Aug. 14, 2025 -- Halda Therapeutics, a clinical-stage biotechnology company developing a novel class of therapies called RIPTAC™ Therapeutics, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to HLD-0915, the company’s lead development candidate, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). “We are pleased HLD-0915 has been granted Fast Track designation by FDA for patients with mCRPC,” said Christian

Echocardiographic data analysis demonstrated favorable impact of atrioventricular interval modulation (“AVIM”) therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failure with preserved ejection fraction (“HFpEF”) Hypertension is the leading cause of diastolic dysfunction and the most common comorbidity in older patients indicated for a pacemaker Aug. 14, 2025 -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “

Aug. 15, 2025 -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it reported stockholders’ equity of $3 million and therefore satisfied Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”), as of June 30, 2025. The Equity Rule requires listed companies to maintain a minimum of $2.5 million in stockholders’ eq

Patient visits are now complete in the final cohort of Phase 1b trial, consisting of Parkinson’s disease patients receiving 300 mg doses of HER-096 or placebo twice weekly over a four-week period Primary objective is to assess the safety, tolerability and pharmacokinetics of repeated subcutaneous doses of HER-096; the trial will also evaluate selected biomarkers, and aims to identify novel treatment response biomarkers and monitor symptoms associated with Parkinson’s disease Topline Phase 1b r

Aug. 15, 2025 -- Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received U.S. FDA clearance. While the initial focus is on treating aplastic anemia, a rare orphan indication, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in markets poised for significant growth. Regen sees substantial potential in t

First-in-human study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102, an orally available small molecule with potential best-in-class profile Initial development planned in obesity; BGE-102 demonstrated robust weight loss in preclinical models, both as monotherapy and in combination with GLP-1 receptor agonists Initial Phase 1 SAD data anticipated by end of 2025, with top-line readout of obesity study by end of 2026 Aug. 15, 2025 -- BioAge Labs, Inc. (Nasdaq:

Breakthrough Protein Phosphatase 2A inhibitor LB-100 Targets Ovarian Clear Cell Carcinoma, Advanced Soft Tissue Sarcoma, and MSS Metastatic Colon Cancer 24/7 Market News Issues Corrected Information on Previously issued Press Release with same title Aug. 14, 2025 -- 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, spotlights LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage pharmaceutical com

Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at EULAR 2025 Additional orphan designation underscores Sanofi commitment to advancing new medicines in immune-mediated rare diseases August 14, 2025. The European Medicines Agency has granted orphan designation to rilzabrutinib, a reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for IgG4

Aug. 14, 2025 -- 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, spotlights LIXTE Biotechnology Holdings (Nasdaq: LIXT), a clinical-stage pharmaceutical company focused on developing novel cancer therapies by targeting the epigenetic modulation of key cellular pathways. 2025 is shaping up to be a defining year for LIXTE. With a focus on its lead compound LB-100, a first-in-class small molecule inhibitor of pr

Webinar to Review Results from Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Allocetra™ in Patients with Moderate to Severe Knee Osteoarthritis Aug. 14, 2025 -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced it will host a webinar on Monday, August 18, 2025, at 8:00 AM Eastern Time to present and discuss 3-month topline results from the Phase IIa stage of its Phase I/IIa EN