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Vanda Pharmaceuticals Inc. (VNDA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-15 22:26
Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on innovating to enhance people's happiness [2] - The company employs an innovation-led strategy with a successful track record in developing and commercializing therapies over decades [2] Product Portfolio - Vanda has a robust commercial portfolio anchored by four FDA-approved brands: Fanapt (atypical antipsychotic), HETLIOZ (for two orphan sleep disorders), PONVORY (for multiple sclerosis), and the recently approved NEREUS (for motion-induced vomiting) [3] - The company maintains a strong debt-free balance sheet, providing substantial capital for R&D and commercial activities [3] Pipeline and Growth Potential - Vanda has a late-stage growth pipeline with numerous high-potential programs targeting significant unmet needs in billion-dollar markets [4] - The company is positioned for imminent regulatory catalysts, including the recently approved NEREUS [4]
Weekly Buzz: ARS Pharma's Neffy Goes East, SLS Advances, A Signal Of Hope For IFRX?
RTTNews· 2026-01-02 11:37
FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].
S&P 500 Falls For Fourth Session But Records Gains In 2025: Investor Sentiment Declines, Fear & Greed Index Remains In 'Neutral Zone - Vanda Pharmaceuticals (NASDAQ:VNDA)
Benzinga· 2026-01-02 07:06
Market Sentiment - The CNN Money Fear and Greed index showed a decline in overall market sentiment, remaining in the "Neutral" zone with a current reading of 45.8, down from 48.4 [1][4] - U.S. stocks settled lower, with the Dow Jones index falling more than 300 points, closing at 48,063.29, while the S&P 500 and Nasdaq Composite also recorded declines [1][3] Stock Performance - The S&P 500 increased by 16.39% for the year, marking its third consecutive double-digit annual surge, while the Nasdaq Composite gained 20.36% and the Dow added 12.97% in 2025 [2] - Vanda Pharmaceuticals Inc. saw its shares jump over 25% after receiving FDA approval for NEREUS, aimed at preventing motion-induced vomiting [2] - FuelCell Energy Inc. experienced an 8% decline in its shares following the filing for an amended common stock offering [2] Economic Data - U.S. initial jobless claims decreased by 16,000 to 199,000 for the week ending December 27, which was better than market estimates of 220,000 [3] - All sectors on the S&P 500 closed negatively, with real estate, industrials, and materials stocks experiencing the largest losses [3]
S&P 500 Falls For Fourth Session But Records Gains In 2025: Investor Sentiment Declines, Fear & Greed Index Remains In 'Neutral Zone
Benzinga· 2026-01-02 07:06
Market Sentiment - The CNN Money Fear and Greed index showed a decline in overall market sentiment, remaining in the "Neutral" zone with a current reading of 45.8, down from 48.4 [1][4] - U.S. stocks settled lower, with the Dow Jones index falling more than 300 points, closing at 48,063.29, while the S&P 500 and Nasdaq Composite also recorded declines [1][3] Stock Performance - The S&P 500 increased by 16.39% for the year, marking its third consecutive double-digit annual surge, while the Nasdaq Composite gained 20.36% and the Dow added 12.97% in 2025 [2] - Vanda Pharmaceuticals Inc. saw its shares jump over 25% after receiving FDA approval for NEREUS, aimed at preventing motion-induced vomiting [2] - FuelCell Energy Inc. experienced an 8% decline in its shares following the filing for an amended common stock offering [2] Economic Data - U.S. initial jobless claims decreased by 16,000 to 199,000 for the week ending December 27, which was better than market estimates of 220,000 [3] - All sectors on the S&P 500 closed negatively, with real estate, industrials, and materials stocks recording the largest losses [3]
Nasdaq Moves Lower; US Crude Oil Inventories Decline Sharply
Benzinga· 2025-12-31 17:56
Market Overview - U.S. stocks traded lower, with the Dow Jones index falling more than 100 points, down 0.28% to 48,229.87, NASDAQ down 0.26% to 23,359.33, and S&P 500 down 0.26% to 6,878.07 [1] - European shares were also lower, with the eurozone's STOXX 600 slipping 0.14%, Spain's IBEX 35 Index down 0.27%, London's FTSE 100 down 0.09%, and France's CAC 40 down 0.23% [6] - Asian markets closed mixed, with Hong Kong's Hang Seng Index falling 0.87%, China's Shanghai Composite gaining 0.09%, and India's BSE Sensex gaining 0.64% [7] Commodities - Oil traded up 0.1% to $58.02, while gold traded down 0.8% at $4,351.00, silver down 7.3% to $72.255, and copper fell 1.9% to $5.6710 [5] Company News - Anghami Inc. shares surged 50% to $3.7306 after reporting a year-over-year increase in H1 results [9] - Vanda Pharmaceuticals Inc. shares rose 32% to $9.28 following FDA approval of NEREUS for motion-induced vomiting prevention [9] - Intelligent Bio Solutions Inc. shares increased 102% to $8.27 after announcing a strategic manufacturing partnership with Syrma Johari MedTech [9] - Corcept Therapeutics Incorporated shares dropped 52% to $34.04 after receiving a Complete Response Letter from the FDA for Relacorilant [9] - FuelCell Energy, Inc. shares fell 10% to $7.18 after filing for an amended common stock offering [9] - SMX (Security Matters) Public Limited Company shares decreased 37% to $32.30 [9] Economic Indicators - U.S. initial jobless claims declined by 16,000 to 199,000, compared to market estimates of 220,000 [10] - U.S. crude oil inventories, excluding the Strategic Petroleum Reserve, dipped by 1.934 million barrels, marking the largest weekly decline since mid-November, against market estimates of a 0.9 million-barrel fall [2][10]
Nasdaq Moves Lower; US Crude Oil Inventories Decline Sharply - Anghami (NASDAQ:ANGH), Corcept Therapeutics (NASDAQ:CORT)
Benzinga· 2025-12-31 17:56
Market Overview - U.S. stocks experienced a decline, with the Dow Jones index falling over 100 points, down 0.28% to 48,229.87, NASDAQ slipping 0.26% to 23,359.33, and S&P 500 dropping 0.26% to 6,878.07 [1] - European shares also fell, with the eurozone's STOXX 600 down 0.14%, Spain's IBEX 35 Index down 0.27%, London's FTSE 100 down 0.09%, and France's CAC 40 down 0.23% [6] - Asian markets closed mixed, with Hong Kong's Hang Seng Index down 0.87%, China's Shanghai Composite up 0.09%, and India's BSE Sensex up 0.64% [7] Commodities - In commodity trading, oil increased by 0.1% to $58.02, while gold decreased by 0.8% to $4,351.00. Silver fell 7.3% to $72.255, and copper dropped 1.9% to $5.6710 [5] Company News - Anghami Inc. shares surged 50% to $3.7306 following a year-over-year increase in H1 results [9] - Vanda Pharmaceuticals Inc. saw a 32% increase in shares to $9.28 after receiving FDA approval for NEREUS [9] - Intelligent Bio Solutions Inc. shares rose 102% to $8.27 due to a strategic manufacturing partnership with Syrma Johari MedTech [9] - Corcept Therapeutics Incorporated shares plummeted 52% to $34.04 after receiving a Complete Response Letter from the FDA [9] - FuelCell Energy, Inc. shares fell 10% to $7.18 after filing for an amended common stock offering [9] - SMX Public Limited Company shares dropped 37% to $32.30 [9] Economic Indicators - U.S. initial jobless claims decreased by 16,000 to 199,000, better than market estimates of 220,000 [10] - U.S. crude oil inventories, excluding the Strategic Petroleum Reserve, fell by 1.934 million barrels, marking the largest weekly decline since mid-November, compared to market estimates of a 0.9 million-barrel decrease [10][2]
Why FuelCell Energy Shares Are Trading Lower By Around 9%? Here Are Other Stocks Moving In Wednesday's Mid-Day Session - Antelope Ent Hldgs (NASDAQ:AEHL), Aimei Health Technology (NASDAQ:AFJK)
Benzinga· 2025-12-31 17:40
Summary of Key Points Core Viewpoint - FuelCell Energy, Inc. (NASDAQ:FCEL) experienced a significant decline in share price following the announcement of an amended common stock offering, which allows the company to sell up to $200 million in shares [1]. Company Specifics - FuelCell Energy shares dropped by 8.9%, closing at $7.23 after the announcement of the amended sales agreement [1]. - Intelligent Bio Solutions Inc. (NASDAQ:INBS) saw a remarkable increase of 107% in share price, reaching $8.51, due to a strategic manufacturing partnership with Syrma Johari MedTech [4]. - ESH Acquisition Corp. (NASDAQ:ESHA) gained 59% to $22.86, while Northann Corp. (NYSE:NCL) rose by 58.2% to $0.3071 [4]. - Aimei Health Technology Co., Ltd (NASDAQ:AFJK) shares surged by 50.3% to $127.00 [4]. - Anghami Inc. (NASDAQ:ANGH) reported a year-over-year increase in H1 results, leading to a 44.6% rise in share price to $3.6000 [4]. - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares increased by 33.1% to $9.36 after receiving FDA approval for NEREUS [4]. - Datavault AI Inc. (NASDAQ:DVLT) gained 32% to $0.6802, while Oriental Rise Holdings Limited (NASDAQ:ORIS) jumped 31% to $1.6001 following a non-binding letter of intent to acquire Hubei Daguan Tea Industry Group [4]. - Urgent.ly Inc. (NASDAQ:ULY) rose 31% to $3.6000 after adjourning its annual stockholder meeting due to insufficient votes [4]. - Momentus Inc. (NASDAQ:MNTS) gained 26.4% to $6.53, and Axsome Therapeutics, Inc. (NASDAQ:AXSM) rose 16.1% to $172.90 after announcing plans to file a new drug application [4]. Market Movements - Corcept Therapeutics Incorporated (NASDAQ:CORT) saw a significant decline of 50.8% to $34.51 after receiving a Complete Response Letter from the FDA [4]. - SMX (Security Matters) Public Limited Company (NASDAQ:SMX) fell 39.2% to $31.30, while Delixy Holdings Limited (NASDAQ:DLXY) dipped 37.2% to $0.8853 [4]. - MultiSensor AI Holdings, Inc. (NASDAQ:MSAI) declined by 30.7% to $0.2831, and Profusa, Inc. (NASDAQ:PFSA) fell 21.3% to $0.0958 after announcing a new distributor partnership in France [4]. - NIO Inc. (NYSE:NIO) experienced a drop of 9.2% to $4.9950, and Wheels Up Experience Inc. (NYSE:UP) fell 6.3% to $0.5844 [4].
Axsome Therapeutics, Plug Power And Other Big Stocks Moving Higher On Wednesday - Aimei Health Technology (NASDAQ:AFJK), Axsome Therapeutics (NASDAQ:AXSM)
Benzinga· 2025-12-31 15:12
Core Insights - U.S. stocks experienced a decline, with the Dow Jones index dropping over 100 points on Wednesday [1] Group 1: Axsome Therapeutics - Axsome Therapeutics, Inc. (NASDAQ:AXSM) shares surged 16.1% to $172.90 after announcing plans to file a new drug application for AXS-12 in January following FDA feedback [1] - The FDA granted Priority Review to Axsome's AXS-05 for Alzheimer's Agitation [1] Group 2: Other Notable Stock Movements - Aimei Health Technology Co., Ltd (NASDAQ:AFJK) shares increased by 50.3% to $127.00 [3] - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) saw a gain of 34.4% to $9.45 after receiving FDA approval for NEREUS, aimed at preventing motion-induced vomiting [3] - Jyong Biotech Ltd. (NASDAQ:MENS) rose 11.8% to $4.7107 [3] - SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) increased by 7.5% to $3.5598 [3] - Empresa Distribuidora y Comercializadora Norte Sociedad Anónima (NYSE:EDN) rose 6% to $31.93 [3] - mF International Limited (NASDAQ:MFI) gained 4.8% to $19.46 [3] - Plug Power Inc. (NASDAQ:PLUG) increased by 4.1% to $2.0150, with Clear Street analyst Tim Moore upgrading the stock from Hold to Buy and lowering the price target from $3.5 to $3 [3]
U.S. Stock Futures Dip on Year’s Final Day as “Santa Rally” Hopes Fade, Fed Outlook Divides Investors
Stock Market News· 2025-12-31 11:07
Market Overview - The U.S. stock market is closing 2025 on a cautious note, with major index futures edging lower, extending a three-session losing streak, and hopes for a year-end "Santa Claus" rally fading [1] - Despite the recent pullback, 2025 has been a remarkable year for equities, with the S&P 500 poised for its third consecutive year of double-digit gains [1] Premarket Trading and Futures Movements - As of early Wednesday, U.S. stock futures indicated a softer open, with Nasdaq 100 futures down 0.43%, S&P 500 futures down 0.28%, and Dow Jones futures down 0.14% [2] - The S&P 500, Nasdaq Composite, and Dow Jones all finished slightly lower on Tuesday, marking the third consecutive day of losses [2] Commodities Market - Crude oil futures were trading lower by 0.38%, around $57.72 per barrel, while Gold Spot was down 0.35% to approximately $4,324.59 per ounce [3] Major Market Indexes Performance - The S&P 500 is on track for an annual gain of 17-18%, the Dow Jones has advanced 13-14%, and the Nasdaq Composite has jumped nearly 21% in 2025 [4] - This performance marks the S&P 500's third consecutive year of double-digit returns, a rare achievement since the 1940s [4] Federal Reserve Outlook - The Federal Reserve is expected to cut rates in 2026, with uncertainty regarding the extent and pace due to internal divisions and mixed economic data [6] - The FOMC approved a quarter-point reduction in December 2025, bringing the main interest rate to a range between 3.5% and 3.75% [6] - Inflation remains above the Fed's 2% target, with unemployment rising to 4.6% in November and only 64,000 jobs added [6] Corporate Developments - Vanda Pharmaceuticals shares surged over 18% after receiving FDA approval for its drug NEREUS [13] - Nike shares rose 1.54% following CEO Elliott Hill's purchase of approximately $1 million in company shares [13] - Nvidia's stock surged approximately 180% in 2025, driven by robust demand for AI chips, with ByteDance planning to increase spending on Nvidia's AI chips to around $14 billion in 2026 [13] - Urgent.ly Inc. shares rose significantly after the adjournment of its annual stockholder meeting [13] - Applied Digital announced a proposed merger with EKSO Bionics, leading to a 40% surge in EKSO shares [13] - FONAR Corporation shares surged 28.4% after confirming its acquisition by an insider-led group [13] - Society Pass Incorporated shares jumped 16.4% following a newly priced public offering [13] - Palantir and Tesla saw their shares decline amidst concerns about technology giants' capital expenditures [13] - Boeing shares advanced 0.6% after being awarded an $8.58 billion contract by the Defense Department [13] - Meta Platforms shares ended up 1.1% following its acquisition of an AI startup for over $2 billion [13]
Stock Market Today: S&P 500, Dow Jones Futures Down As Santa Rally Hopes Fade—Investors Await Initial Jobless Claims Report - SPDR S&P 500 (ARCA:SPY)
Benzinga· 2025-12-31 09:09
Market Overview - U.S. stock futures are down on New Year's Eve, with markets closing lower on Tuesday, diminishing hopes for a year-end Santa Claus rally [1] - The Dow Jones, S&P 500, Nasdaq 100, and Russell 2000 all experienced declines in premarket trading [4] - The 10-year Treasury bond yielded 4.12%, while the two-year bond was at 3.44%, with an 82.8% likelihood of the Federal Reserve maintaining current interest rates in January [3] Stocks in Focus - iSpecimen Inc. (NASDAQ:ISPC) shares rose 36.95% pre-market after announcing a $5.5 million private placement [6] - Anghami Inc. (NASDAQ:ANGH) shares increased by 56% following a report of a 97% year-over-year revenue surge [6] - Urgent.ly Inc. (NASDAQ:ULY) saw a significant rise of 52.49% on Tuesday and an additional 26.81% pre-market on Wednesday after adjourning its annual stockholder meeting [6] - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares climbed 19.06% pre-market after FDA approval of its new drug for motion-induced vomiting [13] - Core AI Holdings Inc. (NASDAQ:CHAI) shares increased by 2.78% after announcing a divestiture agreement, despite a previous drop of 5.75% [13] Economic Indicators - Investors are anticipating the Initial Jobless Claims report set to be released before market opening [2][11]