Category: 3. Business

Over 26 weeks, the complement C5 inhibitor gefurulimab showed its ability to produce statistically significant improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score, a clinically meaningful result, as well as reduce Quantitative Myasthenia Gravis (QMG) total scores at week 4 and week 26.¹ These new top-line results from the phase 3, randomized, double-blind, placebo-controlled PREVAIL study (NCT05556096) were presented at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting by Kelly G. Gwathmey, MD, associate professor at Virginia Commonwealth University (VCU) School of Medicine, director of the VCU amyotrophic lateral sclerosis clinic, and Division of Neuromuscular chief. She is also principal investigator of PREVAIL.

Compared with conventional monoclonal antibodies, which typically require intravenous infusion by a health care professional, gefurulimab has the added convenience of being available as a prefilled syringe or autoinjector, Gwathmey explained. Gefurulimab is administered subcutaneously, with its low molecular weight and ability to extend the half-life of albumin—its dual-binding activity blocks C5 activation and binds to the liver-produced protein—key to its weekly administration.²

The adult patients evaluated in PREVAIL had anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalized myasthenia gravis (gMG).¹ They also had to have Myasthenia Foundation of America (MGFA) class II-IV disease, an MG-ADL score of 5 or higher, and be stable on standard-of-care therapy. They were randomized 1:1 to self-administered weekly gefurulimab (n = 131) or placebo (n = 129) for 25 weeks. The primary end point is change from baseline in MG-ADL total score at week 26, and the secondary end point is change from baseline in QMG total score at week 26. Most patients were female (59.5% who received gefurulimab, 61.2% who received placebo), older than age 50 at first dose, age 43 at first clinical presentation of MG, and a White race (52.7% and 57.4%, respectively).

Overall, most patients had MGFA class II disease (36.6% and 34.9%) or class III disease (58.0% and 59.7%), mean (SD) MG duration of 9.2 (8.45) and 8.2 (8.79) years, mean MG-ADL score of 9.0 years (across both groups), and mean QMG score of 14.9 (4.38) or 14.7 (4.39). The least squares mean (LSM) change in MG-ADL was –4.2 (0.29) from gefurulimab and –2.6 (0.27) from placebo, for a treatment difference of –1.6 (0.40) (95% CI, –2.4 to –0.8; P < .0001). The early MG-ADL score improvement seen in week 1 after the loading dose was sustained through week 26.

For QMG change, the treatment difference seen by week 4 (LSM, –1.8 [0.37]; 95% CI, –2.5 to –1.1; P < .0001) rose through week 26 (LSM, –2.1 [0.50]; 95% CI, –3.1 to –1.1; P < .0001). As with the treatment cohort, the improvement first seen at week 4 was sustained through week 26.

“People living with gMG face fluctuating and often debilitating symptoms, including loss of muscle function and severe weakness, Gwathmey said in a statement.² “Results from the PREVAIL phase 3 trial demonstrating early and lasting benefits in MG-ADL and QMG scores support the potential for gefurulimab to offer an efficacious and convenient self-administered treatment option that may help address the unpredictability of this disease.”

Treatment-emergent adverse events were typically injection site reactions (9.9%), headache (9.9%), and back pain (7.6%) among the gefurulimab group and headache (12.4%), diarrhea (8.5%), and upper respiratory tract infection (7.8%) among the placebo group. There were more TEAEs in the gefurulimab vs the placebo group (75.6% vs 80.6%), but these rates were considered similar overall.

Of the patients from the original PREVAIL treatment group, 4 discontinued treatment during the study, and all remaining 127 patients entered the open-label extension (OLE) analysis, which is investigating gefurulimab over a maximum of 202 weeks. Of the placebo group, 7 discontinued treatment and all remaining 122 patients entered the OLE analysis.

“Based on these clinical benefits and the advantage of self-administered [subcutaneous] weekly dosing,” the study authors concluded,” gefurulimab may offer patients with AChR-Ab+ gMG a convenient and effective treatment option.”

References

1. Gefurulimab demonstrates statistically significant and clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) at week 26 with clinically meaningful improvement seen as early as week one in adults with gMG in PREVAIL phase III trial. News release. AstraZeneca. October 30, 2025. Accessed November 7, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/positive-results-from-prevail-phase-iii-trial-at-aanem-mgfa-scientific-session.html
2. Efficacy and safety of subcutaneous self-administered gefurulimab in generalized myasthenia gravis: topline results from a phase 3, randomized, double-blind, placebo-controlled study (PREVAIL). Presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting; October 29-November 1, 2025; in San Francisco, California.

Story Continues

Story Continues

monday.com (MNDY) just released its latest earnings, showcasing revenue growth of 27% and outpacing expectations on important financial measures. Management sounded upbeat about scaling efficiently and maintaining momentum.

See our latest analysis for monday.com.

Despite these upbeat results, momentum has been hard to hold onto. monday.com’s share price delivered a 1-day gain of 4.7%, but is still down 17.9% year-to-date. Over the past year, the total shareholder return sits at a steep -41.5%, reflecting a sharp pullback from recent highs. Long-term holders are still up nearly 100% over three years. The stock’s recent moves signal investors are weighing short-term uncertainty against the company’s longer-term growth story.

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With shares trading well below analyst targets despite robust financials and upbeat management commentary, investors are left to wonder: is monday.com undervalued at current levels, or is the market already factoring in future growth?

monday.com’s fair value, according to the most widely followed narrative, lands significantly above its latest close. This outlook sees major catalysts on the horizon, setting up an intriguing argument for upside if the story unfolds as projected.

Ongoing global shift toward digital transformation, remote/hybrid work, and rising SaaS adoption continues fueling strong demand for cloud-based productivity and collaboration platforms like monday.com, supporting high double-digit revenue growth and future ARR expansion.

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Looking at price-to-sales, monday.com trades at 8.9x, which is noticeably steeper than the US Software sector average of 4.8x and its peer group at 8.5x. While the company’s growth prospects could justify a premium, the current multiple stands below the fair ratio of 11.9x. This may imply room for the stock to re-rate if market sentiment turns more positive. However, these multiples could also signal vulnerability if growth expectations fall short.

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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 MNDY.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

Somnigroup International (SGI) has been attracting attention as its shares climbed 3% today, continuing strong gains from the past month. Investors are watching closely as ongoing shifts occur in the consumer durables space.

See our latest analysis for Somnigroup International.

After a year of strong momentum, Somnigroup International’s 1-year total shareholder return now stands at 69.2%, with a share price last closing at $91.25. That is on top of an impressive 308% total return over the past five years. With recent buying pressure and upbeat sentiment in consumer durables, it appears that investors are increasingly pricing in growth potential and improved fundamentals for SGI.

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Yet with shares near record highs and analyst targets not far ahead, the big question for investors is whether Somnigroup remains undervalued or if the stock’s recent jump simply reflects confidence in future growth prospects.

Somnigroup International’s most followed narrative places fair value at $88.38 per share, just below the recent closing price of $91.25. This narrow gap places the spotlight on ambitious long-term growth assumptions that drive the valuation debate.

The integration of Mattress Firm is already generating meaningful sales and cost synergies, with $100 million in annual net cost synergies projected and sales synergies ahead of schedule. These operational improvements are set to expand EBITDA and enhance net margins moving into 2026 and beyond.

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Result: Fair Value of $88.38 (OVERVALUED)

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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 SGI.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

EU trade chief Maros Sefcovic said on social media that, effective immediately, exports of the company’s chips to the bloc for non-military uses will not be subject to Chinese licensing requirements.

“My team and I have been in constant contact with the Chinese authorities, and welcome the confirmation provided today to the European Commission by Mofcom regarding the further simplification of export procedures for next-period chips destined for EU and global clients,” Sefcovic said.

“Mofcom will grant exemptions from licensing requirements to any exporter, provided that it is declared that the goods are intended for civilian use,” he added.

“Close engagement with both the Chinese and Dutch authorities continues as we work towards a lasting, stable, predictable framework that ensures the full restoration of semiconductor flows.”

Compared with placebo, PCSK9 inhibition with evolocumab reduced the risk of first cardiovascular events among patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke, based on findings from the VESALIUS-CV trial presented at AHA 2025 and simultaneously published in NEJM.

Researchers randomly assigned 12,257 patients to receive either evolocumab (140mg every two weeks; n=6,129) or placebo (n=6,128). All participants had an LDL-C level of at least 90 mg per deciliter, 43% were women, 93% were white and the median age was 66 years. The two primary end points were a composite of death from coronary heart disease, myocardial infarction or ischemic stroke (3-point MACE) and a composite of 3-point MACE or ischemia-driven arterial revascularization (4-point MACE).

Overall results showed evolocumab reduced the risk of coronary heart disease death, heart attack or ischemic stroke by 25%. Participants in the evolocumab group also experienced a 19% reduction in the risk of death, heart attack, ischemic stroke or arterial revascularization over a median follow-up period of 4.5 years.

According to researchers, the dual primary endpoints were consistent across key subgroups, including in participants with high-risk diabetes without qualifying ASCVD, who represented roughly one-third of the total study population. In a substudy evaluating LDL-C levels over time, LDL-C was lowered by nearly 55% in the evolocumab group at 48 weeks, resulting in a median LDL-C level of 45 mg/dL compared with 115 mg/dL at enrollment. In contrast, LDL-C levels remained elevated among those in the placebo group, at a median of 109 mg/dL.

“The results from the VESALIUS-CV trial represent the first demonstration of improved cardiovascular outcomes with a PCSK9 inhibitor, or any nonstatin for that matter, in patients without a previous heart attack or stroke who are already being treated with a high-intensity lipid-lowering regimen ,” said Erin Ann Bohula, MD, DPhil, FACC, who presented the findings.

The study had several limitations to note, including that a small group of patients (8%) were not being treated with any cholesterol-lowering treatment at the beginning of the study. In addition, the majority of study participants were White. Further studies that include participants of various racial and ethnic backgrounds are needed to confirm if these findings apply across diverse populations, said Bohula.

In a related editorial comment published in NEJM, Chiadi E. Ndumele, MD, PhD, and Roger S. Blumenthal, MD, FACC, say the findings “represent an important step forward in clinical knowledge.” They write: “Although PCSK9 inhibitors had been shown to reduce the risk of atherosclerotic cardiovascular disease events among patients with previous myocardial infarction or stroke, this new trial has shown their clinical benefit in patients without previous myocardial infarction or stroke. With a longer follow up than earlier PCSK9 inhibitor trials … numerically fewer deaths were observed in the evolocumab group than in the placebo group. Although this result was not significant owing to the hierarchical testing approach, it is likely to reflect a true signal.”

Clinical Topics:
Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention

Keywords:
AHA Annual Scientific Sessions, AHA25, Dyslipidemias, Secondary Prevention