Amneal Pharmaceuticals(AMRX)
Search documents
Take the Zacks Approach to Beat the Markets: Amneal Pharmaceuticals, Leidos & Vishay Precision in Focus
ZACKS· 2025-10-06 13:11
Market Performance - The U.S. stock market showed strong performance last week, with major indices like the S&P 500, Nasdaq Composite, and Dow Jones Industrial Average increasing by 0.82%, 0.84%, and 0.96% respectively [1] - Investor optimism was fueled by advancements in Artificial Intelligence and expectations for further interest rate cuts by the Federal Reserve, despite a partial government shutdown creating uncertainties [1] Consumer Confidence and Labor Market - The Conference Board's Consumer Confidence Index for September dropped by 3.6 points to 94.2, marking its lowest level since April, attributed to inflation and a weakening job market [2] - Job openings increased slightly by 19,000 to 7.227 million in August, while hiring decreased by 114,000 to 5.126 million according to the Job Openings and Labor Turnover Survey [2] Zacks Research Performance - Amneal Pharmaceuticals saw a stock increase of 29.9% since its Zacks Rank upgrade on July 25, outperforming the S&P 500's 5.5% increase [4][7] - Leidos Holdings experienced a 19.8% return following a Zacks Rank upgrade on July 28, also surpassing the S&P 500's 5.1% increase [5][7] - A hypothetical portfolio of Zacks Rank 1 stocks returned +8.64% in 2025 through September 1, compared to +7.60% for the S&P 500 index [5] Focus List and Model Portfolios - The Zacks Focus List portfolio returned 13.74% in 2025 through August 31, outperforming the S&P 500 index's 10.79% [12] - Intellia Therapeutics gained 85.9% and Shopify returned 38.3% over the past 12 weeks, significantly outperforming the S&P 500's 7% increase during the same period [11] Earnings Certain Admiral Portfolio (ECAP) - The ECAP returned +0.20% in Q2 2025, underperforming the S&P 500 index's +10.94% gain [16] - The portfolio aims to minimize capital loss by holding shares of companies with a proven track record of earnings stability over 20+ years [17] Earnings Certain Dividend Portfolio (ECDP) - Johnson & Johnson returned 20.9% and Home Depot increased by 6.3% over the past 12 weeks, benefiting from investor preference for quality dividend stocks amid market volatility [19] - The ECDP returned -3.17% in Q2 2025, compared to the S&P 500 index's +10.94% gain [20] Top 10 Stocks Performance - Goldman Sachs, part of the Zacks Top 10 Stocks for 2025, increased by 38% year-to-date, outperforming the S&P 500 index's 14.2% increase [22] - The Top 10 portfolio has produced a cumulative return of +2,369.7% since 2012, significantly outperforming the S&P 500 index's 522.5% [24]
3 Lesser-Known Healthcare Names With Major Upside in Store
MarketBeat· 2025-10-02 12:19
Industry Overview - The global healthcare market is projected to grow at a 6.9% CAGR, reaching over $22.3 trillion by 2033, driven by resilient demand linked to health needs and demographics rather than economic conditions [1] Company Highlights Sanuwave Health - Sanuwave Health Inc. has a market cap of just under $300 million and reported a surprise earnings beat in its second-quarter report, with a 42% year-over-year revenue increase [3][4] - The UltraMIST system, which promotes wound healing, saw sales increase by 61% year-over-year, contributing to a high gross margin of 78.3% [4] - The company's business model includes both one-time equipment purchases and recurring high-margin consumable components, supporting ongoing revenue growth [5] - Analysts have a positive outlook on Sanuwave, with a consensus price target suggesting a potential gain of approximately 59% from its current price [6] Amneal Pharmaceuticals - Amneal Pharmaceuticals Inc. focuses on generic pharmaceuticals and has a diversified portfolio, including FDA-approved products like Brekiya for migraines [7][8] - The company reported an EPS of 23 cents, exceeding analyst expectations, with a 3% year-over-year revenue increase and a 13% rise in adjusted EBITDA [8] - Amneal refinanced $2.7 billion in debt, reducing annual interest expenses by about $33 million, while maintaining a strong pipeline of drugs [9] - All five analysts rating Amneal shares have given a Buy recommendation, indicating an estimated 22% upside potential [9] Belite Bio - Belite Bio Inc. is a clinical-stage biotech firm developing treatments for unmet medical needs, including conditions like NASH and obesity [11][12] - The company has a promising clinical trial activity and ended the latest quarter with nearly $150 million in cash, indicating strong funding success [12] - Analysts are optimistic about Belite, with four out of five rating it as a Buy, suggesting a potential upside of nearly 32% [12]
Amneal Pharmaceuticals, Inc. (AMRX) Files BLA for XOLAIR® Biosimilar, Targets Multi-Billion-Dollar Market
Yahoo Finance· 2025-10-01 17:44
Core Insights - Amneal Pharmaceuticals, Inc. is actively enhancing its position in the healthcare sector through significant regulatory achievements and financial growth [1][5]. Regulatory Milestones - On September 26, Amneal submitted a Biologics License Application (BLA) for a biosimilar to XOLAIR® (omalizumab), targeting a multi-billion-dollar market related to asthma and other conditions [2]. - The company received multiple FDA approvals in September, including Bimatoprost Ophthalmic Solution 0.01% for glaucoma, with a market reference of approximately $685 million annually [3]. - Approval was also granted for Risperidone Extended-Release Injectable Suspension, expected to launch in Q4 2025, and Sodium Oxybate Oral Solution, expanding its specialty portfolio [3]. Financial Performance - In Q2 2025, Amneal reported revenue of $725 million, a 3% increase year-over-year, with net income of $22 million and a 13% rise in adjusted EBITDA to $184 million [4]. - The company has upgraded its full-year outlook, projecting adjusted EBITDA of $665–$685 million and EPS of $0.70–$0.75 [4]. Strategic Developments - Amneal completed a $2.7 billion debt refinancing, extending maturities to 2032 and reducing interest costs, which enhances financial flexibility for growth [5]. - The combination of regulatory successes and financial strategies positions Amneal for long-term expansion in complex generics and specialty medicines [5].
Amneal to Report Third Quarter 2025 Results on October 30, 2025
Globenewswire· 2025-09-30 20:05
Core Viewpoint - Amneal Pharmaceuticals, Inc. is set to release its third quarter 2025 financial results on October 30, 2025, prior to market opening, and will host an audio webcast for investors [1][2]. Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals primarily in the United States [3]. - The company operates in multiple segments, including Affordable Medicines, which focuses on complex product categories and therapeutic areas such as injectables and biosimilars, and Specialty, which emphasizes branded pharmaceuticals for central nervous system and endocrine disorders [3]. - Through its AvKARE segment, Amneal distributes pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets [3].
Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)
Globenewswire· 2025-09-26 12:00
Core Insights - Amneal Pharmaceuticals has submitted a Biologics License Application (BLA) for a proposed biosimilar to XOLAIR (omalizumab), marking a significant step into the U.S. market valued at over $4 billion [1][4][5] - The submission is expected to act as a growth catalyst for Amneal, with plans for additional biosimilar launches from 2026 to 2027 [4] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, focusing on the development, manufacturing, and distribution of over 280 pharmaceuticals [6] - The company is expanding its portfolio in complex product categories, including injectables and biosimilars, while also maintaining a growing specialty segment focused on central nervous system and endocrine disorders [6] Product Details - Omalizumab is a humanized monoclonal antibody used for treating moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria [2] - The drug carries a black boxed warning for anaphylaxis, necessitating administration in a healthcare setting with close patient monitoring [3] Market Potential - The U.S. annual sales for XOLAIR reached approximately $4.1 billion for the 12 months ending July 2025, highlighting the lucrative market opportunity for Amneal's biosimilar [4] Financial Implications - Due to the earlier-than-expected BLA submission, Amneal anticipates a $22.5 million R&D milestone charge in Q3 2025, which was previously expected in Q4 [5]
Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%
Globenewswire· 2025-09-23 12:00
Core Insights - Amneal Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01%, a generic equivalent of LUMIGAN® [1][4] - Bimatoprost is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension [2] - The approval is part of Amneal's strategy to expand its Affordable Medicines portfolio, addressing the rising prevalence of glaucoma, especially among the aging population [3] Financial Impact - The annual sales for bimatoprost ophthalmic solution 0.01% were approximately $685 million for the 12 months ending July 2025 [4] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals [5] - The company is expanding its Affordable Medicines segment across various complex product categories, including injectables and biosimilars [5]
Amneal's generic targeting Jazz Pharma’s Xyrem cleared (AMRX)
Seeking Alpha· 2025-09-11 15:56
Core Viewpoint - Amneal Pharmaceuticals received FDA approval for its generic version of Jazz Pharmaceuticals' sleep disorder therapy Xyrem, allowing market entry for the product [2] Company Summary - Amneal Pharmaceuticals' Abbreviated New Drug Application (ANDA) has been approved by the FDA, enabling the launch of its generic product [2]
Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution
Globenewswire· 2025-09-11 12:00
Core Insights - Amneal Pharmaceuticals has received FDA approval for its sodium oxybate oral solution 500 mg/mL, expanding its Affordable Medicines portfolio and providing a more affordable alternative for narcolepsy treatment [1][3]. Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. [4]. - The company operates in various segments, including Affordable Medicines, Specialty, and AvKARE, focusing on complex product categories and therapeutic areas [4]. Product Details - Sodium oxybate is a central nervous system depressant used to treat cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy [2]. - The approval of sodium oxybate oral solution addresses a critical therapy area for approximately 150,000 individuals in the U.S. living with narcolepsy [3]. Market Impact - The introduction of sodium oxybate by Amneal is significant as it provides patients, providers, and payers with a more affordable option in a market historically dominated by a single manufacturer [3].
Amneal Pharmaceuticals: A Large, Diversified Clinical Portfolio That Keeps Growing
Seeking Alpha· 2025-09-11 11:23
Core Insights - Albert Anthony is a Croatian-American business author and media contributor with a focus on real estate investment trusts (REITs) [1] - He has a background in IT analysis for Fortune 500 companies and experience in financial services with Charles Schwab [1] - Anthony is launching a book on REITs in 2025 and operates his own equities research firm remotely [1] Background and Experience - The author has participated in numerous business and innovation conferences in the EU and has a strong educational background, including degrees from Drew University [1] - He is currently pursuing the CMSA certification at the Corporate Finance Institute in Vancouver [1] - Anthony has also been involved in digital media, including a YouTube channel focused on REITs [1] Professional Focus - The firm does not engage with non-publicly traded companies, small-cap stocks, or startup CEOs [1] - Albert Anthony & Company provides general market commentary and research based on publicly available data [1] - The author does not hold material positions in any stocks rated at the time of writing unless disclosed [1]
Amylyx, Amneal, And Argenx Hit 52-Week Highs Amid Drug Pipeline Momentum And Strategic Catalysts
RTTNews· 2025-09-11 09:41
Core Insights - Multiple biotech companies are experiencing significant stock price increases, reaching new 52-week highs due to clinical advancements, regulatory milestones, and strategic funding initiatives [1] Company Summaries Amylyx Pharmaceuticals Inc. (AMLX) - On September 10, 2025, Amylyx reached a new 52-week high of $12.25, a substantial increase from its previous low of $2.47 [2] - The company announced a $175 million underwritten public offering of common stock, consisting of 17.5 million shares priced at $10.00 each, with an option for underwriters to purchase an additional 2.625 million shares [3] - Proceeds from the offering will support the commercial launch of avexitide, currently in Phase 3 trials, and fund ongoing research and development, general corporate purposes, and working capital [3] - Despite discontinuing the ORION program for AMX0035 due to disappointing results, Amylyx continues to advance other candidates, including AMX0035 for Wolfram syndrome and AMX0114 for ALS [4] Amneal Pharmaceuticals Inc. (AMRX) - On September 10, 2025, Amneal's stock reached a new 52-week high of $9.97 during intraday trading, closing at $9.82, reflecting a slight decline of 0.71% from the previous close [4][5] - The stock's performance is supported by the approval of its risperidone extended-release injectable suspension, enhancing its central nervous system portfolio [5] - Amneal is awaiting FDA decisions on biosimilar candidates for denosumab, with potential regulatory approval expected later in 2025, which could significantly boost revenue [6] - The company is also expanding its specialty portfolio with the rollout of Brekiya and the adoption of CREXONT, alongside a collaboration with Metsera to develop GLP-1 therapies [6] argenx SE (ARGX) - On September 10, 2025, argenx reached a new 52-week high of $779.03, closing slightly lower at $762.89, reflecting a modest intraday decline of 0.54% [7] - The increase in share price follows positive topline results from the ADAPT-SERON trial for VYVGART in seronegative generalized myasthenia gravis, which met its primary endpoint [8] - The successful trial positions argenx to pursue FDA label expansion for VYVGART, potentially broadening its market reach and revenue [8][9] - Upcoming milestones include an R&D spotlight webinar on ARGX-119 and expected label expansion decisions for VYVGART-SC in Japan and Canada by year-end [10]