Novartis culls ianalumab in HS after Phase IIb trial failure
The study (NCT03827798) had enrolled 248 patients with HS and was evaluating the change in simplified Hidradenitis Suppurativa Clinical Response (sHiSCR) after 16 weeks.
The termination of the therapy in HS was announced in Novartis' Q2 results, with the company stating: 'Novartis will not advance investigation of ianalumab in HS following a Phase II proof-of-concept study which did not meet our target criteria despite demonstrating efficacy vs placebo. No new safety signals were observed, and all other studies for ianalumab in B-cell driven diseases continue as planned.'
The indications Novartis will continue the development of ianalumab for include lupus nephritis, Sjögren syndrome, and autoimmune hepatitis.
Ianalumab is a monoclonal antibody directed against the BAFF (B cell-activating factor belonging to the TNF family) receptor. It acts by preventing the activation of B cells to avoid overproduction. By reducing the number and activity of B cells, ianalumab can help to dampen the harmful immune responses that drive autoimmune diseases.
If approved, GlobalData predicts ianalumab to reach sales of $638m in 2031.
GlobalData is the parent company of Clinical Trials Arena.
Four other pipeline drugs in Phase IIb study
The Phase IIb trial also evaluated the efficacy of four other drugs in Novartis' pipeline, namely iscalimab, remibrutinib, LYS-006 and MAS-825.
Data from the remibrutinib was presented at the American Academy of Dermatology (AAD) meeting in March 2024, with the drug having met its primary endpoint. As a result, Novartis is now running a Phase III trial of the therapy in HS (NCT06799000).
Novartis has already secured a drug in the HS treatment space, after Cosentyx (secukinumab) gained approval from the US Food and Drug Administration (FDA) in October 2023.
UCB's Bimzelx (bimekizumab) is the most recent biologic in HS, having been approved by the FDA in November 2024.
AbbVie's flagship Humira (adalimumab) is also approved in HS and was the first biologic to be approved in the indication in 2015.
"Novartis culls ianalumab in HS after Phase IIb trial failure" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
5 hours ago
- Yahoo
Tesla's auto revenue drops in Q2 2025
Tesla has reported a 12% year-on-year (YoY) decrease in total revenue for the second quarter (Q2) of 2025, with figures falling to $22.49bn from $25.5bn in the same period last year. The company's Q2 2025 financial results reflect vehicle delivery decline and lower regulatory credit revenue, among other factors. The company sold 384,122 cars in Q2, down 13.5% from the sales total a year ago. Total automotive revenues saw a 16% YoY decrease for a second straight quarter to $16.6bn in Q2 2025. Net income attributable to common stockholders (GAAP) for the quarter also fell by 16% to $1.17bn, while non-GAAP net income saw a 23% decline to $1.39bn. The company's total gross profit dropped by 15% YoY to $3.87bn. Net cash from operating activities decreased by 30% to $2.54bn, and adjusted EBITDA was down 7% at $3.40bn for Q2 2025. Operating expenses also experienced a slight decrease of 1% to $2.95bn. Income from operations plummeted by 42% to $923m, mainly affected by lower regulatory credit revenue, increased operating expenses due to AI and research and development (R&D) projects, and vehicle delivery decline. Tesla has noted in the update letter that its lithium refining and cathode production plants are set to start production in 2025, aiming to onshore the production of critical battery materials in the US. The company is also preparing to start domestic production of its first LFP cells for energy storage products later in 2025. Tesla emphasises a 'capex-efficient' approach to growing vehicle volumes, utilising current production capacity before expanding. The anticipated launch of new vehicles in 2025, including 'a more affordable model' in the first half of the year, remains on schedule. Tesla's Cybercab, a Robotaxi product, is expected to enter volume production in 2026. The company sold 384,122 cars in Q2, down 13.5% from the sales total a year ago. In the first quarter (Q1) revenues 2025, which ended on 31 March, Tesla reported a 20% decline. "Tesla's auto revenue drops in Q2 2025" was originally created and published by Just Auto, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
7 hours ago
- Yahoo
Top M&A legal advisers in automotive revealed for H1 2025
A&O Shearman has emerged as the top legal adviser for mergers and acquisitions (M&A) by deal value in the automotive sector for the first half (H1) of 2025, while CMS and Kirkland & Ellis have taken the lead by deal volume, as per data and analytics firm GlobalData's latest legal advisers league table. A&O Shearman advised on automotive M&A deals worth $2.17bn, securing the top spot by value according to GlobalData's Deals Database. CMS and Kirkland & Ellis, each advising on four deals, have co-led the automotive sector in terms of volume. GlobalData lead analyst Aurojyoti Bose said: 'Kirkland & Ellis was the top adviser by volume in H1 2024 and retained the top spot by this metric in H1 2025 as well. Meanwhile, CMS registered an improvement in its ranking by volume from the third position in H1 2024 to the top position in H1 2025. 'Meanwhile, A&O Shearman's ranking by value jumped from eighth position in H1 2024 to the top position in H1 2025 as there was more than a four-fold jump in the total value of deals advised by it during the period. "This jump in value was driven by its involvement in $1.4bn deal for the acquisition of Dowlais by American Axle & Manufacturing. Apart from leading by value, A&O Shearman also held the fifth position by volume in H1 2025.' Cravath Swaine & Moore, Norton Rose Fulbright, and Slaughter and May shared the second spot by value, each advising on a $1.4bn worth deal. Following closely, Cleary Gottlieb Steen & Hamilton advised on a deal valued at $735m, showcasing their ability to handle significant transactions within the industry. In terms of volume, AZB & Partners and Baker McKenzie were tied for the third position, each firm advising on three deals. They were followed by A&O Shearman advising on two deals. GlobalData's league tables are based on the real-time tracking of thousands of company websites, advisory firm websites and other reliable sources available on the secondary domain. A dedicated team of analysts monitors all these sources to gather in-depth details for each deal, including adviser names. To ensure further robustness to the data, the company also seeks submissions of deals from leading advisers. "Top M&A legal advisers in automotive revealed for H1 2025" was originally created and published by Just Auto, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.


Business Insider
9 hours ago
- Business Insider
Eastern Region Group: Crypto Firms Shift from Singapore to Dubai Amid Regulatory Changes
Dubai, United Arab Emirates, July 25th, 2025, Chainwire Eastern Region Group announced the publication of a new analysis examining recent shifts in crypto business migration patterns, with a particular focus on movement between Singapore and Dubai. Based on the firm's direct experience advising digital asset companies, investors, and international founders in both jurisdictions, the report outlines key regulatory, operational, and strategic factors influencing these relocations and explores the broader implications for the digital assets industry. Over the past year, a decisive shift has taken place in the global crypto market. For more than a decade, Singapore was seen as the go-to destination for digital asset businesses in Asia — offering regulatory credibility, political stability, and institutional respect. But that reputation has come under pressure. In 2025, the Monetary Authority of Singapore (MAS) introduced a sweeping requirement: any crypto company serving clients abroad must obtain a full domestic license — regardless of whether they onboard Singaporean users or not. There was no grace period, no transitional licensing path, and no exemptions for smaller players or startups. As a result, a number of major crypto firms have begun shifting their core operations to Dubai, a jurisdiction that increasingly offers what Singapore no longer can: regulatory clarity, licensing flexibility, and structural support for global businesses. From Asia's Crypto Darling to a Regulatory Bottleneck Singapore's goal in tightening its rules was clear: reduce risk, protect retail investors, and prevent crypto-related financial crimes. But in doing so, it has made it almost impossible for non-institutional platforms to grow globally under its regime. Licensing can take more than a year, and approval is far from guaranteed, even for large, well-capitalized companies. Projects focused on DeFi, tokenization, Web3 services, or blockchain-based financial products often find themselves in legal grey zones, facing operational uncertainty and mounting legal costs. This shift in regulatory approach has led to a noticeable increase in corporate relocations within the digital assets sector. Several major firms have scaled back their operations or licensing efforts in Singapore, redirecting compliance and operational resources to jurisdictions such as the United Arab Emirates. In parallel, a number of mid-sized platforms and token issuers have withdrawn regulatory applications or suspended expansion plans in Singapore, opting to explore alternative hubs for growth and compliance alignment. Dubai's Rise: More Than Just Tax-Friendly Dubai's appeal lies not only in its 0% personal income and capital gains tax on crypto earnings, but in the regulatory optionality it offers. Companies can choose between: VARA, the world's first dedicated virtual assets regulator; DIFC, home to fintech and funds operating under English common law; ADGM, offering regulated digital finance with direct access to global capital; Free Zones like IFZA and DMCC for support functions and tech development. Licensing timelines are faster — often between 4 and 6 weeks — and the process is more transparent, with fewer surprises and stronger regulator engagement. The UAE maintains FATF-aligned AML standards and requires economic substance, giving credibility in the eyes of banks and global investors. Meanwhile, the government is actively backing blockchain development: Incentives for Web3 firms and token-based projects Flagship events like TOKEN2049 Dubai with 15,000+ attendees Dedicated real estate projects like Crypto Tower, turning the city into a global hub for next-gen digital finance What This Means for the Industry The decision between Singapore and Dubai is no longer only about geography — it's about vision. One model is increasingly focused on restriction and containment. The other enables innovation under clear rules. For founders, investors, and developers, Dubai is no longer the backup — it is the benchmark for globally scalable, legally sound, and economically viable crypto ventures. Eastern Region Group: At the Forefront of the Shift Eastern Region Group is actively tracking regulatory shifts and policy developments across major financial centers, with particular attention to the United Arab Emirates. The firm's regulatory specialists identify Dubai as a jurisdiction gaining prominence in the global digital assets sector. In response to these developments, Eastern Region Group has expanded its focus on Web3 strategy, licensing, and corporate structuring. The firm offers advisory services to companies evaluating jurisdictional options to support scalable and compliant digital asset operations. Eastern Region Group, where expertise meets innovation, and tailored solutions pave the way to a business's triumph. At ERG, they are more than just a service provider. They're a strategic ally, dedicated to supporting business founders, investors, employees, and their families in navigating the complex world of business in the United Arab Emirates and abroad.