[Music] [Applause] [Music] [Applause] [Music] [Applause] Wowch. Good afternoon to you all one and all lovely people of this nation of ours Australia. If it was just you and me guided by old ways, words would come to me in their own time. knowledge was implanted in me to share with you. But today we will tell try to tell this story in just 15 minutes. UAW Sai Gat North Queensland. My name is Taya Mcros Elu. I am a descendant of the Saibby Kadal Chipton clan in the top western islands of the Tor Strait called ...

[Music] [Applause] [Music] See, I had an amazing family, incredible friends, and I didn't ever feel like anything was missing. by not knowing my birth family or my birth culture. And for as far back as I can remember, my life was full. But our stories, they always run deeper than what we can remember. Ah, over the last four years, what was once just my fun fact has now become a central part of my funky Georgian American life. something that has redefined my every move, given me a new sense of purpose, and h ...

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]

SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that deploy phagocytic mechanisms, announces that the U.S. Food and Drug Administration (FDA) has granted CERo’s Orphan Drug Designation (ODD) for the company's lead drug candidate CER-1236, for the treatment of acute myeloid leukemia (AML). CER-1236 is an innovat ...

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].

Core Viewpoint - Equinox Gold Corp. has successfully completed the acquisition of Calibre Mining Corp., creating a diversified gold producer focused on the Americas with significant growth potential [1][2]. Company Overview - The merger has resulted in a company with a portfolio of mines across five countries, highlighted by two major Canadian gold mines: Greenstone Gold Mine in Ontario and Valentine Gold Mine in Newfoundland & Labrador [2]. - Valentine Gold Mine is nearing completion, with first gold production expected by the end of Q3 2025 [2]. - With both Greenstone and Valentine operating at full capacity, Equinox Gold is positioned to become the second largest gold producer in Canada [2]. Leadership Changes - The Board of Directors of Equinox Gold has seen new appointments from Calibre, including Blayne Johnson, Doug Forster, Omaya Elguindi, and Mike Vint, while retaining several existing directors [4]. - The leadership team will include Greg Smith as CEO, Darren Hall as President and COO, and Peter Hardie as CFO [4]. Strategic Importance - The merger is described as transformative, combining the strengths of both companies to enhance production capabilities and long-term value for shareholders [5]. - Equinox Gold plans to delist Calibre shares from the Toronto Stock Exchange and cease its public reporting requirements [5]. Shareholder Information - Calibre shareholders will automatically receive Equinox Gold shares in their trading accounts within two weeks of the merger closing [6]. - Shareholders with physical certificates must submit a Letter of Transmittal to receive their Equinox Gold shares [6]. Advisory Roles - BMO Capital Markets and GenCap Mining Advisory served as financial advisors to Equinox Gold, while multiple firms provided advisory services to Calibre [7].

Shares of U.S. Steel soared Monday after President Donald Trump issued an executive order on Friday approving U.S. Steel’s merger with Japan’s Nippon Steel through a National Security Agreement (NSA).  The stock gained over 5% in the biggest percentage rise since March 2011, as tracked by Dow Jones Market Data Group. Ticker Security Last Change Change % X UNITED STATES STEEL CORP. 54.85 +2.66 +5.10% U.S. Steel .The NSA includes a commitment to more than $11 billion in new steelmaking investments in the U ...