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Argenica Therapeutics Limited (ASX: AGN) (“Argenica” or the “Company”), a biotechnology company developing novel therapeutics to reduce brain tissue death after brain injury, is pleased to announce positive initial preclinical data on ARG- 007’s ability to inhibit human recombinant Amyloid-Beta (Abeta) aggregation in a preclinical (in vitro) model of Alzheimer’s Disease. Abeta aggregation is thought to be one of the main causes of Alzheimer’s Disease, with the Abeta accumulation in senile plaques causing memory loss and confusion.1
Highlights:
- Preclinical data has shown ARG-007 significantly inhibited the aggregation of human recombinant Amyloid-Beta (Abeta) in a cell-free Abeta aggregation assay model.
- Abeta aggregation is thought to be one of the main causes of Alzheimer’s Disease, with the Abeta accumulation in senile plaques causing memory loss and confusion.
- At 16 hours following ARG-007 administration, a 25 µM dose of ARG-007 reduced Abeta aggregation by more than 50% compared to vehicle controls.
- Argenica will now progress to animal studies to further confirm the efficacy of ARG-007 in Alzheimer’s Disease and will update the market as milestones are meet.
- The global Alzheimer's therapeutics market size was valued at USD4.04 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 16.2% from 2022 to 2030.
Argenica engaged leading preclinical Contract Research Organisation QPS, based in Austria, to undertake the study. The aim of the study was to determine the effects of ARG-007 in comparison to controls in inhibiting human recombinant Abeta aggregation using the cell- free Abeta aggregation assay.
In this study, three concentrations of ARG-007 were used to determine the drug’s efficacy in inhibiting human recombinant Abeta aggregation – 2.5 µM, 7.5 µM and 25 µM. Abeta aggregation was assessed at 4 hours, 10 hours and 16 hours post administration of ARG-007. The results of this study show ARG-007 has a positive effect in inhibiting Abeta aggregation at the 10 hour and 16 hour post administration time points, compared to the vehicle controls. At the 16-hour time point, when Abeta had reached maximum aggregation, all three concentrations of ARG-007 showed a large significant reduction in Abeta aggregation compared to the control, with the 25 µM showing a greater than 50% reduction in Abeta aggregation, as shown in the graph below:
Concentration of ARG-007
Figure 1. An assessment of the extent of Abeta aggregation inhibition at Abeta plateau, 16 hours after the administration of ARG-007, at three different concentrations of the drug, 2.5 µM, 7.5 µM and 25 µM. Data are shown as % of vehicle control (VC) and displayed as bar graphs with group means +SEM (n=4 per group). Statistical analysis involved a two-tailed ANOVA followed by Bonferroni’s Multiple comparison Test (post hoc test) compared to VC *p<0.05; **p<0.01; ***p<0.001.
This in vitro (in petri dish) cell-free Abeta aggregation assay model provides important insights into the pathogenesis of Alzheimer’s Disease by simulating the disease in a less complex environment compared to in vivo (in living organism) systems. It provides preliminary information on mechanisms and possible protective roles of ARG-007 in Alzheimer’s Disease.
Dr Liz Dallimore, Argenica’s Managing Director, said“This is extremely encouraging data showing a potential new indication for ARG-007. It is well recognised that Abeta aggregation in the brain plays a key role in initiating Alzheimer’s Disease, and therefore a safe therapeutic drug that can reduce Abeta aggregation is a huge opportunity. We look forward to continuing to progress this exciting opportunity into further animal studies.”
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Amgen, Merck and Pfizer Release Latest Quarterly Earnings, Share 2025 Plans
Amgen reports strong Q4, will focus on trials in 2025
Amgen’s financial results for Q4 and the full 2024 year reveal quarterly revenue of over US$9 billion, beating analysts’ estimates of US$8.87 billion. Revenue for the year came in at US$33.42 billion, ahead of projections of US$33.19 billion, driven by an overall increase in the volume of demand for its products.
An 11 percent year-on-year increase in product sales was primarily by the pharmaceutical company's strong performance in oncology and immunology therapies, along with sales of Repatha, which treats high cholesterol, and Evenity, which treats osteoporosis in postmenopausal women.
Earning per share (EPS) also beat estimates of US$5.08, coming in at US$5.31.
Amgen performance, February 4, 2025.
Chart via Google Finance.
Looking ahead, Amgen’s revenue guidance for fiscal year 2025 was between US$34.3 billion and US$35.7 billion, in line with the average estimate of US$34.53 billion. Phase III trials of its weight management candidate MariTide, a dual GIP and GLP-1 receptor modulator, are expected to begin in H1 2025.
While Amgen's shares have decreased by over ten percent year-on-year, they have increased by nearly 11 percent year-to-date. The stock closed with a marginal gain of 0.05 percent at US$289.01.
Merck beats on revenue, but Gardasil sales decline
Merck fell by nearly 11 percent ahead of the opening bell on Tuesday after its Q4 and full-year 2024 financial results showed adjusted sales revenue for its key vaccine, despite exceeding sales and profit expectations.
The company reported revenue of US$15.62 billion, beating analysts estimates of US$15.55 billion.
Earnings per share for the quarter were also ahead of expectations, US$1.72 compared to US$1.69; however, earnings per share were US$6.74 for the full year, compared to analysts' estimates of US$7.62.
Sales reached US$15.6 billion in Q4, an increase of 7 percent from the prior year.
Full-year sales also rose by 7 percent to US$64.2 billion, driven by sales of Keytruda, the company’s leading cancer therapy. Keytruda brought in US$29.5 billion, representing an annual growth of 18 percent.
The company also announced positive topline results from a Phase 3 trial evaluating a subcutaneous formulation of pembrolizumab used in combination with Keytruda in adult patients with metastatic non-small cell lung cancer.
However, sales of Gardasil and Gardasil 9, two HPV vaccines, declined by 3 percent to US$8.6 billion.
Merck performance, February 4, 2025.
Chart via Google Finance.
For its 2025 fiscal year, Merck expects full-year adjusted EPS to be between US$8.88 and US$9.03, and revenue to fall somewhere between US$64.1 billion and US$65.6 billion. Analysts had been projecting EPS of US$9.13 and revenue of US$67.07 billion. The company also withdrew its US$11 billion sales target for Gardasil by 2030.
“This sales range reflects a decision to temporarily pause shipments of GARDASIL/GARDASIL 9 into China beginning February 2025 through at least mid-year,” the company said in an accompanying statement. According to Biopharma Dive, CEO Rob Davis clarified in the firm's earnings call that the pause will “facilitate a more rapid reduction of inventory and help support the financial position” of its Chinese distribution partner, Zhifei Biological Products.
“China still represents a significant long-term opportunity for Gardasil given the large number of females, and now males with our recent approval, that are not yet immunized,” Davis said.
Pfizer discusses Seagen acquisition impact and 2025 outlook
Pfizer’s Q4 and 2024 financial results show revenue at US$17.8 billion, an increase of 22 percent compared to the previous year and exceeding expectations of US$14.31 billion. Revenue, excluding COVID-19-related therapies, was largely driven by Seagan’s portfolio of cancer therapies following its acquisition in December 2023.
However, full-year revenue fell slightly short at US$63 billion, compared to projections of US$63.6 billion. EPS was also below analysts' estimates of US$0.71, coming in at US$0.63.
Its share price fell by 4.3 percent in early trading and ended the day down 1.26 percent.
Pfizer performance, February 4, 2025.
Chart via Google Finance.
Looking ahead, Pfizer will continue to focus on growing its pipeline of cancer drugs in 2025, with three potential therapies awaiting regulatory approval in 2025. The company will also initiate clinical trials for therapies related to inflammation, immunology, and internal medicine. For its 2025 fiscal year, Pfizer is projecting revenue of between US$61 billion and US$64 billion, aligning with the average estimate of US$63.22 billion.
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Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
