Kuala Lumpur, Malaysia, July 16, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative medicines, today commented on recent stock price volatility. The Company is not aware of any material developments or changes to its operating or financial condition that precipitated the volume and price movements that occurred on July 15, 2025. There have been no material adverse changes to the company’s opera ...

Core Insights - Silo Pharma, Inc. has completed dosing in a large animal study requested by the FDA for its lead asset SPC-15, with results expected in 60 days [1] - The company is confident in the safety and therapeutic delivery of SPC-15 and is on track to submit an investigational new drug (IND) application [2] - Silo plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite clinical timelines and reduce development costs [3] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and CNS diseases [5] - The company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia, and preclinical assets targeting Alzheimer's disease and multiple sclerosis [5] - Silo collaborates with leading universities and laboratories for its research initiatives [5] Product Details - SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders like PTSD and anxiety [4] - The drug has potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, which may accelerate its approval process [4] - Silo Pharma has exclusive global rights for the development and commercialization of SPC-15 in collaboration with Columbia University [4]

Core Viewpoint - Aptorum Group Limited has announced a definitive agreement for an all-stock merger with DiamiR Biosciences, which will become a wholly-owned subsidiary of Aptorum, retaining its name and continuing to be listed on the Nasdaq Stock Market after the merger [1][4]. Company Overview - Aptorum Group is a clinical stage biopharmaceutical company focused on addressing unmet medical needs in oncology and infectious diseases [8]. - DiamiR Biosciences specializes in developing proprietary blood-based tests for brain health and other diseases, operating a CLIA licensed, CAP accredited clinical laboratory [1][9]. Merger Details - The merger will involve Aptorum re-domiciling to Delaware and acquiring all outstanding capital stock of DiamiR in exchange for shares representing approximately 70% of the combined company's common stock, with current Aptorum equity holders retaining 30% [3][4]. - The merger agreement has been approved by the boards of both companies and is subject to stockholder approval and customary closing conditions, with an expected closing in the fourth quarter of 2025 [4][6]. Leadership and Structure - Post-merger, the combined company will be headquartered in Princeton, New Jersey, with Ian Huen as CEO, Dr. Alidad Mireskandari as President and COO, and Gary Anthony as CFO [5]. - The board of directors will consist of five members, with three designated by Aptorum and two by DiamiR [5]. Strategic Goals - The merger aims to create a global life sciences company capable of generating revenue through biopharma services and offering biomarker panels for complex-biology indications, particularly in aging-related diseases and brain health [2][3]. - DiamiR's expertise in assay development and commercialization is expected to enhance the combined company's capabilities in non-invasive blood-based testing [2].

Contact: Crescendo Communications, LLC David Waldman / Alexandra Schilt Tel: 212-671-1020 GLEN ALLEN, Va., July 16, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it received notice from Nasdaq on July 14, 2025 that the Company has regained compliance with Nasdaq Listing Rule 5550(b)(1), which req ...

NEW YORK, July 16, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Organon & Co. (NYSE: OGN) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Organon you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/organon-co-class-action. Investors have until July 22, 2025, to ask the Court to be appointed to lea ...

CINCINNATI, July 16, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”) and Ocuvex Therapeutics, Inc. (“Ocuvex”), a privately held biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates, today announced that they have entered into a definitive merger agreement (the “Merger Agreement”). Andrew J. Oakley, Chairman of the Board of Onconetix, stated, “We continue to believe that the proposed transaction with Ocuvex, whi ...

Core Insights - Madrigal Pharmaceuticals has received a Notice of Allowance from the USPTO for Rezdiffra™, the first FDA-approved treatment for adults with noncirrhotic MASH with moderate to advanced liver fibrosis [1][2] - The patent protection for Rezdiffra is set to last until September 30, 2044, and will be included in the FDA's Orange Book [2] - The CEO of Madrigal emphasized that this milestone supports the company's long-term strategy for Rezdiffra and highlights the significance of their clinical development program [3] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - Rezdiffra (resmetirom) is a once-daily oral THR-β agonist aimed at addressing the underlying causes of MASH, specifically approved for patients with moderate to advanced fibrosis (F2 to F3 stages) [3] - An ongoing Phase 3 trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c stage) [3]

Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient's body. The company's proprietary platform, Immuno-STAT (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body's intrinsic immune system without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we a ...

Summary of Regeneron's Q1 2025 Earnings Conference Call Company Overview - **Company**: Regeneron Pharmaceuticals - **Date of Call**: Q1 2025 earnings conference call Key Industry Insights - **Branded Anti-VEGF Category**: The overall size contracted due to increased usage of low-cost off-label repackaged Avastin, likely driven by patient affordability issues related to funding gaps at copay assistance foundations [2][11] - **Regulatory Environment**: The FDA issued a complete response letter (CRL) for the ILEA HD pre-filled syringe submission, with the key issue related to a third-party component supplier [3][19] Financial Performance - **Total Revenues**: $3 billion for Q1 2025, driven by higher collaboration revenue and U.S. net sales of ILEA HD [15] - **Net Sales of ILEA**: $736 million, down 39% year-over-year and down 38% sequentially [2][11] - **Net Sales of ILEA HD**: $307 million, up 54% year-over-year, flat sequentially [3][11] - **Diluted Earnings Per Share**: $8.22, with net income of $928 million [15] - **R&D Expenses**: $1.2 billion, reflecting continued investments in the innovative pipeline [15] - **Gross Margin**: 85%, lower than the previous year due to higher inventory write-offs [15][17] Product Performance - **Dupixent**: - Global net product sales grew 20% year-over-year, with U.S. sales growing 19% [4] - Leading in new-to-brand prescription share across all approved indications, except for chronic spontaneous urticaria (CSU) [4][12] - Recently approved for CSU, marking the first new treatment option in over a decade [6][13] - **ILEA and ILEA HD**: - Combined U.S. net sales of $1.04 billion, down 30% sequentially [10] - ILEA HD maintained market leadership with 41% share of the anti-VEGF category despite challenges [11] - **Liptio**: Now second in new-to-brand prescription share in the advanced non-small-cell lung cancer market [5] Pipeline Developments - **Pipeline Candidates**: Approximately 45 product candidates in clinical development [5] - **Upcoming Regulatory Approvals**: Anticipated approvals for Limboseltamib, Ogenexamib, and Dupixent in various indications [5][8] - **Dupixent's Expansion**: Expected approval for bullous pemphigoid, representing a significant opportunity in chronic skin diseases [6][13] - **Idapecimab**: Investigating its role in COPD, with promising phase II data [28] Strategic Initiatives - **Investment in Manufacturing**: Over $7 billion planned for U.S. investments to expand R&D and manufacturing capabilities [16] - **Shareholder Returns**: $1.1 billion in share repurchases in Q1 2025, with a new quarterly dividend initiated [16][17] Challenges and Risks - **Competitive Pressures**: Ongoing competition in the anti-VEGF category and the impact of funding gaps on patient access to treatments [11][12] - **Regulatory Scrutiny**: Increased scrutiny from the FDA on contract manufacturers, leading to multiple CRLs [26][32] Conclusion - **Outlook**: Regeneron remains well-positioned scientifically and financially, with a strong pipeline and commitment to innovation despite facing regulatory and competitive challenges [6][10]

Core Insights - The FDA has granted fast track designation to Sanofi's SAR446597, a one-time intravitreal gene therapy for geographic atrophy due to age-related macular degeneration [1][2] - This designation aims to expedite the development and review of treatments for serious conditions, addressing unmet medical needs [1] Product Details - SAR446597 delivers genetic material encoding two therapeutic antibody fragments that inhibit critical components of the complement pathway, potentially offering sustained complement suppression and reducing treatment burden [2] - The therapy targets the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins after a single intervention [2] Clinical Development - Sanofi plans to initiate a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597 [3] - Additionally, Sanofi is evaluating another gene therapy, SAR402663, for neovascular wet age-related macular degeneration in a phase 1/2 study [3] Market Context - Age-related macular degeneration (AMD) affects approximately 200 million people globally, with geographic atrophy being a severe form that can lead to permanent vision loss [4] - Geographic atrophy impacts around 1 million people in the US, over 2.5 million in Europe, and more than 5 million worldwide, significantly affecting quality of life [4] Company Focus - Sanofi aims to improve the lives of individuals with serious neuroinflammatory and neurodegenerative diseases, including AMD, through innovative therapies [5] - The company is leveraging scientific innovations and investments in ophthalmology to drive growth and address unmet needs in retinal diseases [5][6]