Tag: Roche

89bio, Inc. Announces Agreement to be Acquired by Roche

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– 89bio stockholders to receive up to $20.50 per share in cash, comprised of $14.50 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $6.00 per share in cash; transaction represents total equity value of up to approximately $3.5 billion – – Transaction reflects pegozafermin’s potential best-in-disease profile for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH) – – 89bio to join the Roche Group as part of Roche’s Pharmaceuticals Division – SAN FRANCISCO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that it has entered into a merger agreement to be acquired by Roche at a price of $14.50 per share in cash at closing, representing a premium of approximately 79% to 89bio’s closing stock price on September 17, 2025, the last trading day before the announcement of the transaction, and a premium of 52% to 89bio’s 60-day volume-weighted average price (VWAP). In addition, 89bio stockholders will receive a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $6.00 per share in cash upon achievement of specified milestones, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. The merger agreement has been unanimously approved by 89bio’s Board of Directors, and 89bio’s Board of Directors unanimously recommends that 89bio stockholders tender their shares in the tender offer. “Our mission at 89bio has always been to develop innovative therapies to help patients with serious liver and cardiometabolic diseases, a commitment demonstrated by the strategic design and successful execution of the development program for pegozafermin over the years,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are thrilled to be joining with Roche to combine the promise of pegozafermin with Roche’s established global development, manufacturing, and commercialization capabilities, to accelerate and maximize potential benefit for patients in need and unlock significant shareholder value. I am tremendously proud of the entire team at 89bio and would like to express my deepest thanks and gratitude to them, our Board, investigators, clinical trial participants, numerous vendors, and MASH and SHTG communities for helping us reach this pivotal moment.” “We are excited about this agreement and to further develop this promising therapy, which we hope will provide people with moderate to severe MASH a new treatment option,” said Boris L. Zaïtra, Head of Roche Corporate Business Development. “By adding pegozafermin to our cardiovascular, renal, and metabolism portfolio and with our Diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients’ lives.” Transaction TermsUnder the terms of the merger agreement, an affiliate of Roche will commence a tender offer to acquire all of 89bio’s outstanding shares for a price of $14.50 per share in cash at closing, representing an aggregate payment of $2.4 billion. In addition, 89bio’s stockholders will receive a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. Each non-tradeable CVR will entitle its holders to receive the following contingent cash payments, conditioned upon the achievement of certain milestones, within specified time periods: $2.00 per share in cash, upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients (by March 31, 2030)$1.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US $3.0 billion in any calendar year (by December 31, 2033)$2.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US $4.0 billion in any calendar year (by December 31, 2035) The closing of the transaction is subject to customary closing conditions, including the tender of shares representing at least a majority of 89bio’s outstanding shares (other than shares held by 89bio, Roche or any of their respective subsidiaries, and any dissenting shares), the completion of regulatory review and other customary closing conditions. Upon the successful completion of the tender offer, Roche will acquire all remaining 89bio shares that are not tendered into the tender offer through a second-step merger at the same price of $14.50 per share in cash at closing, plus a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, payable upon achievement of the specified milestones. The closing of the transaction is currently expected to take place in the fourth quarter of 2025, subject to satisfaction of the closing conditions described above. Until that time, 89bio will continue to operate as a separate and independent company. Moelis & Company LLC and Centerview Partners LLC are serving as financial advisors to 89bio and Gibson, Dunn & Crutcher LLP is serving as legal counsel to 89bio. Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The Company is in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The Company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the Company on LinkedIn. Additional Information and Where to Find ItThe tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of 89bio, Inc. (“89bio”), nor is it a substitute for the tender offer materials that Roche Holdings, Inc. (“Roche”) and its wholly owned acquisition subsidiary, Bluefin Merger Subsidiary, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of 89bio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Roche and Merger Sub intend to file with the SEC. In addition, 89bio will file with the SEC a Solicitation/ Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the Solicitation/Recommendation Statement of 89bio on Schedule 14D-9 and related materials with respect to the tender offer and merger, free of charge at the website of the SEC at www.sec.gov or from the information agent named in the tender offer materials. Investors may also obtain, at no charge, the documents filed with or furnished to the SEC by 89bio under the “Investors & Media” section of 89bio’s website at www.89bio.com. STOCKHOLDERS AND INVESTORS ARE STRONGLY ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF 89BIO ON SCHEDULE 14D-9 AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding the ability to complete and the timing of completion of the transactions contemplated by the Agreement and Plan of Merger dated as of September 17, 2025 by and among 89bio, Roche and Merger Sub (the “Merger Agreement”), including the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions to the consummation of the subsequent merger set forth in the Merger Agreement, and the possibility of any termination of the Merger Agreement. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “anticipate,” “goal,” “opportunity,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur; uncertainties as to how many of 89bio’s stockholders will tender their shares in the offer; the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the possibility that competing offers will be made; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction; the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the announcement of the proposed transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction; risks related to non-achievement of the CVR milestones and that holders of the CVRs will not receive payments in respect of the CVRs; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor & Media Contacts: Ryan Martins89bio, Inc.ryan.martins@89bio.com Annie Chang89bio, Inc.investor@89bio.com Eva Bilange89bio, Inc.eva.bilange@89bio.com Sheryl SeapyReal Chemistrysseapy@realchemistry.com

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Roche and Alnylam advance zilebesiran into global phase III cardiovascular outcomes trial for people with uncontrolled hypertension

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Phase III trial informed by comprehensive KARDIA data set generated through three Phase II studies: KARDIA-1, KARDIA-2 and KARDIA-3In the Phase II KARDIA-3 study, presented today as a late breaker at the European Society of Cardiology Congress 2025, zilebesiran demonstrated clinically meaningful reductions in office systolic blood pressure at month three with continuous control through month sixZilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensivesPhase III cardiovascular outcomes trial expected to be initiated by the end of the year Basel, 30 August 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam (Nasdaq: ALNY) today announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ability of zilebesiran, a RNAi therapeutic, to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension. This decision was informed by the comprehensive KARDIA Phase II programme, including KARDIA 1, KARDIA 2 and the most recent KARDIA-3 study evaluating the efficacy and safety of zilebesiran in patients with uncontrolled hypertension and high cardiovascular (CV) risk, on two to four standard of care antihypertensives. In particular, KARDIA-3 aimed to define the patient population to be investigated in the Phase III CV outcomes trial. Results of KARDIA-3 showed that a single dose of zilebesiran (300 mg every six months, subcutaneous injection) resulted in clinically meaningful placebo-adjusted reductions of office systolic blood pressure (SBP) in all comers at the month three primary endpoint (-5.0 mmHg; p=0.0431) with sustained benefits out to month six (-3.9 mmHg; 95% CI: [-8.5, 0.7]). There were no additional benefits of the 600 mg dose at month three (-3.3 mmHg; p=0.1830) or month six (-3.6 mmHg; 95% CI: [-8.2, 1.0]). The overall KARDIA-3 study did not meet the pre-specified definition for statistical significance, because of a multiplicity statistical testing approach. However, the study met the aim of identifying the patient population that could potentially benefit the most from zilebesiran and also showed encouraging safety and clinically meaningful placebo adjusted reductions in blood pressure. As observed in the KARDIA-2 Phase II study, the KARDIA-3 results support a robust benefit of combining zilebesiran with a diuretic, a commonly used antihypertensive. In an analysis of patients that were on diuretics and had a baseline BP >140 mm Hg, the placebo-adjusted reduction was -9.2mmHg; (-17.3, -1.2) at month three and -8.3mmHg (-16.4, -0.2) at month six. A precedent for enhanced blood pressure reduction conferred by this type of combination is established in both literature and clinical practice. “Zilebesiran has the potential to become a best-in-disease treatment for many patients with uncontrolled hypertension. Its blood pressure-lowering effects and twice-yearly dosing could reduce the risk of serious health complications and death,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. “Detailed analysis of our comprehensive Phase II clinical trials have informed our decision to move zilbesiran into Phase III. Despite current treatment options, up to 80% of people with hypertension do not achieve adequate blood pressure control putting them at higher risk of cardiovascular events. Therefore, additional treatment options are needed.” Zilebesiran also demonstrated encouraging safety in patients with comorbidities on multiple background therapies – more than 90% of whom were receiving treatment with an ACE inhibitor or an Angiotensin Receptor Blocker (ARB). These findings reinforce confidence in zilebesiran’s ability to be combined with standard of care antihypertensives. As a result, the ZENITH (ZilebEsiraN CardIovascular OuTcome Study in Hypertension) Phase III trial has been submitted to global regulators and is expected to be initiated by the end of 2025. ZENITH will be a CVOT enrolling approximately 11,000 patients and evaluating zilebesiran (300 mg) every six months compared to placebo in patients with uncontrolled hypertension with either established CV disease or at high risk for CV disease on two or more antihypertensives, one being a diuretic. Hypertension is the primary cause of and number one modifiable risk factor for cardiovascular disease. An estimated one in three adults, over 1,2 billion people worldwide, have hypertension and despite the wide availability of antihypertensives, up to 80% of them do not achieve adequate blood pressure control. Poor adherence to daily oral therapies is an important contributor to poor blood pressure control and CV outcomes. An effective long-acting therapy that provides continuous control of blood pressure may help to reduce the burden of uncontrolled hypertension. With its growing cardiometabolic portfolio and strong diagnostic expertise, Roche is advancing transformative standards of care to improve the lives of people living with cardiometabolic diseases as well as reducing the significant burden on healthcare systems and society. About the KARDIA-3 study KARDIA-3 (NCT06272487), the third phase II study in the KARDIA programme, included two Cohorts (A and B). Cohort A assessed zilebesiran in patients with eGFR ≥ 45 mL/min/1.73m2, while Cohort B included patients with advanced kidney dysfunction (i.e., eGFR between 30 and

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Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

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Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. The test has been developed in collaboration with Amgen. Basel, 22 May 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. “While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,2” said Matt Sause, CEO of Roche Diagnostics. “Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem. Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.” “Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels,3” said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. “By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease.” Once approved, the new Tina-quant® test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy. About Lp(a)Globally, as many as one in five people have elevated Lp(a),1 where lifestyle interventions such as diet and exercise have no significant impact. While Lp(a) levels can be influenced by non-genetic factors including menopause, kidney and liver disease and hyperthyroidism, they are predominantly ( >90%) determined by genetic variations in the LPA gene.4 Raised Lp(A) is particularly prevalent among women, and people of African descent.5,6 High levels of Lp(a) have been shown to promote the buildup of lipids in artery walls, leading to the development of plaques, and have been associated with an increased risk of cardiovascular (CV) events4. Lp(a) testing is therefore an important tool for clinicians, enabling them to make a more accurate assessment of CV risk, and it is expected to become a part of regular diagnostic testing in the coming years. Professional bodies around the world, including the National Lipid Association, Canadian Cardiovascular Society, European Atherosclerosis Society, European Society of Cardiology, and the Beijing Heart Society have recommended that Lp(a) measurement should be considered at least once in every adult person’s life. As Lp(a) has no single, defined molecular weight, there is a consensus in the scientific community that, ideally, Lp(a) levels should be measured in terms of the number of molecules per litre of blood (nmol/L). This contrasts with widely available tests that measure the molecular weight of Lp(a) in the blood (mg/L). About Tina-quant® Lp(a) RxDx assay The FDA has granted Breakthrough Device Designation to the Tina quant Lp(a) RxDx assay for use in selecting patients with elevated Lp(a) and a history of atherosclerotic disease for treatment with an Lp(a) lowering drug. A lipoprotein (a) test involves a routine blood draw during which a small sample of blood is used for measurement. This test measures the number of Lp(a) molecules per litre in a person’s bloodstream, which paves the way for Lp(a) to serve as an actionable biomarker in future. If approved, it will be available on selected cobas® platforms. Currently, there is no FDA authorised Lp(a) assay measuring Lp(a) in nmol/L available in the US. This assay will be part of Roche’s wider portfolio of tests for cardiovascular diseases. Together, these tests provide healthcare professionals the opportunity to make informed decisions, allowing patients to access new and innovative treatments. About Breakthrough Device DesignationThe Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.  About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week, J Am Coll Cardiol. 2022 Aug, 80 (9) 934–946 ​​ https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019[2] Beaglehole, R., Reddy, S., Leeder, S.R. (2007). Poverty and human development: the global implications of cardiovascular disease. Circulation 116, 1871–1873.[3] Zheng W, Chilazi M, Park J, et al. Assessing the Accuracy of Estimated Lipoprotein(a) Cholesterol and Lipoprotein(a)‐Free Low‐Density Lipoprotein Cholesterol. Journal of the American Heart Association. 2022;11(2). d oi: 10.1161/jaha.121.023136[4] Kronenberg F. et al, Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement, European Heart Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946, https://doi.org/10.1093/eurheartj/ehac361[5] Simony SB, Mortensen MB, Langsted A, Afzal S, Kamstrup PR, Nordestgaard BG. Sex differences of lipoprotein(a) levels and associated risk of morbidity and mortality by age: The Copenhagen General Population Study. Atherosclerosis. 2022 Aug;355:76-82. doi: 10.1016/j.atherosclerosis.2022.06.1023. Epub 2022 Jun 27. PMID: 35803767.[6] Mehta A, Jain V, Saeed A, Saseen JJ, Gulati M, Ballantyne CM, Virani SS. Lipoprotein(a) and ethnicities. Atherosclerosis. 2022 May;349:42-52. doi: 10.1016/j.atherosclerosis.2022.04.005. PMID: 35606075. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25  Simon GoldsboroughPhone: +44 797 32 72 915  Karsten KleinePhone: +41 79 461 86 83  Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262  Yvette PetillonPhone: +41 79 961 92 50 Dr. Rebekka SchnellPhone: +41 79 205 27 03   Roche Investor Relations Investor Relations North America
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Roche enters partnership with Alnylam to co-develop and co-commercialise RNAi therapeutic zilebesiran to treat hypertension in patients with high cardiovascular risk

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Basel, 24 July 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today a new partnership with Alnylam to develop and commercialise zilebesiran, an investigational RNAi therapeutic currently in Phase 2 for the treatment of hypertension. Hypertension affects more than 1.2 billion adults worldwide and is the main, independent, preventable […]

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STRONG-HF study results demonstrate clear benefits for acute heart failure patients

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STRONG-HF study primary outcomes showed significant reduction of all cause death or acute heart failure readmissions, at day 180, when the study strategy was implemented Rapid, simultaneous up-titration of therapies, and close follow-up, led to increased patient quality of life. The Roche Elecsys® NT-proBNP biomarker is an integral part of the treatment […]

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Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people

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Cardiovascular diseases are responsible for 17.9 million deaths every year¹, a third of all deaths globally² Roche announces five new intended uses for key cardiac biomarkers to help identify cardiovascular risk, better diagnose patients and support early treatment Early diagnosis and treatment can contribute to saving or improving people’s lives […]

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