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Why Your Name Matters | Wenli Xie | TEDxYouth@CardiffSixthFormCollege
TEDx Talks· 2025-06-17 15:31
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 ...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program
GlobeNewswire News Room· 2025-06-17 13:00
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]
CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the Treatment of Acute Myeloid Leukemia (AML)
Globenewswire· 2025-06-17 12:15
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]
Quantum BioPharma Announces First Person with Multiple Sclerosis (MS) Scanned in Joint Study with Massachusetts General Hospital
Globenewswire· 2025-06-17 12:00
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]
Dyne Therapeutics Announces FDA Breakthrough Therapy Designation for DYNE-101 and Updated Plan for Accelerated Approval in DM1 Following Type C Meeting
GlobeNewswire News Room· 2025-06-17 11:00
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].
Equinox Gold and Calibre Mining Complete Business Combination
Newsfile· 2025-06-17 07:02
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].
Trump greenlights U.S. Steel deal, promising $11B investment and 100,000 American jobs
Fox Business· 2025-06-16 20:16
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 ...
The Iranians aren't done yet, this conflict will last, says Columbia University's Richard Nephew
CNBC Television· 2025-06-16 15:34
Richard Nephew, Columbia University senior research scholar, joins 'Money Movers' to discuss the ongoing conflict in the Middle East and what happens from here. ...
X @Elon Musk
Elon Musk· 2025-06-16 15:14
If this continues, America goes de facto bankrupt and all tax revenue will go to paying interest on the national debt with nothing left for anything else.Wall Street Mav (@WallStreetMav):How did we arrive at a point in this country where 25% of all tax revenue goes to just paying the interest in $37 trillion in govt debt?Annually:US govt total reveneue = about $5 trillionUS govt interest on debt = about $1.2 trillionUS govt spending = about $7 trillion https://t.co/d0te2sZ7is ...
X @Tesla Owners Silicon Valley
Tesla Owners Silicon Valley· 2025-06-16 15:05
Let’s help @JohnnaCrider1 raise $10k for St JudeDonate here https://t.co/AmA3djxUAnJohnna (@JohnnaCrider1):Since I reached my $1,000 goal for St. Jude, I’ve updated the goal to $10,000.00.For context:I am running my first 5K race in October and I hope to reach this goal by my run date - October 4, 2025.Donation linked below👇 https://t.co/KkLDxft1Rf ...