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]

Core Viewpoint - HCW Biologics Inc. has regained compliance with Nasdaq's listing requirements, ensuring its continued presence on the Nasdaq Capital Market [1][2]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [3]. - The company aims to improve healthspan and quality of life by addressing age-related and senescence-associated diseases through its proprietary drug platforms [3]. Compliance Details - On June 24, 2025, HCW Biologics received formal notice from Nasdaq confirming compliance with the minimum stockholders' equity requirement [2]. - The company had previously regained compliance with other Nasdaq requirements, including bid price, public float, and market value of publicly held shares [2]. Product Development - The lead product candidate, HCW9302, was developed using the TOBI™ platform, while the TRBC platform allows for the creation of various immunotherapeutic compounds [3]. - The TRBC platform has produced over 50 molecules, with ongoing preclinical evaluations for selected candidates based on early promising data [3].

Core Insights - Quantum BioPharma Ltd. has engaged MZ Digital and Dealmaker to raise up to US$5 million through a Regulation D 506(c) offering for Unbuzzd Wellness Inc., which produces a beverage that accelerates alcohol metabolism and reduces hangover symptoms [1][2] Company Overview - Quantum BioPharma is focused on developing innovative biopharmaceutical solutions for neurodegenerative and metabolic disorders, including alcohol misuse disorders [3] - Unbuzzd Wellness Inc. is a public issuer that offers a scientifically backed beverage designed to help alcohol consumers manage their consumption and recovery [5] Product Details - Unbuzzd is a proprietary blend of vitamins, minerals, and herbs that aids in faster alcohol metabolism, restores mental clarity, and improves cognition [5] - Clinical trials have shown that unbuzzd reduces blood alcohol concentration (BAC) by over 40% faster within 30 minutes compared to control subjects, with significant improvements in alertness and reduced hangover symptoms [6][7][14] Financial Aspects - Quantum BioPharma retains a 20.11% ownership stake in Unbuzzd Wellness Inc. and is entitled to 7% royalty payments on sales until reaching $250 million, after which the royalty rate drops to 3% [3]

Core Viewpoint - Quantum BioPharma Ltd. announces that Unbuzzd Wellness Inc. is raising up to US$5 million through a Regulation D 506(c) offering to support its expansion plans for the unbuzzd™ beverage, which accelerates alcohol metabolism and reduces hangover symptoms [1][2][3] Company Overview - Quantum BioPharma is focused on developing innovative biopharmaceutical solutions for neurodegenerative and metabolic disorders, including alcohol misuse disorders [3] - The company retains a 20.11% ownership stake in Unbuzzd Wellness Inc. and is entitled to 7% royalty payments on unbuzzd™ sales until reaching $250 million, after which the royalty rate drops to 3% [3] Product Details - Unbuzzd™ is a scientifically-backed beverage designed to help alcohol consumers process alcohol faster, restore mental clarity, and alleviate hangover symptoms [5][6] - Clinical trials show that unbuzzd accelerates alcohol metabolism, reducing blood alcohol concentration (BAC) by over 40% faster within 30 minutes compared to control subjects [6][13] - Participants reported significant improvements in alertness and reductions in hangover symptoms, including a 67% reduction in headache severity at four hours post-consumption [13] Leadership and Strategy - John Duffy, CEO of Unbuzzd, emphasizes the commitment to providing a scientifically backed product to alcohol consumers and the importance of the capital raise for expansion [2] - Gerry David, Board Co-Chair, highlights that the capital raise will support company growth and position unbuzzd for a potential initial public offering [3]

PALO ALTO, Calif., June 26, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced the Company will host an investor webinar on Friday, July 11, 2025 at 8:00 am ET with Matthew Wicklund, M.D., FAAN, Professor of Neurology and Vice Chair for Research, Department of Neurology at the University of Texas (UT) Health Science Center San Antonio. Dr. Wicklund will provide an overview of limb ...