NORCROSS, Ga., July 09, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension, announced today it entered into a new $10 million unsecured line of credit facility with Richard E. Uihlein, Chairman of Galectin Board of Directors, and its largest individual stockholder. “Belapectin has the potential to address a significant unmet med ...

Core Viewpoint - ProKidney Corp. is actively engaging with investors through participation in the H.C. Wainwright 4 Annual Kidney Virtual Conference, highlighting its focus on chronic kidney disease and its innovative cellular therapy approach [1]. Company Overview - ProKidney Corp. is a pioneer in chronic kidney disease treatment through cellular therapy innovations, founded in 2015 after a decade of research [2]. - The company's lead product candidate, rilparencel (REACT), is a first-in-class autologous cellular therapy currently in Phase 2 and Phase 3 studies aimed at preserving kidney function in diabetic patients at high risk of kidney failure [2]. - Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating its potential significance in the treatment landscape [2].

Core Insights - BriaCell Therapeutics Corp. announced the sustained complete resolution of lung metastasis in a patient with hormone receptor-positive, HER2-negative metastatic breast cancer treated with Bria-OTS, a personalized off-the-shelf immunotherapy [1][2]. Group 1: Clinical Results - The first patient in the Bria-OTS study, a 78-year-old woman with advanced disease and multiple prior treatment failures, achieved 100% resolution of a lung metastasis after four doses of Bria-OTS monotherapy, confirmed at two, four, and six months [2][3]. - The patient has received a total of 12 cycles of Bria-OTS to date, with no treatment-limiting toxicities observed [6]. Group 2: Expert Commentary - Dr. Neal S. Chawla, Principal Investigator for the Bria-OTS study, highlighted the strong single-agent activity in a challenging patient population and expressed eagerness to explore this approach across more patient subtypes and tumors [5]. - Dr. William V. Williams, BriaCell's President and CEO, emphasized the remarkable and durable clinical response, particularly at the lowest dose level, and indicated plans to evaluate Bria-OTS in combination with a checkpoint inhibitor to enhance outcomes for patients with advanced breast cancer [5]. Group 3: About Bria-OTS - Bria-OTS is a next-generation, off-the-shelf personalized immunotherapy based on BriaCell's lead candidate, Bria-IMT, currently in a Phase 1/2a study for metastatic recurrent breast cancer, which includes both monotherapy dose escalation and combination dose expansion cohorts [7].

Core Insights - Rezolute, Inc. is focused on treating hypoglycemia caused by hyperinsulinism and has announced a late-breaking presentation at ENDO 2025 regarding its Phase 3 study of ersodetug [1][2] Group 1: Study Details - The Phase 3 sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ersodetug in patients aged 3 months to 45 years with congenital hyperinsulinism [3] - The study aims to enroll approximately 56 participants across more than a dozen countries, including the U.S., and has completed enrollment [4] - Key efficacy endpoints include the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia over six months of treatment [4] Group 2: Drug Information - Ersodetug is a fully human IgG2 monoclonal antibody that binds allosterically to the insulin receptor, aiming to decrease receptor over-activation and improve hypoglycemia [5] - The drug has shown substantial benefit in clinical trials and real-world use for treating both congenital and tumor-related hyperinsulinism [7] Group 3: Medical Context - Congenital hyperinsulinism is the most common cause of recurrent hypoglycemia in children, often presenting within the first month of life and can lead to severe complications if not managed properly [6] - More than half of children with congenital hyperinsulinism require long-term medical treatment for hypoglycemia that is not adequately addressed by existing therapies [6]

Core Points - John Houston, Ph.D., plans to retire as CEO of Arvinas after a successor is appointed, but will remain as Chairperson of the Board [1][2] - The Board of Directors is actively searching for a new CEO to ensure continued strong leadership [2] - Dr. Houston has been pivotal in advancing Arvinas' PROTAC programs, including the first positive pivotal Phase 3 trial [3][4] Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing targeted protein degradation therapies [5] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer and ARV-393 for non-Hodgkin lymphoma [5]

Core Viewpoint - Krystal Biotech, Inc. has initiated its Phase 1/2 clinical trial, EMERALD-1, for KB801, a redosable eye drop gene therapy aimed at treating neurotrophic keratitis (NK), a rare degenerative corneal disease [1][2][3] Company Overview - Krystal Biotech, Inc. is a global biotechnology company focused on developing genetic medicines for diseases with high unmet medical needs, with its first commercial product being VYJUVEK, the first redosable gene therapy approved by the FDA and EMA [8] Clinical Trial Details - The EMERALD-1 trial is a randomized, double-masked, multicenter, placebo-controlled study involving up to 27 adults with Stage 2 or Stage 3 NK, where participants will receive either KB801 or a placebo twice weekly for 8 weeks [3][4] - The primary objective of the trial is to evaluate the safety and tolerability of KB801, while the secondary objective focuses on the efficacy measured by the proportion of patients achieving complete durable healing of corneal epithelium at 8 weeks [4] Product Information - KB801 is designed to enable sustained expression of nerve growth factor (NGF) in the front of the eye, potentially reducing the treatment burden for NK patients compared to current therapies that require frequent administration [6] - The estimated prevalence of NK is between 10 to 50 cases per 100,000, with claims data indicating a significant increase in awareness and diagnosis rates in the U.S., from 31,000 patients in 2020 to approximately 68,000 in 2024, representing an increase of over 115% [2][6]

RESEARCH TRIANGLE PARK, N.C., July 09, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present new findings from patient-focused research highlighting the burden of current treatments for HAE on pediatric patients under the age of 12 and their caregivers and perspectives on the importance of HAE treatments. The findings will be presented in posters at the 2025 US HAEA National Summit in Baltimore, which is taking place July 10-13, 2025. “For more ...

Core Viewpoint - Maravai LifeSciences Holdings, Inc. is under investigation for potential claims related to a class action complaint alleging breaches of fiduciary duties by its board of directors during a specified class period [1] Financial Reporting Issues - On February 25, 2025, Maravai announced a postponement of its fiscal 2024 earnings release and the filing of its annual report due to an error in revenue recognition, which resulted in approximately $3.9 million being incorrectly recorded [2] - The company identified a material weakness in its internal controls over revenue recognition and required additional time to assess a potential non-cash impairment charge related to goodwill from its acquisition of Alphazyme LLC [2] Class Action Allegations - The class action complaint alleges that Maravai's executives made materially false and misleading statements and failed to disclose adverse facts about the company's operations and financial reporting [3] - Specific allegations include inadequate internal controls over financial reporting, inaccurate revenue recognition, overstated goodwill, and misleading positive statements about the company's business prospects [3]

Company Overview - ProKidney shares surged 515% to close at $3.73, contrasting with declines in the S&P 500 and Dow Jones Industrial Average [1] - The company specializes in chronic kidney disease and has recently announced positive topline results from its Phase 2 REGEN-007 clinical trial for its autologous cell therapy, rilparencel [2] Market Context - The stock exhibited significant volatility, trading between $0.46 and $4.86 before stabilizing near the upper range [2] - Competitors in the sector, such as FibroGen and Vertex Pharmaceuticals, also experienced gains, indicating a broader enthusiasm for kidney-related innovations [3] Technology and Innovation - ProKidney's proprietary React technology platform is gaining attention as the RMCL-002 trial progresses, highlighting its focus on cellular regeneration rather than traditional pharmaceutical interventions [4]

Group 1 - The article does not provide any specific company or industry analysis, focusing instead on the author's qualifications and disclosures [1][2][3]