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Cellectar Biosciences and U.S.-based Nusano Enter Into Multi-Isotope Supply Agreement
Globenewswire· 2025-06-26 12:05
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]
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Agreement to Acquire Interest in Cohen and Associates, LLC for HOPE's Network of Interventional Psychiatry Clinics
Prnewswire· 2025-06-26 12:03
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].
Arcutis' ZORYVE® (roflumilast) Cream 0.15% Receives Strong Recommendation in American Academy of Dermatology Updated Guidelines for Adult Atopic Dermatitis
Globenewswire· 2025-06-26 12:00
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 ...
GRI Bio’s GRI-0621 Demonstrates Encouraging Safety Results at Planned Interim 6-Week Analysis in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)
Globenewswire· 2025-06-26 12:00
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]
Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression
Prnewswire· 2025-06-26 12:00
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]
ZyVersa Therapeutics Announces First Clinical Site Activation, Initiating Patient Recruitment for Cholesterol Efflux Mediator™ VAR 200's Phase 2a Clinical Trial in Patients with Diabetic Kidney Disease (DKD)
Globenewswire· 2025-06-26 11:55
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]
HCW Biologics Regains Compliance with Nasdaq Capital Market Requirements
Globenewswire· 2025-06-26 11:55
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].
Quantum BioPharma Licensee Unbuzzd Wellness Inc. Launches $5 Million Reg D Capital Raise to Fund Growth and Path to Possible Initial Public Offering
Globenewswire· 2025-06-26 11:30
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]
Quantum BioPharma Licensee Unbuzzd Wellness Inc. Launches $5 Million Reg D Capital Raise to Fund Growth and Path to Possible Initial Public Offering
GlobeNewswire News Room· 2025-06-26 11:30
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]
BridgeBio to Host Limb-girdle Muscular Dystrophy Type 2I/R9 Investor Webinar on Friday, July 11th at 8:00 am ET
Globenewswire· 2025-06-26 11:30
Core Insights - BridgeBio Pharma, Inc. is hosting an investor webinar on July 11, 2025, focusing on limb-girdle muscular dystrophy (LGMD) and its unmet needs [1][2] - Dr. Matthew Wicklund will present on LGMD, particularly LGMD2I/R9, and discuss the disease burden and standard of care [2] - The webinar will also cover the progress of BBP-418 and expectations for the Phase 3 interim analysis results in the second half of 2025 [3] Company Overview - BridgeBio Pharma is a biopharmaceutical company established to develop transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [5] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient treatment [5]