MELVILLE, N.Y., June 18, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to announce that its Chief Executive Officer, Lance Alstodt, will be interviewed during the Benzinga All-Access Show today, Wednesday, June 18, 2025, at 10:50 a.m. Eastern time. Benzinga All-Access Show Date: Wednesday, June 18, 2025 Time: 10:50 a.m. Eastern Ti ...

Provides Accelerated Path to Market for PharmaTher's Ketamine-based Proprietary Delivery Systems & Orphan Drug Designations, and Leveraging its Ketamine Product, having an FDA Approval Goal Date on August 9, 2025 TORONTO, June 18, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a company focused on unlocking the pharmaceutical potential of ketamine, today announced its strong support for the U.S. Food and Drug Administration's (FDA) new Commissio ...

Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3,700,000 compared to $1,200,000 for the same period last year [5][19] - The company anticipates revenue of at least $1,700,000 for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12,000,000 and $16,000,000 [6][21] - The net loss attributed to common stockholders for the fiscal year was $46,600,000, or a loss of $0.69 per share, compared to a net loss of $60,200,000, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [8] - The company has established a solid customer base across key target regions in the US, with 45 hospitals either installed or using the LungFit system [68] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2,000,000,000 lives [11] - Initial shipments of LungFit PH to international customers have begun, with expectations for meaningful contributions to financial results starting in the latter half of fiscal 2026 [12] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market, overcoming barriers to entry and enhancing customer confidence through increased usage [7] - The introduction of LungFit PH2, a next-generation system, is expected to significantly impact market share and logistics within hospitals [10] - The company is focused on cost reduction efforts, having reduced operating expenses from over $17,000,000 to just above $7,000,000 in the current quarter, translating to a 58% reduction [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets for the upcoming quarter and fiscal year, citing strong customer interest and flexibility in contract structures [66] - The company is optimistic about the potential for international growth, although it acknowledges the longer tender processes outside the US [31][59] Other Important Information - The company received orphan drug designation from the FDA for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company announced the appointment of Bob Goodman to the board of directors, bringing extensive commercial leadership experience [16] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to US hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the US takes longer [31] Question: What is the expected timeline for FDA approval of LungFit 2.0? - Management refrained from providing a specific timeline, noting the current upheaval at the FDA [40] Question: What factors could lead to achieving the higher end of the revenue guidance range? - Management mentioned that securing large contracts and regulatory approvals could significantly impact revenue [42] Question: How is the company addressing potential geopolitical impacts on supply and sales? - Management stated that the majority of manufacturing is in the US, and geopolitical issues have minimal impact on costs [53] Question: How does LungFit 2.0 expand the market? - Management noted that the new system would allow access to every hospital wanting to use nitric oxide, significantly increasing market reach [82]

Revenues increased 220% to $3.7 million, compared with $1.2 million for the fiscal year ended March 31, 2024 Expect to report revenue of at least $1.7 million for quarter ending June 30, 2025, and introducing revenue guidance of $12-$16 million for the full fiscal year 2026 Submitted PMA supplement for second-generation LungFit® PH to FDA International distribution partnerships now provide access to markets representing over 2 billion lives, with LungFit® PH actively shipping to Europe, Australia, and the ...

You know that feeling when you have an intuition about how things will turn out. And the more you think about it, the more confident you become. Just until the exact moment you realize you're not.That's intuition. And that's intuition failure. Intuition is safe, cozy, often helpful, yet sometimes can be a disaster.Let me give you an example I love. Imagine it's 1964 and you're standing in a chic art gallery in Sweden. You're surrounded by people gazing at paintings filled with bold, expressive strokes, dyna ...

So, uh, first I'm going to talk about why men's hormonal health is in crisis. And I'm going to frame it in a way where we're really talking about health. Um, I'm going to specifically talk about testosterone, but not testosterone from a like I I want to be big and strong.Testosterone from the perspective of living a long and healthy life and, uh, avoiding chronic disease. So, uh, two really important points. The two greatest drivers of long life seen in published peer-reviewed research are high levels of st ...

U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseasesCapricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseas ...

>> All right. Welcome back, everybody. The Trump administration has cut health research funding to $2.8% billion in May.That's down 28% from April. That's according to data from the Treasury Department. Joining us right now to discuss the implications is former FDA Commissioner Scott Gottlieb.He's 2828. It's 2.8%, not 28. He's a board member with Pfizer and Illumina.Also a CNBC contributor. Doctor Gottlieb, thanks for being here today. First of all, describe what happened.Why was the funding cut and where w ...

Core Insights - Lyell Immunopharma, Inc. announced positive clinical data for LYL314, a CAR T-cell therapy for relapsed/refractory large B-cell lymphoma (LBCL), showing an 88% overall response rate and a 72% complete response rate in patients treated in the third- or later-line setting [1][3][4] Clinical Data Summary - In a Phase 1/2 trial, 25 patients in the 3L+ setting demonstrated an 88% overall response rate and a 72% complete response rate, with 71% of those achieving complete response remaining so at ≥ 6 months [1][3][4] - The efficacy evaluable population included 36 patients, with a median follow-up of 9 months for 3L+ patients and 5 months for 2L patients [2][3] - Among 51 CAR T-naive patients, 70% of those with primary refractory disease achieved a complete response [4] Safety Profile - The safety profile of LYL314 was manageable for outpatient administration, with no Grade ≥ 3 cytokine release syndrome reported and low rates of Grade 1 (22%) and Grade 2 (35%) adverse events [3][5] - Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 6% (Grade 1), 2% (Grade 2), and 14% (Grade ≥ 3) of patients, with a median resolution time of 5 days [5] Ongoing Trials - The pivotal single-arm PiNACLE trial is currently underway, targeting approximately 120 patients with relapsed/refractory LBCL in the third- or later-line setting [6][12] - The trial aims to evaluate the overall response rate as the primary endpoint [12] Regulatory Designations - LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of relapsed/refractory aggressive B-cell lymphoma [11] Manufacturing and Technology - LYL314 is designed to target B cells expressing either CD19 or CD20, utilizing a proprietary manufacturing process to enhance T-cell activity [10][9] - The Lyell LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses at full capacity [13]

Key Takeaways ADMA saw record demand for Asceniv and plans a 2025 filing to expand into pediatric use. Label expansion and new patient starts are expected to drive growth in Asceniv sales. ADMA trades at 8.75X forward sales, above its historical average and industry valuation levels.ADMA Biologics (ADMA) markets plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.ADMA’s lead product, Asceniv, is a plasma-derived Intravenous Immune Globulin th ...