Joining me now is Matt Stucky. He's the chief portfolio manager for equities at Northwestern Mutual Wealth Management. And Matt, you know, markets seem to be taking a breather today after yesterday's bounceback.How do you think investors are processing the latest risks here. Not just tariffs and inflation, but now that escalating geopolitical headwinds are on the table, that's another risk that we're going to have to deal with. Well, good morning, Ally.Thanks for having me back. Um yeah, there is no shortag ...

Let's talk more about that Middle East conflict and the impact of the president leaving the G7. Fred Kemp is president and CEO of the Atlantic Council and a CNBC contributor joining us from the Atlantic Council's Global Energy Forum, matter of fact, in Washington DC. And Fred, what's the buzz.What's the latest, especially amid the president's really sharp messaging on Iran just within the past hour or two. Uh, well, let's start with the G7. It says nothing good about the organization that the president leav ...

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Hey, good morning again, guys. Carl, that that sudden and surprised departure was by far the biggest headline coming out of this summit and the biggest moment as well. The president scrapping quite suddenly plans for his whole day today that included sitdown meetings with the presidents of Ukraine and Mexico as well as some other closed-d dooror private sessions as well.The White House of course saying he had to get back to Washington to focus on the ongoing conflict in the Middle East. And we do expect tha ...

So, I've only actually ever been to Starbucks once, and it's quite a funny story. So, because it was my first time there, I had no idea how the ordering process worked. And couple that with the fact that I was quite an awkward person, and you get an interaction that went a little something like this.Uh, hi. Can Can I get the small lemonade, please. Oh, I'm sorry.You must mean the the tall cool line. Oh. Oh, yeah.Sorry. Yeah, that's right. That's right.Okay, that'll be 390. Thank you. And then the barista as ...

Core Viewpoint - Capricor Therapeutics has received Orphan Drug Designation from the FDA for its lead cell therapy candidate, Deramiocel, for the treatment of Becker Muscular Dystrophy, enhancing its strategic position in the neuromuscular disease market [1][3][7] Company Overview - Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, with Deramiocel as its lead product candidate [9] - The company is advancing a fully integrated platform targeting cardiac and skeletal complications associated with muscular dystrophy [1][9] Product Details - Deramiocel (CAP-1002) is an allogeneic cell therapy derived from cardiosphere-derived cells (CDCs), which have shown immunomodulatory and anti-fibrotic effects in preserving muscle function in dystrophies [6][9] - The therapy is currently in late-stage development for Duchenne Muscular Dystrophy (DMD) and has received multiple designations from regulatory bodies, including Orphan Drug Designation for both DMD and Becker Muscular Dystrophy [8][11] Disease Context - Becker Muscular Dystrophy (BMD) is a progressive neuromuscular disorder affecting approximately 5,000 individuals in the U.S., characterized by slower disease progression compared to Duchenne Muscular Dystrophy (DMD) [5] - Both BMD and DMD are caused by mutations in the dystrophin gene, leading to significant muscle deterioration and serious cardiac complications [2][4][5] Regulatory Milestones - Capricor has successfully completed its Pre-License Inspection, a key regulatory milestone for its Biologics License Application (BLA) for DMD, with a target action date set for August 31, 2025 [3][7] - The company is preparing for the potential commercial launch of Deramiocel, aiming to deliver meaningful benefits to patients with both DMD and BMD [3][7]

Core Insights - CERo Therapeutics Holdings, Inc. has received Orphan Drug Designation from the FDA for its lead drug candidate CER-1236, aimed at treating acute myeloid leukemia (AML) [1][3] - CER-1236 is currently undergoing Phase 1 clinical trials to assess its safety and preliminary efficacy in AML patients [2] - The FDA's Orphan Drug program supports the development of treatments for conditions affecting fewer than 200,000 patients annually, providing various incentives to CERo [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that combines innate and adaptive immunity [4] - The company’s innovative therapy, CER-1236, employs phagocytic mechanisms to enhance the effectiveness of T cell therapies against tumors [4] - CERo aims to differentiate its CER-T cells from existing CAR-T therapies, potentially expanding their application to both hematological malignancies and solid tumors [4]

Core Insights - Quantum BioPharma Ltd. has initiated a joint clinical study with Massachusetts General Hospital to validate a novel PET imaging technique for monitoring myelin integrity in multiple sclerosis (MS) patients [1][2] - The study utilizes the PET tracer [F]3F4AP, which has shown high sensitivity to demyelinated lesions and favorable pharmacokinetics in previous studies, indicating its potential as a biomarker for monitoring demyelination [1][3] - The new combined GE Signa PET-MR scanner at MGH enhances the imaging process by allowing simultaneous acquisition of PET and MRI signals, improving the accuracy of monitoring demyelination over time [2][3] Company Overview - Quantum BioPharma is focused on developing innovative biopharmaceutical solutions for neurodegenerative and metabolic disorders, with a lead compound, Lucid-MS, aimed at preventing and reversing myelin degradation in MS [4] - The company retains a 20.11% ownership stake in Unbuzzd Wellness Inc. and has a royalty agreement that includes 7% of sales until total payments reach $250 million, after which the royalty rate drops to 3% [4] - Quantum BioPharma also maintains a portfolio of strategic investments through its subsidiary, FSD Strategic Investments Inc., which includes loans secured by residential or commercial property [4]

Core Viewpoint - Dyne Therapeutics has received Breakthrough Therapy Designation from the FDA for DYNE-101, aimed at treating myotonic dystrophy type 1 (DM1), and has outlined a revised plan for U.S. Accelerated Approval based on new long-term functional data [1][2][10]. Group 1: FDA Designations and Approvals - The FDA granted Breakthrough Therapy Designation to DYNE-101 for DM1, which expedites development and review for drugs showing substantial improvement over existing therapies [10]. - Dyne is pursuing U.S. Accelerated Approval for DYNE-101, with a revised protocol submitted to the FDA following a Type C meeting [6][5]. Group 2: Clinical Trial Updates - The ongoing Registrational Expansion Cohort of the ACHIEVE trial will enroll 60 participants, with video hand opening time (vHOT) as the primary endpoint for potential Accelerated Approval [6][5]. - New long-term data from the ACHIEVE trial indicate that DYNE-101 led to a 3.3 seconds improvement in vHOT at 6 months compared to placebo, with sustained improvements observed at 12 months [12]. - The trial's secondary endpoints include various measures of muscle strength and performance, with a reported 20% improvement in strength at 12 months relative to baseline [12]. Group 3: Financial Guidance - As of March 31, 2025, Dyne reported cash, cash equivalents, and marketable securities totaling $677.5 million, expected to fund operations into Q4 2026 [7]. Group 4: Future Plans - Dyne plans to complete enrollment in the Registrational Expansion Cohort by Q4 2025, with data expected in mid-2026 to support a potential U.S. Accelerated Approval submission in late 2026 [6]. - A confirmatory Phase 3 clinical trial is anticipated to begin in Q1 2026 [6].