Vanda Pharmaceuticals (NASDAQ:VNDA) shares are up during Wednesday’s premarket session following the FDA’s approval of Bysanti, a new oral treatment for bipolar I disorder and schizophrenia, as well as the company’s rare skin disease drug is under FDA review.This approval marks a significant milestone for Vanda, as it positions the company to potentially capture a substantial market share in these therapeutic areas, which is reflected in the stock’s positive movement following the news.Seeks FDA Approval Fo ...

are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's assumptions regarding how imsidolimab achieves its therapeutic effect; Vanda's ability to obtain FDA approval ...

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...

Market Overview - The Dow Jones Industrial Average fell 689 points, or 1.39%, closing at 48,936.45, raising concerns of a broader market crash [1][24] - The S&P 500 and Nasdaq Composite also declined, with the S&P 500 down 0.67% to 6,863.01 and the Nasdaq down 0.60% to 22,749.39 [1][11] Tariff Impact - A primary driver of the market decline is the announcement of a 15% global tariff increase, which raises import costs and could lead to inflation and squeezed profit margins for multinational companies [3][24] - The Dow is more sensitive to global trade issues compared to tech-heavy indexes, as many of its components rely on international supply chains [5][24] Investor Sentiment - Investors are reacting to uncertainty surrounding the tariffs, with fears of retaliation from Europe and other economies, as well as concerns over whether official tariff documents have been signed [6][7][24] - The Nasdaq's decline indicates a risk-off behavior, with growth and technology stocks typically falling during periods of macro uncertainty [8][24] Commodity Movements - Gold prices surged 2.7% to $5,217.90, reflecting increased inflation fears and geopolitical uncertainty, while silver gained 5.25% [2][9][12] - Oil prices also rose, suggesting that markets are pricing in inflation risk rather than an immediate demand collapse [9][13] Cryptocurrency Trends - Bitcoin fell below $66,000, indicating stress in crypto markets, as it continues to behave like a risk asset during periods of market volatility [10][14][24] Federal Reserve Position - The Federal Reserve is taking a cautious approach to future interest rate decisions, with Governor Christopher Waller indicating that tariff-related inflation may be short-lived [15][24] - The Fed's decisions will be data-dependent, and rate cuts are not expected in March unless economic data deteriorates significantly [21][24] Market Outlook - Investors are questioning whether the current market conditions represent a short-term selloff or the beginning of a deeper correction, with tariff uncertainty being the dominant market driver [19][25] - Upcoming events, including the March 6 jobs report and the Fed's March meeting, will be critical in determining market direction [23][25]

Core Insights - Vanda Pharmaceuticals experienced a significant stock price increase of approximately 45% following the FDA's approval of its treatment for schizophrenia and bipolar I disorder [1] Company Summary - The FDA has granted approval for Vanda Pharmaceuticals' treatment, which is expected to enhance the company's market position in the psychiatric treatment sector [1]

Vanda Pharmaceuticals (NASDAQ:VNDA) shares are trading higher during the premarket session on Monday following the announcement of FDA approval for Bysanti (milsaperidone), a new treatment for bipolar I disorder and schizophrenia.FDA ApprovalThe FDA’s approval of Bysanti marks a significant milestone for Vanda, as it is positioned as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults.Bysanti is a new chemical entity (NCE ...

To add Benzinga News as your preferred source on Google, click here .Here are some other stocks moving in pre-market trading.Shares of Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) rose sharply in pre-market trading after the company reported the FDA approval of BYSANTI™ (milsaperidone) for the treatment of bipolar I disorder and schizophrenia – a new chemical entity opening new horizons in psychiatric innovation. ...

Core Viewpoint - Vanda Pharmaceuticals Inc. (VNDA) shares surged over 40% in after-hours trading following FDA approval of BYSANTI, a new treatment for bipolar I disorder and schizophrenia in adults [1] Group 1: Product Approval and Market Impact - The FDA has approved BYSANTI as a first-line therapy for acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults [1] - BYSANTI is expected to be commercially available in the third quarter of this year [1] - Following the approval, VNDA shares closed at $5.76, down 5.57% during regular trading, but rose to $8.30 in after-hours trading [3] Group 2: Intellectual Property and Future Developments - BYSANTI will be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, which supports long-term innovation and patient benefits [2] - This approval marks the second new drug for Vanda in less than two months, following the approval of NEREUS for motion-induced vomiting in December 2025 [3] - A phase 3 trial for BYSANTI as a once-daily adjunctive treatment for major depressive disorder (MDD) is currently underway, with results expected this year [3] Group 3: Stock Performance - VNDA has traded between $3.81 and $9.60 over the past year [3]

US FDA approves Vanda's psychiatric drug | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo [Purchase Licensing Rights, opens new tab]- Companies[Vanda Pharmaceuticals Inc]FollowFeb 20 (Reuters) - The U.S. Food and Drug Administration has approved Vanda Pharmaceutical's [(VNDA.O ...

Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at [www.sec.gov].All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is ...