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Neumora depression drug fails; EnGene to cut 50% of staff

Today, a brief rundown of news involving Neumora Therapeutics and enGene, as well as updates from Johnson & Johnson, Cellares and Faeth Therapeutics that you may have missed. Shares of Neumora Therapeutics lost half their value after one of the company’s drugs

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Today, a brief rundown of news involving Neumora Therapeutics and enGene, as well as updates from Johnson & Johnson, Cellares and Faeth Therapeutics that you may have missed. Shares of Neumora Therapeutics lost half their value after one of the company’s drugs failed a pair of Phase 3 trials in major depressive disorder. Neumora’s drug navacaprant is part of a class of medicines that target kappa opioid receptors and have been hailed as potential blockbusters. But two prospects — navacaprant and J&J’s aticaprant — have now missed key goals in depression studies, and Neumora said Monday that it plans to end development of its drug altogether. The latest findings are “disappointing but not unexpected,” wrote William Blair analyst Myles Minter in a Monday note to investors. Minter referred to the setback as a “clearing event” that shifts focus to a pipeline that now includes drugs for obesity, schizophrenia and Alzheimer’s disease agitation. Neumora has lost most of its value since going public in 2023 . — Ben Fidler EnGene will lay off half of its workforce and pare down an ongoing trial in a bid to conserve cash. In an earnings release Monday, enGene announced the layoffs as well as plans to stop enrollment in three cohorts of a trial testing its experimental gene therapy against a form of bladder cancer. The moves come ahead of a study readout that could form the basis of a U.S. approval application. Those results, and subsequent Food and Drug Administration discussions, are “key determinants” for enGene’s “regulatory and commercial outlook,” wrote Mani Foroohar, an analyst at Leerink Partners . — Ben Fidler Cell therapy manufacturer Cellares added $50 million to what’s now a $327 million Series D financing, the company said Monday. The new investment from Prime Radiant Partners will be used to support an ongoing international expansion into Europe for Cellares via a new facility in the Netherlands and comes ahead of a potential initial public offering in 2027. Cellares helps companies speed up the production of cell therapies and has already partnered with drugmakers like Bristol Myers Squibb and Cabaletta Bio . The San Francisco-area biotechnology company has raised more than $680 million since launching in 2019. — Gwendolyn Wu Johnson & Johnson will invest more than $1 billion in Jacksonville, Florida, as part of a $55 billion plan to onshore more drug production in the U.S. That investment includes a new distribution facility for its Acuvue contact lenses and adds to other announced commitments, such as a cell therapy plant in Pennsylvania and a biologics manufacturing hub in North Carolina. J&J is one of more than a dozen drugmakers to make a drug pricing deal with the White House in exchange for a reprieve on pharmaceutical tariffs. — Gwendolyn Wu Four months after acquiring Faeth Therapeutics , the biotech formerly known as Sensei Biotherapeutics is taking on the cancer drugmaker’s name. The new Faeth is developing a combination drug called “ Piktor ” aimed at multiple parts of a pathway, “PAM,” that’s dysregulated in as many as half of all solid tumors. Piktor is in a Phase 2 trial in second-line endometrial cancer that’ll produce data later this year. Results from a second study in breast cancer should come in 2027. The combined company will trade on Nasdaq under the ticker symbol “FTH.” — Gwendolyn Wu Atlanta-based Celltaxis has named a new CEO, promoting Eileen Heffernan , one of its co-founders and current chief business officer, to the role, according to a Monday announcement . Heffernan, who has more than three decades of experience across therapeutics and diagnostics developers, was hailed as “a driving force behind Celltaxis” in a statement from the company's Chief Scientific Officer Eric Springman. The company was previously led by Michael Masters. Celltaxis has a drug in mid-stage testing for lymphedema, and is developing other medicines for lymphatic diseases. — Gwendolyn Wu

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01Lifestyle 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 ↗
02China: 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 ↗
03How Real Brain Cells Respond to Artificial Neurons

Holla, who completed her PhD in Raman’s lab and is now a postdoctoral researcher studying memory at New York University in New York City, designed and ran experiments in mouse cerebellar slices. She positioned a stimulation electrode on the parallel fibers, the main pathway that excites Purkinje cells, and a recording electrode on the Purkinje cells themselves. She played recordings of the artificial neurons’ waveforms into the tissue through a standard stimulation electrode at four different speeds: 7, 60, 218, and 740 spikes per second. At every speed below 200 spikes per second, the Purkinje cells fired in response. The strongest results came at 60 spikes per second, where each artificial spike lasted 0.7 milliseconds, which is fast enough to trigger the cell but brief enough to avoid flooding the tissue with unnecessary current. Above 200 spikes per second, the cells stopped responding. They simply cannot fire that fast. The team included the 740-spikes-per-second condition on purpose to directly challenge the many engineering groups building artificial neurons that operate at those speeds. “We had to show them [740 spikes] wasn’t sufficient,” Brown said. “You can’t work that fast.” “You can see the living neurons respond to our artificial neuron,” Hersam said. But he is careful to note a caveat: The printed artificial neurons were not touching the brain tissue. The waveforms they generated were recorded and then played back into the slice through standard laboratory stimulation equipment. The next step is to prove the printed device itself can interface with living tissue.

Source: www.medscape.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 ↗
05What 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 ↗
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Peptide Therapy Guide Editorial Team

Editorial team for Peptide Therapy Guide.

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