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AMRX stock advances as Generic to Ipsen's hormone shot gets FDA nod. Published: Sep 19 2026, 04:00 AM IST * FB * TW * Linkdin * Whatsapp * GNFollow Us The Food and Drug Administration (FDA) cleared a 120-milligram prefilled syringe that copies Ipsen's Somatuline Depot, a long-acting under-the-skin injection. * Ipsen's Somatuline Depot booked $983 million in U.S. sales in the year through July, according to IQVIA. * The agency also granted Competitive Generic Therapy status, a label meant to speed copies of drugs that still face thin competition. * For Amneal, the launch is another hard-to-make injectable in its Affordable Medicines lineup. Shares of Amneal Pharmaceuticals (AMRX) extended their gains after the closing bell on Friday after the company said the U.S. Food and Drug Administration (FDA) had approved its lanreotide injection and that the product would go on sale immediately. The stock closed at $18.71, up 2.35% in regular trading, then rose another 2% after-hours to $19.17 as investors reacted to the long-awaited launch in a market worth almost $1 billion. Green light, then an immediate start. The FDA cleared a 120-milligram prefilled syringe that copies Ipsen's Somatuline Depot, a long-acting under-the-skin injection. Doctors use it to tame excess growth hormone in acromegaly, slow certain gut and pancreatic neuroendocrine tumors, and ease carcinoid syndrome flare-ups. The agency also granted Competitive Generic Therapy status, a label meant to speed copies of drugs that still face thin competition. Amneal said the product is ready now. Ipsen's brand booked $983 million in U.S. sales in the year through July, according to IQVIA. Rivals are already on the market, such as one made by Cipla's InvaGen unit. A date the company had been circling. This was not a sudden win. Amneal's public pipeline had pointed to a third-quarter 2026 decision. On the July earnings call, co-CEO Chirag Patel said the file had a formal goal date in the quarter and that some sales were already in the forecast, though conservatively. For Amneal, the launch is another hard-to-make injectable in its Affordable Medicines lineup, made in company plants rather than farmed out. Srinivas Kone, the unit's chief scientific officer, said the company can supply the market at scale and use the product as a growth engine. How did AMRX retail traders react? On Stocktwits, retail sentiment around AMRX stock stayed in 'bearish' territory over the past 24 hours, while message volume remained 'high.' AMRX stock has risen 48% year-to-date. For updates and corrections, email newsroom[at]stocktwits[dot]com. Stay updated with all the latest Business News, including market trends, Share Market News, stock updates, taxation, IPOs, banking, finance, real estate, savings, and investments. Track daily Gold Price changes, updates on DA Hike, and the latest developments on the 8th Pay Commission. Get in-depth analysis, expert opinions, and real-time updates to make informed financial decisions. Download the Asianet News Official App from the Android Play Store and iPhone App Store to stay ahead in business. 0 Comments / 0 New

Ipsen appoints Mariette Finet to its Board of Directors. GlobeNewswire Published Sep 18, 2026 PARIS, FRANCE, 18 SEPTEMBER 2026 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today the co-optation of Mariette Finet as a Director to its Board of Directors, effective immediately. Ms. Finet succeeds Ms. Michèle Ollier, who resigned from her position as Director on 1 August 2026. A Doctor of Medicine and graduate of the University of Nancy, Ms. Finet brings more than 35 years of experience across the healthcare, pharmaceutical and life sciences sectors. Ms. Finet began her career in the Medical Department of Laboratoires Beaufour in Paris, where she held positions in pharmaceutical asset analysis and conducted clinical research across several therapeutic areas, with a particular focus on gastroenterology. She subsequently joined Beaufour-Ipsen Pharma and later Ipsen, where she held positions in the Marketing Department. Top Stories Interested in more newsletters? Browse here. Since 2007, Ms. Finet has served in scientific and medical advisory roles at Mayroy and Highrock S.àr.l., providing expertise in investment analysis and portfolio oversight, with a particular focus on pharmaceutical, MedTech and life sciences sectors. She also served on the boards of Lightinderm SAS and Kaerus Bioscience Ltd. The Board of Directors has also appointed Ms. Finet to the Board Portfolio Committee, succeeding Ms. Ollier. Ms. Finet's appointment will be submitted for ratification at the next Annual Shareholders' Meeting. Subject to ratification, she will serve for the remainder of Ms. Ollier's term, which expires at the Annual Shareholders' Meeting convened to approve the financial statements for the year ending 31 December 2026. Following this appointment, Ipsen's Board of Directors continues to comprise 14 directors, with balanced representation of seven women and seven men[1]. The Board includes four independent directors and two employee representatives. About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. | Ipsen Contacts | / | / | | Investors | / | / | | Henry Wheeler | [email protected] | +33 7 66 47 11 49 | | Khalid Deojee | [email protected] | +33 6 66 01 95 26 | | Media | / | / | | Sally Bain | [email protected] | +1 857 320 0517 | | Anne Liontas | [email protected] | +33 7 67 34 72 96 | This advertisement has not loaded yet, but your article continues below. Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on ipsen.com. 1 Representing 42%, with directors representing employees not taken into account in this calculation, pursuant to article L. 225-18-1 of the French Code of Commerce Quick Picks How my job helps me win at work and at home"I can make an impact at a Fortune 100 company."Liberty Mutual | Sponsored Join the Conversation Postmedia is committed to maintaining a lively but civil forum for discussion. Please keep comments relevant and respectful. Comments may take up to an hour to appear on the site. You will receive an email if there is a reply to your comment, an update to a thread you follow or if a user you follow comments. Visit our Community Guidelines for more information.