Nereus (tradipitant)
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Immuneering, Phathom Pharmaceuticals, Canadian Solar And Other Big Stocks Moving Lower In Thursday's Pre-Market Session - Canadian Solar (NASDAQ:CSIQ), Elme (NYSE:ELME)
Benzinga· 2026-01-08 13:06
Core Insights - U.S. stock futures are lower, with Dow futures dropping over 100 points on Thursday [1] - Immuneering Corp's shares fell 20.7% to $6.61 in pre-market trading following the announcement of updated survival and safety data from its Phase 2a trial for pancreatic cancer [1] Company Movements - Elme Communities shares decreased 82.8% to $2.98 in pre-market trading [3] - Erasca Inc shares fell 14% to $4.45 after a previous rise of 42% on Wednesday [3] - Phathom Pharmaceuticals Inc shares dropped 13.7% to $15.60 after announcing a $130 million public offering [3] - United Microelectronics Corp shares declined 6.3% to $8.37 after a 10% increase on Wednesday due to reported sales growth [3] - Canadian Solar Inc shares decreased 6.1% to $20.68 following a proposed $200 million public offering [3] - Trevi Therapeutics Inc shares fell 6.1% to $11.00 in pre-market trading [3] - Revolution Medicines Inc shares dipped 6% to $96.57 after reports that AbbVie is not in discussions with the company [3] - Sibanye Stillwater Ltd shares decreased 5.7% to $15.01 in pre-market trading [3] - Vanda Pharmaceuticals Inc shares fell 5% to $8.11 despite FDA approval of its product to prevent motion-induced vomiting [3] - Logitech International SA shares declined 4.8% to $94.91 ahead of its third quarter fiscal year 2026 financial results release [3]
VNDA Obtains FDA Nod for Motion Sickness Drug, Stock Gains
ZACKS· 2025-12-31 13:40
Core Insights - Vanda Pharmaceuticals, Inc. (VNDA) received FDA approval for its drug tradipitant, branded as Nereus, for preventing motion sickness-induced vomiting, marking the first new pharmacologic therapy for this condition in over 40 years [1][2][8] - Following the announcement, VNDA shares surged 18% in after-hours trading on December 30 and continued to rise in pre-market trading on December 31 [1][8] Company Developments - The efficacy of Nereus is backed by three clinical studies, including two phase III trials conducted at sea, demonstrating its effectiveness in individuals with a history of motion sickness [3] - VNDA is also exploring tradipitant for other conditions, including gastroparesis and nausea associated with GLP-1 receptor agonists, which are common side effects in obesity and diabetes treatments [4] - VNDA's stock has increased by 38.6% over the past three months, outperforming the industry growth of 13.9% [5] Regulatory Updates - VNDA has established a collaborative framework with the FDA to resolve disputes regarding tradipitant and Hetlioz, with an expedited re-review of the clinical hold on tradipitant's long-term studies now set for completion by December 5, 2025 [6][9] - The FDA has agreed to pause ongoing administrative proceedings related to VNDA's new drug application for tradipitant in gastroparesis until January 7, 2026 [10] - VNDA has submitted a Biologics License Application (BLA) for imsidolimab, a novel treatment for generalized pustular psoriasis, expanding its portfolio in rare diseases [13] Future Prospects - VNDA has multiple upcoming regulatory catalysts, including FDA reviews for Bysanti (milsaperidone) targeting bipolar I disorder and schizophrenia, with a target action date of February 21, 2026 [14]