NEW YORK, June 26, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Iovance you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/iovance-biotherapeutics-inc-class-action-lawsuit. Investors have until July 14, 2 ...

NEW YORK, June 26, 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 ...

NEW YORK, June 26, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Sarepta Therapeutics, Inc. (NASDAQ: SRPT) for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Why is Sarepta being Investigated? Sarepta is a biopharmaceutical company focused on developing treatment ...

Company Overview - Coeptis Therapeutics Holdings, Inc. is a next-generation technology and biopharmaceutical company focused on developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases [3][4] - The company has a therapeutic portfolio that includes assets licensed from Deverra Therapeutics, featuring an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage natural killer cell therapy technology [4] - Coeptis is also developing a universal, multi-antigen CAR technology licensed from the University of Pittsburgh, alongside GEAR cell therapy and companion diagnostic platforms in collaboration with VyGen-Bio and the Karolinska Institute [4] Recent Developments - Coeptis has filed a registration statement on Form S-4 with the SEC related to a proposed merger agreement with Z Squared Inc. [1][2] - The Form S-4 includes a preliminary proxy statement/prospectus regarding the proposed transaction, which has not yet become effective [2] Technology Division - Coeptis has established a Technology Division aimed at enhancing operational capabilities through advanced technologies, including AI-powered marketing software and robotic process automation tools acquired from NexGenAI Solutions Group [5] Z Squared Overview - Z Squared Inc. is focused on digital asset compute mining, primarily generating Dogecoin (DOGE) and other digital assets like Litecoin, with a market cap of $20 billion [7]

Core Insights - Cellectar Biosciences has signed a multi-year supply agreement with Nusano for iodine-125 and actinium-225, essential for its clinical studies and future commercial needs [1][2] - This partnership is crucial for advancing Cellectar's targeted radiotherapy programs, including CLR-125 for triple-negative breast cancer and CLR-225 for pancreatic cancer [2][5] - Nusano's next-generation production facility in Utah will produce these isotopes, addressing supply chain challenges and enabling innovation in cancer treatment [2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4] - The company's product pipeline includes iopofosine I-131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [5][6] - Cellectar has received multiple designations from the FDA for its products, including Breakthrough Therapy Designation and Orphan Drug Designation [6] Industry Context - Nusano aims to stabilize the supply of medical radioisotopes, which are critically undersupplied in the market, and to support innovation across multiple industries [3] - The partnership between Cellectar and Nusano highlights the growing importance of reliable access to high-quality radioisotopes for advancing cancer therapies [2][3]

Core Viewpoint - HOPE Therapeutics, Inc. has signed a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, LLC, a leading Interventional Psychiatry clinic in Florida, which is expected to enhance HOPE's clinical care capabilities in the region [1][2][8]. Company Overview - HOPE Therapeutics, Inc. is a subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics to provide treatments for suicidal depression and related disorders [8][9]. - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD [6]. Acquisition Details - The acquisition of Cohen is anticipated to be immediately accretive to revenue and EBITDA for HOPE Therapeutics [8]. - The transaction is subject to the execution of definitive documents and standard closing requirements, with further details to be disclosed later [5]. Cohen and Associates - Cohen and Associates, founded by Dr. Rebecca Cohen, is recognized for its comprehensive treatment options for suicidal depression, PTSD, and other CNS disorders, including ketamine and Transcranial Magnetic Stimulation (TMS) [2][3]. - Dr. Rebecca Cohen is an expert in mood and anxiety disorders, with a strong academic background and recognition in the field of TMS [3]. Leadership Statements - The leadership of HOPE Therapeutics expressed enthusiasm about the acquisition, highlighting Dr. Cohen's experience and commitment to patient care as a perfect fit for the company's mission [4][5].

The American Academy of Dermatology (AAD) provided evidence-based recommendation for the use of ZORYVE® (roflumilast) cream 0.15% in adults with mild to moderate atopic dermatitis (AD)Recommendation reflects ZORYVE’s proven efficacy, safety, and tolerability as a next-generation, steroid-free, topical phosphodiesterase-4 (PDE4) inhibitorAmong newly evaluated branded topical therapies, ZORYVE is the only treatment with a strong recommendation for adults with mild to moderate atopic dermatitis in AAD’s focuse ...

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the study for GRI-0621, indicating no safety concerns in the reviewed data [1][3] - Interim results show GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated, with no adverse events related to hyperlipidemia [3][4] - The company expects to report 6-week interim biomarker data in July 2025, with topline results anticipated in Q3 2025 [5] Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][7] - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [2][7] - The ongoing Phase 2a study is randomized, double-blind, and placebo-controlled, enrolling approximately 36 subjects with idiopathic pulmonary fibrosis (IPF) [4][5] Study Details - The Phase 2a study evaluates GRI-0621 at a dose of 4.5mg orally once daily for 12 weeks, with a primary endpoint focused on safety and tolerability [4][5] - Secondary endpoints include changes in serum biomarkers at weeks 6 and 12, pharmacokinetics assessment, and pharmacodynamic activity of GRI-0621 [4][5] - The study also includes a sub-study examining NKT cell activity in bronchoalveolar lavage fluid [4]

Core Insights - Lipocine Inc. has initiated a pivotal Phase 3 clinical trial for LPCN 1154, an oral treatment for postpartum depression (PPD), with the first patient dosed [1][3] - The trial aims to support a New Drug Application (NDA) submission in mid-2026, following FDA feedback that allows for an outpatient study without medical monitoring [2][5] - LPCN 1154 is designed to provide rapid relief for PPD, addressing a significant unmet medical need in the treatment landscape [5][6] Company Overview - Lipocine is a biopharmaceutical company focused on developing innovative products with effective oral delivery, targeting large markets with significant unmet medical needs [9][10] - The company has multiple drug candidates in development, including LPCN 2101 for refractory epilepsy and LPCN 2203 for essential tremor, alongside LPCN 1154 for PPD [10] Clinical Trial Details - The Phase 3 trial is a two-arm, randomized, blinded study involving women aged 15 and older with severe PPD, assessing the efficacy of LPCN 1154 compared to a placebo [3][4] - The primary endpoint is the change in the Hamilton Depression Rating Scale (HAM-D), with secondary endpoints including the Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Rating Scale (HAM-A) [4] Market Context - Postpartum depression is a major depressive disorder that can affect 20-40% of obstetric patients, with traditional antidepressants having slow onset and side effects [7] - LPCN 1154 aims to offer a differentiated treatment option with a 48-hour dosing regimen, potentially becoming the standard of care for PPD [5][6]

Core Insights - ZyVersa Therapeutics, Inc. has initiated patient recruitment for its VAR 200 Phase 2a clinical study targeting diabetic kidney disease (DKD) [1][2] - VAR 200 is designed to address renal lipotoxicity by removing excess lipids from the kidneys, which is a significant factor in the progression of kidney diseases [3][7] - The study aims to evaluate the efficacy and safety of VAR 200 in patients with type 2 diabetes and DKD, with preliminary data expected in the second half of 2025 [7] Company Overview - ZyVersa is a clinical stage specialty biopharmaceutical company focused on developing first-in-class drugs for renal and inflammatory diseases with significant unmet medical needs [8] - The company is advancing a therapeutic pipeline that includes VAR 200 and another program targeting inflammation [8] Clinical Study Details - The VAR 200 Phase 2a trial will be an open-label study conducted at one to two US sites, enrolling an adequate number of subjects to complete eight [2][7] - The primary efficacy endpoint is the percent change from baseline to week 12 in urinary albumin to creatinine ratio, with treatment lasting 12 weeks followed by a four-week follow-up [2][7] Drug Mechanism and Indications - VAR 200, a Cholesterol Efflux Mediator™, is an injectable drug that aims to reduce renal lipid accumulation, which damages the kidney's filtration system [3][5] - Preclinical studies have shown that VAR 200 can reduce cholesterol and lipid levels, protect against renal injury and fibrosis, and improve proteinuria in various kidney disease models [4][7] Future Prospects - The lead indication for VAR 200 is focal segmental glomerulosclerosis (FSGS), with plans to expand indications based on the results of the ongoing trials [5][7] - The initiation of patient recruitment is considered a key milestone in the development of VAR 200, with the potential to be a first-in-class treatment for kidney disease [7]