Novartis AG’s blockbuster drug Cosentyx failed in a late-stage trial for treating blood vessel inflammation, a setback to the company’s efforts to broaden its uses https://t.co/3StOAgtgqw ...

In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and biological endpoints. Treatment with XPro™ was well-tolerated and safe, eve ...

Company in full compliance for continued listingMIRAMAR, Fla., June 26, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, announced today that it has received notice from The Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that it has regained compliance with the ...

Core Insights - Kodiak Sciences Inc. is presenting KSI-101, a bispecific investigational biologic targeting macular edema secondary to inflammation, at the 2025 Congress of the International Ocular Inflammation Society in Rio de Janeiro [1][6] - The company aims to address the significant unmet need in treating macular edema caused by inflammation, which can lead to vision loss [3][4] Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on developing therapeutics for retinal diseases, utilizing its ABC Platform for innovative drug design [8][9] - The company is advancing its pipeline, which includes three late-phase clinical assets expected to deliver Phase 3 topline data in 2026 [9] Product Details - KSI-101 is a high-strength (100 mg/mL) bispecific protein designed to target both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), addressing the dual mechanisms of macular edema [6][5] - The ongoing Phase 1b study, APEX, is evaluating the safety and tolerability of KSI-101, with plans to progress into dual Phase 2b/3 studies [7]

CARSON CITY, Nev., June 24, 2025 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson’s disease will be presented in poster session at the upcoming Adv ...

Cincinnati Children’s Hospital Medical Center Discusses QUELIMMUNE Therapy Adoption A Father and Patient Describe Their Real-Life Experience with the QUELIMMUNE Therapy DENVER, June 24, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today that the QUELIMMUNE therapy will be featured in a two-part video series that will be ...

June 24, 2025 7:00 AM EDT | Source: InMed Pharmaceuticals Vancouver, British Columbia--(Newsfile Corp. - June 24, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced new preclinical data demonstrating that INM-901 significantly reduces inflammation in ex vivo models of neuroinflammation, further supporting its potential a ...

Key Takeaways Sanofi's Dupixent is now approved by the FDA for treating bullous pemphigoid in U.S. adults. The approval is backed by phase II/III data showing better remission and reduced steroid use. Dupixent's expanding label reinforces its role in treating type II inflammation-driven diseases.Sanofi (SNY) and its partner, Regeneron (REGN) , announced that the FDA has approved their blockbuster medicine, Dupixent (dupilumab), for the treatment of adult patients with bullous pemphigoid (BP), a rare skin ...

Core Insights - The FDA has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP), a rare skin disease affecting approximately 27,000 adults in the U.S. [1][6] - Dupixent is now approved for eight distinct diseases related to type 2 inflammation, demonstrating its broad therapeutic potential [1][12]. Group 1: Approval and Clinical Data - The approval is based on pivotal results from the ADEPT Phase 2/3 trial, which showed significant improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo [1][5][7]. - In the trial, 18.3% of patients experienced sustained disease remission compared to 6.1% in the placebo group, indicating a 12.2% difference [5]. - Additionally, 38.3% of patients achieved clinically meaningful itch reduction compared to 10.5% in the placebo group [5]. Group 2: Patient Impact and Treatment Paradigm - Dupixent offers a novel treatment approach for elderly patients suffering from BP, who previously had limited therapeutic options [3][4]. - The drug targets two central drivers of type 2 inflammation, potentially allowing patients to achieve sustained remission and reduce itch [4][10]. - The approval reinforces Dupixent's safety profile across a broad age range, from infants to the elderly, and across various diseases [3][10]. Group 3: Regulatory and Market Context - The FDA evaluated Dupixent under Priority Review, indicating its potential for significant improvements in treating serious conditions [6]. - Dupixent has received regulatory approvals in over 60 countries for various indications, with more than 1,000,000 patients treated globally [12][29]. - The drug was previously granted Orphan Drug Designation by the FDA for BP, highlighting its importance in treating rare diseases [6].

Core Insights - Dupixent (dupilumab) has demonstrated superiority over Xolair (omalizumab) in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in patients with coexisting asthma, as evidenced by the EVEREST phase 4 study results presented at the EAACI Annual Congress [1][4][6] Study Overview - The EVEREST study involved 360 adults with severe, uncontrolled CRSwNP and coexisting asthma, randomized to receive either Dupixent 300 mg every two weeks or omalizumab based on weight and IgE levels [2][6] - Both treatments were administered alongside mometasone furoate nasal spray [2] Efficacy Results - Dupixent showed a 1.60-point superior reduction in nasal polyp size (p<0.00011) and an 8.0-point superior improvement in the ability to identify different smells (p<0.00011) compared to omalizumab [5] - Other significant improvements included a 0.58-point reduction in nasal congestion (p<0.00011), a 1.74-point reduction in symptom severity (p<0.00011), and a 12.7-point difference in health-related quality of life (p<0.00012) [5] - Asthma-related endpoints also favored Dupixent, with a 150 mL difference in lung function (pre-bronchodilator FEV1; p=0.0032) and a 0.48-point difference in asthma control (p<0.00012) [5] Safety Profile - The safety results were consistent with the known profiles of both medications, with adverse events reported in 64% of Dupixent patients and 67% of omalizumab patients [3][4] - Serious adverse events occurred in 2% of Dupixent patients and 4% of omalizumab patients, while discontinuation due to adverse events was reported in 3% and 1% respectively [3][4] Mechanism of Action - Dupixent targets interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of type 2 inflammation, reinforcing its efficacy in treating both upper and lower respiratory diseases [4][8] Regulatory Status - Dupixent has received regulatory approvals in over 60 countries for various indications, including CRSwNP, asthma, and other allergic conditions, with more than one million patients currently treated globally [9][10]