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Moderna leans on cost cuts, pipeline as vaccine sales dip

Moderna again reported declining vaccine sales and tempered its 2025 revenue outlook, but expressed confidence in its plan to break even financially in a few years. In third-quarter earnings on Thursday , Moderna reported $1 billion in revenue, down roughly 45

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Moderna again reported declining vaccine sales and tempered its 2025 revenue outlook, but expressed confidence in its plan to break even financially in a few years. In third-quarter earnings on Thursday , Moderna reported $1 billion in revenue, down roughly 45% from the same three-month period a year ago. The company also lowered the top end of its projected revenue forecast for 2025. It now expects between $1.6 and $2 billion, down from an expected range of $1.5 billion to $2.2 billion. Still, Moderna shares, which have lost more than half of their value over the last year, ticked up as much as 5% in early trading Thursday. One reason why is progress the company has made in cutting costs, with Moderna claiming that, so far, it’s ahead of its projected target for the year. “We give credit where it’s due, and [Moderna] is clearly making progress on cost control,” Leerink analyst Mani Foroohar wrote in a note to clients Thursday. Moderna rose to stardom during the COVID-19 pandemic, bringing to market one of the first vaccines for COVID and quickly earning billions of dollars as a result. But the company has struggled mightily to follow that success with another big seller. COVID vaccine sales have fallen considerably from their pandemic heights, leading Moderna to revise its financial forecasts multiple times. Meanwhile, a combination flu and COVID vaccine hasn’t yet gotten to market, a cytomegalovirus vaccine failed in clinical testing , and another approved shot for respiratory syncytial virus, mResvia, has generated minimal sales in a competitive market. Moderna reported only $2 million in mResvia sales in the third quarter. Leadership changes at the Department of Health and Human Services and Food and Drug Administration have hurt the biotech as well. HHS Secretary Robert F. Kennedy Jr. has cut funding for messenger RNA technology and recast a key vaccine committee that softened recommendations for COVID shots , while new FDA leaders have outlined stricter approval frameworks and issued narrower approvals . Those combined factors have heightened pressure on Moderna not only to cut costs, but come through with newer pipeline projects. The company has made progress on the former front over the last year, dialing back its research strategy in September 2024 and, more recently in July, announcing plans to lay off 10% of its workforce . On Thursday, Moderna indicated its exceeding its cost-cutting targets — a crucial part of its plan to get to a break-even point by 2028. Operational expenses between July and September were about 34% lower than they were over the same three-month period last year, leaving Moderna on target to reduce those costs by more than $1 billion in 2025. The company is expecting further R&D cuts “over the coming year or two,” Moderna president Stephen Hoge said during an earnings call. Beyond cost cuts, Moderna aims to grow revenue through broader use, internationally, of its COVID shots. Approvals could come in Australia, Europe, Japan and Taiwan this year. Its combination flu and COVID vaccine is currently under review in Europe and, in the U.S., Moderna is awaiting guidance about a future resubmission. Moderna also has a few cancer vaccines in its pipeline, most notably a melanoma shot that’s partnered with Merck & Co. and in late-stage development. For investors, a “lack of near-term catalysts” and recent failure of its cytomegalovirus shot will keep the focus on “vaccine uptake, headlines from the current administration” and further cost cuts, Foroohar wrote.

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01What Comes Next

With data expected in the fourth quarter of 2026, we are prioritizing histology alongside patient-reported outcomes using the Celiac Disease Symptom Diary, one of only two instruments developed in line with U.S. Food and Drug Administration (FDA) guidance, to capture changes in symptoms such as abdominal pain and nausea. Ultimately, the broader aim is to give gastroenterologists and patients a therapeutic option for a disease that has long been managed without one. The future of drug development will not be defined by statistical significance alone, but by whether new therapies also improve the daily burden of living with celiac disease. “The first therapy to cross the line could change the field,” Geller concluded. “It would help establish celiac as a serious medical condition with options beyond a restrictive diet and open the door for what comes next.” Dr. Paul Lizzul is chief medical officer at First Tracks Biotherapeutics, a clinical ‑ stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases. Marilyn Geller serves as an advisor to First Tracks Bio. Footnotes Abadie V, Jabri B. IL-15: a central regulator of celiac disease immunopathology. Immunol Rev . 2014;260(1):221-234. https://doi.org/10.1111/imr.12191. Yokoyama S, Watanabe N, Sato N, et al. Antibody-mediated blockade of IL-15 reverses the autoimmune intestinal damage in transgenic mice that overexpress IL-15 in enterocytes. Proc Natl Acad Sci U S A . 2009;106(37):15849-15854. https://doi/full/10.1073/pnas.0908834106. Anthony S, Schluns KS. Emerging roles for IL-15 in the activation and function of T-cells during immune stimulation. Research and Reports in Biology . 2015;6:25-37. https://doi.org/10.2147/RRB.S57685.

Source: www.biopharmadive.com ↗
02What the Artificial Neuron Cannot Do

Hersam’s next goal is a small circuit — perhaps 10 artificial neurons — where each one fires differently, and together they accomplish what would require thousands of conventional transistors. “ Silicon achieves complexity by having billions of identical devices,” Hersam said. “The brain is the opposite. It’s heterogeneous. The complexity is at the device level.” But Gaudet sees a gap no circuit design can yet fill: Biological neurons grow new connections and prune old ones, strengthening pathways that are used and weakening those that aren’t. Hersam’s lab’s printed neurons — or any other neuromorphic technology that mimics neuronal dynamics — can’t achieve that level of complexity yet. Brown is careful about the distance remaining between these printed neurons and the real thing. “Neurons are just so flexible,” he said. “They can totally change what they’re doing based on whether they’ve learned something and based on your emotional state. There’s a lot of hidden mysteries.” Sangwan suspects the device has more to reveal. “It’s a nonlinear dynamical system,” he said. “We don’t fully know how many different variables you need to explain it. It’s just the beginning.” Hersam, Sangwan, Brown, Holla, and Gaudet reported having no relevant financial disclosures. Disclosure information for study authors is available in the original study publication.

Source: www.medscape.com ↗
03Lifestyle Matters: How do environmental and lifestyle factors influence Alzheimer’s disease?

Dr. Harrison and Finnish neuroscientist Dr. Miia Kivipelto explore the complex interplay between genetics and lifestyle in Alzheimer's development. Learn how the groundbreaking FINGER study demonstrates potential prevention strategies, and discover the latest evidence on how environmental factors, diet, and chronic conditions influence Alzheimer's risk.

Source: www.biopharmadive.com ↗
04Why Muscle Cells Might Do Some Heavy Lifting

Brown was studying gene therapy in the 1990s when he designed a technology to turn mRNA expression on or off in different cells. For the new mouse study, published in Nature Biotechnology , he adapted the technology to turn off mRNA expression in dendritic cells, muscle cells, or liver cells. The researchers then vaccinated the mice with each version, delivering the vaccines both intravenously and intramuscularly. “The results were pretty stunning,” Brown said. When mRNA expression was turned off in muscle cells, T-cell response went down, suggesting muscle cells play a role in immunity. When expression was turned off in liver cells, T-cell expression tripled — indicating liver cells dampen immunity. Turning off expression in dendritic cells had no effect on T-cell activation, though it did reduce the number of killer T cells by as much as half. (Interestingly, no such reduction occurred when the antigen was SARS-CoV-2 spike. Brown is now investigating why different antigens had varying effects.) Knowing all this is crucial for designing effective mRNA vaccines and therapies. That’s because different mRNA therapies require different strategies. Cancer vaccines must boost tumor-fighting killer (CD8+) T cells. For genetic disease treatments, scientists want to avoid triggering the immune system to prevent killing the very cells the mRNA is meant to modify. “Understanding the immunology is extremely important for this class of drug,” Brown said. The finding doesn’t mean dendritic cells aren’t important for mRNA vaccines to work. “It just means that the mRNA doesn’t have to get into those cells to induce an immune response,” Brown said. Instead, the antigen can be transferred to those dendritic cells.

Source: www.medscape.com ↗
05China: Threat or opportunity?

One of the biggest biotech news stories of recent years is China’s continued rise as a biotech and life sciences powerhouse. China conducts a quarter of all clinical trials and drug development and has almost 1,500 new drugs in development.¹ Many China-based biotechs have benefitted from government funds, out-licencing deals with large pharmas and venture capital funding. However, policymakers in the US and EU have concerns about the possible threat to their region’s biosecurity and competitiveness as centres for health and life science research. Given China’s increased importance, ICON Biotech conducted the same biotech sector survey with 100 China-based biotech leaders. The results show that Chinese biotechs face many of the same challenges as biotechs located elsewhere. They share the same funding challenges and burdens associated with increasingly complex clinical trials and regulations.

Source: www.biopharmadive.com ↗
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Peptide Therapy Guide Editorial Team

Editorial team for Peptide Therapy Guide.

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