TORONTO, July 08, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., the submission of its patented candidate breakthrough drug, Lucid-21-302 (Lucid-MS), to the Innovative Licensing and Access Pathway (ILAP) Passport program in the United Kingdom (UK). Th ...

MIAMI and JERUSALEM, July 08, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) (“OPKO”) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress, taking place September 13–16, 2025, in Prague, Czech Republic. Abstract Title: First-in-Class Oral GLP-2 Analog for Treatment of Sho ...

Core Viewpoint - ZyVersa Therapeutics, Inc. has received FDA authorization for Emergency Compassionate Use of its investigational drug Cholesterol Efflux Mediator™ VAR 200 for a patient with ApoCII amyloidosis, a condition with no effective treatment options available [1][4]. Group 1: Product Development and Clinical Trials - VAR 200 is currently in phase 2 development aimed at treating renal lipid accumulation, which is critical for protecting kidney function and preventing disease progression [5][8]. - The drug is being administered at the University of Miami under the supervision of Dr. Alessia Fornoni, who is also the inventor of VAR 200 [2]. - Preclinical studies have shown that VAR 200 can reduce cholesterol and lipid levels, protect against renal injury, and improve proteinuria in various kidney disease models [6][8]. Group 2: Company Overview and Future Directions - ZyVersa is focused on developing first-in-class drugs for renal and inflammatory diseases, leveraging proprietary technologies [9]. - The company is advancing a therapeutic pipeline that includes VAR 200 for kidney diseases and another product, Inflammasome ASC Inhibitor IC 100, targeting CNS and peripheral inflammatory diseases [9]. - The lead indication for VAR 200 is orphan kidney disease, specifically focal segmental glomerulosclerosis (FSGS), with ongoing trials expected to provide quicker proof-of-concept [7].

PRINCETON, N.J., July 8, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.Dear Friends and Shareholders,I would like to start by thanking you for your continued support, and hope ...

Core Insights - Crescent Biopharma has appointed Dr. Jan Pinkas as chief scientific officer, bringing over two decades of experience in oncology drug development [1][2] - The company is advancing its portfolio of next-generation therapeutics for solid tumors, with plans to initiate a global Phase 1 trial for CR-001 in early 2026 and an IND submission for CR-002 in mid-2026 [2][5] Company Overview - Crescent Biopharma aims to build a leading oncology company focused on developing innovative therapies for cancer patients, including a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates [5] - The company’s pipeline is designed to leverage advancements in cooperative PD-1 x VEGF therapies and next-generation ADCs, targeting both monotherapy and combination treatment opportunities [2][5] Leadership Background - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology, where he established preclinical research for ADC programs [3] - His experience includes significant roles at Magenta Therapeutics and ImmunoGen, where he contributed to the development of approved therapies such as ELAHERE and SARCLISA [3][4]

BEIJING, July 8, 2025 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has entered into a share and warrant purchase agreement (the "Purchase Agreement") with an institutional investor for the issuance and sale of 16,987,542 ordinary shares of the Company, par value U ...

LA JOLLA, Calif., July 8, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced that Rachel Leheny, Ph.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025, at 2:0 ...

Core Insights - Upstream Bio has initiated a Phase 2 clinical trial, VENTURE, to evaluate the efficacy and safety of verekitug in patients with moderate-to-severe COPD, marking the expansion of its global development program into a third indication [1][3] - Verekitug is a novel antibody antagonist targeting the TSLP receptor, which plays a significant role in the inflammatory response associated with allergic and inflammatory diseases [2][6] - The trial aims to assess the annualized rate of moderate or severe COPD exacerbations as the primary endpoint, with secondary endpoints including changes in symptoms and lung function [4] Company Overview - Upstream Bio is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases, particularly severe respiratory disorders [17] - The company is advancing verekitug, the only known monoclonal antibody in clinical development targeting the TSLP receptor, through multiple Phase 2 trials for CRSwNP, severe asthma, and COPD [9][17] - The company aims to address unmet needs in patient populations underserved by current standard treatments [18] Clinical Trial Details - The VENTURE trial is a randomized, double-blind, placebo-controlled study involving approximately 670 adults with moderate-to-severe COPD, with treatment periods ranging from 60 to 108 weeks [3][4] - Participants will receive either verekitug at doses of 100 mg every 12 weeks, 400 mg every 24 weeks, or a placebo [3] - The trial is designed to potentially support regulatory submissions based on the data collected [4] Current Research and Development - Upstream Bio has completed enrollment in separate Phase 2 trials for CRSwNP and severe asthma, with top-line data expected in the third quarter of 2025 and the first quarter of 2026, respectively [5] - Preclinical studies have shown that verekitug effectively inhibits TSLP signaling and demonstrates potential efficacy against various types of inflammation [10][11] Disease Context - COPD is a chronic inflammatory disease that significantly impacts airflow and is associated with high morbidity and mortality, being the fourth leading cause of death globally [12][14] - The prevalence of COPD is projected to increase due to ongoing exposure to risk factors and an aging population [14] - Current treatments for COPD include inhaled steroids and bronchodilators, with biologics emerging as new treatment options [16]

Core Viewpoint - A class action has been filed against Sarepta Therapeutics, Inc. for allegedly misleading investors regarding the safety of its gene therapy drug, ELEVIDYS, during the period from June 22, 2023, to June 24, 2025 [1][2]. Allegations - The complaint alleges that Sarepta failed to disclose significant safety risks associated with ELEVIDYS, including the inability of trial protocols to detect severe side effects and the potential for adverse events to halt recruitment and dosing in clinical trials [2]. - Specific incidents include a patient death reported on March 18, 2025, leading to a stock price drop of $27.81 per share (27.44%) to close at $73.54 [3]. - A second patient death due to acute liver failure was disclosed on June 15, 2025, resulting in a further stock price decline of $15.24 per share (42.12%) to close at $20.91 [3]. - Following an FDA investigation announcement regarding acute liver failure risks on June 24, 2025, Sarepta's stock fell by $1.52 per share (8.01%) to close at $17.46 [4]. Class Action Participation - Shareholders interested in participating as lead plaintiffs must file a motion by August 25, 2025, but can remain absent class members without taking action [5].

Core Insights - Ascendis Pharma A/S announced two oral presentations at ENDO 2025, showcasing data on the safety and efficacy of its treatments for hypoparathyroidism and achondroplasia [1][2] Group 1: Hypoparathyroidism - Dr. Aliya Khan will present data from Week 156 of the Phase 3 PaTHway Trial, highlighting the long-term safety and efficacy of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism [1][2] - The presentation will cover maintenance of serum and urine biochemistries within normal levels and sustained improvement in renal function [1] Group 2: Achondroplasia - Dr. Carlos Bacino will present safety and tolerability data from Week 52 of the pivotal ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia [1][2] - The data is expected to support the transformative potential of the investigational therapy for this rare genetic condition [2] Group 3: Company Overview - Ascendis Pharma is focused on applying its innovative TransCon technology platform to develop therapies that address unmet medical needs [5] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [5]