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Gluten Could Be Wrongly Blamed for Americans' Stomach Troubles

Gluten Could Be Wrongly Blamed for Americans' Stomach Troubles

Gizmodo22-07-2025
For many of us, gluten is a dietary villain, capable of causing all sorts of gastrointestinal troubles. Research out this week looks to complicate that narrative, however, finding that people are sometimes wrongly blaming gluten for triggering their symptoms of irritable bowel syndrome.
Scientists at McMaster University in Canada conducted the study, a small, randomized trial of IBS patients. People became sicker just as often after eating food containing gluten or wheat as they did after eating food without the ingredient, they found. Gluten is likely safer to eat for those with IBS than commonly thought, the researchers say.
'These findings suggest that expectations played a major role in symptom generation and that only some of these patients could benefit from gluten or wheat restriction,' they wrote in their paper, published Monday in The Lancet Gastroenetrology and Hepatology.
IBS is a complex, chronic, and relatively common condition, estimated to affect between 5 and 10% of the population worldwide (including up to 45 million people in the U.S.). Its symptoms include stomach pain, bloating, and diarrhea or constipation. Unlike the closely named inflammatory bowel disorder, IBS isn't marked by physical changes or visible damage along the digestive tract, but it can still be a debilitating burden for many, with around 20% of sufferers experiencing severe bouts. The exact causes of IBS remain unclear, though scientists have speculated it can arise from a miscommunication between the nerves found in the gut and the brain.
People with IBS tend to report having specific triggers that can cause a flare-up of illness, gluten included, and often manage their condition by avoiding these triggers. The researchers behind the new study aimed to better understand gluten's potential role in IBS, so they recruited over two dozen people with IBS for their randomized, double-blinded trial, all of whom had reported improving after switching to a gluten-free diet.
At first, the volunteers were randomly assigned to one of three groups. All the groups were first told to eat cereal bars for a week. One group ate bars made with flour containing gluten, the second ate bars made with wheat flour, and the third ate bars made with gluten- and wheat-free flour. Afterward, the volunteers took a break for two weeks. Then they switched to eating the bars they hadn't eaten yet for another round of testing, a process repeated twice. By the study's end, all the volunteers had eaten all three kinds of bars, though on different schedules and without knowing which bars they had eaten on a given week.
A total of 28 people completed the trial. A significant percentage of people reported having worsening IBS symptoms after eating gluten or wheat bars, the study showed, but about just as often as they did after eating non-gluten/wheat bars (roughly a third experienced worsening IBS during each of the three conditions). 93% of participants also reported having adverse events after each scenario of bar-eating. Interestingly enough, tests of the participants' stool found that only a third strictly followed their diets as instructed, with likely many fearing they would get sick.
The findings are based on a very small sample size, so it's not yet certain that they apply to the general population of people with IBS tied to gluten. There are also, of course, digestive conditions clearly caused by an intolerance to gluten, particularly celiac disease. And the researchers aren't saying gluten can't sometimes be a genuine trigger for people's IBS. But they argue that in many cases, people's negative perception of gluten is causing a nocebo effect, the dark cousin of the placebo effect. In other words, someone's belief that gluten is bad for them can potentially spark or worsen the IBS symptoms seen after eating it, rather than gluten itself.
The researchers say better communication and follow-up care from doctors are needed for IBS patients, given the findings.
'What we need to improve in our clinical management of these patients is to work with them further, not just tell them that gluten is not the trigger and move on. Many of them may benefit from psychological support and guidance to help destigmatize gluten and wheat and reintroduce them safely in their diet,' said senior author Premysl Bercik, a professor at McMaster's Department of Medicine, in a statement from the university.
That may be easier said than done, though. The researchers note that most patients, upon learning the team's findings, staunchly refused to entertain the idea of gluten not being a trigger for their IBS symptoms. So it looks like gluten may need a promotional campaign to win back its reputation.
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Rocket Pharmaceuticals Reports Second Quarter 2025 Financial Results and Highlights Recent Progress
Rocket Pharmaceuticals Reports Second Quarter 2025 Financial Results and Highlights Recent Progress

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Rocket Pharmaceuticals Reports Second Quarter 2025 Financial Results and Highlights Recent Progress

Prioritizing development of RP-A501 (Danon disease), RP-A601 (PKP2-ACM), and RP-A701 (BAG3-DCM) to advance AAV cardiovascular gene therapy platform for sustained value creation FDA RMAT designation awarded to RP-A601 for PKP2-ACM; Engaging with FDA on pivotal trial design following encouraging initial Phase 1 data at ASGCT IND accepted and FDA Fast Track designation received for RP-A701 in BAG3-DCM program; Phase 1 trial start-up activities underway Organizational restructuring expected to reduce headcount by approximately 30% and lower 12-month cash burn by nearly 25% Chris Stevens appointed Chief Operating Officer Cash, cash equivalents and investments of approximately $271.5M; expected operational runway into the second quarter of 2027 CRANBURY, N.J., August 07, 2025--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today reported financial and recent operational results for the second quarter ending June 30, 2025. "The second quarter of 2025 marked an important inflection point for Rocket as we refined our strategic focus around our AAV cardiovascular gene therapy platform and took multiple decisive steps to strengthen our financial foundation and thoughtfully adjust to market dynamics. We are fortifying our path to sustained value creation by leaning into programs with the highest value, conserving cash, and driving an efficient, agile organization," said Gaurav Shah, M.D., Chief Executive Officer of Rocket Pharmaceuticals. "With regulatory alignment to resolve the clinical hold for RP-A501 in Danon disease in progress, momentum building for RP-A601 in PKP2-ACM as it advances toward a pivotal Phase 2 trial, and RP-A701 preparing to enter the clinic for the treatment of BAG3-DCM, Rocket is positioned as the leader in the development of gene therapies for inherited cardiomyopathies. While we are pausing additional investments in the FA and PKD programs, we are deeply grateful and committed to the patient communities and are exploring strategic alternatives to advance these programs externally. Finally, our recent reorganization ensures we are appropriately resourced to execute on our near-term milestones with nearly two years of capital." Recent Pipeline and Operational Updates Investigation into the Serious Adverse Event (SAE) from the Phase 2 pivotal study of RP-A501 for Danon disease is ongoing. Rocket previously disclosed an SAE, related to clinical complications from capillary leak syndrome and unfortunately leading to the patient's death. In response, Rocket paused dosing and initiated a root cause analysis, focusing on the recent addition of a C3 inhibitor to the pre-treatment regimen. On May 23, 2025, FDA placed the trial on clinical hold for further evaluation. Rocket is actively working with FDA, independent safety monitors, and clinical experts to ensure patient safety and resume the trial. While the clinical hold remains in place, the company cannot provide guidance on trial completion timing. Actively engaging with FDA on the advancement of RP-A601 for PKP2 arrhythmogenic cardiomyopathy (PKP2-ACM) in potential pivotal trial following initial positive Phase 1 data at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). In July, Rocket received FDA Regeneration Medicine Advanced Therapy (RMAT) designation for RP-A601 for PKP2-ACM. Initial Phase 1 data demonstrating encouraging safety and preliminary efficacy outcomes of RP-A601 for PKP2-ACM were presented at ASGCT in May 2025. Rocket is engaging with FDA on potential pivotal trial design to evaluate the efficacy and safety of RP-A601. Phase 1 trial start-up activities are underway for RP-A701 in BAG3-associated dilated cardiomyopathy (BAG3-DCM). In June, an Investigational New Drug (IND) application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-DCM, received clearance from FDA. RP-A701 was recently granted FDA Fast Track designation, designed to facilitate the development and expedite the review of therapies for serious or life-threatening conditions that fill an unmet medical need. This enables increased communication with FDA, the potential for accelerated approval, and permits a rolling Biologics License Application (BLA) review. The first-in-human Phase 1 clinical trial will be a multi-center, dose-escalation study designed to evaluate the safety, biological activity, and preliminary efficacy of RP-A701 in adults with BAG3-DCM. BAG3-DCM is a rare, inherited heart condition caused by mutations in the BAG3 gene, leading to early-onset, progressive heart failure due to impaired cardiac function, high morbidity, and premature mortality. Rocket estimates that the prevalence of BAG3-DCM in the U.S. is as many as 30,000 individuals. FDA review of limited additional Chemistry Manufacturing and Controls (CMC) information ongoing for KRESLADITM (marnetegragene autotemcel; marne-cel) for the treatment of severe leukocyte adhesion deficiency-I (LAD-I). Rocket previously disclosed that FDA requested limited additional CMC information to complete its review of KRESLADI to treat severe LAD-I. The Company continues to work with senior leaders and reviewers from FDA's Center for Biologics Evaluation and Research and submission of complete BLA to resolve Complete Response Letter is anticipated before the end of 2025. Ongoing strategic corporate restructuring and pipeline prioritization. As part of its broader strategic reorganization, Rocket implemented a workforce reduction of approximately 30%, across all functions, to align with a pipeline prioritization plan focused exclusively on its AAV cardiovascular gene therapy platform. This restructuring, together with other cost-saving measures, is expected to reduce operating expenses by nearly 25% over the next 12 months. The reorganization enables the company to focus on its late‑stage AAV gene therapy programs in Danon disease, PKP2‑ACM, and BAG3‑DCM, while advancing regulatory activities for KRESLADI™ in severe LAD‑I. As part of this realignment, Rocket is pausing additional investments in its Fanconi Anemia (FA; RP-L102) and Pyruvate Kinase Deficiency (PKD; RP-L301) programs. The company continues to evaluate options to advance the FA program with health authorities in alignment with its refined strategic focus and broader corporate priorities. In July, Rocket appointed Chris Stevens as Chief Operating Officer. Chris Stevens is a highly seasoned executive with 25 years of experience across technical operations, product strategy, and general management, bringing immense commercial technical operations experience to Rocket. Stevens most recently served as the Executive Vice President and Chief Patient Supply Officer at Spark Therapeutics (subsidiary of Roche), where he successfully led teams across manufacturing, supply chain, quality, compliance, engineering, EHS, and facilities management, playing a key role in delivering gene therapies to patients. Second Quarter 2025 Financial Results Cash position. Cash, cash equivalents and investments as of June 30, 2025, were $271.5 million. Rocket expects such resources, excluding any potential proceeds from a Priority Review Voucher that may be granted upon FDA approval of KRESLADITM, will be sufficient to fund its operations into the second quarter of 2027. R&D expenses. Research and development expenses were $42.7 million for the three months ended June 30, 2025, compared to $46.3 million for the three months ended June 30, 2024. The decrease of $3.7 million in R&D expenses was primarily driven by decreases in manufacturing and development and direct material costs of $2.3 million, professional fees of $2.0 million and building supplies and consumables of $0.8 million, offset by an increase in clinical trial expenses of $1.2 million. G&A expenses. General and administrative expenses were $25.0 million for the three months ended June 30, 2025, compared to $27.4 million for the three months ended June 30, 2024. The decrease in G&A expenses was primarily driven by decreases in commercial preparation related expenses of $1.4 million and compensation and benefits expense of $0.9 million. Net loss. Net loss was $68.9 million or $0.62 per share (basic and diluted) for the three months ended June 30, 2025, compared to $69.6 million or $0.74 (basic and diluted) for the three months ended June 30, 2024. Shares outstanding. 107,884,420 shares of common stock were outstanding as of June 30, 2025. Restructuring Expenses and Financial Guidance Restructuring expenses. Approximately $3.5 million in restructuring and restructuring-related charges were incurred in the first half of 2025. About Rocket Pharmaceuticals, Pharmaceuticals, Inc. (NASDAQ: RCKT) is a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of investigational genetic therapies designed to correct the root cause of complex and rare disorders. Rocket's innovative multi-platform approach allows us to design the optimal gene therapy for each indication, creating potentially transformative options that enable people living with devastating rare diseases to experience long and full lives. Rocket's adeno-associated viral (AAV) vector-based cardiovascular portfolio includes a late-stage clinical program for Danon Disease, a devastating heart failure condition resulting in thickening of the heart, and an early-stage clinical program for PKP2-arrhythmogenic cardiomyopathy (ACM), a life-threatening heart failure disease causing ventricular arrhythmias and sudden cardiac death. Rocket has also received IND clearance for its AAV-based gene therapy for BAG3-associated dilated cardiomyopathy (DCM), a heart failure condition that causes enlarged ventricles. Rocket's lentiviral (LV) vector-based hematology portfolio consists of late-stage programs for Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Fanconi Anemia (FA), a difficult-to-treat genetic disease that leads to bone marrow failure (BMF) and potentially cancer, and Pyruvate Kinase Deficiency (PKD), a monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia. For more information about Rocket, please visit and follow us on LinkedIn, YouTube, and X. Rocket Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements concerning Rocket's future expectations, plans and prospects that involve risks and uncertainties, as well as assumptions that, if they do not materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this release are forward-looking statements. You should not place reliance on these forward-looking statements, which often include words such as "could," "believe," "expect," "anticipate," "intend," "plan," "will give," "estimate," "seek," "will," "may," "suggest" or similar terms, variations of such terms or the negative of those terms. These forward-looking statements include, but are not limited to, statements concerning Rocket's ability to realize the intended benefits of the restructuring plan and reduction in workforce, expectations regarding the safety and effectiveness of product candidates that Rocket is developing to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Danon Disease (DD) and other diseases, the expected timing and data readouts of Rocket's ongoing and planned clinical trials, the expected timing and outcome of Rocket's regulatory interactions and planned submissions, including the timing and outcome of the FDA's review of the additional CMC information that Rocket will provide in response to the FDA's request, the safety, effectiveness and timing of pre-clinical studies and clinical trials, Rocket's ability to establish key collaborations and vendor relationships for its product candidates, Rocket's ability to develop sales and marketing capabilities or enter into agreements with third parties to sell and market its product candidates, Rocket's ability to expand its pipeline to target additional indications that are compatible with its gene therapy technologies, Rocket's ability to transition to a commercial stage pharmaceutical company, and Rocket's expectation that its cash, cash equivalents and investments will be sufficient to fund its operations into the second quarter of 2027. There can be no assurance that the restructuring plan or the planned reduction in workforce will have the intended effect on the Company's operational results and strategic decisions, that any anticipated charges and any anticipated cost savings associated with the restructuring plan or the reduction in workforce will achieve their intended benefits. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, unexpected expenditures, Rocket's competitors' activities, including decisions as to the timing of competing product launches, pricing and discounting, Rocket's ability to develop, acquire and advance product candidates into, enroll a sufficient number of patients into, and successfully complete, clinical studies, the integration of new executive team members and the effectiveness of the newly configured corporate leadership team, Rocket's ability to acquire additional businesses, form strategic alliances or create joint ventures and its ability to realize the benefit of such acquisitions, alliances or joint ventures, Rocket's ability to obtain and enforce patents to protect its product candidates, and its ability to successfully defend against unforeseen third-party infringement claims, as well as those risks more fully discussed in the section entitled "Risk Factors" in Rocket's Annual Report on Form 10-K for the year ended December 31, 2024, filed February 27, 2025 with the SEC and subsequent filings with the SEC including our Quarterly Reports on Form 10-Q. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 42,658 $ 46,345 $ 78,600 $ 91,572 General and administrative 25,020 27,367 53,466 49,515 Restructuring 3,471 - 3,471 - Total operating expenses 71,149 73,712 135,537 141,087 Loss from operations (71,149 ) (73,712 ) (135,537 ) (141,087 ) Interest expense (473 ) (471 ) (945 ) (942 ) Interest and other income, net 483 2,294 1,819 5,323 Accretion of discount on investments, net 2,220 2,243 4,410 5,006 Net loss (68,919 ) (69,646 ) (130,253 ) (131,700 ) Net loss per share - basic and diluted $ (0.62 ) $ (0.74 ) $ (1.18 ) $ (1.40 ) Weighted-average common shares outstanding - basic and diluted 111,019,647 93,746,243 110,559,113 93,759,894 June 30, 2025 December 31, 2024 Cash, cash equivalents, and investments $ 271,494 $ 372,336 Total assets 420,979 527,700 Total liabilities 66,768 64,466 Total stockholders' equity 354,211 463,234 View source version on Contacts InvestorsMeg Dodgemdodge@ MediaKevin Giordanomedia@ 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

What are ultra-processed foods and how do they impact our health?
What are ultra-processed foods and how do they impact our health?

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What are ultra-processed foods and how do they impact our health?

The term "ultra-processed foods" has become common when discussing how healthy -- or unhealthy -- American diets are. A report from the Centers for Disease Control and Prevention published early Thursday found that U.S. children and adults are getting more than 50% of their total calories from ultra-processed foods. Health and Human Services Secretary Robert F. Kennedy Jr. has warned about the dangers of ultra-processed foods, saying they are one of the reasons behind the rise of chronic diseases in the U.S. MORE: How eating ultra-processed foods could lead to increased risk of death, study shows But knowing what an ultra-processed food is and how to identify it can be difficult. ABC News spoke to public health experts about what constitutes as an ultra-processed food and the negative effects they can have on human health. What are ultra-processed foods? There is no standard definition in the U.S. of what ultra-processed foods are so most nutritionists, dietitians and food policy experts rely on the NOVA classification system developed by researchers at the University of São Paolo in Brazil in 2009. The NOVA system divides foods into four groups, with group one being unprocessed or minimally processed such as fruits and vegetables; group two being processed culinary ingredients such as salt, sugar and oil; and group three being processed foods such as canned fruits and vegetables or salted meats. Group four, or ultra-processed foods, are foods that are significantly altered from their original state through industrial formulations. They can be made in a laboratory using substances extracted or derived from foods, additives, flavor enhancers or colorings. They generally contain little to no whole foods. Examples include sugar-sweetened beverages, sweet or savory packaged snacks, instant soups, breakfast cereals, energy bars, mass-produced packaged breads, ready-to-eat meals, ice cream and pizza. "These foods typically contain little of the original foods," Dr. Brian Wojeck, an assistant professor of medicine at Yale School of Medicine, told ABC News. "So, the difference between apple ice cream and an apple -- there's very little apple in apple ice cream. A lot of it is other ingredients." How to identify ultra-processed foods Experts say the best way to identify ultra-processed foods in the supermarket or grocery store is to read the ingredients list and nutritional facts panel. If the ingredients are not items that would be found in the kitchen, it is likely an ultra-processed food. MORE: Departing FDA chief weighs in on food dyes, safety of nation's food supply "Sometimes the longer the list is, or the harder for you to understand those ingredients, it's going to be maybe a little tip-off that these are going to be an ultra-processed food," Jennifer Taylor, a registered dietitian nutritionist and Rutgers Family and Community Health sciences educator, told ABC News. She went on, "Then looking at your nutrition facts panel is your other important thing. What you really want to look at is your added sugars, your fat content and calories." Michele Polacsek, a professor of public health and director of the Center for Excellence in Public Health at the University of New England, said the one problem with reading food labels is they don't list the industrial processes that led to the creation of the ultra-processed item. "It tells you what's in it, but it doesn't really tell you how it was made," she told ABC News. "So, if there was some way to tell that, you might be able to have more information, but that's not something that is shared with the public at the moment." Are ultra-processed foods unhealthy? Studies have shown that consumption of ultra-processed foods has been linked to weight gain. However, research has also found an association between ultra-processed foods and a higher risk of disease, such as cardiovascular disease, and even death. A 2024 study led by researchers at Harvard T.H. Chan School of Public Health found that a high intake of ultra-processed foods may increase risk of early death. Participants who ate the most ultra-processed food of any kind had a 4% higher risk of death from any cause and an 8% higher risk of death from neurodegenerative diseases. Another 2024 study from researchers in the U.S., France, Ireland and Australia found a direct association between greater ultra-processed food exposure and higher risk of deaths from cardiovascular disease. To limit the amount of ultra-processed foods you are consuming, Taylor recommends making as many meals at home as possible and, on every trip to the grocery store, switching out one item that is typically bought for a less processed item. "It can be very overwhelming, and that's why we want to make sure that people feel in control and able to make these small steps, because every little step is going to make a big difference in their health," she said. Polacsek also recommends that policy makers create a standard definition for ultra-processed foods "so that manufacturers, supermarkets, schools, everybody can use that definition to decide, 'Do we sell this? Do we buy this? Do we not?'" Solve the daily Crossword

Gilead posts flat quarterly profit, raises full-year outlook
Gilead posts flat quarterly profit, raises full-year outlook

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Gilead posts flat quarterly profit, raises full-year outlook

By Deena Beasley (Reuters) -Gilead Sciences on Thursday reported flat quarterly earnings on slightly higher revenue and raised its full-year financial outlook due largely to better-than-expected sales of HIV drugs. Adjusted earnings per share were flat from a year earlier at $2.01, and just ahead of the average analysts' estimate of $1.97, as compiled by LSEG. Revenue rose 2% from a year earlier to $7.1 billion, which was in line analysts' expectations. Gilead did not disclose sales of Yeztugo, a twice-yearly HIV prevention drug approved by U.S. regulators in June. CEO Daniel O'Day told Reuters that the company is very happy with the launch so far. "The first scrip was written within hours... the first dose was delivered within days," he said, adding that the company is on track to achieve its stated goal of 75% insurer coverage of the drug within six months and 90% coverage within a year. Total HIV product sales for the quarter rose 7% year-over-year to $5.1 billion. Gilead said its second-quarter cell therapy sales fell 7% to $485 million due to increased competition, while sales of cancer drug Trodelvy rose 14% to $364 million. Sales of Gilead's portfolio of liver disease treatments fell 4% to $795 million, driven mainly by lower sales of hepatitis C drugs. For the full year, Gilead said it now expects adjusted earnings per share of $7.95 to $8.25, up from its previous estimate of $7.70 to $8.10. The company also bumped up its expectations for 2025 product sales to between $28.3 billion and $28.7 billion from a previous range of $28.2 billion to $28.6 billion. Gilead Chief Financial Officer Andrew Dickinson attributed the new outlook to better-than-expected HIV sales and expense discipline. Analysts have forecast full year earnings of $8.01 per share on revenue of $28.7 billion. (Reporting By Deena BeasleyEditing by Bill Berkrot) 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

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