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 ...

Core Insights - Invivyd, Inc. announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate aimed at preventing and treating COVID-19 [1] - VYD2311 is structurally 99%+ identical to previous antibodies and is designed to enhance potency and resistance against SARS-CoV-2 variants [2][10] - The Phase 1/2 study demonstrated that VYD2311 was well tolerated with mild to moderate adverse events and a long half-life, suggesting potential for long-term protection [4][5] Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies to combat serious viral infectious diseases, starting with SARS-CoV-2 [18] - The company utilizes a proprietary technology platform to create antibodies that can adapt to viral evolution [18] Clinical Trial Details - The Phase 1/2 study involved 40 subjects and tested various routes of administration (IV, IM, SC) and doses to maximize flexibility for future registrational pathways [3] - VYD2311 showed a half-life ranging from 61 days (IV) to 76 days (IM), significantly longer than pemivibart's 49 days [5] Safety and Efficacy - All adverse events reported were mild to moderate, with no serious adverse events linked to the study drug [4] - The modeling analysis indicated that VYD2311 could provide robust protection against symptomatic COVID-19, potentially surpassing vaccine efficacy [8][10] Regulatory Plans - Invivyd plans to engage with the FDA in early Q3 2025 to discuss registration pathways for VYD2311 and subsequent COVID-19 mAbs [6][8] - The company aims to provide non-vaccine mediated protection for vulnerable populations, including the elderly and immunocompromised individuals [8][10]

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]

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]

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 ...

Core Insights - Edgewise Therapeutics has reported positive results from its sevasemten program for Becker and Duchenne muscular dystrophies, demonstrating sustained disease stabilization and a clear path to potential registration as the first therapy for Becker [1][3]. Group 1: Becker Muscular Dystrophy - The MESA trial data showed that 99% of eligible participants (n=85) are enrolled, with significant improvements in North Star Ambulatory Assessment (NSAA) scores, indicating sustained disease stabilization over 18 months [2]. - Participants from the CANYON trial who transitioned to MESA exhibited an average NSAA score improvement of 0.8 points from baseline, while those on placebo showed a 0.2 point improvement after starting sevasemten [2]. - The FDA has provided a clear path for sevasemten registration, emphasizing the importance of NSAA as a clinically meaningful endpoint for traditional approval [3]. Group 2: Duchenne Muscular Dystrophy - Encouraging topline data from Phase 2 trials (LYNX and FOX) indicate that sevasemten is well-tolerated and shows potential for reducing functional decline at a target dose of 10 mg [4][6]. - The LYNX trial focuses on four- to nine-year-old participants, while the FOX trial involves six- to fourteen-year-old participants previously treated with gene therapy, both assessing safety and biomarkers of muscle damage [5][6]. - The company plans to meet with the FDA in Q4 2025 to discuss Phase 3 design, aiming to initiate the pivotal study in 2026 [7]. Group 3: Company Overview - Edgewise Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for muscular dystrophies and cardiac conditions, with sevasemten being a first-in-class fast skeletal myosin inhibitor [9][12]. - The company has achieved significant regulatory milestones, including FDA Orphan Drug Designation and Fast Track designations for both Becker and Duchenne [9]. - Edgewise is dedicated to changing the lives of patients affected by serious muscle diseases, with a strong emphasis on innovative therapeutic solutions [12].

Core Viewpoint - Altimmune, Inc. is set to present topline data from its IMPACT Phase 2b trial evaluating pemvidutide for treating metabolic dysfunction-associated steatohepatitis (MASH) on June 26, 2025 [1][2]. Group 1: Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [5]. - The company's lead program, pemvidutide, is a GLP-1/glucagon dual receptor agonist aimed at treating MASH, obesity, Alcohol Use Disorder (AUD), and Alcohol-associated Liver Disease (ALD) [5]. Group 2: IMPACT Study Details - The IMPACT trial enrolled 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at doses of 1.2 mg and 1.8 mg or placebo for 24 weeks [3]. - Key efficacy endpoints include MASH resolution or fibrosis improvement at 24 weeks, with secondary endpoints focusing on weight loss and non-invasive tests [3]. - A total of 48 weeks of treatment is planned, with final readout expected in Q4 2025 [3]. Group 3: Pemvidutide Characteristics - Pemvidutide is an investigational peptide-based dual receptor agonist that mimics the effects of diet and exercise on weight loss, suppressing appetite and increasing energy expenditure [4]. - Clinical trials have shown significant MASH resolution, liver fibrosis improvement, and weight loss, along with reductions in liver fat content, triglycerides, LDL cholesterol, and blood pressure [4]. - The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, with ongoing trials for AUD and ALD [4].