Latest news with #AmnealPharmaceuticals
Yahoo
6 days ago
- Business
- Yahoo
Knight Therapeutics Announces Regulatory Submission of CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Mexico
MONTREAL, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has submitted a marketing authorization application for CREXONT® to COFEPRIS, the Mexican health regulatory agency, for the treatment of Parkinson's disease (PD), post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson's disease. In January 2024, Knight announced that it had entered into an agreement with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal") for the exclusive rights to seek regulatory approval and commercialize CREXONT® in Canada and Latin America. In July 2025, Knight announced that CREXONT® submission was accepted for review by Health Canada. 'This submission of CREXONT® in Mexico demonstrates Knight's continued execution of our strategy to expand our neurology portfolio,' said Samira Sakhia, President and Chief Executive Officer of Knight. 'There is a high unmet medical need in the treatment of Parkinson's disease, and we are confident that, with CREXONT®, we will be bringing a much-needed novel treatment option to Parkinson's patients.' About CREXONT® CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) capsule that combines both immediate-release granules and extended-release beads for the treatment of Parkinson's disease. CREXONT® contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for gradual drug release, a mucoadhesive polymer designed to prolong adhesion at absorption site, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. CREXONT® was studied in the RISE-PD clinical study which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients. The RISE-PD study successfully met its primary and secondary endpoints, demonstrating that treatment with CREXONT® significantly improved daily "Good On" time with fewer doses compared to IR CD/LD. Specifically, CREXONT® showed an improvement of 0.53 hours (least squares mean, 95% CI, 0.09-0.97), with an average dosing frequency of three times per day versus five times per day for IR CD/LD1. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.55 more hours of 'Good On' time per dose of CREXONT, compared to IR CD/LD.2 About Parkinson's disease Parkinson's disease has become the fastest growing neurological disorder worldwide, with approximately 1 million patients diagnosed in the U.S.3,4 In Mexico, the Parkinson's Movement Disorders Clinic at Manuel Velasco Suárez National Institute of Neurology and Neurosurgery estimates that 500,000 people between the ages of 45 and 60 are affected by the illness5. Parkinson's disease is characterized by slowness of movement, stiffness, resting tremor and impaired balance6. While Parkinson's disease is not considered a fatal disease, it is associated with significant morbidity and disability7. The average age at diagnosis for patients with Parkinson's disease is 60; as people live longer, the number of patients living with Parkinson's disease is predicted to grow significantly over the coming decades.3,8 About Knight Therapeutics Inc. Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at or Forward-Looking Statement This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. References 1 Hauser RA et al. JAMA Neurol. 2023 Oct 1;80(10):1062-1069.2 Hauser RA et al. Neurology 2022;98 (supplement 18).3 Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.4 Marras et al. NPJ Parkinsons Dis. 2018;4:21.5 Secretaría de Salud. Enfermedad de Parkinson, segundo lugar entre los padecimientos neurodegenerativos. Gobierno de México. Published April 11, 2018. Accessed March 27, 2025. NINDS. Parkinson's disease: challenges, progress, and promise. Reviewed August 2019. Accessed April 16, 2021.7 Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.8 John Hopkins Medicine. Young-Onset Parkinson's disease. Accessed August 17, 2021. CONTACT INFORMATION: Investor Contact: Knight Therapeutics Inc. Samira Sakhia Arvind Utchanah President & Chief Executive Officer Chief Financial Officer T: 514.484.4483 T. +598.2626.2344 F: 514.481.4116 Email: IR@ Email: IR@ Website: Website: in to access your portfolio
San Francisco Chronicle
6 days ago
- Business
- San Francisco Chronicle
Amneal: Q2 Earnings Snapshot
BRIDGEWATER, N.J. (AP) — BRIDGEWATER, N.J. (AP) — Amneal Pharmaceuticals, Inc. (AMRX) on Tuesday reported second-quarter net income of $22.4 million. On a per-share basis, the Bridgewater, New Jersey-based company said it had net income of 7 cents. Earnings, adjusted for amortization costs and non-recurring costs, were 25 cents per share. The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for earnings of 18 cents per share. Amneal expects full-year revenue in the range of $70 million to $75 million. Amneal shares have risen 0.5% since the beginning of the year. The stock has risen 14% in the last 12 months. _____
Yahoo
04-08-2025
- Business
- Yahoo
Amneal Earnings: What To Look For From AMRX
Pharmaceutical company Amneal Pharmaceuticals (NASDAQ:AMRX) will be reporting earnings this Tuesday before the bell. Here's what investors should know. Amneal missed analysts' revenue expectations by 3.4% last quarter, reporting revenues of $695.4 million, up 5.5% year on year. It was a mixed quarter for the company, with an impressive beat of analysts' EPS estimates but a slight miss of analysts' full-year EPS guidance estimates. Is Amneal a buy or sell going into earnings? Read our full analysis here, it's free. This quarter, analysts are expecting Amneal's revenue to grow 5.8% year on year to $742.8 million, slowing from the 17.1% increase it recorded in the same quarter last year. Adjusted earnings are expected to come in at $0.17 per share. The majority of analysts covering the company have reconfirmed their estimates over the last 30 days, suggesting they anticipate the business to stay the course heading into earnings. Amneal has missed Wall Street's revenue estimates three times over the last two years. Looking at Amneal's peers in the pharmaceuticals segment, some have already reported their Q2 results, giving us a hint as to what we can expect. Bristol-Myers Squibb posted flat year-on-year revenue, beating analysts' expectations by 7.8%, and Merck reported a revenue decline of 1.9%, falling short of estimates by 1.1%. Bristol-Myers Squibb traded down 3.9% following the results while Merck was also down 2.7%. Read our full analysis of Bristol-Myers Squibb's results here and Merck's results here. The euphoria surrounding Trump's November win lit a fire under major indices, but potential tariffs have caused the market to do a 180 in 2025. While some of the pharmaceuticals stocks have shown solid performance in this choppy environment, the group has generally underperformed, with share prices down 4.3% on average over the last month. Amneal is down 5.1% during the same time and is heading into earnings with an average analyst price target of $11.75 (compared to the current share price of $7.98). Today's young investors likely haven't read the timeless lessons in Gorilla Game: Picking Winners In High Technology because it was written more than 20 years ago when Microsoft and Apple were first establishing their supremacy. But if we apply the same principles, then enterprise software stocks leveraging their own generative AI capabilities may well be the Gorillas of the future. So, in that spirit, we are excited to present our Special Free Report on a profitable, fast-growing enterprise software stock that is already riding the automation wave and looking to catch the generative AI next. StockStory is growing and hiring equity analyst and marketing roles. Are you a 0 to 1 builder passionate about the markets and AI? See the open roles here. Error 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
02-08-2025
- Business
- Yahoo
Truist Financial Maintains a Buy on Amneal Pharmaceuticals (AMRX) With an $8 PT
Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is one of the best strong buy stocks to buy under $10. In a report released on July 25, Les Sulewski from Truist Financial maintained a Buy rating on Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) with a price target of $8.00. A pharmaceutical laboratory filled with shelves of medicines, highlighting the company's specialty drug production. The rating update followed Amneal Pharmaceuticals, Inc.'s (NASDAQ:AMRX) announcement of certain unaudited preliminary financial results for fiscal Q2 on July 21. The company has plans to report the actual Q2 2025 results on August 5. The unaudited preliminary financial results for the quarter showed a net revenue of $720 million to $730 million, suggesting an increase of around 3% versus the same period last year. Adjusted EBITDA rose around 13% to $180 million to $185 million, with income before income taxes of $45 million to $56 million, compared to $20 million in the same period in 2024. Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) is a medicine company that provides pharmaceuticals. The company's product portfolio encompasses biosciences, specialty, generics, 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
28-07-2025
- Business
- Yahoo
Is Amneal Pharmaceuticals (AMRX) Outperforming Other Medical Stocks This Year?
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Amneal Pharmaceuticals (AMRX) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out. Amneal Pharmaceuticals is one of 984 companies in the Medical group. The Medical group currently sits at #7 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 different sector groups. The average Zacks Rank of the individual stocks within the groups is measured, and the sectors are listed from best to worst. The Zacks Rank emphasizes earnings estimates and estimate revisions to find stocks with improving earnings outlooks. This system has a long record of success, and these stocks tend to be on track to beat the market over the next one to three months. Amneal Pharmaceuticals is currently sporting a Zacks Rank of #2 (Buy). Within the past quarter, the Zacks Consensus Estimate for AMRX's full-year earnings has moved 4.4% higher. This signals that analyst sentiment is improving and the stock's earnings outlook is more positive. Our latest available data shows that AMRX has returned about 1.8% since the start of the calendar year. At the same time, Medical stocks have lost an average of 2.5%. This means that Amneal Pharmaceuticals is performing better than its sector in terms of year-to-date returns. Another Medical stock, which has outperformed the sector so far this year, is Boston Scientific (BSX). The stock has returned 18.8% year-to-date. In Boston Scientific's case, the consensus EPS estimate for the current year increased 2.2% over the past three months. The stock currently has a Zacks Rank #2 (Buy). To break things down more, Amneal Pharmaceuticals belongs to the Medical - Drugs industry, a group that includes 155 individual companies and currently sits at #78 in the Zacks Industry Rank. This group has gained an average of 6.8% so far this year, so AMRX is slightly underperforming its industry in this area. In contrast, Boston Scientific falls under the Medical - Products industry. Currently, this industry has 84 stocks and is ranked #173. Since the beginning of the year, the industry has moved +6.7%. Amneal Pharmaceuticals and Boston Scientific could continue their solid performance, so investors interested in Medical stocks should continue to pay close attention to these stocks. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AMNEAL PHARMACEUTICALS, INC. (AMRX) : Free Stock Analysis Report Boston Scientific Corporation (BSX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error 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
