Kennedy's MAHA strategy won't be publicly released Aug. 12
The White House said Monday that it expected the Make America Healthy Again Commission, which President Donald Trump created in February to revamp the nation's food supply and chronic health outcomes, to send the strategy to the president Tuesday, as required by an executive order.
However, spokesperson Kush Desai added that it will take more time to coordinate officials' schedules to release the report to the public.
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The upcoming MAHA policy recommendations are expected to suggest a restructuring of the government's response to childhood chronic diseases and will have wide-ranging implications for food, farm and health policy.
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Yahoo
11 minutes ago
- Yahoo
Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launch DNL126 accelerated approval path for Sanfilippo syndrome Type A aligned with FDA; Phase 1/2 study nearing completion of enrollment; planning underway for a global Phase 3 confirmatory study On track to submit regulatory applications in 2025 to begin clinical testing of one to two additional TransportVehicleTM (TV)-enabled programs Preclinical research on ATV:Abeta program for Alzheimer's disease published in the journal Science SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the second quarter ended June 30, 2025, and provided business highlights. 'The FDA's priority review of our BLA for tividenofusp alfa and alignment on an accelerated approval path for DNL126 are key milestones highlighting the potential of our Transport Vehicle (TV) platform to catalyze a new class of blood-brain barrier-crossing therapeutics,' said Ryan Watts, Ph.D., CEO of Denali Therapeutics. 'With launch readiness in motion and a growing portfolio of TV-enabled enzyme, antibody, and oligonucleotide programs, Denali is poised to deliver meaningful treatments for people living with lysosomal, neurodegenerative, and other serious diseases.' Second Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) In July 2025, Denali announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for tividenofusp alfa for priority review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2026. The BLA seeks accelerated approval based on a data package including results from the Phase 1/2 study in individuals with Hunter syndrome. Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. The FDA previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Denali continues to prepare for commercial launch and is conducting the Phase 2/3 COMPASS study to support global regulatory submissions. DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) Today, Denali announced that it has reached alignment with the FDA's Center for Drug Evaluation and Research (CDER) that cerebrospinal fluid heparan sulfate (CSF HS) may be considered a reasonably likely surrogate endpoint to predict clinical benefit and may therefore be used to support accelerated approval of DNL126 for MPS IIIA. Additional 49-week data from the ongoing open-label Phase 1/2 study are consistent with previously announced 25-week data, demonstrating a significant reduction in CSF HS from baseline, including normalization, and a safety profile that supports continued development. Enrollment in the Phase 1/2 study is nearly complete, and planning is underway for a confirmatory global Phase 3 study. TAK-594/DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia Denali and Takeda continue their collaboration to develop DNL593, an investigational therapeutic designed to deliver progranulin across the BBB for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN). A Phase 1/2 study is ongoing. BIIB122/DNL151 (small molecule LRRK2 inhibitor) for the treatment of Parkinson's disease (PD) Denali and Biogen are co-developing LRRK2 inhibitors for Parkinson's disease. In May 2025, Biogen announced that the Phase 2b LUMA study of BIIB122 completed enrollment, with a readout expected in 2026. Denali is also conducting the Phase 2a BEACON study focused on LRRK2-associated PD. IND-ENABLING STAGE PROGRAMS Denali expects to submit regulatory applications to begin clinical testing of one to two TV-enabled programs each year over the next three years across its Enzyme TV (ETV), Antibody TV (ATV), and Oligonucleotide TV (OTV) franchises. The most advanced programs include: DNL952 (ETV:GAA) for Pompe disease; DNL111 (ETV:GCase) for Parkinson's/Gaucher disease; DNL622 (ETV:IDUA) for MPS I; DNL921 (ATV:Abeta) for Alzheimer's disease; DNL628 (OTV:MAPT) for Alzheimer's disease; and DNL422 (OTV:SNCA) for Parkinson's disease. Denali announced publication of preclinical data on ATV:Abeta in the August 7, 2025, issue of the journal Science. The research demonstrated that delivering an anti-amyloid beta antibody across the BBB using Denali's TV platform improved brain distribution and reduced the risk of amyloid-related imaging abnormality (ARIA) in a mouse model of Alzheimer's disease, compared to conventional antibody treatment. The findings suggest that TV platform-enabled brain delivery of immunotherapy bypasses amyloid-laden large vessels by traveling through smaller capillaries, offering a potential strategy to mitigate ARIA risk seen with first-generation anti-amyloid therapies. The Science article can be accessed here. Participation in Upcoming Investor Conferences Cantor Global Healthcare Conference 2025, September 3 - 5 (New York City) Morgan Stanley 23rd Annual Global Healthcare Conference, September 8 - 10 (New York City) Baird 2025 Global Healthcare Conference, September 9 - 10 (New York City) H.C. Wainwright 27th Annual Global Investment Conference, September 8 - 10 (New York City) Deutsche Bank BioPharm Corporate Day, September 18 - 19 (Austria) Stifel 2025 Healthcare Conference, November 11 - 13 (New York City) Jefferies Global Healthcare Conference, November 17 - 20 (London) Second Quarter 2025 Financial Results Net loss was $124.1 million for the quarter ended June 30, 2025, compared to net loss of $99.0 million for the quarter ended June 30, 2024. Total research and development expenses were $102.7 million for the quarter ended June 30, 2025, compared to $91.4 million for the quarter ended June 30, 2024. The increase of approximately $11.3 million was attributable to an increase of $7.3 million in TV program external research and development expenses, primarily driven by increased spend on multiple preclinical programs, and increases of $7.6 million and $6.2 million in other research and development expenses and personnel-related expenses, respectively, both driven by the commencement of operations at Denali's large molecule manufacturing facility in Salt Lake City, Utah. These increases were partially offset by a $9.8 million decrease in small molecule programs, primarily due to the winding down of activities related to the Phase 2/3 HEALEY ALS Platform Trial. General and administrative expenses were $32.3 million for the quarter ended June 30, 2025, compared to $25.2 million for the quarter ended June 30, 2024. The increase of $7.1 million was primarily driven by activities related to preparations for a potential commercial launch for tividenofusp alfa. Cash, cash equivalents, and marketable securities were approximately $977.4 million as of June 30, 2025. About Denali Therapeutics Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB, and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali's TV platform and its therapeutics and commercial potential; statements made by Denali's Chief Executive Officer; plans, timelines, and expectations relating to DNL310, including the PDUFA target action date and the timing, likelihood of, and scope of regulatory approval, the ongoing global Phase 2/3 COMPASS study and the likelihood of global approvals, and planned commercial launch; plans, timelines, and expectations related to DNL126, including enrollment in the ongoing Phase 1/2 study, plans regarding the confirmatory global Phase 3 study, planned engagement with the FDA, and the likelihood and scope of regulatory approvals; plans regarding DNL593 and the ongoing Phase 1/2 study; plans, timelines, and expectations regarding DNL151, including with respect to the ongoing Phase 2b LUMA study and the timing and likelihood of readout, and the ongoing Phase 2a BEACON study; plans and expectations for Denali's preclinical programs, including the timing of advancement to clinical studies; the findings from Denali's recent Science publication and their therapeutic potential regarding ARIA risk; Denali's participation in upcoming investor conferences; and Denali's future operating expenses and anticipated cash runway. All drugs currently being developed by Denali are investigational and have not received regulatory approval for any indication. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: the impact of adverse economic conditions, tariffs, and inflation on Denali's business and operations; the occurrence of any event, change, or other circumstance that could give rise to the termination of Denali's agreements with Sanofi, Takeda, Biogen, or other collaborators; Denali's transition to a late-stage clinical drug development company; Denali's and its collaborators' ability to complete the development and, if approved, commercialization of its product candidates; Denali's and its collaborators' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali's dependence on successful development of its blood-brain barrier platform technology and its programs and product candidates; Denali's and its collaborators' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali's product candidates may not translate in clinical trials; the potential for clinical trials to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities, or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali's ability to continue to create a pipeline of product candidates or commercialize products; developments relating to Denali's competitors and its industry, including competing product candidates and therapies; Denali's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Denali's strategic plans for its business, product candidates, and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results and hedge against financial risk in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual Report and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 27, 2025 and May 6, 2025, and Denali's future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results, or to make changes in Denali's expectations, except as required by law. Denali Therapeutics Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 102,696 $ 91,399 218,923 198,415 General and administrative 32,267 25,194 61,620 50,430 Total operating expenses 134,963 116,593 280,543 248,845 Gain from divestiture of small molecule programs — — — 14,537 Loss from operations (134,963 ) (116,593 ) (280,543 ) (234,308 ) Interest and other income, net 10,844 17,567 23,454 33,480 Net loss $ (124,119 ) $ (99,026 ) $ (257,089 ) $ (200,828 ) Net loss per share, basic and diluted $ (0.72 ) $ (0.59 ) $ (1.50 ) $ (1.26 ) Weighted average number of shares outstanding, basic and diluted 171,449,847 168,831,329 171,336,568 159,117,759 Denali Therapeutics Consolidated Balance Sheets(Unaudited)(In thousands) June 30, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 141,207 $ 174,960 Short-term marketable securities 757,745 657,371 Prepaid expenses and other current assets 35,754 32,105 Total current assets 934,706 864,436 Long-term marketable securities 78,463 359,373 Property and equipment, net 58,717 55,236 Finance lease right-of-use asset 50,363 47,533 Operating lease right-of-use asset 21,022 22,861 Other non-current assets 22,970 24,741 Total assets $ 1,166,241 $ 1,374,180 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 10,844 $ 11,137 Accrued compensation 12,068 24,728 Accrued clinical and other research & development costs 23,379 22,822 Accrued manufacturing costs 9,028 12,779 Operating lease liability, current 8,871 8,308 Deferred research and development funding liability, current 19,861 14,129 Other accrued costs and current liabilities 7,006 8,305 Total current liabilities 91,057 102,208 Operating lease liability, less current portion 32,110 36,673 Finance lease liability, less current portion 5,577 5,615 Deferred research funding and development liability, less current portion 10,444 — Total liabilities 139,188 144,496 Total stockholders' equity 1,027,053 1,229,684 Total liabilities and stockholders' equity $ 1,166,241 $ 1,374,180 Investor Contact:Laura Hansen, Media Contact:Erin Pattonepatton@ 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
Yahoo
11 minutes ago
- Yahoo
Laxxon Medical Announces Successful Product Development Milestone with Novel Oral Modified-Release Formulation of Veru's Enobosarm, Utilizing Laxxon's SPID®-Technology
NEW YORK, August 11, 2025--(BUSINESS WIRE)--Laxxon Medical Corp., a leading pharmaceutical technology company pioneering a new generation of advanced oral drug delivery systems, today announced that Veru Inc. (NASDAQ: VERU), a late clinical-stage biopharmaceutical company advancing treatments for cardiometabolic and inflammatory diseases, has selected a novel modified-release oral formulation of enobosarm that will utilize Laxxon's proprietary SPID® (Screen Printing Innovation Drug)-Technology. The novel tablet formulation achieved the desired target release profile, including a reduced maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak plasma concentration, and a similar extent of absorption (AUC) compared to historical values for immediate release enobosarm capsules. "This milestone underscores the strength of our SPID®-Technology in enhancing bioavailability and optimizing drug release profiles," said Helmut Kerschbaumer, Chief Executive Officer of Laxxon Medical. "The collaboration with Veru reflects our commitment to advancing next-generation drug formulations, and we are excited to support them on their product development pathway." Sequential release of APIs, processing of molecules like peptides in combination with permeation enhancers, processing of nanoparticles, multi-compartment tablets starting at a micro-tablet dimension as small as < 750 micron, are just some of the various possibilities which SPID®-Technology enables, and multiple other functionalities can be combined in one tablet with the potential upscaling from lab to mass production. "Selecting Laxxon as our formulation development partner was a strategic decision, driven by the strength of their SPID® platform and their proven expertise in advanced drug formulation," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "The resulting modified-release oral formulation of enobosarm has multiple benefits when treating the intended patient population and represents a significant advance over conventional drug product dosage forms as we move towards Phase 3 clinical trials and potential commercialization, pending regulatory approval." About Laxxon MedicalLaxxon Medical Corp. is a leading pharma-technology company and global leader of smart drug delivery systems in the pharmaceutical industry, pioneering a new generation of advanced pharmaceuticals designed to optimize drug delivery and maximize patient success through SPID®-Technology, Laxxon's proprietary screen printing technology platform. SPID®-Technology unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities in drug development and commercialization. With SPID®-Technology, Laxxon can develop and manufacture advanced versions of new and existing pharmaceutical drugs while extending and adding new patent protection through the technology transfer process. Laxxon can fully utilize the FDA's 505b(2) regulatory pathway in the US and Hybrid applications under article 10(3) of Directive 2001/83/EC in the EU, which fast tracks product routes to market. Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 13 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing, and together with the licensed IP from Exentis Group, consists of >230 patents and patent applications with more than 5,000 patent claims. About Veru Inc. is a late clinical-stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass, thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. For more information, visit View source version on Contacts Laxxon Investor and Media Contacts: IR@ Veru Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@ 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
Gizmodo
12 minutes ago
- Gizmodo
The Food Is Trashy, But Dollar Stores Aren't Ruining Our Diets, Study Claims
Some good news for bargain hunters out there: New research shows that while the food bought at dollar stores is generally less healthy, customers' diets aren't suffering greatly as a result. Scientists at Tufts University and the USDA-Economic Research Service collaborated for the study, which tracked the food purchasing habits of nearly 200,000 American families. They found that a growing number of people are buying food from dollar stores, particularly people with lower incomes. At the same time, the overall diet quality wasn't significantly different between those who shop and don't shop at these outlets. Dollar stores have become a ubiquitous presence across the U.S. over the past few decades. Research has shown how these stores have reshaped the local economy, particularly in small towns. For the new study, the researchers wanted to get a better sense of how they've changed our diets. To that end, they analyzed yearly data from a nationally representative sample of Americans' household food purchases. They also used USDA data to rate the quality of people's store-bought food. According to the study, dollar store foods made up 3.4% of a household's total calories in 2008, nearly doubling to 6.5% by 2020. People of color, people living in rural neighborhoods, and those with lower incomes were more likely to buy foods from dollar stores. As other research shows, dollar store food purchases are less healthy than food bought elsewhere. These stores are less likely to carry fresh produce, for example, and more likely to have sweets, snacks, and other processed foods. But strangely enough, the quality of people's diets didn't shift much regardless of whether they ate dollar store food. People who reported never buying foods at dollar stores had a healthy eating score of 50.5, for instance, whereas people who most shopped at these stores had a score of 46.3 (the scale goes to 100). On average, even the most frequent dollar store customers still got more than 90% of their at-home calories from somewhere else. The findings suggest that the impact of these stores on Americans' health is more complicated than assumed, the researchers say. People who shop at these stores seem to be changing their food-buying behavior in other ways. 'Although foods purchased in dollar stores are less healthy, households may compensate through healthier purchases elsewhere,' they wrote in their paper, published Monday in the Journal of the Academy of Nutrition and Dietetics. The researchers note that some towns and neighborhoods have taken action to limit the growth of these stores. But given their findings, they argue that more study is needed to understand exactly how these businesses are shaping people's eating habits. 'We need more data on the real effects of dollar stores on healthy eating as some communities may be putting the policy cart before the horse,' said senior study researcher Sean Cash, an economist at Tufts' Friedman School of Nutrition Science and Policy, in a statement from the university.
