrixdown 8%FactSetdown 3%Jabil Circuitdown 3%Conagradown 3%LOWER -Northrop Grummandown 4% after Boeing was selected to build a next-generation fighter jet by the PentagonModernadown 8% after Citi downgraded the stock to Sell