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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
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 ...
Invivyd Announces Positive Full Phase 1/2 Clinical Data for VYD2311, a Next Generation COVID-19 Monoclonal Antibody for Potential Use as a Non-Vaccine Preventative and for Treatment of Active Infection
Globenewswire· 2025-06-26 11:01
Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observedFollowing a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose route having the longest duration at 76.0 (CI: 68.5 – 90.7) days Comprehensive ...
Altimmune Announces Positive Topline Results from the IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH
Globenewswire· 2025-06-26 11:00
Core Insights - Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), demonstrating significant MASH resolution and weight loss at 24 weeks [2][4][5] Study Results - The Phase 2b trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks [3][10] - In an intent-to-treat (ITT) analysis, MASH resolution without worsening of fibrosis was achieved in 59.1% and 52.1% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 19.1% for placebo (p< 0.0001) [3][7] - Fibrosis improvement without worsening of MASH was observed in 31.8% and 34.5% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, versus 25.9% for placebo [3][7] - Weight loss at 24 weeks was 5.0% for the 1.2 mg group and 6.2% for the 1.8 mg group, compared to 1.0% in the placebo group (p< 0.001) [3][7] - Liver fat reductions of 58.0% and 62.8% were achieved in participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, versus 16.2% in the placebo group (p< 0.001) [7][8] Safety and Tolerability - Pemvidutide demonstrated potentially best-in-class tolerability, with less than 1% treatment discontinuations due to adverse events [2][4] - Adverse events leading to treatment discontinuation were 0.0% and 1.2% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 2.4% in the placebo group [3][7] Future Outlook - The company anticipates a successful End of Phase 2 meeting with the FDA in the fourth quarter of 2025, enabling rapid progression to Phase 3 [5][4] - The ongoing IMPACT trial is expected to provide a final readout in the fourth quarter of 2025 [10]
CRISPR Therapeutics Reports Positive Additional Phase 1 Data for CTX310™ Targeting ANGPTL3 and Provides Update on In Vivo Cardiovascular Pipeline
Globenewswire· 2025-06-26 11:00
Core Insights - CRISPR Therapeutics announced new Phase 1 clinical data for CTX310™, showing dose-dependent reductions in triglycerides (TG) by up to 82% and low-density lipoprotein (LDL) by up to 86%, with a favorable safety profile [1][5] - Complete Phase 1 data for CTX310 is expected to be presented at a medical meeting in the second half of 2025 [1][2] - Data update for CTX320™, targeting the LPA gene, is anticipated in the first half of 2026 [1][2] - The preclinical program CTX340™, targeting refractory hypertension, is advancing towards IND/CTA filings [1][7] Company Updates - CRISPR Therapeutics is focused on executing strategic priorities and advancing its innovative therapy portfolio [2] - The ongoing Phase 1 clinical trial for CTX310 reinforces the potential of the platform to transform treatment for serious cardiovascular diseases [2] - CTX310 targets ANGPTL3, a gene associated with regulating LDL and TG levels, addressing a significant unmet medical need for over 40 million patients in the U.S. [5][8] Clinical Trials - CTX310 is in a Phase 1 trial involving patients with various conditions, including homozygous familial hypercholesterolemia and severe hypertriglyceridemia, with eligibility based on specific TG and LDL-C levels [5][8] - The trial has shown promising results with peak reductions in TG and LDL, maintaining a safety profile consistent with previous findings [5] - CTX320 is also in a Phase 1 trial, focusing on patients with elevated lipoprotein(a) [Lp(a)], a risk factor for major adverse cardiovascular events [5][8] Research and Development - CRISPR Therapeutics has established a proprietary lipid nanoparticle platform for delivering CRISPR/Cas9 to the liver, enhancing its in vivo portfolio [8] - The company is advancing additional candidates, including CTX340 for refractory hypertension and CTX450™ for acute hepatic porphyria [8]
Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Globenewswire· 2025-06-26 10:55
Study met its primary and key secondary endpoints, demonstrating rapid and sustained improvement in near visual acuitySafety profile consistent with previous clinical trials and no treatment-related serious adverse events reported in the studyNo evidence of tachyphylaxis was observed in this study over the 6-week periodManagement to Host Webcast and Conference Call Today at 8:00 A.M. ET RESEARCH TRIANGLE PARK, N.C., June 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopha ...