Latest news with #regulatoryapproval
Zawya
4 hours ago
- Business
- Zawya
Saudi Industrial Development Company eyes big capital hike
The Saudi Industrial Development Company (SIDC) said it has won regulatory approval from the kingdom's Capital Market Authority (CMA) to more than double its capital from SAR135 million ($36 million) to SAR300 million ($80 million) through a rights issue. Accordingly, the number of company's ordinary shares will increase from 13.5 million to 30 million, an increase of 16.5 million ordinary shares at a ratio of (1.222) shares for every one owned share and at an offering price of SAR10 per share, said SIDC in its filing to Saudi bourse Tadawul. The Saudi group said the rights issue will be open only for those who are registered in its shareholders' register at the Securities Depository Center Company (Edaa) at the end of the second trading day following the date of the EGA that approves the capital increase through a rights issue, which will be announced at a later stage. The approval from CMA came yesterday (August 10) after SIDC fulfilled all the regulatory requirements and comments relating to the capital increase application including publishing the rights issue prospectus and inviting the company's Extraordinary General Assembly (EGA) in this regard. The company will now have to get the go-ahead from its shareholders at the EGA and completing all relevant regulatory procedures and requirements. Copyright 2025 Al Hilal Publishing and Marketing Group Provided by SyndiGate Media Inc. (
Yahoo
3 days ago
- Business
- Yahoo
Boeing's $8.3B Power Move Just Got the Green Light -- Here's What Happens Next
Boeing (NYSE:BA) just cleared a key runway. The UK's Competition and Markets Authority has signed off on Boeing's $4.7 billion all-stock buyout of Spirit AeroSystems (NYSE:SPR), ending its initial review without escalating to a deeper investigation. No detailed reasoning was published, but the decision removes a major regulatory overhang and keeps Boeing's Q4 2025 deal timeline intact. Spirit confirmed Friday that progress is still on track. Boeing has yet to comment. Warning! GuruFocus has detected 6 Warning Signs with BA. The transaction, first announced last July, values Spirit at $37.25 per share and $8.3 billion including debt. But this isn't just another M&A headlineit's a strategic reunion. Spirit was spun off from Boeing two decades ago in a cost-cutting move. Now, the supplier responsible for key components of the 737 and 787 Dreamliner could be coming home. This carve-up could help regulators stay comfortable and keep competitive tensions in check. One important caveat: Airbus SE (EADSY), Boeing's biggest competitor, will be taking over the Spirit operations tied to Airbus jets. This carve-up could help regulators stay comfortable and keep competitive tensions in check. For now, the market will be watching closely. The outcome could reshape how Boeing manages its supply chainagainand possibly define the next phase of its turnaround. This article first appeared on GuruFocus. 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
4 days ago
- Business
- Yahoo
Arrowhead Pharmaceuticals Reports Fiscal 2025 Third Quarter Results
- Conference Call and Webcast Today, August 7, 2025, at 4:30 p.m. ET PASADENA, Calif., August 07, 2025--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2025 third quarter ended June 30, 2025. The Company is hosting a conference call today, August 7, 2025, at 4:30 p.m. ET to discuss the results. "Arrowhead continues to achieve strong execution in discovery, clinical and regulatory, and business development. Our pipeline has become quite mature, with four Arrowhead discovered candidates currently in pivotal Phase 3 studies. In addition, our commercial buildout is designed to make us launch ready on day one, should plozasiran receive regulatory approval on the November 18, 2025, PDUFA date," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. "We continue to maintain a strong balance sheet, which we believe gives us the financial resources to move multiple innovative new medicines through the clinical and regulatory process and ultimately get them to the patients who need them." Selected Recent Events Announced the signing of an asset purchase agreement between Sanofi and Visirna Therapeutics, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead's investigational cardiometabolic candidates in Greater China. Summary terms of the agreement include: Visirna will receive an upfront payment of $130 million from Sanofi. In addition, Visirna will be eligible to receive further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China. Sanofi will receive an exclusive license to develop and commercialize investigational plozasiran in Greater China from Visirna Therapeutics, offering potential treatment to people living with elevated triglycerides. Earned a $100 million milestone payment from Sarepta Therapeutics when Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta. Completed enrollment in investigational plozasiran clinical studies SHASTA-3, SHASTA-4, and MUIR-3, the company's global Phase 3 clinical studies designed to support regulatory submissions for marketing approval in the treatment of severe hypertriglyceridemia. Arrowhead anticipates completing the primary portion of these studies in mid-2026 with topline data expected shortly thereafter and planned submissions for regulatory review and potential approval to follow. The company previously submitted a New Drug Application (NDA) for plozasiran based on positive Phase 3 PALISADE study results in patients with familial chylomicronemia syndrome, which the U.S. FDA has accepted with a Prescription Drug User Fee Act (PDUFA) action date set for November 18, 2025. Dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company's investigational RNAi therapeutic being developed as a potential treatment for homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that leads to severely elevated LDL-cholesterol and early onset cardiovascular disease. Zodasiran is the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage pivotal studies, after investigational drugs plozasiran, fazirsiran (licensed to Takeda) and olpasiran (licensed to Amgen). Dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, the company's investigational RNAi therapeutic being developed as a potential treatment for obesity. ARO-ALK7 is designed to intervene in a known pathway that signals the body to store fat in adipose tissue with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies. The study initiates in otherwise healthy obese subjects using single and multiple escalating doses of ARO-ALK7 monotherapy and is expected to progress rapidly to investigate combinations of ARO-ALK7 with tirzepatide in obese patients with and without type 2 diabetes. Selected Fiscal 2025 Third Quarter Financial Results ARROWHEAD PHARMACEUTICALS, INC. CONSOLIDATED CONDENSED FINANCIAL INFORMATION (in thousands, except per share amounts) Three Months Ended June 30, OPERATING SUMMARY 2025 2024 (Unaudited) Revenue $ 27,767 $ — Operating Expenses: Research and development 162,368 152,431 General and administrative expenses 30,949 23,710 Total operating expenses 193,317 176,141 Operating loss (165,550 ) (176,141 ) Total other (expense) income (13,539 ) 2,164 Loss before income tax expense and noncontrolling interest (179,089 ) (173,977 ) Income tax (benefit) expense (437 ) — Net loss including noncontrolling interest (178,652 ) (173,977 ) Net loss attributable to noncontrolling interest, net of tax (3,411 ) (3,184 ) Net loss attributable to Arrowhead Pharmaceuticals, Inc. $ (175,241 ) $ (170,793 ) Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted $ (1.26 ) $ (1.38 ) Weighted-average shares used in calculating - Diluted 139,039 124,199 FINANCIAL POSITION SUMMARY June 30, 2025 September 30, 2024 (unaudited) Cash, cash equivalents and restricted cash $ 129,793 $ 102,685 Available-for-sale securities, at fair value 770,579 578,276 Total cash resources (Cash, cash equivalents and restricted cash and Available-for-sale securities, at fair value) 900,372 680,961 Other current and long-term assets 480,240 458,841 Total Assets $ 1,380,612 $ 1,139,802 Liability related to the sale of future royalties $ 360,254 $ 341,361 Credit Facility 240,332 393,183 Deferred revenue 22,979 — Other liabilities 237,241 214,195 Total Liabilities $ 860,806 $ 948,739 Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity 522,313 185,444 Noncontrolling Interest (2,507 ) 5,619 Total Noncontrolling Interest and Stockholders' Equity $ 519,806 $ 191,063 Total Liabilities, Noncontrolling Interest and Stockholders' Equity $ 1,380,612 $ 1,139,802 Shares Outstanding 138,144 124,376 Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate," "continue," "target," "forecast" or "continue" or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, including the timing of achievement of the next ARO-DM1 milestone, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements, including our ability to achieve such milestones on projected timelines (if at all) and receive timely payment if milestones are achieved; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We disclaim any intention to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on Contacts Arrowhead Pharmaceuticals, Anzalone, CFA626-304-3400ir@ Investors: LifeSci Advisors, LLCBrian Ritchie212-915-2578britchie@ Media: LifeSci Communications, LLCKendy Guarinoni, Ph.D.724-910-9389kguarinoni@
Washington Post
4 days ago
- Health
- Washington Post
GLP-1 weight-loss pills are coming. So are doubts about their potency.
Next-generation weight-loss pills could hit the market in the coming months, with new data raising a key question: Will patients embrace a more convenient alternative to injecting themselves, even if it means losing less weight? Eli Lilly said Thursday it will seek regulatory approval for its experimental weight-loss pill by the end of the year, announcing results from its latest clinical trial that, while positive, did not appear to be as potent as injectable anti-obesity medications.
Daily Mail
4 days ago
- Health
- Daily Mail
Daily weight loss pill that works like Ozempic helped users lose an average of almost TWO STONES in groundbreaking trial
A daily weight loss pill that works like breakthrough fat jab Ozempic can help users lose an average of almost two stones (12.4kg), a study reveals. People taking the new wonder drug orforglipron lost an average of 12.4 per cent of their body weight after 72 weeks in a groundbreaking final stage trial. The participants, who were overweight but did not have diabetes, also benefited from reductions in bad cholesterol, blood fats and blood pressure. Manufacturer Lilly said the once-a-day pill - the first of its kind - could be launched 'at scale' worldwide and 'without supply constraints' as early as next year. It now plans to apply for regulatory approval within months. Previous studies examined patients with diabetes. The drug works by targeting the same GLP-1 receptors as Blockbuster weight-loss jabs Ozempic, Wegovy and Mounjaro, which suppress appetite and make users fill fuller for longer. Lilly has not yet decided how much the drug will cost but it is easier to produce and transport that injections so is likely to be a cheaper option. The pill can be stored at room temperature and taken at any time of day, with or without food. It is seen as a new tool in the nation's fight against obesity and is likely to appeal to a wider audience who are uncomfortable with injecting themselves. The 72-week study involved 3,127 adults who were obese or were overweight and had a weight-related medical problem. Participants were given either a placebo or one of three possible doses of orforglipron. All three doses delivered 'clinically meaningful weight loss' but those taking the highest dose of 36mg lost an average of 27lbs (12.4kg), or 12.4 per cent of their body weight, over the study period. Almost six in ten patients (59.6 per cent) in the highest dose group lost at least 10 per cent of their body weight and four in ten (39.6 per cent) lost at least 15 per cent. Those in the placebo group lost an average of just 0.9 per cent of their body weight over the course of the study, known as ATTAIN-1. Researchers say it demonstrates the tablet has 'significant efficacy' and a safety and tolerability profile consistent with fat jabs. Lilly said it is making 'substantial investments to meet anticipated demand at launch'. Dr Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said: 'Obesity is one of the most pressing global health challenges of our time, driving global chronic disease burden and impacting more than one billion people worldwide. 'With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments. 'With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need.' Side effects on the tablet were similar to the weight-loss injections. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. Some 33.7 per cent of participants on the highest dose reported nausea, 25.4 per cent constipation and 23.1 per cent diahorrea. One in ten (10.3 per cent) of those on the highest dose discontinued treatment due to adverse events. The detailed ATTAIN-1 results will be presented next month at the European Association for the Study of Diabetes Annual Meeting and published in a peer-reviewed journal. Previous studies found people injected with semaglutide, the active ingredient in Wegovy and Ozempic, lost 14 per cent of their body weight over 72 weeks. And those taking tirzepatide, known as Mounjaro or the 'king kong' of weight-loss jabs, lost 20 per cent of their body weight over the the same period. Two in three adults in Britain are obese or overweight and more than 5million people have type-2 diabetes, which is linked to poor lifestyles. Estimates suggest one in ten women already take weight loss jabs. GLP-1 injections suffered global shortages after celebrity users sparked a surge in popularity and the NHS has warned people against buying them from unauthorised sources.
