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Despite heart disease being the leading cause of death in the U.S., millions lack access to affordable, accurate diagnostics. Peerbridge Health, the company transforming how heart disease is diagnosed, is working to close that gap and announced a series of milestones today that will move it closer to that goal. […]
Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc. Mont-Saint-Guibert, Belgium – September 15, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) and Nyxoah, Inc. (collectively, “Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that it has filed a lawsuit against Inspire Medical Systems, Inc. (“Inspire”) alleging that the Inspire IV and Inspire V devices infringe the following three patents held by the Company; U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216. The suit was filed in the United States District Court for the District of Delaware, seeking injunctive relief and damages for infringement. “We will defend our intellectual property portfolio and the proprietary, minimally invasive Genio® system, which does not rely on traditional pacemaker hardware but is a differentiated solution offering bi-lateral stimulation, full body MRI compatibility and an upgradable technology platform that does not require re-surgery for battery replacements,” said Olivier Taelman, Chief Executive Officer. “At Nyxoah, we remain committed to putting patients first and offering physicians an alternative, trusting them to make the best decision for their patients suffering from OSA. We’re excited about the positive feedback we have received from both physicians and patients in the first month post-US commercial launch and look forward to introducing the Genio system to more physicians and OSA patients so they can choose the best solution for their needs.” About NyxoahNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and U.S. FDA approval of a Premarket Approval application. For more information, please visit http://www.nyxoah.com/. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio system; planned and ongoing clinical studies of the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; the Company’s intellectual property portfolio; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, or adverse litigation outcomes can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: NyxoahJohn Landry, CFOIR@nyxoah.com
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GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced the appointment of Linda M. Richardson to the role of Chief Commercial Officer, effective September 16, 2025. Ms. Richardson joins the Company with more than 30 years of experience in sales and marketing, commercial, corporate and business development across a range of therapeutic areas, including metabolic disease, hepatology, cardiovascular and addiction medicine. During her career, she has led multiple product launches, built successful commercial franchises and contributed to a variety of business development transactions. “Linda joining Altimmune marks a key strategic addition to our executive team as we approach the initiation of Phase 3 development of pemvidutide in MASH. To add a leader with her pedigree positions Altimmune, and pemvidutide, for future commercial success,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “Her deep expertise and strong track record will be instrumental to our strategic business execution and growth.” Ms. Richardson added, “I believe that pemvidutide represents a rare opportunity in the area of hepato-metabolic disease and is differentiated from other marketed and development-stage therapies with significant potential to improve the lives of patients with MASH. Additionally, there are sizeable opportunities in Alcohol Use Disorder and Alcohol-associated Liver Disease where we continue to investigate the potential utility of pemvidutide in these highly prevalent and underserved indications. I am pleased to bring my experience to Altimmune and thrilled to begin leading Altimmune’s commercial-readiness efforts.” Ms. Richardson served as Chief Commercial Officer and Executive Vice President at Intercept Pharmaceuticals, a liver disease company, departing in early 2024 following the Company’s acquisition by Alfasigma. Prior to joining Intercept, she was Chief Strategy and Commercial Officer at Chimerix. Earlier in her career, she held a variety of senior-level marketing and commercial positions, including at Sanofi, where she was Global Commercial Head of Lixisenatide, the Company’s GLP-1 program and Marketing Lead for MULTAQ and AUVI-Q, Reliant Pharmaceuticals, where she launched Lovaza for hypertriglyceridemia, and at GSK. She holds a bachelor’s degree in English from the University of Pennsylvania. Inducement GrantIn connection with being named as Chief Commercial Officer, Ms. Richardson will receive, in the aggregate, options to purchase 278,000 shares of Altimmune’s common stock, and 96,000 restricted stock units (“RSUs”). The options will have an exercise price equal to the closing price of Altimmune’s common stock on September 16, 2025 (the “Grant Date”). Based on the closing price of Altimmune’s common stock on September 12, 2025, Altimmune would issue approximately 168,112 options as inducement awards under its 2018 Inducement Grant Plan, and the balance as incentive stock options under its 2017 Omnibus Incentive Plan. The final allocation of options between the 2018 Inducement Grant Plan and 2017 Omnibus Plan are subject to adjustment based on the closing price of Altimmune’s common stock on the Grant Date. One-fourth of the shares underlying the options will vest on the one-year anniversary of the Grant Date and thereafter 1/36th of the shares underlying the options will vest monthly, such that the shares underlying the options will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to Ms. Richardson’s continued employment with Altimmune on such vesting dates. One-fourth of the RSUs will vest on the one-year anniversary of the Grant Date and thereafter the RSUs will vest in three substantially equal annual installments, such that the RSUs will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to Ms. Richardson’s continued employment with Altimmune on such vesting dates. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). About AltimmuneAltimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead product candidate is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-associated Liver Disease (ALD) and obesity. For more information, please visit www.altimmune.com. Forward-Looking StatementsAny statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, the timing of key milestones for the Company’s clinical assets, future plans or expectations for pemvidutide for the treatment of MASH, AUD, ALD and obesity, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements, or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Jake RobisonInizio Evoke CommsPhone: 619-849-5383jake.robison@inizioevoke.com This press release was published by a CLEAR® Verified individual.
KIRKLAND, Wash., Sept. 11, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today reported financial results for the first quarter fiscal 2026, which ended July 31, 2025. Financial Highlights Generated revenue of $19.4 million in Q1 FY26, an increase of 52% compared to the prior year period.Expanded gross margin to 45.7% in Q1 FY26 compared to 32.9% in the prior year period.Increased FY26 revenue guidance to $88 million, representing growth of 47% compared to FY25. “We had a strong start to fiscal 2026, with our sustained commercial momentum generating revenue growth of over 50% in the first quarter,” said Brian Webster, President and CEO. “We also continued to make progress on several key operational objectives, including growing the commercial organization, enhancing our revenue cycle management capabilities, and expanding gross margin. As we progress on our journey to category leadership, we remain focused on both market share capture and growing the wearable defibrillator market, while executing on our commitments to patients and their prescribers.” First Quarter Fiscal 2026 Financial Results Total revenue was $19.4 million, an increase of 52% compared to the prior year period. 4,205 prescriptions were written for the ASSURE® system, an increase of 51% compared to the prior year period.Revenue growth was driven by higher market share with existing customers and activation of new accounts. Revenue also benefited from a higher mix of in-network patients and improvements in revenue cycle management capabilities. Gross profit was $8.9 million compared to $4.2 million in the prior year period. Gross margin expanded to 45.7% compared to 32.9% in the prior year period, driven by volume leverage and a higher mix of in-network patients. GAAP operating expenses were $37.7 million and included $2.9 million of non-recurring new public company costs. GAAP operating expenses were $22.6 million in the prior year period. Excluding non-recurring new public company costs and share-based compensation expense, operating expenses were $30.3 million in Q1 FY26. The increase was attributable to growth in expenses related to commercial and revenue cycle resources. GAAP net loss and comprehensive loss was $25.8 million compared to GAAP net loss and comprehensive loss of $20.3 million in the prior year period. Adjusted EBITDA* loss was $19.4 million compared to an adjusted EBITDA loss of $15.7 million in the prior year period. Cash and cash equivalents totaled $201.2 million as of July 31, 2025. *Adjusted EBITDA is a non-GAAP financial measure. See “Use of Non-GAAP Financial Measures” below for additional information. A reconciliation of Adjusted EBITDA to the most directly comparable GAAP measure is included in this press release. Fiscal Year 2026 Revenue GuidanceKestra is increasing its FY26 revenue guidance to $88 million, representing growth of 47% compared to FY25. This compares to prior FY26 revenue guidance of $85 million. Webcast and Conference CallKestra will host a conference call today at 4:30 p.m. ET to discuss first quarter fiscal 2026 financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website. Use of Non-GAAP Financial MeasuresThis press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including Adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP. Adjusted EBITDA, which is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, share-based compensation expense, and non-recurring new public company costs, is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate the Company’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of Adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results. The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of Adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of September 11, 2025. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share amounts)(unaudited) Three Months Ended July 31, 2025 2024 Revenue $19,371 $12,782 Cost of revenue 10,520 8,582 Gross profit 8,851 4,200 Operating expenses: Research and development 4,001 3,404 Selling, general and administrative 33,728 19,227 Total operating expenses 37,729 22,631 Loss from operations (28,878) (18,431)Other expense (income): Interest expense 1,912 1,874 Interest income (2,167) (37)Other expense (income) (2,830) 48 Net loss before provision for income taxes (25,793) (20,316)Provision for income taxes 33 7 Net loss and comprehensive loss (25,826) (20,323)Net loss attributable to non-controlling interest — (439)Net loss and comprehensive loss attributable to Kestra Medical Technologies, Ltd. (25,826) (19,884)Less: Undeclared preferred stock dividends — 2,383 Net loss attributable to common shareholders, basic and diluted $(25,826) $(22,267) Net loss per share attributable to common shareholders, basic and diluted $(0.50) $(1.12)Weighted-average shares of common shares outstanding, basic and diluted 51,304,599 19,885,382 RECONCILIATION OF GAAP NET LOSS AND COMPREHENSIVE LOSS TO ADJUSTED EBITDA(in thousands)(unaudited) Three Months Ended July 31, 2025 2024 GAAP Net loss and comprehensive loss $(25,826) $(20,323)Non-GAAP Adjustments: Interest expense 1,912 1,874 Interest income (2,167) (37)Other expense (income) (2,830) 48 Provision for income taxes 33 7 Depreciation expense 2,028 2,375 Share-based compensation expense 4,579 377 Non-recurring new public company costs 2,866 — Adjusted EBITDA $(19,405) $(15,679) KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)(unaudited) July 31, April 30, 2025 2025 Assets Current assets Cash and cash equivalents $201,214 $237,595 Accounts receivable, net 9,246 8,081 Disposable medical equipment supplies 6,802 6,572 Prepaid expenses and other current assets 3,429 3,080 Total current assets 220,691 255,328 Right-of-use assets 2,046 2,078 Deposits 1,787 2,021 Restricted cash 334 334 Property and equipment, net 40,376 34,830 Other long-term assets 1,062 1,153 Total assets $266,296 $295,744 Liabilities and Shareholders’ Equity Current liabilities Accounts payable $18,570 $23,961 Accrued liabilities 13,650 13,829 Operating lease liabilities, current portion 36 187 Total current liabilities 32,256 37,977 Operating lease liabilities, net of current portion 3,067 3,026 Warrant liabilities 5,188 8,097 Other long-term liabilities 140 140 Long-term debt, net 41,486 41,098 Total liabilities 82,137 90,338 Commitments and contingencies Shareholders’ equity Common shares, $1.00 par value; 100,000,000 shares authorized as of July 31, 2025 and April 30, 2025; 51,348,656 shares issued and outstanding as of July 31, 2025 and April 30, 2025 51,349 51,349 Additional paid-in capital 678,885 674,306 Accumulated deficit (546,075) (520,249)Total shareholders’ equity 184,159 205,406 Total liabilities and shareholders’ equity $266,296 $295,744 CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
The anticipated acquisition aligns with GE HealthCare’s precision care strategy with the goal of strengthening the company’s portfolio of offerings in neurological care and its quantitative analysis of brain MRI icometrix’s icobrain platform – a comprehensive set of solutions for neurological disease analysis – includes icobrain aria, the first AI […]
Strategic Rebranding to Focus on Expanded Business Model and Growth Strategy. New Ticker Symbol “STEX”.LOS ANGELES & VANCOUVER, British Columbia, Sept. 10, 2025 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig”), which recently merged with Streamex Exchange Corporation (“Streamex”) (together, “BSGM” or the “Company”), announced today that it will change its name to Streamex Corp., effective at 12:01 am Eastern Time on Friday, September 12, 2025. In connection with the name change, the Company will change its trading symbol to “STEX.” The Company’s common stock will commence trading on the Nasdaq Capital Market exchange under the new name and trading symbol on September 12, 2025. As of September 12, 2025, all Company stock trading, filings, and market related information will be reported under the new symbol “STEX”. The Company’s CUSIP number will remain unchanged, and no action is required from shareholders. No other aspects of the Company’s corporate structure or operations are impacted by the ticker symbol change. About Streamex Exchange Corporation Streamex is a Real World Asset (“RWA”) tokenization company with Institutional grade infrastructure to bring the gold and commodities market on chain. Enabled by a gold denominated treasury and tokenization technology powering the modern commodities market. Streamex is a wholly owned subsidiary of BioSig Technologies, Inc. About BioSig Technologies, Inc. BioSig Technologies, Inc. is a medical device technology company with an advanced digital signal processing technology platform, the PURE EP™ Platform that delivers insights to electrophysiologists for ablation treatments of cardiovascular arrhythmias. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. It is possible that our actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether we will be able to realize the benefits of the acquisition of Streamex, whether shareholder approval of the acquisition will be obtained, and whether we will be able to maintain compliance with Nasdaq’s listing criteria in connection with the acquisition and otherwise. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in forward-looking statements, see our filings with the Securities and Exchange Commission, including the section titled “Risk Factors” in our Annual Report on Form 10-K, filed with the SEC on April 15, 2025. We assume no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250714401245/en/ Investor Relations ContactAdele CareyAlliance Advisors Investor Relationsacarey@allianceadvisors.com Henry McPhieCEO of BioSig, Co-Founder of Streamexcontact@Streamex.comhttps://www.streamex.com/https://x.com/streamexSource: BioSig and Streamex
Innovative vascular health company recognized for commitment to growth, innovation, and community impact in North Texas DALLAS, Sept. 9, 2025 /PRNewswire/ — Koya Medical (“Koya”), a global leader in vascular health innovation, is proud to announce it has been honored with the Building…
Tourmaline Bio is a clinical-stage biopharmaceutical company developing pacibekitug, an anti-IL-6 mAb, as a treatment option for atherosclerotic cardiovascular diseasePacibekitug is a promising targeted therapy with the potential to reduce systemic inflammation—an independent and significant driver of cardiovascular risk—addressing a critical unmet need in ASCVD treatment Offer price of USD 48 per share valuing the company at approximately USD 1.4bn on a fully diluted basis Basel, September 9, 2025 – Novartis today announced that it has entered into an agreement to acquire Tourmaline Bio, Inc. (“Tourmaline”) (Nasdaq: TRML), a New York-based, publicly traded clinical-stage biopharmaceutical company focused on developing pacibekitug, an anti-IL-6 mAb, as a treatment option for atherosclerotic cardiovascular disease. Pacibekitug complements Novartis’ cardiovascular strategy by targeting IL-6, a key upstream cytokine that promotes systemic inflammation, thus addressing a critical unmet need. With Phase 21 trials already well advanced, Novartis will acquire a Phase 3 ready asset which will complement its existing cardiovascular disease portfolio. “With no widely adopted anti-inflammatory therapies currently available for cardiovascular risk reduction, pacibekitug represents a potential breakthrough in addressing residual inflammatory risk in ASCVD with a differentiated mechanism of action targeting IL-6,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. “Inflammation is a major driver of cardiovascular disease, and the team at Tourmaline has made significant progress with this asset. We are excited to bring pacibekitug into the Novartis portfolio and collaborate with the Tourmaline team to advance its development as we diversify our efforts in cardiovascular care.” Pacibekitug is an investigational anti-IL-6 IgG2 human monoclonal antibody designed to mitigate systemic inflammation implicated in ASCVD and has demonstrated high affinity binding to IL-6. The Phase 2 TRANQUILITY 90-day study results which were released on May 20, 2025, showed that pacibekitug reduced median high-sensitivity C-reactive protein (hs-CRP) levels by 85% through day 90 at a dose of 15 mg once monthly and by 86% at a dose of 50 mg delivered quarterly, with overall incidence rates of adverse events and serious adverse events comparable to placebo. These promising results underscore the potential for pacibekitug to address the unmet need in cardiovascular care by targeting residual inflammatory risk more effectively than current therapies and with convenient once quarterly administration. Transaction detailsUnder the terms of the transaction, which has been unanimously approved by the Boards of Directors of both companies, Novartis will, through an indirect wholly owned subsidiary, commence a tender offer to purchase all outstanding shares of Tourmaline common stock. Holders of Tourmaline common stock would receive USD 48 per share in cash at closing. Following completion of the tender offer, Novartis expects to merge the acquiring subsidiary with and into Tourmaline, resulting in Tourmaline becoming an indirect wholly owned subsidiary of Novartis. The transaction is expected to close in the fourth quarter of 2025, subject to the satisfaction or waiver of customary closing conditions, including the tender of a majority of the outstanding shares of Tourmaline common stock and the receipt of regulatory approvals. Until closing, Novartis and Tourmaline will continue to operate as separate and independent companies. About Novartis in Cardiovascular DiseaseAt Novartis, our mission is to ensure no heart is lost too soon. We envision a world where preventable cardiovascular deaths are no longer part of our lives. We’re proud of the positive impact we’ve made over the past 40 years and remain dedicated to tackling the most challenging problems in CVD. Through cutting-edge science and technology, we are focusing on areas of high unmet need, including scaling our xRNA platform across multiple risk factors and pioneering breakthroughs for genetically driven CVD risk factors and common heart conditions, including atrial fibrillation. We also work with patients, healthcare professionals, and organizations around the world to improve cardiovascular care beyond medicine alone. Together, we can help people with CVD enjoy longer, healthier lives and more time with their loved ones. Additional informationThis press release is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock, par value USD 0.0001 (the “Shares”), of Tourmaline or any other securities. The tender offer for the outstanding Shares described in this press release has not commenced. At the time the tender offer is commenced, Novartis and its indirect wholly owned subsidiary, Torino Merger Sub Inc. (“Purchaser”), will file a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the U.S. Securities and Exchange Commission (the “SEC”), and Tourmaline will file a solicitation/recommendation statement on Schedule 14D-9 with the SEC, in each case with respect to the tender offer. INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE TENDER OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. An offer to purchase the Shares will only be made pursuant to the offer to purchase, the letter of transmittal and related offer documents filed as a part of the Schedule TO. Those materials and all other documents filed by, or caused to be filed by, Novartis, Purchaser and Tourmaline with the SEC will be available at no charge on the SEC’s website at www.sec.gov or by directing such requests to the information agent for the offer, which will be named in the tender offer statement. The offer to purchase and related materials also may be obtained for free under the “Investors – Financial Data” section of Novartis website at www.novartis.com/investors/financial-data/sec-filings. The solicitation/recommendation statement also may be obtained for free under the “Investors” section of Tourmaline’s website at ir.tourmalinebio.com. In addition, Tourmaline files annual, quarterly and current reports and other information, and Novartis files annual reports and other information with the SEC, which are also available to the public at no charge at www.sec.gov. DisclaimerThis press release contains statements that are not statements of historical fact, or “forward-looking statements,” including with respect to Novartis’ proposed acquisition of Tourmaline. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Tourmaline’s product candidates, Tourmaline’s platform, the proposed acquisition of Tourmaline and the expected timetable for completing the proposed acquisition, the benefits sought to be achieved in the proposed acquisition, or potential future revenues from Tourmaline’s product candidates. You should not place undue reliance on these statements. Such forward-looking statements are based on Novartis’ current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that clinical trials for any of Tourmaline’s product candidates will be successful, that Tourmaline’s approach to the discovery and development of product candidates based on its AOC™ platform will produce any products of commercial value, that any of Tourmaline’s product candidates will be submitted for marketing approval or approved for sale or, if approved, receive approval for any additional indications or labeling, in any market, or at any particular time, nor can there be any guarantee that, if approved, any of Tourmaline’s product candidates will be commercially successful in the future. Neither can there be any guarantee that the conditions to the closing of the proposed acquisition will be satisfied on the expected timetable or at all or that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all. In particular, expectations regarding Tourmaline or the transaction described in this press release could be affected by, among other things, the timing of the offer and the satisfaction of customary closing conditions, including the tender of a majority of the outstanding shares of Tourmaline common stock and the receipt of regulatory approvals on acceptable terms or at all; the risk that competing offers or acquisition proposals will be made; the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on Novartis and/or Tourmaline’s businesses, including their relationships with employees, business partners or governmental entities; the risk that the offer or the merger may be more expensive to complete than anticipated; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; a diversion of management’s attention from ongoing business operations and opportunities as a result of the offer, the merger or otherwise; general industry conditions and competition; general political, economic and business conditions, including interest rate and currency exchange rate fluctuations; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s and Tourmaline’s filings and reports with the SEC, including Novartis AG’s Annual Report on Form 20-F for the year ended December 31, 2024, Tourmaline’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and any subsequent filings made by either party with the SEC, available on the SEC’s website at www.sec.gov. Novartis is providing the information in this press release as of this date and Novartis does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except to the extent required by law. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References 1 A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP (TRANQUILITY). Clinicaltrials.gov. (2025). https://clinicaltrials.gov/study/NCT06362759?tab=table # # # Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com
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