Bipolar Disorder

BOSTON & SAN DIEGO--(BUSINESS WIRE)-- Rapport Therapeutics, Inc., a clinical-stage biotechnology company leveraging the science of receptor-associated proteins (RAPs) to advance precision neuromedicines, today announced the appointment of John Maraganore, Ph.D., to its Board of Directors. Dr. Maraganore, former founding Chief Executive Officer of Alnylam Pharmaceuticals, Inc. (Alnylam), currently serves as Venture Partner at both ARCH Venture Partners and Atlas Ventures, as Senior Advisor at Blackstone Life Sciences, and as Principal and Chief Executive Officer at JMM Innovations, LLC. This press release features multimedia. View the full release here: John Maraganore, Ph.D. “As Rapport sets out to build a leading precision neuroscience company, we are incredibly fortunate to have Dr. Maraganore join our board,” said Abraham Ceesay, Chief Executive Officer of Rapport. “John is among a few visionary leaders who have guided a new modality from concept to a dynamic platform for drug discovery. He has been a driving force for innovation within our industry, and we believe his leadership will be indispensable as we work to advance our pipeline and potentially deliver much-needed new treatment options to patients with neurological disorders.” “I am thrilled to once again work alongside John to help Rapport realize its vision to become a preeminent precision neuroscience company. John has an impressive track record of building great science-based companies. His wisdom and experience will be invaluable as we advance our pipeline of precision neuroscience product candidates to positively impact the lives of those affected by debilitating neurological conditions,” said Steve Paul M.D., Chairman of the Rapport Board of Directors and Venture Partner at Third Rock Ventures. Dr. Maraganore served as founding CEO of Alnylam from 2002 to 2021, where he led the development of a novel class of medicines, referred to as RNAi therapeutics. Under his leadership, Alnylam built over $25 billion in market capitalization, established more than 20 major pharmaceutical alliances and saw the approval and commercialization of four of its RNAi medicines, ONPATTRO®, GIVLAARI®, OXLUMO®, and Leqvio®. Prior to founding Alnylam, Dr. Maraganore held leadership positions at Millennium Pharmaceuticals, Inc. and Biogen, Inc. He also previously served as Chair of the Biotechnology Innovation Organization. Dr. Maraganore received his B.A. in biological sciences and M.S. and Ph.D. in biochemistry and molecular biology from the University of Chicago. “There's a significant need and opportunity for new approaches in the treatment of neurological disorders, and Rapport has the potential to revolutionize care with its transformational science,” said Dr. Maraganore. “I'm honored to work with a team of such talented and accomplished individuals in these exciting times for both the company and the field at large.” About Rapport ( ) Rapport is developing a new class of precision neuromedicines aimed at providing patients with better alternatives to existing treatments for central nervous system disorders. Current options often come with debilitating and intolerable side effects, leading to suboptimal dosing and noncompliance that limit drug efficacy and can result in discontinuation. The company’s platform, built and refined over the past decade by its founding scientific team, is designed to achieve precision through the discovery and targeting of receptor-associated proteins, or RAPs, which display regional or neural circuit-specific expression. By more precisely targeting the diseased brain regions, Rapport believes its platform has the potential to improve tolerability and clinical benefit. Rapport has ongoing clinical trials in epilepsy and discovery-stage programs in neuropathic pain, hearing disorders and bipolar disorder.

This latest deal will aid BMS in bolstering its neuroscience portfolio. Credit: Katherine Welles / Shutterstock.com. Bristol Myers Squibb (BMS) has concluded the acquisition of biopharmaceutical company Karuna Therapeutics for $14bn in cash. The transaction was finalised following a definitive agreement signed by the companies in December 2023 . Karuna now becomes a wholly owned BMS subsidiary. The deal will boost BMS’s neuroscience portfolio. BMS has acquired Karuna’s lead asset, KarXT (xanomeline-trospium), along with its early-stage and pre-clinical pipeline. KarXT is an antipsychotic with a unique mechanism of action and a promising efficacy and safety profile. See Also: CST-2140 by CuraSen Therapeutics for Orthostatic Hypotension: Likelihood of Approval Q&A: Increasing awareness around digital therapeutics key to realising full potential The US Food and Drug Administration (FDA) recently accepted a new drug application for KarXT for the treatment of adults with schizophrenia, with an approval decision anticipated on 26 September 2025 under the Prescription Drug User Fee Act. KarXT is also undergoing registrational trials as an adjunctive therapy for schizophrenia and for treating psychosis in Alzheimer’s disease patients. Its potential for further indications such as bipolar 1 disorder and agitation in Alzheimer’s disease is being explored. Financial advisory services for the deal were provided to BMS by Gordon Dyal and Citi, with Covington & Burling offering legal counsel. Goldman Sachs acted as exclusive financial adviser to Karuna, with Simpson Thacher & Bartlett providing legal counsel. Bristol Myers Squibb CEO Chris Boerner stated: “We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb. “Importantly, this transaction aligns with our commitment to strengthening BMS’s growth profile in the latter half of the decade and beyond. We look forward to working with Karuna’s talented team to bring KarXT to patients with schizophrenia later this year.” The new development comes after the FDA’s committee voted eight to three to approve BMS and 2seventy bio’s Abecma to treat relapsed or refractory multiple myeloma .

KarXT, Karuna’s Lead Asset, Is a Potential First-in-Class Treatment for Schizophrenia with Multi-Billion Dollar Sales Potential Across Multiple Indications PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb Company (NYSE: BMY) today announced that it has successfully completed its acquisition of Karuna Therapeutics , Inc. (“Karuna”). With the acquisition's completion, Karuna shares have ceased trading on the Nasdaq Global Select Market and Karuna is now a wholly owned subsidiary of Bristol Myers Squibb (“BMS”). “We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb,” said Chris Boerner, Ph.D., Chief Executive Officer, Bristol Myers Squibb. “Importantly, this transaction aligns with our commitment to strengthening BMS’s growth pro the latter half of the decade and beyond. We look forward to working with Karuna’s talented team to bring KarXT to patients with schizophrenia later this year.” Through this transaction, BMS has added KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action and a differentiated efficacy and safety profile, and Karuna’s early-stage and pre-clinical pipeline. KarXT has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including Bipolar I disorder and Alzheimer’s disease agitation. As previously disclosed, the transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, which is primarily from a recently completed new debt issuance. Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued disciplined resource allocation, cost efficiencies and portfolio prioritization. Bristol Myers Squibb’s cash flows and strong financial pro continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases. The transaction will be accounted for as an asset acquisition resulting in an approximately $12 billion one-time, non-deductible Acquired In-Process Research and Development (Acquired IPR&D) charge impacting both 2024 first quarter and full-year GAAP and non-GAAP EPS by approximately $5.93. Consistent with past practice, Bristol Myers Squibb generally provides updates to its financial outlook once each quarter. When considering Bristol Myers Squibb’s financial outlook issued on February 2, 2024, investors and analysts should take into account the impacts outlined above. Bristol Myers Squibb will provide an update to its financial outlook when it reports first quarter 2024 results on April 25, 2024. Advisors Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as exclusive financial advisor to Karuna, and Simpson Thacher & Bartlett LLP is serving as legal counsel. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This communication contains “forward-looking statements” regarding, among other things, the acquisition of Karuna by Bristol Myers Squibb and Bristol Myers Squibb’s anticipated Acquired IPR&D charges for the quarter ending March 31, 2024, and the related impact to its GAAP and non-GAAP earnings per share. These statements may be identified by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. These statements are only predictions, and such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Actual results may differ materially from current expectations because of numerous risks and uncertainties including with respect to (i) the risk that the expected benefits or synergies of the acquisition will not be realized, including with respect to the potential commercialization of KarXT, (ii) risks associated with legal proceedings instituted related to the merger agreement (iii) unanticipated difficulties or expenditures relating to the transaction, the response of business partners and competitors to the consummation of the transaction and/or potential difficulties in employee retention as a result of the consummation of the transaction and (iv) completion of Bristol Myers Squibb’s quarter-end closing process, including review by management and the audit committee of the Bristol Myers Squibb’s board of directors, which could result in changes to the preliminary estimates described herein. Forward-looking statements in this communication should be evaluated together with the many uncertainties that affect Bristol Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023 and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and other documents that may be filed by Bristol Myers Squibb from time to time with the U.S. Securities and Exchange Commission. Bristol Myers Squibb does not undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Use of Non-GAAP Financial Information and Financial Guidance In discussing financial guidance, Bristol Myers Squibb refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. Non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because Bristol Myers Squibb believes they neither relate to the ordinary course of Bristol Myers Squibb’s business nor reflect Bristol Myers Squibb’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely recur in future periods. Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not without unreasonable effort, able to reliably predict the impact of accelerated depreciation, and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. In addition, the non-GAAP financial guidance in this press release excludes the impact of any potential additional future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this communication. corporatefinancial-news