Novartis AG

– Novartis to acquire Tourmaline Bio for $48.00 per share in cash for a total equity value of approximately $1.4 billion – – Transaction reflects the potential of Tourmaline’s pacibekitug, a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential, for the treatment of cardiovascular diseases – – Transaction is expected to be completed in the fourth quarter of 2025, subject to customary closing conditions – Sept. 09, 2025 -- Tourmaline Bio, Inc. (“Tourmaline”) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines that establish new standards of care for patients with life-altering inflammatory and immune diseases, today announced that it has entered into a merger agreement with Novartis AG (“Novartis”), pursuant to which Novartis will acquire Tourmaline for $48.00 per share in cash at closing, or a total equity value of approximately $1.4 billion. This represents a premium of 59% to Tourmaline’s closing stock price on September 8, 2025, the last trading day before the announcement of the transaction, and 127% to Tourmaline's 60-day volume-weighted average stock price as of that same date. The transaction has been unanimously approved by the Boards of Directors of both companies. “Our mission at Tourmaline has been to establish new standards of care in areas of high unmet medical need, and today’s transaction announcement both underscores our commitment to that focus and also delivers compelling shareholder value,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “We are thrilled that Novartis, a company with deep roots and a commitment to innovation in the cardiovascular, renal, and metabolic disease space, will continue to advance this mission. Novartis shares our conviction in the critical, but largely unaddressed, role of inflammation in driving cardiovascular diseases and will be an ideal partner to accelerate the development of pacibekitug. I want to extend my heartfelt thanks to our Tourmaline colleagues and advisors for their dedication and hard work, as well as to our investigators and clinical trial participants who have helped expand our understanding of cardiovascular inflammation.” “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.” Under the terms of the merger agreement, a subsidiary of Novartis will commence a tender offer to acquire all of Tourmaline's outstanding shares for a price of $48.00 per share in cash at closing. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Tourmaline's outstanding shares and receipt of regulatory approvals, and other customary closing conditions. Completion of the transaction is expected in the fourth quarter of 2025, subject to the satisfaction or waiver of customary closing conditions. Until that time, Tourmaline will continue to operate as a separate and independent company. Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties, including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that establish new standards of care for patients with life-altering inflammatory and immune diseases. Tourmaline’s lead asset is pacibekitug. The content above comes from the network. if any infringement, please contact us to modify.

Nearing its goal of submitting a marketing application for its experimental Duchenne muscular dystrophy (DMD) therapy by year-end, Avidity Biosciences reported functional data on Wednesday that could further bolster the candidate's case for approval. While the company's shares traded mostly flat for the day, it proposed after market close to raise $500 million in a follow-on.Delpacibart zotadirsen (del-zota) is an antibody oligonucleotide conjugate (AOC) that delivers a phosphonodiamidite morpholino oligomer to muscle tissues, enabling dystrophin production in patients with DMD mutations amenable to exon 44 skipping.The biotech evaluated two doses of del-zota — 5 mg/kg every six weeks and 10 mg/kg every eight weeks — in 26 participants in the placebo-controlled Phase I/II EXPLORE44 trial. A total of 12 ambulatory and 5 non-ambulatory patients elected to continue treatment at the 5 mg/kg dose level in the EXPLORE44 open-label extension (OLE).Positive results from the Phase I/II portion reported in March showed that the AOC increased dystrophin production to approximately 25% of normal levels, with restored total dystrophin reaching up to 58% of normal. In addition, creatine kinase, a marker of muscle damage, was reduced by over 80% from baseline.Preventing declineIn its Wednesday update, Avidity shared functional data from patients in the OLE who had been followed for about a year, and contrasted their results with a DMD natural history study that included 22 patients amenable to exon 44 skipping. On several functional endpoints, patients taking del-zota saw benefits while the natural history group worsened over the same time period. For the 4-Stair Climb test and the 10-Meter Walk/Run Test, 10 patients in the experimental cohort experienced improvements from baseline of 2.1 seconds and 0.7 seconds, respectively, versus the comparator, which declined by 2.7 seconds and 1.5 seconds, respectively.Ten participants in the OLE remained stable at the one-year mark, as measured by the North Star Ambulatory Assessment (NSAA), while the natural history group declined from baseline by 2.4 points.In addition, six evaluable del-zota recipients improved their Time to Rise from Floor score by 3.2 seconds from baseline, contrasting with a 1.6-second decline from baseline for the comparator.  All 17 participants in the OLE had data on the Performance of Upper Limb endpoint, showing a gain of 1.5 points, while the natural history group declined from baseline by 0.7 points."For the first time, we have data showing that sustained muscle protection leads to meaningful improvements across multiple key functional measures in DMD," said CEO Sarah Boyce. "These unprecedented data underscore the impact of our revolutionary targeted approach to deliver RNA directly to muscle."'Smooth approval'The company is planning to file its biologics license application by the end of the year. BMO Capital Markets analyst Kostas Biliouris predicted in August that Avidity was on-track for an accelerated approval in the second half of 2026. "We anticipate a smooth approval given high unmet need (no approved exon-44 skipping treatments) and potential heightened patients' hesitancy around gene therapy following recent FDA/[Sarepta] headlines," he wrote. Shipping of Sarepta Therapeutics' DMD gene therapy Elevidys was briefly halted in July following safety concerns spurred by several patient deaths (see – Physician Views In-Depth: Elevidys fallout contained to non-ambulatory DMD, for now). Unlike Elevidys, del-zota is not delivered via AAV vector, nor is it a one-time treatment.The potential for the AOC to avoid the safety issues associated with the gene therapy, and its high likelihood for approval, could prompt an Avidity acquisition. In early August, rumours emerged that Novartis was eyeing a takeout of Avidity, which bumped up the biotech's shares by about 20%. As of Wednesday, the company has a roughly $6-billion market cap.

Basel: Swiss pharma major Novartis is moving to acquire a New York based cardiovascular therapy developer Tourmaline Bio for s total cash consideration of $1.4 billion. Under the agreement Novartis through an indirect wholly owned subsidiary will commence a tender offer to purchase all outstanding shares of Tourmaline at a floor price of $48 per share in cash accumulating to total value of around $1.4 billion. Novartis will own Tourmaline as an indirect wholly owned subsidiary and expects to close the acquisition by the fourth quarter of 2025. ‘ Key driver of the deal is Tourmaline ‘s Pacibekitug , a Phase-3 ready human monoclonal antibody investigated over atherosclerotic cardiovascular disease (ASCVD). The experimental biologic targets interleukin 6 ligand (IL-6) a pro-inflammation related in various kinds of inflammation and the drug inhibits its interaction with the receptor thereby blocking the signaling pathway that promotes systemic inflammation. Subject to approval, the therapy is in contest with Tocilizumab marketed by another Swiss giant Roche under the name Actemra/RoActemra. Another IL-6 inhibitor available in the market is Regeneron’s Sarilumab, marketed under the brand name Kevzara. “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, Chief Medical Officer, Novartis. By Online Bureau ,