CSL (ASX:CSL) Secures NICE Approval For Sparsentan Use In NHS England
CSL saw its stock price rise by 3% over the last month, amid important developments and a fluctuating market environment. CSL Vifor's notable progress with the National Institute for Health and Care Excellence recommending sparsentan for primary IgA nephropathy treatment may have provided positive momentum. This significant medical endorsement, alongside CSL's continued engagement with shareholders through meetings, could have added weight to its share performance. Meanwhile, broader market volatility, influenced by global trade tensions and declining major indexes, may have tempered the extent of CSL's gains, which align closely with general market movement, as the market faced a 1% decline.
We've spotted 1 possible red flag for CSL you should be aware of.
The latest GPUs need a type of rare earth metal called Dysprosium and there are only 24 companies in the world exploring or producing it. Find the list for free.
The recent developments regarding CSL's approval for sparsentan, a treatment recommended by the National Institute for Health and Care Excellence, may enhance the company's market position, potentially fueling revenue growth. Over the past three years, however, CSL's total return, inclusive of share price changes and dividends, recorded a decline of 4.64%. This contrasts against a broader 1-year underperformance both relative to the Australian market's 4.9% increase and the Australian Biotechs industry's -9.4% decrease, highlighting a need to bridge the performance gap with new advancements.
Looking forward, the impact of these medical endorsements might influence CSL's revenue and earnings forecasts positively, with anticipated expansion in the HAE and vaccine sectors playing a crucial role. Despite the current share price of A$251.13 being lower than the consensus analyst price target of A$311.94, suggesting a potential upswing, the market's fluctuations must be considered in investment evaluations. As CSL continues to hone operational efficiencies and product rollouts, assessing these factors against earnings projections will be vital in understanding its long-term trajectory.
According our valuation report, there's an indication that CSL's share price might be on the cheaper side.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include ASX:CSL.
This article was originally published by Simply Wall St.
Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@simplywallst.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Bloomberg
6 hours ago
- Bloomberg
Walmart CFO Says Shoppers Remain Focused on Food, Essentials
Walmart Inc. said shoppers are still spending about the same as they did a year or two ago, with a focus on food and essentials over discretionary purchases. 'It's been very consistent,' Chief Financial Officer John David Rainey told reporters in a question-and-answer session at the company's annual shareholders' week in Bentonville, Arkansas. 'Wallets are stretched. And so they're still stretched, but the overall level of behavior has not been that different than what we've seen in the last year.'
Medscape
8 hours ago
- Medscape
Sibeprenlimab Halves uPCR in IgA Nephropathy Trial
VIENNA — Sibeprenlimab, a novel selective immune antibody, reduced the urine protein-to-creatinine ratio (uPCR) by more than half in patients with immunoglobulin A (IgA) nephropathy, according to an interim analysis of the VISIONARY trial. Beyond this clinical effect, a notable observation was the lack of safety concerns, especially given that, although sibeprenlimab is a selective agent, there may have been unexpected off-target effects. 'Safety's been a key consideration with these drugs,' study presenter Vlado Perkovic, MD, PhD, provost and scientia professor, University of New South Wales, Sydney, Australia, told Medscape Medical News . Sibeprenlimab represents a new mechanism of action and 'we don't yet fully understand the profile, so we've been looking at that data very carefully,' explained Perkovic. 'In particular, the infection risk has been my biggest concern, given we know that infections are dramatically increased in people with steroid therapy for example, in IgA nephropathy.' The results of the trial — the largest to date in the field — were presented at the 62nd European Renal Association Congress 2025 on June 6 and drew a warm applause from the audience. An Underestimated Condition IgA nephropathy is estimated to affect 2.5 per 100,000 people per year, although 'it's possible that that number is a significant underestimate,' said Perkovic. Diagnosis typically occurs between 20 and 40 years of age. And, despite supportive care, the majority of patients have a high lifetime risk of end-stage kidney disease (ESKD), with up to 50% of patients progressing to ESKD within 20 years of their clinical presentation. 'It's quite likely we've underestimated just how important this condition is,' said Perkovic, but 'we're fortunate that we're in the middle of something of a golden age of developing new treatments.' A number of therapies have been shown to reduce the risks associated with the disease, although they do not necessarily address the immunological basis of the condition. In addition to newer treatments, 'corticosteroids have long been used for people with IgA nephropathy,' Perkovic said, 'but of course, corticosteroids also have a range of different effects across the immune system,' which can lead to adverse outcomes. Sibeprenlimab is a selective IgG2 antibody that binds to and inhibits the biological activity of APRIL (a proliferation-inducing ligand), which is produced by mucosal epithelial and myeloid cells and binds to B cells. APRIL regulates B-cell-mediated immune responses and mediates IgG and IgA class switching in mature B cells. It is these two actions that make APRIL a key factor in the so-called 4-Hit process in the pathogenesis of IgA nephropathy, which results in the deposition of immune complexes in the glomerulus, leading to proteinuria and loss of kidney function. Phase 3 VISIONARY TRIAL Following on from the successful phase 2 ENVISION trial of sibeprenlimab, the researchers undertook the phase 3 VISIONARY trial, an ongoing study involving patients with biopsy-confirmed IgA nephropathy from 240 sites in 31 countries, who were randomized to sibeprenlimab or placebo for 100 weeks and followed up for a further 12 weeks. All patients were required to have a uPCR of ≥ 0.75 g/g or urine protein excretion of ≥ 1.0 g/day, an estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m2, and to have been on a stable dose of either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, with or without a SGLT2 inhibitor, for ≥ 3 months prior to screening. For the current pre-specified interim analysis, Perkovic reported the efficacy and safety results in the first 320 randomized patients (152 in the sibeprenlimab group and 168 in the placebo group), focusing on the primary endpoint of 24-hour uPCR at 9 months vs baseline, with eGFR and other data expected to be presented in 2026. The median age of the patients was 42-43 years. There were proportionally fewer females in the sibeprenlimab group (34.2%) vs the placebo group (40.5%). The majority of the patients were Asian, at 61.8% and 56.5%, respectively. Compared with a rise in uPCR at the 9-month follow-up in the placebo group, sibeprenlimab was associated with a 50.2% reduction in uPCR, giving a highly significant placebo-adjusted treatment effect of 51.2% ( P < .0001). Importantly, the benefit of sibeprenlimab on uPCR was seen as early as 4 weeks after initiating treatment and continued to accrue throughout follow-up. Ronald T. Gansevoort, MD, PhD, professor of medicine and a nephrologist at the Department of Nephrology, University Medical Center Groningen, Netherlands, who co-chaired the session, told Medscape Medical News that the results look 'very promising.' 'Recently, we have had several agents working in different ways that all show proteinuria lowering,' he continued, but the results from those studies show that the improvements seen in VISIONARY are 'the best proteinuria lowering' seen so far. Gansevoort noted, however, that this remains an interim analysis, and that he is really looking forward to seeing the kidney function results, adding: 'It was a little bit of a pity that they were not allowed to show at least the 9-month interim data on kidney function, which would have been so interesting.' Safety Results In terms of safety, the proportion of patients experiencing a treatment-related treatment-emergent adverse event (TEAE) was marginally lower with sibeprenlimab, at 32.9% vs 31.0% with placebo. The proportion of patients having a TEAE that led to treatment discontinuation was 0.7% vs 2.4%, respectively, and there were fewer severe and serious TEAEs with the experimental drug. 'If we focus on the infection-related adverse events,' Perkovic said, 'we can see that rates were numerically slightly higher in the sibeprenlimab than the placebo group, with a pattern that was broadly consistent, but with perhaps a slight excess of COVID 19.' He noted that this was 'the reverse of the pattern we've seen in the phase 2 trials, suggesting a chance' outcome. 'The data so far look remarkably encouraging,' he added. There's really no suggestion of an increased risk of infection,' with no opportunistic infections identified, 'and certainly no deaths.' More data is required from the ongoing follow-up to support what has been observed so far, but if the final results do bear out both the efficacy and safety outcome, it will show that sibeprenlimab is 'a precision approach to the fundamental abnormality in IgA nephropathy: that's the really exciting part,' said Perkovic. The study was funded by Otsuka Pharmaceutical Development and Commercialization. Perkovic declares relationships with Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Chinook Therapeutics, Eli Lilly & Company, Gilead Sciences, GlaxoSmithKline, Guard Therapeutics, Incyte, Janssen, Merck, Mitsubishi Tanabe Pharma, Mundipharma, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi, Shaanxi Micot Technology, Travere Therapeutics.
Yahoo
8 hours ago
- Yahoo
Coal mines on Alberta's eastern slopes could push fishery 'beyond recovery': study
CALGARY — Old coal mines on the eastern slopes of the Alberta Rockies are leaching chemicals that are poisoning the fish downstream, says a new study by Alberta government scientists. It also suggests any new coal developments could result in "population collapse" of fish species in a nearby lake. The findings were made in a provincial government study posted online May 27. The paper is awaiting peer review. The scientists who authored it were not made available to speak to reporters. The other authors not employed by the province did not respond to requests for comment. Alberta has responded to the study with an advisory saying people should consider "limiting consumption" of three fish species drawn from Crowsnest Lake, a fishing spot downstream from the coal mines. Those species were found to have dangerously high levels of selenium, a mineral found in coal-rich deposits, in their body tissue. The authors write the study shows that "biological impacts of (mountaintop removal) coal mining can persist long after mining operations end." They suggest that "any further coal mine development may well push the Crowsnest fishery beyond sustainability.' The study comes after the Alberta Energy Regulator, or AER, granted an Australia-based coal company permission to start a controversial coal exploration on the eastern slopes. The project was initially rejected in 2021 when a panel ruled the likely environmental effects on fish and water quality outweighed potential economic benefits. But the regulator said last month it's possible there will be runoff from the nearby pit lake that Northback Holding Corp. is using. It ultimately concluded the project won't have any effect on the water quality downstream. The AER said that "out of an abundance of caution," Northback will have to comply with a directive for managing drilling waste in response to concerns over selenium. The new study measured selenium levels in fish from Crowsnest Lake, which is fed by creeks connected to Tent Mountain and Grassy Mountain – both former coal mine sites. Alberta has a fish tissue selenium guideline of four micrograms per gram. The authors write that every single fish sample analyzed exceeded this value. Average selenium concentrations were highest in Brown Trout, coming in at 18 micrograms per gram. The authors write that the selenium levels could lead to 'behavioural changes, physical symptoms ... respiratory issues, reproductive issues and ultimately population collapse." Accumulating fluid in body tissue or fin and tail damage are among other side effects. Most people are exposed to healthy levels of selenium through grains and flours, but Health Canada says elevated consumption can lead to hair loss, decreased cognitive function and gastrointestinal disorders. The high selenium concentrations can only be explained by "the incorporation of legacy coal mine pollution,' the authors write. The study goes on to say selenium levels in fish in Crowsnest Lake are similar to those found in water bodies near Fernie, B.C., that resulted in Teck Mining Company, which owned and operated a nearby mine, being forced in 2021 by B.C. provincial court to pay a $60 million fine – the largest fine ever imposed under the Fisheries Act. Fish populations in those mining-impacted streams were found in 2011 to have an average selenium concentration of 7.6 micrograms per gram. Nine years later, the adult westslope cutthroat population had suffered a 93 per cent decline, the study says. The authors conclude that factors including the emergence of Whirling Disease, drought conditions, high fishing activity -- and now high selenium levels in fish -- make the Crowsnest Lake and River "an especially vulnerable system.' 'Any new development of coal mining along the eastern slopes may well push the Crowsnest fishery beyond recovery,' they write. Colin Cooke, one of the authors, published a 2024 study that found a former coal mine in the Crowsnest River watershed was releasing selenium to fish at rates more than dozens of times higher than federal and provincial guidelines. Cooke is a senior aquatic scientist with the Alberta government, according to LinkedIn. Peter Doyle, CEO of Evolve Power Ltd., formerly Montem Resources Ltd., which previously sought to restart an old mine on Tent Mountain, said in an email that the company is complying with terms set out by the AER. "As reflected in other work by the author, there are numerous contributors to water quality in the Crowsnest River valley, not related to Tent Mountain, including changes in upstream conditions, changes in weathering rates and other anthropogenic changes in the watershed," Doyle wrote, referring to Cooke's 2024 study. That report notes those factors, among others, could be contributing to contaminant levels and concluded that coal mining activities in the Crowsnest River watershed "have been impacting ecosystems downstream for decades." Northback, in an email, wrote that Crowsnest Lake is unrelated to its Grassy Mountain project. "However, with our own project, Northback is committed to adhering to the highest environmental standards and ensuring a safe water supply." Ryan Fournier, press secretary for Alberta's environment ministry, deferred questions about monitoring and enforcement to the AER. He said the province is funding a series of studies and submitting them to peer-reviewed academic journals as the province revises its coal policy. He also said the authors were not available to speak to media because they "are not trained spokespeople." The AER told The Canadian Press that it has directed Evolve Power, the Tent Mountain owner, to submit a "selenium management plan proposal" that targets reductions in selenium in mine-affected water. Evolve was to submit that plan by July 31 of last year, but the AER said it granted the company an extension to March 31, 2026. The energy regulator also said that while selenium levels are elevated, "there is no evidence of non-compliance on monitoring or selenium management requirements at this time." The province announced in December it would allow coal mining to take place in Alberta under certain conditions. However, it exempted Northback and Evolve Power's projects from those rules because they were considered "advanced." Fisheries and Oceans Canada said in a statement that it doesn't comment on provincial permitting decisions and it hasn't been asked to review the local impacts to wildlife in the area. This report by The Canadian Press was first published June 6, 2025. Matthew Scace, The Canadian Press 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
