Latest news with #AmnealPharmaceuticals
Yahoo
11-07-2025
- Business
- Yahoo
Amneal Pharmaceuticals (AMRX) Announces FDA Approval of Prednisolone Acetate Ophthalmic Suspension
Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is one of the 13 Best Healthcare Stocks to Buy Under $10. On June 12, Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) announced the FDA approval of prednisolone acetate ophthalmic suspension, with launch planned for Q3 2025. A pharmaceutical laboratory filled with shelves of medicines, highlighting the company's specialty drug production. Prednisolone acetate ophthalmic suspension, USP 1% is a topical, sterile anti-inflammatory agent for ophthalmic use and treatment of steroid-responsive ocular inflammation. Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines, stated that the Affordable Medicines portfolio is growing continuously, with a diverse and strong pipeline supporting 'broader access to high-quality treatments across the US healthcare system.' Boyer also stated that the prednisolone acetate ophthalmic suspension is a complex product to manufacture and develop, and its approval reflects the quality of Amneal Pharmaceuticals, Inc.'s (NASDAQ:AMRX) R&D capabilities and the strength of its supply and manufacturing operations. Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is a medicine company that develops pharmaceuticals, with a product portfolio spanning specialty, generics, biosciences, and product catalog. Its operations are divided into the Generics, Specialty, and AvKARE segments. While we acknowledge the potential of AMRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
04-07-2025
- Business
- Yahoo
Analysts Bullish as Amneal Pharmaceuticals, Inc. (AMRX) Director Sells Over 94K Shares
Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is among the best growth stocks to invest in for the next 5 years. Gautam Patel, the director of Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), sold 94,906 shares of Class A Common Stock, worth around $761,146, on June 16, 2025. The prices fluctuated between $8.00 and $8.05 per share, while the current trading price stands at $7.92. As a result of the transaction, Patel's stake now amounts to 1,609,144 shares of Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX). The sale was executed automatically in accordance with a pre-determined trading plan adopted on August 15, 2024, and in compliance with Rule 10b5-1(c). In general, analysts remain optimistic regarding the stock, with price targets ranging between $11 and $12 per share. A pharmaceutical laboratory filled with shelves of medicines, highlighting the company's specialty drug production. Just recently, analysts at Goldman Sachs reviewed the generic drug industry and initiated coverage on Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) with a positive outlook. The reasons cited were many, from current portfolio changes favoring higher-value products to the company's track record of business execution. With a 12-month price target of $12, the analyst supported the potential upside of over 50%. Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), headquartered in Bridgewater, New Jersey, is a leading biopharmaceutical company that develops and markets generics, injectables, biosimilars, and specialty branded pharmaceutical products. Founded in 2002, the company operates through three main segments: Affordable Medicines, Specialty, and AvKARE. The giant is committed to advancing innovation in healthcare. While we acknowledge the potential of AMRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Miami Herald
05-06-2025
- Health
- Miami Herald
Urinary tract infection drug recalled. Tablets could be tainted and deadly
Three lots of a drug designed to treat various urinary tract infections have been recalled because the white round tablets might have black spots from microbial contamination. The spotting of spots 'was reported in a product quality complaint,' Amneal Pharmaceuticals said in its FDA-posted recall notice about Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg. As for what problems this might cause, Amneal's notice said: 'Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.' Sulfamethoxazole/Trimethoprim is used for UTIs caused by a broad list of strains, among which are E. coli; middle-ear infections in children; streptococcus pneumoniae aka pneumococcus, which the Cleveland Clinic says can cause pneumonia, sepsis or bacterial meningitis; and 'traveler's diarrhea.' READ MORE: USDA public health alert: E. coli found in beef sent to Whole Foods stores What exactly has been recalled? Recalled tablets with 400 mg of Sulfamethoxazole and 80 mg Trimethoprim went to wholesalers and distributors around the nation from Dec. 4 through May 15. If you have these tablets but got them before Dec. 4, you're safe. Bottles in lot No.s AM241019 and AM241020 are 100-count bottles. Bottles in lot No. AM241019A have 500 tablets. If you're taking these drugs, for instructions on returning them or to ask questions about this recall, contact Amneal at 833-582-0812, Monday through Friday, 8 am. to 5 p.m., Eastern time; email sulfamethoxazole-trimethoprim-recall@ or fax to 631-983-2595. If you experience any medical problems, tell a medical provider. Then inform the FDA's MedWatch program, either online or by downloading a form, then faxing it to 800-332-0178. If you can't download a form, call 800-332-1088 to ask for a form. Then you should report the problem to Amneal at 877-835-5472, Monday through Friday, 8 a.m. to 6 p.m., Eastern time or by emailing DrugSafety@
Yahoo
29-05-2025
- Business
- Yahoo
Amneal to Participate at Upcoming Investor Conferences in June
BRIDGEWATER, N.J., May 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) will participate in two upcoming investor conferences: Jefferies Global Healthcare Conference on June 5, 2025, with company presentation at 9:20 AM ET, and Goldman Sachs Global Healthcare Conference on June 10, 2025, with fireside chat at 10:40 AM ET. Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Executive Vice President and Chief Financial Officer, will participate in both conferences. A live webcast will be accessible at with replays available following both events. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit and follow us on LinkedIn. Investor ContactAnthony DiMeoVP, Investor in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-05-2025
- Business
- Yahoo
AMRX Q1 Earnings Call: Miss on Revenue, Margin Expansion, and Product Pipeline Progress
Pharmaceutical company Amneal Pharmaceuticals (NASDAQ:AMRX) fell short of the market's revenue expectations in Q1 CY2025, but sales rose 5.5% year on year to $695.4 million. On the other hand, the company's full-year revenue guidance of $3.05 billion at the midpoint came in 0.8% above analysts' estimates. Its non-GAAP profit of $0.21 per share was 43.2% above analysts' consensus estimates. Is now the time to buy AMRX? Find out in our full research report (it's free). Revenue: $695.4 million vs analyst estimates of $720.2 million (5.5% year-on-year growth, 3.4% miss) Adjusted EPS: $0.21 vs analyst estimates of $0.15 (43.2% beat) Adjusted EBITDA: $170 million vs analyst estimates of $161.7 million (24.4% margin, 5.1% beat) The company reconfirmed its revenue guidance for the full year of $3.05 billion at the midpoint Management reiterated its full-year Adjusted EPS guidance of $0.68 at the midpoint EBITDA guidance for the full year is $662.5 million at the midpoint, in line with analyst expectations Operating Margin: 14.4%, up from -1.6% in the same quarter last year Free Cash Flow was -$5.75 million compared to -$13.61 million in the same quarter last year Market Capitalization: $2.35 billion Amneal's first quarter was shaped by steady revenue growth across its core generics and branded specialty segments, with management crediting robust uptake of the Parkinson's drug CREXONT and expansion in injectables for the period's performance. The company continued to benefit from a diverse portfolio, new product launches, and a growing U.S. manufacturing footprint, while leadership cited operational efficiency initiatives and favorable product mix as factors behind the improvement in margins. Co-CEO Chirag Patel highlighted, 'We are embarking on our next phase of growth with momentum and confidence in our ability to deliver on our goals in 2025 and beyond.' Looking ahead, Amneal's management remains focused on execution across multiple growth drivers, including the scaling of its biosimilars business and the anticipated launch of additional specialty products. The company reaffirmed its full-year guidance, pointing to upcoming milestones in its injectable and biosimilar portfolios, the expansion of GLP-1 manufacturing capabilities, and further market access for CREXONT. Management stated that ongoing investments in digitization and automation support its long-term strategy of becoming a leading supplier of affordable medicines. Amneal's leadership attributed the quarter's outcome to portfolio breadth, successful new launches, and efficiency gains. Revenue missed Wall Street's expectations, but adjusted profit and margins exceeded consensus due to product mix and cost controls. CREXONT launch momentum: CREXONT, Amneal's branded Parkinson's medication, continued to exceed early expectations, with rapid market share gains and expanded insurance coverage from 30% to 60% of U.S. covered lives in six months. Management cited strong patient and provider feedback and expects CREXONT to reach peak sales between $300 million and $500 million. Injectables and new launches: The affordable medicines segment grew through a mix of complex generic and injectable product launches. The company introduced BORUZU, its fourth 505(b)(2) injectable in a year, highlighting a strategic emphasis on hospital-ready formulations that improve efficiency and reimbursement for providers. Biosimilars as a growth vector: Amneal's first three biosimilars generated $125 million in revenue in the last year. Five additional biosimilar regulatory filings are planned for this year, with a goal of vertical integration to capture more value and address a market where many biologic drugs are losing exclusivity. U.S. manufacturing as a differentiator: Leadership underscored Amneal's large U.S. manufacturing footprint, producing two-thirds of its medicines domestically. This provides supply chain resilience and a potential advantage if tariffs on imported pharmaceuticals increase. GLP-1 partnership and facility buildout: The partnership with Metsera positions Amneal as a supplier and commercial partner for next-generation weight loss (GLP-1) therapies. Construction of new peptide and oral fill-finish facilities is underway, aiming to support future supply and contract manufacturing opportunities. Management's outlook for the coming quarters is anchored in the expansion of its specialty and biosimilar portfolios, operational leverage, and continued investment in manufacturing capacity, with a focus on mitigating external risks such as tariffs. Specialty and biosimilars expansion: Growth is expected from additional launches in the specialty segment—including the DHE autoinjector for migraines—and the scaling of biosimilar offerings, which management believes will drive both revenue and margin improvement. Operational efficiency initiatives: Investments in automation, digitization, and supply chain optimization are expected to enhance margins and support cost containment, even as the company ramps up new product introductions. Tariff and regulatory risk management: The company's U.S. manufacturing base and proactive inventory and sourcing strategies are intended to limit the impact of potential tariffs or regulatory delays, though management noted that economic viability and customer acceptance of any cost increases remain important variables. David Amsellem (Piper Sandler): Asked for details on biosimilar revenue contribution and vertical integration timing; leadership confirmed a $150–$160 million target for biosimilars this year and expects vertical integration options to be finalized by early next year. David Amsellem (Piper Sandler): Inquired about the focus between complex and shortage-driven injectables; management stated they are prioritizing both equally, with ongoing launches in each area and infrastructure to support growth. Les Sulewski (Truist Securities): Queried about AvKARE's exposure to federal cuts; management responded federal cuts do not apply to pharmaceuticals and sees ongoing volume growth in government channels. Les Sulewski (Truist Securities): Asked about FDA approval timelines and CREXONT's ex-U.S. expansion; management reported no FDA delays and outlined ongoing partnerships for CREXONT in Europe, Latin America, and Asia. Chris Schott (JPMorgan): Requested insight on leverage of U.S. manufacturing in the event of tariffs; management highlighted available capacity and willingness to increase domestic production if economically justified, with discussions ongoing with major customers about sharing potential cost increases. In the quarters ahead, the StockStory team will be monitoring (1) the commercial uptake and payer coverage expansion of CREXONT and upcoming specialty launches, (2) progress on biosimilar regulatory filings and the pace of vertical integration, and (3) operational milestones related to new manufacturing facility buildouts and the GLP-1 partnership with Metsera. Sustained margin improvement and execution on complex injectable launches will also be key indicators of strategic progress. Amneal currently trades at a forward P/E ratio of 10.7×. In the wake of earnings, is it a buy or sell? Find out in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. 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